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Lupine Publishers|The Effect of Body Mass Index on Components Size in Patients With Total Knee Replacement

Abstract

Introduction: Nowadays, one of the most common practices in orthopedic surgery is the Total Knee Arthroplasty. Logistic equipment, including prostheses, is the cornerstone of this surgical procedure. Clearly having a general overview of the size of consumable prostheses, the surgeons will act more confidently.

Materials and Method: This descriptive-analytic study employed a census method based on the inclusion criteria of the medical records of all patients who underwent knee replacement surgery in Besat Hospital of Hamedan in 1395 (2016-17) in terms of body mass index, age, gender, and size of tibial and femoral components. Data were analyzed by SPSS software version 16.

Results: A total of 214 patients were included: 21.5% male and 78.5% female. The mean age of patients was 67.95 years, and the mean body mass index was 27.98 kg/m2. As for the assessment of the size of components, most tibial components were of medium size (49.5%) and femoral components were of small size (65.9%). It was seen that there was an inverse correlation between tibial component and body mass index (BMI), and a direct and significant correlation between tibial component and height and weight in terms age and gender (p<0.05). Nevertheless, the correlation between femoral component and weight was statistically significant only at ages under 65 years and it was indirect (p=0.02).

Conclusion: Determining factors of the size of components used in joint replacement surgery include body mass index (BMI), weight and height of the patients for tibial surgeries, and weight of the patients for femoral ones.

Keywords: Body mass index (BMI); tibial component; femoral component

Abbreviations: OA: Osteoarthritis; BMI: body mass index; TKA: Total knee arthroplasty

Introduction

gradually causes various deformities in knee joint and makes it painful while walking. It also disrupts skeletal alignment and increases the risk of Osteo arthritisfalling and fractures. The disease usually affects both limbs and this mutuality can exacerbate functional disorders [8]. Osteoarthritis causes major health and social problems in the elderly and brings a heavy economic burden on the health and social welfare system [9]. Progression of the disease in this weight-bearing joint leads to significant disability and reduced functional capacity in a wide range of daily activities. The main causes of this functional decline in the patients are weakness of the quadriceps muscle, deep-seated perturbation and poor stability [10,11,12]. Common therapies for reducing pain and improving patients’ function include lifestyle changes and daily habits, rehab Rehabilitation and medicine therapy [13]. Patients with symptoms of pain, joint instability, reduced range of motion and deformity, and lack of response to conservative treatment need to have a surgery, which may include knee joint replacement. In spite of reducing the patients’ pain and improving the quality of their life, this surgery is a costly process with relatively high complications. Therefore, accurate preoperative planning for reducing costs and probable complications is so important for these patients. The planning procedure includes the preparation of medicine, equipment and operating room. Logistic equipment, including prostheses, is the cornerstone of this surgical procedure. Clearly having a general overview of the size of consumable prostheses, the surgeons will act more confidently. Since the results of various studies regarding body mass index, component size and surgical complications are controversial and sufficient studies have not been done in this field, this study aimed to examine the effect of BMI on the size of components used in patients undergoing knee joint replacement surgery.

Method

This descriptive-analytic study examined all patients suffering from severe knee joint osteoarthritis who had came to the orthopedic clinic and after clinical examination, had undergone arthroplasty surgery. The required data for patients’ medical records and surgical description were extracted and recorded in the checklist. Preoperative data, including preoperative examinations, lateral and patellar radiographies, and lower limb alignment were documented. Preoperative counseling was done and its information was recorded. In the alignment graph, the angle between the mechanical axis of femur and tibia was measured. The BMI of the patients after recording height and weight was calculated using SPSS software. The patients transferred to the operating room and received anesthetic injections. Their consciuosness was assessed and the size of tibial and femoral component used for them was measured by the the classic anterior midline approach after incising tibia and femur. Finally, the joint replacement was completed using a cement prosthesis (ZIMMER, NEXGEN LPS, WARSAW, US), and the day after surgery, patients were prepared for recovery and discharged with appropriate equipment. The common size of the femoral component used for patients was 8. To facilitate the analysis, the sizes 1 to 3 were classified in the small group, the sizes 4 and 5 in the medium group and the sizes 6 to 8 in the large group. Moreover, body mass index (BMI) was classified in very fat (35≤), fat (34.9-30), normal (24.9-20), and thin (20>), based on the WHO standard categorization. Then, the relationship between BMI and size of measurements was measured using statistical analysis. The inclusion criteria of the study were all patients with severe knee joint osteoarthritis who were candidates for joint replacement surgery, along with their satisfaction for participation in the study, and exclusion criteria were the incompleteness of the data recorded in the case, the patients’ discontent and their unwillingness to co operatation.

Statistical analysis

The collected data were entered into computer and analyzed using SPSS version 16.0 statistical software. Quantitative data were described using mean and standard deviation; qualitative data were described in the form of tables, charts and frequency ratios. In the analytical section, Pearson correlation coefficient (PCC) was used to determine the correlation between quantitative variables and the size of tibial and femoral components; Spearman’s correlation coefficient was used to determine the correlation between ranked variables and the size of tibial and femoral components. The significance level in this study was considered as 0.05.

Results

Descriptive data of the 214 patients examined in the study are as follows

In terms of gender, the highest frequency belongs to the female group of 168 (78.5%) and the frequency of male group is 46 (21.5%). In terms of age, mean age of the participants of this study was 67.95 years. The minimum age was 32 years and maximum age was 94 years. The most frequent ages among patients undergoing knee joint replacement surgery was 60 to 69 years (46.26%). As for BMI of the patients undergoing knee joint replacement surgery, the mean body mass index was 27.89 kg/m2 (range 17.58-44 kg/ m2; standard deviation 4.49 kg/m2). The highest frequency was in the overweight group (25-29.9) (Table 1).

In terms of component size frequency, most tibial components were of medium size (49.5%) and most femoral components were of small size (65.9%). For used tibial components (small-mediumlarge) classified by various categories of BMI, no statistically significant rank correlation was observed between the size of used tibial component and BMI (P=0.097). According to the results of one way ANOVA test, a statistically significant difference was observed between the mean BMI and the size of used tibial component (P=0.005). The results of Tukey follow-up test showed that the mean BMI in small component (P=0.006) and in medium component (P=0.013) were significantly more than the mean BMI in large component (Table2).

Table 2: Comparison of mean BMI in terms of the type of used tibial component.

For used femoral components (small-medium-large) classified by various categories of BMI, no statistically significant rank correlation was observed between the size of used femoral component and BMI (P=0.570) (Table3).

According to the results of one way ANOVA test, no statistically significant difference was observed between the mean BMI and the size of femoral component (P=0.156). As for the relation between the size of tibial and femoral component and weight in terms of gender and age, a direct and significant was observed between tibial component and weight in terms age and gender (p<0.05). Nevertheless, the correlation between femoral component and weight was statistically significant only at ages under 65 years (p=0.02) (Table 4).

Moreover, for the relation between the size of tibial and femoral component and height in terms of gender and age, a direct and significant was observed between tibial component and heightin terms age and gender (p<0.05). Nevertheless, the correlation between femoral component and height was not statistically significant (p<0.05) (Table 5).

Discussion

Knee joint is one of the main joints of human body which is usually affected by various progressive degenerative and inflammatory diseases, which ultimately lead to the destruction of articular cartilage (arthrodial cartilage) and its dysfunction [1]. Nowadays, knee joint replacement arthroplasty is a helpful method for the patients with severe knee joint In this study, there was no statistically significant difference between mean BMI and the size of femoral component. Also, the correlation between femoral component with height was not statistically significant. There was an inverse correlation between the size of tibial component and BMI and a significant correlation between the size of tibial component and height and weight in terms of gender and age. There was no statistically significant correlation between the size of femoral component and BMI and height, but a significant and direct correlation was observed between the size of the femoral component and weight at the age under 65 years. According toa study by Sershon et al. about the effect of body mass index on the accuracy of measuring the size of components (templating), there was no significant relation between between body mass index and measuring the size of femur acetabular components [14]. Similarly, this study didn’t find any statistically significant relation between body mass index and the size of femoral component. However, there was a statistically significant and direct correlation between the size of the femoral component and weight at the age under 65 years. The results of one-year research of Stickles et al. on patients with knee joint surgery showed that in terms of postoperative satisfaction, there was no difference between the obese and non-obese patients [15]. Another study by Collins et al. in 2012 regarding the effect of obesity on the need for re-surgery and patient’s satisfaction after knee replacement, revealed that 9 months after the surgery, obese (BMI>30) and non-obese patients’ level of satisfaction was good. There was no need to re-surgery among two groups, however obese patients showed a lower functional performance scores than non-obese patients [16]. Jackson et al. conducted a study in 2009 which followed535 patients for 9 years. The results showed that obese patients had lower functional performance scores than non-obese patients [17]. Two different studies conducted by Nunes et al. examined the effective factors on the final outcome of Total knee arthroplasty (TKA) during 3 years and 7 years follow-up respectively [18,19]. McElroy et al. developed a structured review in 2013 and their patients were followed up for at least 5 years. The results showed that BMI>30 had lower functional performance scores and lower complications and only few of them used partial prosthesis [20]. A study by Isa et al. in 2013 found that obesity had no significant effect on TKA outcomes. In this study, 210 of 174 patients were obese. According to the gained results, obese patients showed more complications than non-obese patients (10.5% vs. 3.8%). In terms of other outcomes, there was no significant difference between the two groups [21].This study, in contrary to the mentioned studies, didn’t examine the realtion between patients’ body mass index and their postoperative satisfaction. Nevertheless, there was a statistically significant correlation between body mass index and the size of tibial component. The fact that the mean body mass index has an inverse correlation with the size of tibial component but a significant and direct correlation with the height, is probably due to its inverse correlation with the square of the height, that is, the higher the height, the smaller will be the body mass index. However, as mentioned by previous studies, the body mass index not only determines the size of tibial component, it is also a variable predictor of the long-term result of tibia and femur joint replacement surgery. Those with a higher mass body index are more likely to give pressure to the prosthesis and feel more pain and discomfort. In result, they are more likely to have need to re-surgery.

Conclusion

In patients undergoing knee joint replacement surgery, BMI and height don’t affect the size of femoral component, but at ages under 65 year, size of this component increases with weigh gain. Size of tibial component has an inverse correlation with the mean body mass index (BMI) and has a direct correlation with height and weight. Moreover, the results of this study showed that the increase in BMI is predominantly due to an increase in body fat mass.

Declarations

Ethics approval and consent to participate The study was conducted under the auspices of the ethical board of Hamadan University of Medical Sciences and registered with the number IR. 1396.286 in the Research Ethics Committee of the University of Medical Sciences.

Acknowledgements

There was no conflict of interest by any of the authors including financial and personal relationships with other people or organizations that inappropriately influenced this study.There has been no financial support with the project.

Limitations of the study

This study examines the results of just one health center. It is likely that the patients who have not visited this center would be different from those who participated in the study. It is recommended to conduct a similar study with a larger sample.

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Lupine Publishers| Oral Manifestations of Covid-19 In Children and Adults

Abstract

COVID-19 has caused a pandemic and it still going quite strong. This disease has many general or constitutional manifestations, among which oral manifestations can also be present. These manifestations are often non-specific and can occur in any viral infections as well. Hence, they have to be recognized distinctly by the dentist as well as Laboratory personnel. So here we have tried to collect available data regarding this, in the form of a review.

Keywords: COVID-19; Oral; aphthous; tongue

Introduction

Novel Coronavirus infections have caused a pandemic. Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), the agent, is a single‐chain RNA virus that is the cause of novel coronavirus disease known as COVID‐19. The most common clinical symptoms seen are fever, headache, sore throat, shortness of breath, dry cough, abdominal pain, vomiting, and diarrhea(1). At the start of the COVID‐19 pandemic, it was assumed that lack of oral involvement is a distinguishing feature of COVID‐19 exanthema as compared to other viral exanthems. But recently, SARS‐CoV‐2 has been detected from saliva of the patients and it has been shown that reverse transcriptase‐polymerase chain reaction (RT‐PCR) from saliva can be a more sensitive test in comparison with nasopharyngeal swab testing [1]. Also, now many newer manifestations are reported in these infections, and oral lesions are also commonly seen.

Materials and Methods

Thorough scientific literature search was done to collate available information regarding this.

Oral lesions and COVID-19 infection

Oral manifestations of COVID-19 include ulcers, erosion, bullae, vesicles, pustule, fissured or depapillated tongue, macule, papule, plaque, pigmentation, halitosis, whitish areas, haemorrhagic crusts, necrosis, petechiae, swelling, erythema, and spontaneous bleeding. The most common sites of involvement in descending order are tongue (about 38%), labial mucosa (about 26%), and palate (about 22%)(1). Oral lesions are nearly equally found in both genders (49% female and 51% male). Patients with older age and higher severity of COVID-19 disease have more widespread and sever oral lesions. Lack of oral hygiene, opportunistic infections, stress, immunosuppression, vasculitis, and hyper-inflammatory response secondary to COVID-19 are the most important predisposing factors for onset of oral lesions in COVID-19 patients [1]. Other types of lesions are also found, like lesions on the tongue, palate, and commissure compatible with pseudomembranous candidiasis and angular cheilitis [2]. In another study, gustatory or taste impairment was the most common oral manifestation, with a prevalence of 45% [3]. The pooled eligible data in this study, for different taste disorders were 38% for dysgeusia and 35% for hypogeusia, while ageusia had a prevalence of 24%. Oral mucosal lesions presented multiple clinical aspects, including white and erythematous plaques, irregular ulcers, small blisters, petechiae, and desquamative gingivitis. Tongue, palate, lips, gingiva, and buccal mucosa were affected. In mild cases, oral mucosal lesions developed before or at the same time as the initial respiratory symptoms; however, in those who required medication and hospitalization, the lesions developed approximately seven to 24 days after onset symptoms [3].

How and why oral lesions appear in COVID-19

Latest research shows that Coronavirus invades human cells via the receptor angiotensin-converting enzyme 2 (ACE2) as seen by scRNA-seq data analysis [4]. The study identified the organs that are at risk and are vulnerable to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, like lungs(4). So, cells with high ACE2 receptor distribution can become host cells for the virus and cause inflammatory response in related organs and tissues, like the tongue mucosa and salivary glands [4]. SARS-CoV-2 interaction with ACE2 receptors may also impair taste bud sensitivity, which could induce dysfunctional gustatory responses [4]. As regards other oral lesions seen in CIVOID-19 like unspecific oral ulcerations, desquamative gingivitis, petechiae, and coinfections such as candidiasis, however, it is still unclear whether these manifestations could be a typically clinical pattern resulting from the direct SARS-CoV-2 infection or a systemic consequence, given the possibility of coinfections, impaired immune system, and adverse reactions of medical treatment [4].

More about the loss of taste

Firstly, the peripheral nervous system is affected by the new coronavirus, and as gustatory buds are innervated by cranial nerves, related functions may be impaired, resulting in taste disorders [4]. Secondly, SARS-CoV-2 may bind essential salivary mucin components, such as sialic acid, consequently accelerating taste particle degradation and disturbing gustatory sensation [4,5]. Furthermore, ACE2 high expression was demonstrated in the taste buds of rats and was associated with angiotensin II production in mice taste buds. These findings might also point to the inability of ACE2 to break down this protein during COVID-19 infection, resulting in the erratic taste responses [4]. Overall, the global prevalence of taste disorders in patients with COVID-19 is 45%. Researchers have also found with some degree of evidence that taste disorders are associated with COVID-19 positivity, mild/ moderate severity of disease and female gender.

Other lesions

Other lesions like irregular ulcers are also sometimes observed on dorsum of tongue ion some patients, which could be explained by vasculitis that occurs in COVID-19 infection [6].

Clinical dilemma in children

Although much is still unknown about the full-fledged effects of COVID-19, literature from the early stages of the COVID-19 pandemic (spring and summer 2020) shows a post-viral immunologic reaction resulting in a multisystem inflammatory syndrome in children (MIS-C) [7]. The case definition of MIS-C according to the Centers for Disease Control and Prevention (CDC) is a patient lesser than 21 years of age with fever, laboratory evidence of inflammation, and clinical evidence of severe illness requiring hospitalization, including involvement of 2 or more organ systems. These patients also should be positive for SARS-CoV-2 infection, confirmed either by reverse transcription polymerase chain reaction (RT-PCR), serology, or antigen testing, and should not have any other imminent cause of their symptoms [7]. Interestingly, oral mucous membrane changes also appear to be an important finding in MIS-C(7).It can be confused with Kawasaki disease, which can present in children with Strawberry tongue [7]. The intraoral findings in a child affected by the disease are usually nonspecific which can be due to the milder form of COVID-19 in children [8]. There is not much literature yet available that delineate the intraoral findings in a COVID positive child. Paediatric dentists should therefore be vigilant while examining COVID positive children due to the paucity in information [8]. Also, children are generally asymptomatic carriers of COVID-19, and so universal precautions should always be followed by pedodontists [9]. Many dental treatments are aerosol generating procedures (AGPs), which have been associated with the transmission of acute respiratory infections. In addition, dental settings are more likely to have a high number of potentially contaminated surfaces such as dental chairs, their handles, the spittoon, and dental instruments after carrying out a treatment which are possible routes of transmission. SARS‐CoV‐2 virus can survive well on surfaces for up to 72 hours, and all clinic surfaces should hence be disinfected by chemicals recommended for eliminating SARS‐CoV‐2 [9].

Diagnostic challenges

Other viral diseases can also cause mucosal lesions in mouth cavity or enanthems, like Chikungunya which causes Aphthous-like ulcers and oral lesions similar to Koplik’s spots(10). Dengue fever can produce Gingival bleeding and gingival and lip swelling(10). In Ebola virus infection, there can be Gingival bleeding, white or red patches, aphthous-like ulcers and greyish exudative lesions [10,11]. Even in mild infections like Hand, foot and mouth disease caused by Echoviruses and Coxsackie virus types A and B, painful ulcers can be encountered in oral cavity(12). Hence these have to be kept in mind while detecting oral lesions of COVID-19.

Use of Imaging

Imaging, especially MRI, can help in detecting Parotitis as cited by some researchers, since this also occurs commonly in children having COVID-19 [13].

Newer avenues

Tele dentistry can also be used effectively in the COVID-19 pandemic to minimize patient-doctor physical contact. Tele dentistry (a part of telehealth along with telemedicine) is the remote facilitating of dental care, guidance, education or treatment through the use of information technology rather than through direct faceto- face contact with any patient(14). The techniques comprise Teleconsultation that reduces referrals, Telediagnosis using Mobile Mouth Screening Anywhere (MeMoSA) and Whatsapp, Teletriage for management and Telemonitoring [14]. However, both dentists and patients should be comfortable with these new techniques and give consent also for these.

Discussion

Enanthema can develop in various types of viral diseases including dengue fever disease, Ebola virus disease, herpangina, human herpes virus (HHV) infections, measles, and roseola infantum [1]. Infectious diseases, especially of viral etiology, constitute approximately 88% of causes of enanthema. Different types of enanthema , like aphthous‐like ulcers, Koplik’s spots, Nagayama’s spot, petechiae, papulovesicular, or maculopapular lesions, white or red patches, gingival and lip swelling have been reported with various viral infections. Both keratinized (hard palate, gingiva, and dorsum of tongue) and non-keratinized (labial and buccal) mucosae can be affected [1,6]. Covid-19 has a huge range of clinical manifestations and due to the high number of patients involved, the diagnosis is often based on clinical findings or suspicions [6]. Thus, proper suspicion can help in picking up the cases actively and effectively. Diagnosis can be aided by Radiology and tele technology. Clinicians need to be especially vigilant in children regarding this.

Conclusion

Hence COVID-19 can cause many oral and mucosal lesions that have to be correctly identified. Proper clinical suspicion might be present, and dentists must try to exclude COVID-19 infection whenever unexplained ulcers or loss of taste are seen along with other constitutional symptoms. Children with COVID-19 have nonspecific or minimal symptoms or can have oral lesion as part of multi-system, disorders, and hence clinicians should be alert

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Lupine Publishers|An Efficient Protocol for the One Pot Synthesis of Pyranopyrazoles in Aqueous Medium using Triethanolamine as a Catalyst

Abstract

Triethanolamine is an efficient and green catalyst for the synthesis of 6-amino-1, 4-dihydro-4-substituted-3-methylpyrano-[2, 3-c] pyrazole-5-carbonitrile in aqueous medium reflux conditions. The procedure is easier, eco friendly, simple with easy workup affording good yield of the corresponding products.

Keywords: Multi component reaction, Water media, Pyranopyrazole, Catalyst, Triethanolamine

Introduction

The present scenario for organic synthesis indicates the crave for green and economical synthesis of organic compounds. One of it is multi component synthesis. Strecker’s synthesis for amino acids was the first report on multi component reaction [1]. Last few decades show large development in it. The main aim of such reactions is to fasten the reaction rate by reducing number of steps involved and eventually increase the yield of reaction. In this context to achieve great efficiency catalysts are employed. Catalysts such as Nano α-Al2O3 supported ammonium dihydrogenphosphate [2], tungstate sulfuric acid [3], Fe3-xTixO4@SO3H nanoparticles [4], nano-titania sulfuric acid (15-nm TSA) [5], nanostructured MgO [6], H14[NAP5W30O110] [7] and ZnO Nanoparticles [8].

Organic catalysts such as Triethylamine [9] DABCO [10], Trishydroxymethyl aminomethane [11] are also reported in various organic transformations. Triethanolamine contains basic tertiary amine and primary alcoholic part (Figure 1).

It is used for activation of both CO2 and epoxides to convert them in to cyclic carbonates [12]. It is also reported as a legend for copper catalyzed hydroxylation of aryl halides in aqueous medium [13]. It is used as aqueous solvent for controllable preparation of ZnO nano flowers in sol gel technique [14]. Its aqueous solution is reported as electrolyte in CO2 Photo electro-conversion catalyzed by Cu- Doped Graphene-Titania Catalyst [15]. Also it is found to increase the rate of oxidation of mesitylene catalyzed by cobalt bromide [16]. It is used as sacrificial electron donor in photocatalytic system [17]. Furthermore; it improved the catalytic performance of CuBr/ PMDETA in the atom transfer radical polymerization [18]. It is also used as phase transfer catalyst for synthesis of 1-(arylsulfonyl) aryl/heterylmethanes [19]. It is used as medium for synthesis of 3-substituted coumarins using L-proline as a catalyst [20]. It is reported as catalyst in 10 mol% for synthesis of 2-amino-3-cyano- 4H-pyran derivatives under ultrasound irradiation at 600C [21].

Synthesis of substituted pyrano-[2,3-d]-pyrimidines via one-pot three-component condensation of aromatic aldehydes, malononitrile and barbituric acid or 2-thiobarbituric acid using trace amounts of ionic liquid (choline chloride.ZnCl2) and triethanolamine (0.1Mol%) at 75°C with stirring and under ultrasound irradiation [22] is also reported in literature. Herein we successfully attempted a fast and simple protocol for the synthesis of 6-amino-1,4-dihydro-4-substituted-3-methylpyrano [2,3-c]- pyrazole-5-carbonitrile by the one pot three component reaction of aromatic aldehyde, malononitrile and 3-methyl-1H-pyrazol-5(4H)- one using triethanolamine as a catalyst [23].

Results and Discussion

To explore the synthetic application of triethanolamine, in the present work we report the catalytic facet of it for the synthesis of heterocyclic compounds bearing pyrazole skeleton. To optimize the reaction conditions, we chose anisaldehyde as the prototype. Initially, 10mol% of triethanolamine was taken for solvent free reaction at room temperature. But the reaction afforded a low yield of the product after 2 hour stirring. Then we used 10ml of water for room temperature stirring [24]. After 2 hours stirring it gave 62% of yield. The yield of reaction gets drastically changed on increasing temperature. At 900C we got 85% of yield of the product. When 20mol% of triethanolamine was used then we got 92% of yield at 900C in 10 ml water. Other solvents were also studied expecting better yield but other than ethanol and water we got poor yields (Table 1). Further increase of temperature and amount of triethanolamine did not improve yield significantly (Table 1). After optimizing the reaction conditions, differently substituted aldehydes with electron donating as well as electron withdrawing groups were reacted to examine the feasibility of this catalytic reaction (Scheme 1).

Almost all aldehydes bearing various substituents such as –Cl, F, -NO2, -OMe etc afforded good yield of the corresponding products. All the synthesized compounds showed sharp peaks at 3410, 3356cm- 1(-NH2) and 2190cm-1(-CN) in IR spectra which supports for the formation of pyranopyrazole. The formed products being insoluble in water were easy to separate from the aqueous medium by simple filtration. The reason for catalytic activity of triethanolamine is it’s solubility in aqueous medium and basic nature. Products are simply purified by re crystallization with ethanol. Thus the protocol described herein is efficient for the synthesis of pyrazopyrazoles which do not need purification by column chromatography.

Model reaction* for anisaldehyde (2mmol), malononitrile (2mmol) and 3-methyl-1H-pyrazol-5(4H)-one (2mmol) using the above cited conditions @Isolated yield.

Experimental

Melting points were recorded in open capillaries and were uncorrected. Progress of reaction was monitored by TLC (30% of ethyl acetate: n-hexane). IR spectra were taken by KBr disc on Shimadzu IR Affinity 1 spectrophotometer [1]. H NMR spectra were recorded on a Varian 400MHz spectrophotometer in the specified solvents. Chemical shifts were expressed in 𝛿ppm relative to TMS. Mass spectra were recorded on a Macro mass spectrometer (Waters) by electro spray method (ES).

General method for the synthesis of 6-amino-1, 4-dihydro- 4-substituted-3-methylpyrano-[2,3-C]-pyrazole- 5-carbonitrile

To a stirred mixture of aromatic aldehyde (2mmol), malononitrile (2mmol) and triethanolamine (20mol %) in 10ml of water, 3-methyl-1H-pyrazol-5(4H)-one (2mmol) was added. The resulting mixture was stirred and heated at 900C for appropriate reaction time (Table 2). After completion of reaction, the reaction mixture was cooled, filtered off the residue as the crude product which was further purified by re crystallization form ethanol (Scheme 2).

Representative Spectral Data

6-Amino-1,4-dihydro-4-(4-methoxyphenyl)-3-methylpyrano[ 2,3-c]pyrazole-5-carbonitrile (4a)

White solid, [1]H NMR (400 MHz, DMSO-d6): 𝛿 ppm 12.08 (s, 1H), 6.87-7.23 (m, 4H), 6.81 (bs, 2H), 4.45 (s, 1H), 3.78 (s, 3H), 1.81 (s, 3H); IR (KBr) cm-1: 3425, 3128, 2928, 2200, 1597, 1153, 1203; ES-MS m/z: 283.2 (M+1)+.

6-Amino-2,4-dihydro-3-methyl-4-phenylpyrano[2,3-c] pyrazole- 5-carbonitrile (4e)

White solid, M.P. 245-246 0C; 1H NMR (400 MHz, DMSO-d6) : 𝛿 ppm 12.10 (s, 1H), 7.10-7.40 (m, 5H), 6.85 (s, bs, 2H), 4.60 (s, 1H), 1.78 (s, 3H); IR (KBr) cm−1 : 3410, 3356, 3167, 2990, 1646, 1596, 1399, 1276, 870; ES-MS m/z: 253 (M + 1) +.

6 - A m i n o - 4 - ( 4 - c h l o r o p h e n y l ) - 3 - m e t h y l - 2 , 4 - dihydropyrano[2,3-c]pyrazole-5-carbonitrile (4g)

Off-white solid, M.P. 230-2320C; 1H NMR (400 MHz, DMSO-d6): 𝛿 ppm 12.15 (s, 1H), 7.10–7.40 (m, 4H), 6.95 (s, bs, 2H), 4.63 (s, 1H), 1.80 (s, 3H); IR (KBr) cm−1 : 3478, 3035, 2985, 2193, 1647, 1596, 1398, 1284, 870; ES-MS m/z: 287 (M + 1) +.

6-Amino-4-(4-N, N-dimethylaminophenyl)-3-methyl-2, 4-dihydropyrano[2, 3-c]pyrazole-5-carbonitrile (4j)

Yellow solid, M.P. 234-235 0C; 1H NMR (400 MHz, DMSO-d6): 𝛿 ppm 12.10 (s, 1H), 6.70-7.15 (m, 4H); 6.55 (s, bs, 2H), 4.40 (s, 1H); 2.85 (s, 6H), 1.78 (s, 3H); IR (KBr) cm−1 : 3385, 3172, 2957, 2189, 1644, 1601, 1397, 1279, 868; ES-MS m/z: 296 (M + 1) +.

Conclusion

In summary, we have developed an efficient protocol for the synthesis of pyranopyrazoles by a simple method using a catalytic amount of triethanol amine. Herein; not only the yield of reaction is improved but also the reaction time is reduced. The workup of the reaction is very simple which make it easier to isolate the product.

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Lupine Publishers|Ethical Haressment in ICU Workplaces

Abstract

The aim of this study was to determine to what extent, healthcare practitioners in ICU worry about Workplace bullying (WPB) and whether it affects the quality of care and patient safety from their perception. The behaviors of individuals as well as some elements of their personality emerge the phenomenon and contribute to it becoming more intense. Interventions, therefore, aim to change perceptions, attitudes, and behaviors, i.e. the way in which individuals perceive and approach their work. They should also aim to educate individuals so that they respect the personality and accept the diversity of their colleagues, resist manipulation, respect themselves and dare to do self-criticism. For this reason, it should investigate the reasons that cause it in a workplace and review those characteristics of the organization’s functioning that directly or indirectly favor its existence. Researches have highlighted the positive effects of replacing authoritarian management and regular confrontation with employees with a form of management based on the principles of cooperation, meritocracy, and practical interest in the needs of individuals and the team as a whole. The intervention of competent bodies in the ICU and in every professional sector of the hospital is considered necessary to address the problem, as individual solutions usually lead to the victim’s submission or removal or leaving the perpetrator in the workplace and the continuation of unacceptable behavior of. Such solutions succeed in protecting the victim but fail in the administration of justice.

Abbreviations: Health care workers; regression model; working conditions; workplace bullying

Review Article

Workplace bullying (WPB) is a physical or emotional harm that may negatively affect health care services. The term ‘moral harassment’ is considered an old phenomenon that occurs in all societies. Moral harassment is found both in everyday life, but also in the workplace. But what do we mean by moral harassment? There is no clear and commonly accepted definition among researchers of moral harassment internationally. The phenomenon has been approached internationally by countries with different cultural characteristics but also by various scientific disciplines such as psychology, work psychology, sociology, law, etc. However, researchers, regardless of their country and industry, agree that they refer to the same phenomenon and attribute common features to it [1]. Moral harassment is referred to as the attempt to mentally exterminate the other with words, with nods, with implication, without the use of physical force [2]. According to Hirigoyen, some perversions are so common and every day that they are considered the norm. The beginning is made with a simple lack of respect, a lie, or an exploitation. All this is considered unbearable only when they harm us immediately. Later, if the scientific team to which the specific behaviors are applied does not react, the behaviors gradually turn into proven perverts, with serious consequences for the mental health of the victims. Fearing that no one will hear them, the victims are silent and suffering. Thus, the phenomenon remains hidden and the perpetrator is perceived as the master of the medical team, with the result that his manipulations are done in a special way that allows them to be interpreted as a form of conflict or power within the ICU. But in order to better understand the moral harassment or otherwise perverse violence in the ICU, we need to keep in mind that for this to happen there may be an emotional lack of people involved or even an over-intimacy. Thus, excessive intimacy causes fear, with the result that the most intimate people become the object that will suffer the most violence. In this case, the perpetrator perceives this professionalinterpersonal relationship as particularly close and therefore suffocating, so he tries to keep the other person in a relationship of dependence or property in order to be able to maintain his self-control and omnipotence. On the other hand, the victim is overwhelmed by guilt feelings and doubts, so he stays there without reacting. Such a situation does not have to occur from the beginning, but usually occurs in times of crisis where the perpetrator cannot take responsibility for a difficult choice or decision. Thus, due to the perpetrator’s complete refusal to accept the choice, a reaction begins that resembles a persecuting delusion against the victim, usually existing [3]. The other side enters a state of intense stress, experiencing intense anger, but also shame after enduring humiliation feeling unable to react. In such cases, Hirigoyen [3] suggests that victims should remain calm, not doubt themselves and ignore the attacks they receive. Ethical harassment in the workplace has preoccupied researchers and the phenomenon is referred to by the term “mobbing” which means to attack. One of the first researchers to address ethical harassment in the workplace is Leymann, who refers to the phenomenon as psychological violence perpetrated by an individual or group of individuals, against an individual or group of individuals. It is expressed through a chain of unethical behaviors which, while seemingly unrelated to each other, are in fact all part of a strategy of intimidation, humiliation and weakening of the goal. In other words, what happens in interpersonal relationships also happens with the difference that the phenomenon can occur because there is prejudice due to gender, age, physical disability, origin, religious or political beliefs. In addition, the attitude of an employee may be different from that of others, so his conscientiousness, consistency and formality may be taken as a threat as this can “erase” the work environment from long-established and convenient tactics [4]. According to research, moral harassment in the workplace occurs suddenly and unexpectedly and the victim is shocked when he realizes where he is and as a result this experience becomes even more traumatic. This is likely to lead to social stigma, due to the fact that the individual feels exposed to the work environment as it has now become the focus of discussions between colleagues. This increases the chances of a victim to identify socially with the concept of victim and thus be characterized as a weak personality. In addition, according to Toukas, Deliha and Karageorgiou [4], the phenomenon of mobbing as a form of psychological harassment in the workplace, is characterized as a syndrome with specific clinical symptoms, which can be psychosomatic type to be expressed as physical symptoms, psycho-emotional type (anxiety, phobias, uncontrollable aggression) and behavioral type such as problems related to addictive behaviors. Imagine the effects of the phenomenon on ICU staff and the devastating consequences it can have on the team and medical decisions. The important thing is to be able to recognize what is happening and try to avoid the trap that will keep one stuck and passive recipient of such a perverted attack on one’s person. We must recognize our own personal limits, strengths and weaknesses so that in the possibility of our exposure to such a phenomenon we can remain steadfast, defend its position and not forget that ‘the fact that there are some cases of micro-paranoid who favored to appear as victims, does not mean that there are no real victims of harassment ‘Hirigoyen [3]. The paradox is that some people who, from their position, are responsible for dealing with such phenomena, in the area of their responsibility, not only do not support the person who suffers the aggressive behavior, but also participate themselves, strengthening the unethical process. By doing so, they endanger not only the safety and professional interests of the employee, but also the ICU itself, whether in the private or public sector.

Categories of Moral Harassment

Moral harassment according to the origin and direction of psychological violence is classified into the following two main categories.

From Director to incumbent or downhill harassment

It is considered by researchers to be the most common form. It involves the abuse of power, in the sense of overstepping one’s authority and arbitrary conduct contrary to the rule of law. The reasons that can cause this form of harassment are varied. Many times, a Chief adopts such a tactic, because of the feeling of inadequacy he has and his fear of losing “control”. Often an insecure boss can feel “threatened” by the presence in the ICU of an employee who is very capable and efficient or has higher formal qualifications than himself. It is also common for a Director who demands “blind submission” to target a person who, as a person, does not comply with this requirement and does not accept authoritarian behavior. It is “The ability of the worker to resist power, despite the pressures that make him a target” [3]. In cases where the harassment is perpetrated by a boss or a person with a strong personality, it is often observed that people under his influence who want to be liked or are afraid of his anger, in case they openly disagree with him. Under these circumstances, the target is under even greater psychological pressure and feels even weaker, as he lacks support from his colleagues [3].

Peer-to-peer or horizontal harassment

Moral harassment between colleagues can be due to the denial of difference, to the envy of someone who has something that others do not have, to personal dislikes, extreme conflicts, competitions, etc. [5,6] Many times, the target is a group of people, usually small. In cases where there is a conflict of interest between groups, offensive tactics are initially reciprocal and continue to be so, until one side is weakened and the other takes the lead in power. It is observed that the phenomenon of moral harassment, especially in highly competitive and closed areas such as the ICU, is contagious, as its appearance triggers the dark side of the character of people who have not shown such behavioral patterns in the past. When this pathological interaction is consolidated, a vicious circle of situations is created and the crisis generalizes, the consequences for individuals and for the company can be disastrous, if one does not intervene to stop it [3].

Consequences of moral harassment

The exponential course of moral harassment in the workplace has serious consequences for employees, their families, patients, the hospital and society as a whole. The symptoms and the effects (physical and psychological) on the health of the “victim” are what differentiate moral harassment from other situations, such as false complaints. Research over more than three decades shows that systematic exposure of workers to situations of moral harassment has devastating consequences for the health and well-being of those exposed. The phenomenon was found to be associated with chronic fatigue, with psychosomatic, psychological, physical problems and problems related to stress and insomnia and wrong medical choices and decisions. In workplaces where, in the long run, conditions of moral harassment prevail, there is a gradual weakening of the medical staff as the intention of employees to leave the ICU is increased. People who are crucial to its operation, because of their knowledge, skills and experience, are more likely to leave it, regardless of whether they have the same harassment goals or know that it is to the detriment of others. This has a particularly negative effect on ICUs and hospitals with reduced staff or difficulty finding qualified staff. Harassment behaviors absorb a large part of the employees’ time and energy on a daily basis, which in a healthy and pleasant working environment would be invested in productive work. The financial cost of having this phenomenon in an ICU is borne by the process of finding and training new employees. This image of the ICU is usually reflected in its public image and plays the role of negative advertising [7]. It is also a slander in the labor market and negatively affects the potential interest of very capable executives to work on it [8].

Impact on employees

Moral harassment is manifested mainly with serious consequences such as increased difficulties of cooperation, reduced resistance to stress, physical discomfort, abuse and psychological reactions. It can cause the employee difficulty sleeping, depression, mania, sometimes intense aggression, physical fatigue or even suicidal tendencies. If the harassment does not stop immediately, the causes that caused it in the workplace are not investigated and the appropriate measures are not taken, there is a risk that the problems become so serious that long-term medical and psychotherapeutic treatment is needed (Salin, 2003). The negative effects on the ICU of the workplace in terms of efficiency and financial impact are also significant, as it has been observed that the level of performance of a worker who is morally harassed can be reduced by 80% in terms of his abilities, his resistances to work stress and his attention. When an employee experiences aggressive behavior, he or she experiences high levels of stress. Until the necessary measures are taken by the management to deal with these behaviors, the stress mechanism is constantly activated, developing intense biological reactions resulting in the manifestation of mental or physical illness that will lead him to absence from safety work. The consequences can vary, depending on the degree to which each employee has experienced aggressive behavior, the duration, and the intensity of the stress they have. Experience, the way he perceives an event as well as his ability to manage the situation. In a survey conducted in Ireland, 40% of respondents said that harassment had a negative effect on their physical health and 43% on their mental health. 26% and 92%, respectively, needed medical and psychiatric treatment, while 20% started taking medication as a result of moral harassment. Research suggests that long-term psychosomatic and mental impairment experienced by workers who have been exposed to moral harassment is likely to affect their ability to work.

some cases, the employee feels so incapable of meeting the requirements of his position that he forms the view that he is incapable of any decisive decision. In particular, in the medical field, there has been a weakness for initiatives or personal interventions, even if they know that it would be right. The personality of the employee is the one that plays a decisive role, not only in the way one experiences moral harassment in the workplace, but also in the way one will react. Studies have shown that some workers become seriously ill after six months of exposure to severe moral harassment, while other workers after several years of exposure. Difficulty finding work, possible defamation from the theta in possible new work environments and fear of unemployment are the main reasons why the employee continues to endure the negative situations his experiences in the workplace, as a result of which he sinks more and more. more in a personal and work quagmire with consequences in his family environment as well as in the outcome of patients.

Impact on Hospitals as organizations

The effects of moral harassment on the health of employees have similar consequences in the Hospital. They affect the efficiency and effectiveness of the medical staff as well as the quality of the services offered [5]. As mentioned above, ethical harassment affects job satisfaction, commitment to the organization, innovation and creativity. Studies show that employees who have been harassed have low job performance and reduced effort, resulting in reduced productivity and quality. Harassment situations have a negative impact on the ICU’s reputation which may lead to a possible reduction in the quality of medical services, a reduction in the overall scientific development of the ICU, staff layoffs and a reduction in the number of new staff. The damage that can be done to an ICU should not be underestimated in the current period of economic crisis. The existence and tolerance, on the part of management - of moral harassment negatively affects its relationship with employees and the way they see it. In these cases, employees’ confidence in the manager and management and their commitment to ICU goals is shaken. In these circumstances, it has been observed that the motivation and the disposition for taking positive initiatives and the search for innovative ideas decrease. Workers often resort to long-term absences and increased use of sick leave in order to escape moral harassment. The experience of moral harassment also has a serious negative impact on the victim’s family, as it transfers the full range of negative emotions, chronic stress and frustration that the victim experiences both from work and from himself. The family experiences the effects of moral harassment on quality of life, health, social life, and economic status almost daily. The effects of moral harassment on the health of employees have similar consequences in the hospital itself. They affect the efficiency and effectiveness of the organization as well as the quality of services offered. As mentioned above, ethical harassment affects job satisfaction, commitment to the organization, innovation and creativity. Studies show that employees who have been harassed have lower job performance and reduced effort, resulting in reduced productivity and quality of health services. Harassment situations have a negative impact on the organization’s reputation which can lead to possible resentment among patients, suppliers, potential sponsors, staff departures as well as reduced attendance of new employees. The damage that can be caused to an organization should not be underestimated in the current period of economic crisis. The existence and tolerance, on the part of management, of moral harassment negatively affects its relationship with employees and the way they view it. In these cases, employees’ confidence in the manager and their commitment to ICU goals is shaken. In these circumstances, it has been observed that the motivation and the disposition for taking positive initiatives and the search for innovative ideas decrease. Workers often resort to long-term absences and increased use of sick leave in order to escape moral harassment.

Dealing with moral harassment

Moral harassment not only damages working relationships, but also offends the dignity of the individual, threatening the safety of his professional life, the safety of patients, his mental and physical integrity. Dejours considers that moral harassment is rarely an individual phenomenon and its deepest causes should be sought in the organization of social relations in the workplace and especially in the methods of administration and management, in the particular culture of the ICU, in the shortcomings of the organization, in the complexity and pace of work. Moral harassment is an effective strategy of “psychological terrorism” deliberately used by some. At the same time, it expresses the anti-peer cunning that aims at the elimination of competition, underlining the stigma of individualism that prevails in the modern medical community. The dramatic increase in harassment requires strategies to combat conflict and malicious moral behavior.

Conclusion

In this light, the activation of managers and directors is crucial, who must be trained to recognize and deal with the phenomenon from the earliest stages or to ensure the awareness and information of subordinates. At the political level, legislation is considered necessary, as it would be the cornerstone of prevention and provide for ways to resolve and restore the dignity and health of victims. Equally imperative is the conduct of extensive research to better understand the parameters of the phenomenon of moral harassment. Dealing with the phenomenon of moral harassment is part of the general framework of prevention and protection of employees from occupational psychosocial risks and requires the consideration of a holistic approach to working conditions. This includes extended and collaborative interventions, encompassing all aspects of problematic situations, both on a personal and organizational level that aim to reduce the intensity of symptoms and eliminate the occurrence of the phenomenon. The behaviors of individuals as well as some elements of their personality emerge the phenomenon and contribute to it becoming more intense. Interventions, therefore, aim to change perceptions, attitudes and behaviors, i.e. the way in which individuals perceive and approach their work. They should also aim to educate individuals so that they respect the personality and accept the diversity of their colleagues, resist manipulation, respect themselves and dare to do selfcriticism. Working conditions play a key role in the development of psychological violence. For this reason, interventions in the workplace should be aimed at preventing and dealing with the phenomenon by modifying the work environment, the organization of work and enhancing the proper functioning of each ICU. Prevention is achieved on the one hand by raising awareness, recognition and knowledge about the phenomenon of moral harassment and on the other hand by reducing the potential risks to the psychosocial work environment. In addition, training managers and directors on workplace crisis and conflict management, conflict resolution, crisis investigation, case analysis, and mediation can reduce or slow down the development of a conflict or stop the occurrence of recurring abusive behaviors. Also, the goal of interventions at this level is to reduce the organic and psychological effects of moral harassment on employees as well as to maintain a safe and healthy work environment in ICU. At the organizational level, the hospital administration has the greatest responsibility, but also the ability to influence the appearance and development of the phenomena of moral harassment in the workplace. For this reason, it should investigate the reasons that cause it in a workplace and review those characteristics of the organization’s functioning that directly or indirectly favor its existence. Researches have highlighted the positive effects of replacing authoritarian management and regular confrontation with employees with a form of management based on the principles of cooperation, meritocracy and practical interest in the needs of individuals and the team as a whole. The intervention of competent bodies in the ICU and in every professional sector of the hospital is considered necessary to address the problem, as individual solutions usually lead to the victim’s submission or removal or leaving the perpetrator in the workplace and the continuation of unacceptable behavior of. Such solutions succeed in protecting the victim but fail in the administration of justice.

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Lupine Publishers| Preventive Measures against Spread of Coronavirus (COVID-19) following the Natural Laws Volume 5 - Issue 1

Opinion

Coronavirus (COVID-19) is at door of every one across the globe. One can ignore the reality, but no one can ignore its consequences. Soil is the major environmental reservoir of many pathogenic viruses. Unfortunately, the soil biodiversity particularly in cities and metropolitan cities is virtually in active as being detached from atmosphere. As reported by many others elsewhere, corona virus develops with a positive single stranded RNA genome. The scientific efforts to trace the means for controlling coronavirus (COVID-19) epidemic are yet in dark. Microbiological interventions through Biotechnological Research throughout the globe are on way. Moreover, the positively charged RNA lining over corona virus indicated a clue to develop an association of such viruses with negatively charges soil clays preferably bentonite or montmorillonite clay at least to slow down their spread. With such fundamental hypothesis, following points maybe brought to readers: Medical reports may accept that bentonite clays being abundantly available in soils across the globe are a natural source to enhance immunity to human body. If such clays in soils are not contaminated or polluted or have no side effect to human health, such clays may be used as clay tablets daily in amount being verified medically. Of course, WHO appreciated many such qualities in bentonite, but no guideline is available on uses of clays in the form of pellets or tablets. Let Medical Association of India and other nations come forward in collaboration with Microbiologists, Biotechnologists and 1. Soil/Clay Mineralogists to observe and execute protocols on clay uses on way to prevent or minimize the danger, if possible. We strongly propose to move to areas of bare soil preferably in bentonite rich soil/bare land, where the danger may be negligible or low. Our observations are based on a few contacts only. Besides, we collected other reports that the intensity and frequency of thunderstorm/lightening is more disastrous in cities/metro cities. Coronavirus (COVID-19) in rural area having bare soils rich in bentonite or montmorillonite clays may not be so disastrous, we presume. It is further to add that the electric discharge during thunderstorm and lightening keep the earth safe against such dangerous coronavirus, but we need validation based on exploratory facts. There is need to understand preference of making clay rich mud house with mud floor to keep one further protected from continuing danger of coronavirus on globe. We also know that clays especially bentonite/montmorillonite is a good detoxifier even to remove toxic ions from human bodies.

We understand that the researchers, health care takers, and policy makers sit together and decide how to move the ways for the safeguard of human life on globe. Let us collect data based on exploratory facts as above for decision. In India, the government took very timely and smart precautions and whole country is behind complete lockdown in order to maintain isolation (social distancing) during 24th March-14th April 2020(21days). However, some group of workers in New Delhi moved to their respective villages (rural area) on 4th day of lockdown. It was of course a very surprising and disturbing situation on 28th March, though it was set right. Now whoever has returned to village, we hope, they will be safe in the long run.

Conclusively, we prefer to encourage natural environment preferably in rural areas to get rid of this COVID-19, where specific clay rich soils are open and where ground-atmosphere connectivity is sufficiently in equilibrium

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Lupine Publishers|Receptor Status Accuracy in Breast Cancer: Core Biopsy or Excision? A Mini Review

Abstract

Aim

With the advent of minimally invasive surgical techniques core needle biopsy (CNB) has emerged as an accurate method of obtaining representative tissue providing both prognostic and diagnostic valuable information the management of breast cancer. This review aims to compare the precision and limitations in the reporting of CNB and excisional biopsies. (EB)

Materials and Methods: All patients diagnosed with breast cancer were reviewed. Review of the histological data was the essence of this study. Only patients whose receptors were tested in both core and excisions were included. The hormonal status of estrogen receptors (ER), progesterone receptors (PgR) and Her2 were evaluated immunohistochemically. Equivocal HER2 status was reassessed using Fluorescence in situ hybridization (FISH) test.

Results: The total number of patients diagnosed with breast cancer was 112. In 36 (32.1%) patients complete synchronized immunohistological testing for both CNB and EB was executed and compared. The concordance rate observed in was as follows:ER was matched in 27 (75%), PgR in 22 (61.1%) Her2 in 34(94%).The calculated concordance rate was 86%, 80%, 94% for ER PgR and Her2 respectively.

Conclusion: CNB has proven a valuable and an adequate minimally invasive method for obtaining an accurate representative tissue. The reliability in obtaining HER2 status can be precisely determined however, ER and PgR should be interpreted with caution.

Keywords: Core Needle Biopsy; Excision Biopsy; Concordance; Breast Cancer

Introduction

With the increased prevalence of breast cancer internationally, efficient, cost effective and reliable diagnostic methods are continuously sought. In the emerging era of minimally invasive procedures, coupled by the concordance of both excisional biopsies (EB) with core needle biopsies (CNB), the surgical practice has witnessed a decline in diagnostic surgical excisions [1]. Because of the increased incidence of detected Ductal Carcinoma in Situ (DCIS), fine needle aspiration cytology has become less reliable in obtaining adequate diagnostic samples. On the other hand, the currently widely used CNB in breast lesions has gained popularity over recent years due to the high accuracy in tissue diagnosis obtained from adequate diagnostic samples. Clinicians base their management strategy on the histological diagnosis and hormonal receptors (HR) status in [2]. Chemotherapy treatment, in particular relies on CNB and accurate reporting of HR results [3]. Several studies have demonstrated high concordance rate between CNB and EB in terms of HR status. [2-6] Yet, re-biopsy is strongly indicated in metastatic breast cancer, which may show high discordance between primary and metastatic disease [7].

Materials and Methods

All patients diagnosed with breast cancer between 2016-2017 were reviewed. The review of the histological data was the essence of this study. Both core needle biopsies (CNB) and excisional biopsies (EB) were reviewed. Inclusion criteria included all female patients diagnosed with breast cancer who underwent both diagnostic CNB and EB whose histochemical status was tested in both specimens. The hormonal status of estrogen receptors (ER), progesterone receptors (PgR) and Her2 were evaluated immunohistochemically. Equivocal HER2 status was reassessed using Fluorescence in situ hybridization (FISH) test.

Specimen Handling: The samples were examined by hematoxylin and eosin using 4-microns- thick tissue sections processed from a representative part of the tumor. The tissue was fixed for at least 10 hours in neutral buffered formalin (10% BV). For the ER, PgR and HER2 immunostaining, specimens were immersed in 10% neutral buffered formalin within 1 hour of the biopsy or resection procedure and fixed for 6-72 hours. Her2, ER, PgR assay validation was performed using initial test validation included 20 positive and 20 negative cases (FDA-approved Ventana tests). Validation performed by comparing our laboratory’s results with a specialist hospital assay that has been appropriately validated. Concordance levels were 95%. Equivocal cases were not included in Her2 validation.

Reporting and Interpretation Of ER, PgR, HER2 Was Based According To ASCO/CAP Guidelines

ER and PgR reporting follow that positive test means staining of equal or greater than 1.0 % of tumor cells, whereas a negative test result means staining of less than 1.0 % of tumor cells. Staining is reported as indeterminate if there are problems in sample handling and processing. Scoring was based on the percentage of tumor cells with nuclear staining and staining intensity (weak, moderate or strong); (e.g. ER: 90% strong, PgR: 50% weak). As for HER2 immunostaining, positive result is defined as either a (3+) result by immunohistochemistry or a positive Fluorescence In Situ Hybridization (FISH) analysis result. HER-2 scoring criteria: Her-2 Protein Scoring System: Score 0 (Negative): No staining or faint membrane staining of less than 10% of tumor cells. Score 1+ (Negative): Weak incomplete membrane staining in more than 10% of tumor cells. Score 2+ (Weak Positive): Weak/moderate (thin) complete membrane staining in more than 10% of tumor cells. Score 3+ (Strong Positive): Strong (thick) complete membrane staining in more than 10% of tumor cells. Cases reported as equivocal (2+) were tested by FISH. Statistical Analysis was performed using Kappa values.

Results

112 patients were selected for this study. Seventy-six (67.8%) patients were excluded due to non-fulfillment of the inclusion criteria. 36 (32.1%) of both CNB and EB underwent HR analysis in both specimens, and 34 (30.3%) underwent Her2 testing in CNB and EB.

Types of breast cancer encountered were invasive ductal carcinoma, 67 cases (93%), invasive lobular carcinoma, 2 cases (2.7%), mucinous carcinoma, 1 case (1.3%), mammary carcinoma with mucinous features, 1 case (1.3%), and solid papillary carcinoma, 1 case (1.3%). The diagnosis was initially reported by group of certified pathologists; however, these results were reviewed by a single pathologist for the purpose of this study. ER was positive in 27 (75%). Thirty-one cases (86%) were concordant, while five cases (13.8%) were discordant. Kappa value was 0.67 (Table 1). As for PgR, 22 (61.1%) cases were positive in the CNB. Twenty-nine (80%) were concordant with the EB, while 7 (20%) were discordant. Kappa value was 0.62 (Table 2). HER2 scores were concordant in 32 (94%) cases. Nine (26.5%) were positive, while 27 (79.4%) were reported as negative. Discordance was reported in 2 (6%). Kappa value is 0.84 (Table 3). Twenty-nine patients received neoadjuvant chemotherapy prior to EB. Three of them had discordant ER results; one patient had both discordant ER and PgR results, and 1 with discordant HER2 result. Thus, the inter-rater agreement between the CNB and EB is 0.67 for ER, 0.62 for PgR and 0.84 for HER2.

Discussion

Breast cancer continues to be ranked first among females worldwide, the fast leap of expansion in many developing countries have imposed changes in lifestyle has resulted in many alterations in disease pattern increasing the prevalence of breast cancer [1]. To be able to establish the histological diagnosis that impacts on treatment outcomes, adequate tissue biopsy is mandatory. Excisional biopsy certainly provides larger tissue samples which allow the pathologist to work with ease in reaching a diagnosis, however, it may necessitate general anesthesia, open surgical procedure and delayed further management. Furthermore, a second procedure may lead to architectural distortion of the surgical field leading to a higher incidence of incomplete excisions. The growing demand for prognostic information in determining the receptor status preoperatively is considered a corner stone in modern multidisciplinary treatment. Given the available numerous improved types of with the efficiency, cost effectivity and the adequate tissue yield, promotes the diagnostic accuracy on HR status assessment [2-6]. The importance of assessing the HR status is well demonstrated in evaluating molecular subtypes, ER, PgR, and HER2 status in breast cancer. Estrogen receptor remains a powerful predictive factor for response to endocrine treatment and long-term outcome. Similarly, HER2 overexpression has been associated with worse prognosis in patients with newly diagnosed breast carcinoma [8]. In some cases where the inherent Ki67 heterogeneity in ER+/HER2- diagnosed breast tumors, distinguishing the molecular subtypes maybe difficult in the CNB specimens. In such cases, reliability on excisional biopsy is recommended [9]. The receptor status is significantly associated with treatment and monitoring in advanced disease.[10] The liberal use of chemotherapy as neoadjuvant treatment by many oncologists was reported to change the tumor profile and baseline receptor status [11]. Imaging guided biopsy has also proven its reliability with acceptable concordance of the receptor status between surgery and ultrasound-guided CNB [12]. In this review, ER concordance rate in our study was 86%. Four patients were found to be positive in CNB and negative in the subsequent excisional only one was patient found to be positive on excision, while there was no reactivity in CNB. Similarly, PgR concordance rate was 80%. The discordance was only in 7 patients who were initially reported as positive in CNB and were negative in EB although the concordance rate of ER and PgR is within the acceptable range, it may falsely miss a significant number of patients. [2-6] For this reason, it is recommended to reevaluate the HR status in surgically excised specimens. This discrepancy can partly be explained by the known effect of neoadjuvant chemotherapy as shown in 5 of our patients. We believe it is due to tumor heterogeneity, which has aslo been documented by other authors. It was also noted that Her2 results demonstrated more significant concordance rate of 94% this is probably due to the more robust criteria for identifying HER2 immunostaining in addition to the role of FISH in equivocal cases.

Conclusion

The accuracy of the status in is of paramount importance for both prognosis and treatment. Caution in result interpretation by experienced pathologists may impose significant accuracy and eliminate the false positive results.

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Lupine Publishers|Cancer: Our Body’s Global Warming Warning

Keywords: FMTVDM, Cancer

Opinion

Monday 4 February 2019 was yet another World Cancer Day. We celebrated our efforts to find and eradicate cancer without admitting to ourselves that cancer isn’t a single disease, but rather a group of diseases all caused by our bodies responding to the toxic environment we are exposing ourselves to, just as our planet is responding to the toxic wastes we are dumping into it. The question is WHY do our bodies run amok. The answer lies in the same answer to why Global Warming exists. It is the untold unimaginable continued damage and destruction we cause to the world and to ourselves that accounts for the destruction of the planet and the development of cancer within us. While some individuals may have a genetic predisposition [1] for certain types of cancers, it is nonetheless this constant bombarding of ourselves with toxins, which our bodies try to react to and when overwhelmed the climate change of our bodies occur and call for the eradication of first the damaged cells and then eventually ourselves. Just as the continued bombardment of our Earth with environmental toxins is resulting in violent changes on the planet in an attempt to respond to and eradicate the cause of the toxins to the plant, so too are our bodies reacting to try to eradicate these toxins and their effect within our bodies. This process on a biological basis is reflected in how the cells of our body respond to the cellular environment as shown in Figure1. The process of developing cancer or not developing cancer is not a sudden change but rather a transitional series of events resulting from the interaction between the specific responses and expression of the genome of the cell involved and the specific environment in which the cell is immersed. This environment includes both carcinogenic and non-carcinogenic factors. As the insults occur, the cellular mechanisms to respond to those insults include a variety of responses, including cellular repair and immunologic reactions. The outcome is determined by the interaction between these two opposing sets of factors. Progression or regression is determined by these responses. Clearly no one wants to have cancer or for the planet to be destroyed. Confusion comes from not knowing what is helpful and what is hurting us. Until recently [2], we have been limited by testing (qualitative imaging, biomarkers, etc.), which at best can only provide a yes/no answer to the question of whether a person has cancer or not. Many of these tests do not even provide a yes/no answer, but rather infer there could be a problem. These qualitative approaches are unable to provide us with information warning us that these transitional changes are happening [3]; changes which we could act upon if we only knew they were occurring. Changes which when measured could be used to determine if a given treatment is working [4], harming us or having no effect. Measurable changes which can show us cancer in its early stages [5]. These transitional changes can now be measured using FMTVDM [2]. The only question is whether we use this tool to help find these transitional changes and guide our treatment regimens or whether we will continue to pretend that what we are doing is working?

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