Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/59737.17425
S. Priya, M. Rizwana, D. Senthil, B. Appalaraju, M. Arun
Non typhoidal Salmonella usually causes bacteraemia, enterocolitis, and endovascular infection, but pleuro-pulmonary illness is uncommon, mainly observed in patients with a background of malignancy, underlying pulmonary diseases. Localisation of the infection has been witnessed at various sites following a bacteraemia but case reports on pulmonary focus are minimal. Here, we report a case of a 36 year old male patient who presented to Emergency Department with an underlying non Hodgkin’s Lymphoma along with a left sided pleural effusion. Pleural fluid tapping was done and the sample was sent for microbiological analysis. The pleural fluid culture along with serotyping confirmed the organism as Salmonella enterica serovar Typhimurium. The patient was discharged after parenteral Ceftriaxone therapy and symptom resolution. This case adds to the growing body of evidence of rare presentation of non typhoidal Salmonella as a probable etiological agent of infection in exudative pleural effusions.
{"title":"Rare Presentation of Pleural Empyema due to Non Typhoidal Salmonella-A Case Report","authors":"S. Priya, M. Rizwana, D. Senthil, B. Appalaraju, M. Arun","doi":"10.7860/jcdr/2023/59737.17425","DOIUrl":"https://doi.org/10.7860/jcdr/2023/59737.17425","url":null,"abstract":"Non typhoidal Salmonella usually causes bacteraemia, enterocolitis, and endovascular infection, but pleuro-pulmonary illness is uncommon, mainly observed in patients with a background of malignancy, underlying pulmonary diseases. Localisation of the infection has been witnessed at various sites following a bacteraemia but case reports on pulmonary focus are minimal. Here, we report a case of a 36 year old male patient who presented to Emergency Department with an underlying non Hodgkin’s Lymphoma along with a left sided pleural effusion. Pleural fluid tapping was done and the sample was sent for microbiological analysis. The pleural fluid culture along with serotyping confirmed the organism as Salmonella enterica serovar Typhimurium. The patient was discharged after parenteral Ceftriaxone therapy and symptom resolution. This case adds to the growing body of evidence of rare presentation of non typhoidal Salmonella as a probable etiological agent of infection in exudative pleural effusions.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"30 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72591065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/61343.17939
Susmita Ghosh, R. Dasar, Soumyabrata Debnath, Ashu Chakma, DE Asim
Musculoskeletal Tuberculosis (TB) worldwide with wrist involvement is very rare. Maximum cases of tuberculous arthritis arise in patients born in and migrated from endemic regions, particularly in patients who are co-infected with Human Immunodeficiency Virus (HIV). Authors present a rare case of tuberculous arthritis of the wrist joint in a 64-year-old male having pain, swelling, and decreased range of motion in the left wrist for six months. X-ray and Computed Tomography (CT) showed erosion of carpal bones, reduced joint space, and soft tissue oedema and abscess. On Ultrasonography (USG) joint effusion and soft tissue oedema, were seen around the wrist joint, and on Magnetic Resonance Imaging (MRI) along with this marrow oedema were also noted. Aspirated fluid culture from abscess suggested Mycobacterium positive culture and Ziehl–Neelsen (Z-N) staining showed acid-fast bacilli. Antitubercular therapy was the mainstay of treatment. A high level of suspicion should be kept for TB in every infection of the wrist joint.
{"title":"Radiological Overview of Tubercular Arthritis of Wrist Joint: A Case Report","authors":"Susmita Ghosh, R. Dasar, Soumyabrata Debnath, Ashu Chakma, DE Asim","doi":"10.7860/jcdr/2023/61343.17939","DOIUrl":"https://doi.org/10.7860/jcdr/2023/61343.17939","url":null,"abstract":"Musculoskeletal Tuberculosis (TB) worldwide with wrist involvement is very rare. Maximum cases of tuberculous arthritis arise in patients born in and migrated from endemic regions, particularly in patients who are co-infected with Human Immunodeficiency Virus (HIV). Authors present a rare case of tuberculous arthritis of the wrist joint in a 64-year-old male having pain, swelling, and decreased range of motion in the left wrist for six months. X-ray and Computed Tomography (CT) showed erosion of carpal bones, reduced joint space, and soft tissue oedema and abscess. On Ultrasonography (USG) joint effusion and soft tissue oedema, were seen around the wrist joint, and on Magnetic Resonance Imaging (MRI) along with this marrow oedema were also noted. Aspirated fluid culture from abscess suggested Mycobacterium positive culture and Ziehl–Neelsen (Z-N) staining showed acid-fast bacilli. Antitubercular therapy was the mainstay of treatment. A high level of suspicion should be kept for TB in every infection of the wrist joint.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"50 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74600158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/60328.17984
A. Varghese, G. Mathew, Cinderella Xson
Introduction: The prevalence of Attention Deficit Hyperactivity Disorder (ADHD) is on the rise. Among multiple factors that are linked with ADHD, electronic media use has been gaining considerable attention recently. There is only a limited source of information regarding the burden of ADHD and its association with screen time in the Indian context. Aim: Screening of the children for ADHD and its association with mobile phone use at an outpatient service in a tertiary care hospital in Kerala. Materials and Methods: A cross-sectional questionnaire-based study was conducted among 157 children in the outpatient services in a tertiary care hospital in Pathanamthitta district, Kerala, India. School-going children aged between 6 and 11 years were included in the study. ADHD screening was done using Conner’s Abbreviated Rating Scale (CARS). Results: The mean age of children was 8.1±1.9 years. All the participants used mobile phones, and 15 (9.6%) owned one. The mean duration of mobile phone use per day was 1.4±0.7 hours. Among participants, 53 (33.8%) used mobile phones for more than one hour daily. Parents reported that nearly one-fifth of the children use mobile phones late at night (after 10 pm). Among children, 22.9% screened positive for ADHD. The ADHD scores are significantly correlated with the duration of mobile phone use (r=0.368 p<0.001). Among the children who used mobile phones for more than a year, 32.1% screened positive for ADHD (OR=3.21, CI 1.41-7.32). The mean ADHD score was significantly higher among children with >1 hour of mobile phone use/day than those who use <1 hour/day (t-test=-2.27 p-value=0.025). The vast majority, 148 (94.2%), also noticed behavioural changes among children when denied mobile phones. Significant changes included anger (22.9%), sadness (31.8%), withdrawal (20%), frustration (17.8%) and violence (8.9%). Conclusion: In this study, 22.9% of children screened positive for ADHD. Mobile phone use was found to be significantly associated with ADHD.
{"title":"Attention Deficit Hyperactivity Disorder and Use of Mobile Phones among Children- Need for Concern?","authors":"A. Varghese, G. Mathew, Cinderella Xson","doi":"10.7860/jcdr/2023/60328.17984","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60328.17984","url":null,"abstract":"Introduction: The prevalence of Attention Deficit Hyperactivity Disorder (ADHD) is on the rise. Among multiple factors that are linked with ADHD, electronic media use has been gaining considerable attention recently. There is only a limited source of information regarding the burden of ADHD and its association with screen time in the Indian context. Aim: Screening of the children for ADHD and its association with mobile phone use at an outpatient service in a tertiary care hospital in Kerala. Materials and Methods: A cross-sectional questionnaire-based study was conducted among 157 children in the outpatient services in a tertiary care hospital in Pathanamthitta district, Kerala, India. School-going children aged between 6 and 11 years were included in the study. ADHD screening was done using Conner’s Abbreviated Rating Scale (CARS). Results: The mean age of children was 8.1±1.9 years. All the participants used mobile phones, and 15 (9.6%) owned one. The mean duration of mobile phone use per day was 1.4±0.7 hours. Among participants, 53 (33.8%) used mobile phones for more than one hour daily. Parents reported that nearly one-fifth of the children use mobile phones late at night (after 10 pm). Among children, 22.9% screened positive for ADHD. The ADHD scores are significantly correlated with the duration of mobile phone use (r=0.368 p<0.001). Among the children who used mobile phones for more than a year, 32.1% screened positive for ADHD (OR=3.21, CI 1.41-7.32). The mean ADHD score was significantly higher among children with >1 hour of mobile phone use/day than those who use <1 hour/day (t-test=-2.27 p-value=0.025). The vast majority, 148 (94.2%), also noticed behavioural changes among children when denied mobile phones. Significant changes included anger (22.9%), sadness (31.8%), withdrawal (20%), frustration (17.8%) and violence (8.9%). Conclusion: In this study, 22.9% of children screened positive for ADHD. Mobile phone use was found to be significantly associated with ADHD.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"42 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80102856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/59329.17683
Abhishek Sreekumar, Gundyadka Moideen Safwan, Shilpa J Shetty, S. Kumari, R. Shenoy, V. Shenoy
Introduction: Childhood Nephrotic Syndrome (NS) is a podocytopathy. Micro Ribonucleic Acid (miRNA), composed of 21-25 non coding nucleotides, regulates gene expression by inhibiting protein transcription by binding to complementary messenger RNA. The microRNA-30a is expressed in the human glomerular podocytes and collecting ducts. This microRNA protects the podocytes by targeting the Calcineurin-nuclear Factor of Activated T cells (NFATc) pathways. Serum microRNA30a-5p is a validated biomarker which is upregulated in NS. Aim: To determine the serum miRNA-30a-5p in steroid sensitive idiopathic NS in Indian children. Materials and Methods: This case-control study was conducted at the Department of Paediatrics, KS Hegde Medical Academy, Mangalore, Karnataka, India, from from January 2018 to June 2019. Thirty children with NS and age and gender matched controls were recruited. Relative expression of microRNA-30a5p was analysed by Real-Time quantitative Polymerase Chain Reaction (RT-qPCR). Estimations were done both in cases and controls at enrollment and also at four weeks when in remission in cases. The fold change was calculated as a power of cycle threshold. Statistical tests Kolmogorov-Smirnov test was used to establish the normality using Statistical Package for Social Sciences (SPSS) version 22.0. Results: There was upregulation of microRNA-30a-5p expression among children with NS with a significant fold change (~184) at enrollment. The levels declined, but remained above baseline (~6) after four weeks of treatment when compared to controls. The mean differences in delta threshold cycle and threshold cycle between the three groups were significant (p<0.001). There was no correlation with the biochemical parameters. Conclusion: The present study concludes that serum microRNA-30a-5p expression is upregulated in children with steroid sensitive NS in Indian children.
{"title":"Serum miRNA-30a-5p in Steroid Sensitive Idiopathic Nephrotic Syndrome in Indian Children: A Case-control Study","authors":"Abhishek Sreekumar, Gundyadka Moideen Safwan, Shilpa J Shetty, S. Kumari, R. Shenoy, V. Shenoy","doi":"10.7860/jcdr/2023/59329.17683","DOIUrl":"https://doi.org/10.7860/jcdr/2023/59329.17683","url":null,"abstract":"Introduction: Childhood Nephrotic Syndrome (NS) is a podocytopathy. Micro Ribonucleic Acid (miRNA), composed of 21-25 non coding nucleotides, regulates gene expression by inhibiting protein transcription by binding to complementary messenger RNA. The microRNA-30a is expressed in the human glomerular podocytes and collecting ducts. This microRNA protects the podocytes by targeting the Calcineurin-nuclear Factor of Activated T cells (NFATc) pathways. Serum microRNA30a-5p is a validated biomarker which is upregulated in NS. Aim: To determine the serum miRNA-30a-5p in steroid sensitive idiopathic NS in Indian children. Materials and Methods: This case-control study was conducted at the Department of Paediatrics, KS Hegde Medical Academy, Mangalore, Karnataka, India, from from January 2018 to June 2019. Thirty children with NS and age and gender matched controls were recruited. Relative expression of microRNA-30a5p was analysed by Real-Time quantitative Polymerase Chain Reaction (RT-qPCR). Estimations were done both in cases and controls at enrollment and also at four weeks when in remission in cases. The fold change was calculated as a power of cycle threshold. Statistical tests Kolmogorov-Smirnov test was used to establish the normality using Statistical Package for Social Sciences (SPSS) version 22.0. Results: There was upregulation of microRNA-30a-5p expression among children with NS with a significant fold change (~184) at enrollment. The levels declined, but remained above baseline (~6) after four weeks of treatment when compared to controls. The mean differences in delta threshold cycle and threshold cycle between the three groups were significant (p<0.001). There was no correlation with the biochemical parameters. Conclusion: The present study concludes that serum microRNA-30a-5p expression is upregulated in children with steroid sensitive NS in Indian children.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"1 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80120411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/60989.17731
Thacker Shriya Himmat, Sadhana Prasad Kaware
Now-a-days, the number of Caesarean section (c-section) has increased, also the complications of c-section has increased. Obstetricians often encounter uterine scar dehiscence during delivery by c-section. However, it is rare to find a uterine scar dehiscence which is extending over one-third of the anterior uterine wall and it is yet to build the best surgical approach for repairing this rare complication of c-section or a torn anterior wall during delivery. Herein, a 23-year-old female who is Rhesus factor (Rh) negative G2P1L1 with seven months of amenorrhea came with chief complaints of pain in the abdomen since morning. On ultrasonography, severe oligohydramnios was diagnosed as Amniotic Fluid Index (AFI) was >5 cm. Hence, the patient was taken for emergency Lower Segment Caesarean Section (LSCS), Lower Uterine Section (LUS) was papery thin, uterovaginal fold of peritoneum was opened and the bladder was pushed down. One-third of the anterior uterine wall was involved. LUS was sutured using vicryl No. 1 and complete haemostasis was achieved. As uterine scar dehiscence is not preventable, efforts should be made to manage it efficiently and repair the myometrium safely.
{"title":"Multifactorial Intraoperative Uterine Scar Dehiscence: A Case Report","authors":"Thacker Shriya Himmat, Sadhana Prasad Kaware","doi":"10.7860/jcdr/2023/60989.17731","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60989.17731","url":null,"abstract":"Now-a-days, the number of Caesarean section (c-section) has increased, also the complications of c-section has increased. Obstetricians often encounter uterine scar dehiscence during delivery by c-section. However, it is rare to find a uterine scar dehiscence which is extending over one-third of the anterior uterine wall and it is yet to build the best surgical approach for repairing this rare complication of c-section or a torn anterior wall during delivery. Herein, a 23-year-old female who is Rhesus factor (Rh) negative G2P1L1 with seven months of amenorrhea came with chief complaints of pain in the abdomen since morning. On ultrasonography, severe oligohydramnios was diagnosed as Amniotic Fluid Index (AFI) was >5 cm. Hence, the patient was taken for emergency Lower Segment Caesarean Section (LSCS), Lower Uterine Section (LUS) was papery thin, uterovaginal fold of peritoneum was opened and the bladder was pushed down. One-third of the anterior uterine wall was involved. LUS was sutured using vicryl No. 1 and complete haemostasis was achieved. As uterine scar dehiscence is not preventable, efforts should be made to manage it efficiently and repair the myometrium safely.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"8 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80240534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/62390.18134
Mahla Rajabzadeh, R. Naderi, Sattar Bab, M. Riahi, F. Bahrami, M. Eghbali, Fateme Haseli
Introduction: Breast cancer is the most commonly occurring cancer in women. It is also one of the most important health issues in many countries. Its high prevalence in women makes it necessary to encourage breast cancer screening behaviours. Aim: To investigate the relationship between breast cancer prevention behaviour and its screening behaviour in Tehranian women. Materials and Methods: This was cross-sectional study conducted on 859 women from November to December 2019 by the Iran University of Medical Sciences in Tehran, Iran. These women were selected by the multistage cluster method among five socio-economic classes living in different districts of Tehran. Structural Equation Modeling (SEM) was used to determine the relationship between breast cancer prevention behaviour and its screening behaviour. Data were analysed by Statistical Package for Social Sciences (SPSS) version 22.0 and Analysis of Moment Structures (AMOS) software. The level of significance was set at 0.05. Results: The mean age of the participants was 42±6.94 years. Also,137 (15.9%) of the participants were single, and 604 (70.3%) were married, 78 (9.08%) were divorced and rest widow. Among the studied subjects, 510 (57%) had unfavourable breast cancer screening behaviour. In Pearson’s correlation test, there was a direct and significant relationship between the mean score of breast cancer prevention behaviour and its subscales with breast cancer screening behaviour, except for the dimension of information-seeking (r=0.35, p=0.007). In other words, with the increased breast cancer prevention behaviour, breast cancer screening behaviour also increased. The results of SEM analysis showed that breast cancer prevention behaviour was positively correlated to breast cancer screening behaviour (p<0.001), and about 41% of changes in the breast cancer screening behaviour could be explained by the breast cancer prevention behaviour (β=0.41, p=0.01). Conclusion: Based on the results, it seems vital to take measures to inform and educate women about breast cancer and its complications, problems, prevention, screening, and diagnostic methods. The findings of this study can be used to increase motivation in the design of interventions in order to improve attitude, strengthen self-efficacy, reduce stress, and improve breast cancer screening behaviour.
{"title":"The Relationship between Breast Cancer Prevention and Breast Cancer Screening Behaviours in Tehranian Women: A Structural Equation Modeling Analysis","authors":"Mahla Rajabzadeh, R. Naderi, Sattar Bab, M. Riahi, F. Bahrami, M. Eghbali, Fateme Haseli","doi":"10.7860/jcdr/2023/62390.18134","DOIUrl":"https://doi.org/10.7860/jcdr/2023/62390.18134","url":null,"abstract":"Introduction: Breast cancer is the most commonly occurring cancer in women. It is also one of the most important health issues in many countries. Its high prevalence in women makes it necessary to encourage breast cancer screening behaviours. Aim: To investigate the relationship between breast cancer prevention behaviour and its screening behaviour in Tehranian women. Materials and Methods: This was cross-sectional study conducted on 859 women from November to December 2019 by the Iran University of Medical Sciences in Tehran, Iran. These women were selected by the multistage cluster method among five socio-economic classes living in different districts of Tehran. Structural Equation Modeling (SEM) was used to determine the relationship between breast cancer prevention behaviour and its screening behaviour. Data were analysed by Statistical Package for Social Sciences (SPSS) version 22.0 and Analysis of Moment Structures (AMOS) software. The level of significance was set at 0.05. Results: The mean age of the participants was 42±6.94 years. Also,137 (15.9%) of the participants were single, and 604 (70.3%) were married, 78 (9.08%) were divorced and rest widow. Among the studied subjects, 510 (57%) had unfavourable breast cancer screening behaviour. In Pearson’s correlation test, there was a direct and significant relationship between the mean score of breast cancer prevention behaviour and its subscales with breast cancer screening behaviour, except for the dimension of information-seeking (r=0.35, p=0.007). In other words, with the increased breast cancer prevention behaviour, breast cancer screening behaviour also increased. The results of SEM analysis showed that breast cancer prevention behaviour was positively correlated to breast cancer screening behaviour (p<0.001), and about 41% of changes in the breast cancer screening behaviour could be explained by the breast cancer prevention behaviour (β=0.41, p=0.01). Conclusion: Based on the results, it seems vital to take measures to inform and educate women about breast cancer and its complications, problems, prevention, screening, and diagnostic methods. The findings of this study can be used to increase motivation in the design of interventions in order to improve attitude, strengthen self-efficacy, reduce stress, and improve breast cancer screening behaviour.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"15 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78870891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/63352.18192
Shivani Gupta, C. W. Devadass, Shubham Varshney, Sml Prakash Babu
Introduction: Renal Cell Carcinoma (RCC) is the 9th and 14th most common cancer in men and women, respectively, and among the most lethal urological cancers. Upto 30% of patients experience recurrence within five years postnephrectomy. Therefore, the predictors of disease survival and molecular markers associated with clinical prognostic parameters should be identified. Aim: To examine the histopathological features of RCC and investigate the association of Tumour protein p53 (p53) and Cluster of Differentiation 44S (CD44S) expression with prognostic factors. Materials and Methods: The present prospective crosssectional study was conducted in the Department of Pathology, M.S Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India, from June 2017 to May 2019. Radical and partial nephrectomy specimens of RCC patients were obtained for the study. In each case age, tumour histologic type, tumour size, Fuhrman nuclear grade, rhabdoid features, necrosis, tumour stage and p53 and CD44S status were evaluated through immunohistochemistry. The Chi-square test was used to evaluate differences in CD44S and p53 expression among different groups. Data were entered in Microsoft (MS) Excel version 11 and was analysed using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) software version 20.0. Results: The study included 50 RCC patients with a mean age of 56.64 years and male:female ratio was 2.8:1. CD44S and p53 positivity were noted in 33 (66%) and 27 (54%) patients, respectively. Weak, moderate, and strong CD44S expression were observed in 13 (26%), 8 (16%) and 12 (24%) patients, respectively and those of p53 in 9 (18%), 14 (28%) and 13 (26%) patients, respectively. Patients with higher Fuhrman nuclear grades exhibited stronger CD44S (n=24, 85.71%) and p53 (n=19, 67.85%) expression than did those with lower grades. Conclusion: The clear cell carcinoma is the most common histologic subtype. Presence of rhabdoid features and necrosis is seen with advanced Tumour, Nodal and Metastasis (TNM) stage. A significant association between p53 and CD44S immunohistochemical expression and higher Fuhrman nuclear grade suggests increased expression of p53 and CD44S and indicates an aggressive clinical course that can be used as a marker of poor prognosis.
导读:肾细胞癌(RCC)在男性和女性中分别是第9位和第14位最常见的癌症，也是最致命的泌尿系统癌症之一。高达30%的患者在肾切除术后5年内复发。因此，应该确定疾病生存的预测因子和与临床预后参数相关的分子标记。目的:探讨肿瘤蛋白p53 (p53)和分化簇44S (CD44S)表达与肾细胞癌预后的关系。材料与方法:本前瞻性横断面研究于2017年6月至2019年5月在印度卡纳塔克邦班加罗尔M.S Ramaiah医学院和医院病理科进行。本研究收集了肾细胞癌患者的全部和部分肾切除术标本。通过免疫组织化学方法对每例患者的年龄、肿瘤组织学类型、肿瘤大小、Fuhrman核分级、横纹肌特征、坏死、肿瘤分期及p53和CD44S状态进行评估。采用卡方检验评价CD44S、p53在不同组间的表达差异。数据在Microsoft (MS) Excel version 11中输入，并使用International Business Machines Statistical Package for the Social Sciences (IBM SPSS) version 20.0软件进行分析。结果:纳入RCC患者50例，平均年龄56.64岁，男女比例为2.8:1。CD44S阳性33例(66%)，p53阳性27例(54%)。CD44S弱、中、强表达分别为13例(26%)、8例(16%)、12例(24%)，p53表达分别为9例(18%)、14例(28%)、13例(26%)。Fuhrman核分级高的患者CD44S (n=24, 85.71%)和p53 (n=19, 67.85%)表达较低。结论:透明细胞癌是最常见的组织学亚型。在肿瘤、淋巴结和转移(TNM)晚期出现横纹肌样特征和坏死。p53和CD44S免疫组织化学表达与更高的Fuhrman核分级之间的显著关联表明p53和CD44S表达增加，表明临床病程具有侵袭性，可作为预后不良的标志。
{"title":"Histopathological Evaluation and Analysis of Immunohistochemical Markers p53 and CD44S in Renal Cell Carcinoma: A Cross-sectional Study","authors":"Shivani Gupta, C. W. Devadass, Shubham Varshney, Sml Prakash Babu","doi":"10.7860/jcdr/2023/63352.18192","DOIUrl":"https://doi.org/10.7860/jcdr/2023/63352.18192","url":null,"abstract":"Introduction: Renal Cell Carcinoma (RCC) is the 9th and 14th most common cancer in men and women, respectively, and among the most lethal urological cancers. Upto 30% of patients experience recurrence within five years postnephrectomy. Therefore, the predictors of disease survival and molecular markers associated with clinical prognostic parameters should be identified. Aim: To examine the histopathological features of RCC and investigate the association of Tumour protein p53 (p53) and Cluster of Differentiation 44S (CD44S) expression with prognostic factors. Materials and Methods: The present prospective crosssectional study was conducted in the Department of Pathology, M.S Ramaiah Medical College and Hospitals, Bengaluru, Karnataka, India, from June 2017 to May 2019. Radical and partial nephrectomy specimens of RCC patients were obtained for the study. In each case age, tumour histologic type, tumour size, Fuhrman nuclear grade, rhabdoid features, necrosis, tumour stage and p53 and CD44S status were evaluated through immunohistochemistry. The Chi-square test was used to evaluate differences in CD44S and p53 expression among different groups. Data were entered in Microsoft (MS) Excel version 11 and was analysed using International Business Machines Statistical Package for the Social Sciences (IBM SPSS) software version 20.0. Results: The study included 50 RCC patients with a mean age of 56.64 years and male:female ratio was 2.8:1. CD44S and p53 positivity were noted in 33 (66%) and 27 (54%) patients, respectively. Weak, moderate, and strong CD44S expression were observed in 13 (26%), 8 (16%) and 12 (24%) patients, respectively and those of p53 in 9 (18%), 14 (28%) and 13 (26%) patients, respectively. Patients with higher Fuhrman nuclear grades exhibited stronger CD44S (n=24, 85.71%) and p53 (n=19, 67.85%) expression than did those with lower grades. Conclusion: The clear cell carcinoma is the most common histologic subtype. Presence of rhabdoid features and necrosis is seen with advanced Tumour, Nodal and Metastasis (TNM) stage. A significant association between p53 and CD44S immunohistochemical expression and higher Fuhrman nuclear grade suggests increased expression of p53 and CD44S and indicates an aggressive clinical course that can be used as a marker of poor prognosis.","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"27 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79627586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/60310.18141
Haresh Kumar Gobu, D. Pai
Introduction: Gallstones Disease (GSD) is one of the common medical problems leading to surgical intervention. The gold standard treatment for cholelithiasis is cholecystectomy. Co-existence of concurrent Upper Gastrointestinal (UGI) problems in GSD patients have attributed to the Post-cholecystectomy Syndrome (PCS). PCS consists of a group of abdominal symptoms, that recur and/or persist after cholecystectomy. The associated upper Gastrointestinal (GI) pathologies are identified by UGI endoscopy. Helicobacter pylori (H.pylori) infection has been implicated in many GI and extra-GI diseases. This aspect of identifying associated pathologies in symptomatic gallstone disease and identifying H.pylori infection using gene-sequencing method has not been studied in Indian population. Aim: To study the associated UGI pathology detected by preoperative UGI endoscopy in symptomatic GSD and to compare the outcome based on the trend of PCS overtime. Materials and Methods: This prospective cohort study conducted in the Department of Surgery at Mahatma Gandhi Medical College and Research Insititute, Puducherry, India. The duration of the study was 18 months, from January 2019 to July 2020. The individuals over 18 years of age, who were symptomatic and ultrasonographically proven to have cholelithiasis formed the study group. The sample size was calculated to be N=50 (reduced to N=30 due to Coronavirus Disease-2019 (COVID19) pandemic). Patients underwent UGI endoscopy prior to surgery, to assess for associated pathology including H.pylori. They were followed at regular intervals postoperatively and assessed based on questionnaire for the occurrence of PCS. The quantitative and qualitative variables were summarised as frequency, percentage and Pearson’s Chi-square test and Fisher’s-exact test, respectively. The sensitivity and specificity of H.pylori positivity by Histopathological Evaluation (HPE) in biopsy samples was compared to Polymerase Chain Reaction (PCR) as the gold standard. The significance level was set at p-value<0.05. The trend of the symptoms was also studied overtime. Results: The mean age of the study population was 39.4±11.93 years. UGI abnormalities were present in 89.7% of the study group. H.pylori was identified in eight patients by histopathology examination while PCR detected 16 patients to have H.pylori. Sixteen out of 30 patients (53.3%) had PCS. It was also noted that, early PCS numbers tend to reduce over time, but the overall and late PCS numbers tend to increase over time. Although, a statistical analysis could not be performed, a graph was drawn to study the symptoms over the study period allowing observation of vital relation to gallstone disease. UGI pathology and H.pylori infection had a significant association with overall PCS with p-value=0.022 and 0.026, respectively. Conclusion: The present study recommends the use of preoperative UGI endoscopy in symptomatic GSD. The identification of H.pylori by PCR using population-based g
{"title":"Symptomatic Gallstone Disease and Associated Upper Gastrointestinal Pathologies-A Prospective Cohort Study","authors":"Haresh Kumar Gobu, D. Pai","doi":"10.7860/jcdr/2023/60310.18141","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60310.18141","url":null,"abstract":"Introduction: Gallstones Disease (GSD) is one of the common medical problems leading to surgical intervention. The gold standard treatment for cholelithiasis is cholecystectomy. Co-existence of concurrent Upper Gastrointestinal (UGI) problems in GSD patients have attributed to the Post-cholecystectomy Syndrome (PCS). PCS consists of a group of abdominal symptoms, that recur and/or persist after cholecystectomy. The associated upper Gastrointestinal (GI) pathologies are identified by UGI endoscopy. Helicobacter pylori (H.pylori) infection has been implicated in many GI and extra-GI diseases. This aspect of identifying associated pathologies in symptomatic gallstone disease and identifying H.pylori infection using gene-sequencing method has not been studied in Indian population. Aim: To study the associated UGI pathology detected by preoperative UGI endoscopy in symptomatic GSD and to compare the outcome based on the trend of PCS overtime. Materials and Methods: This prospective cohort study conducted in the Department of Surgery at Mahatma Gandhi Medical College and Research Insititute, Puducherry, India. The duration of the study was 18 months, from January 2019 to July 2020. The individuals over 18 years of age, who were symptomatic and ultrasonographically proven to have cholelithiasis formed the study group. The sample size was calculated to be N=50 (reduced to N=30 due to Coronavirus Disease-2019 (COVID19) pandemic). Patients underwent UGI endoscopy prior to surgery, to assess for associated pathology including H.pylori. They were followed at regular intervals postoperatively and assessed based on questionnaire for the occurrence of PCS. The quantitative and qualitative variables were summarised as frequency, percentage and Pearson’s Chi-square test and Fisher’s-exact test, respectively. The sensitivity and specificity of H.pylori positivity by Histopathological Evaluation (HPE) in biopsy samples was compared to Polymerase Chain Reaction (PCR) as the gold standard. The significance level was set at p-value<0.05. The trend of the symptoms was also studied overtime. Results: The mean age of the study population was 39.4±11.93 years. UGI abnormalities were present in 89.7% of the study group. H.pylori was identified in eight patients by histopathology examination while PCR detected 16 patients to have H.pylori. Sixteen out of 30 patients (53.3%) had PCS. It was also noted that, early PCS numbers tend to reduce over time, but the overall and late PCS numbers tend to increase over time. Although, a statistical analysis could not be performed, a graph was drawn to study the symptoms over the study period allowing observation of vital relation to gallstone disease. UGI pathology and H.pylori infection had a significant association with overall PCS with p-value=0.022 and 0.026, respectively. Conclusion: The present study recommends the use of preoperative UGI endoscopy in symptomatic GSD. The identification of H.pylori by PCR using population-based g","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"69 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76307410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/60170.17948
Salma Raja, J. R. James, Tamilselvan Kumar, JP Mohan Raj, S. Divya, P. Fairlin, G. Rajkumar, M. Beulah
Introduction: Periodontitis manifested by the presence of periodontal pocket depth and loss of attachment level is detected and measured by using periodontal probes. Various generations of probes have been discovered and are used to measure the pocket depth. There has been a huge difference in the accuracy of different generations of probe. Aim: To compare the interprobe accuracy of first, second and third generations of probe on clinical parameters in patients with chronic periodontitis. Materials and Methods: This randomised comparative clinical study was conducted at the Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India and included 30 chronic periodontitis patients, randomly allocated into three groups with each group consisting of 10 patients. The study was conducted over a period of eight months, from February 2001 to October 2001. Conventional periodontal probe, True Pressure Sensitive (TPS) probe and Florida probe were used to examine the patients. The probes were used in sequence of I, II and III for first 10 patients, II, III and I for next 10 patients and III, I and II for the last 10 patients to avoid bias due to examiner memory of clinical parameters. The recorded clinical parameters were Plaque Index (PI) (Silness and Loe 1964), Gingival Index (GI) (Loe and Silness 1963), Bleeding On Probing (BOP) index (Ainamo and Bay 1975), Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). At baseline, all the clinical parameters were recorded by two calibrated examiners i.e., Examiner-1 and Examiner-2. Examiner-I recorded all the clinical parameters postoperatively at Ist, IInd, IIIrd and IVth consecutive weeks. The statistical analysis was done using paired t-test, One-way Analysis of Variance (ANOVA), studentised range test and Karl Pearson’s correlation coefficient test for calculation and comparison of interexaminer and intraexaminer variability. Results: Among the 30 patients included in the present study, 22 were males and eight were females. The mean age of the patients involved in the study was 45.16±1.33 years. The mean value of PI and GI showed a statistically significant reduction at different intervals with a value of 0.16±0.21 and 0.22±0.21 postoperatively (4th week). The probing depths measured using Williams periodontal probe, TPS probe and Florida probe were reduced to 4.2±0.4 mm, 3.9±0.4 mm and 3.5±0.4 mm, respectively at the end of 4th week. The CAL measured using Williams periodontal probe, TPS probe and Florida probe were reduced to 7.0±0.6 mm, 6.6±0.5 mm and 6.1±0.6 mm, respectively at the end of 4th week. Conclusion: The TPS probe, Williams probe, and Florida probe showed their superiority regarding the accuracy of recording clinical parameters in the decreasing order respectively
牙周炎表现为牙周袋深度的存在和附着水平的丧失是通过牙周探针检测和测量的。不同世代的探针已被发现并用于测量袋深。不同年代的探针在精度上存在着巨大的差异。目的:比较第一代、第二代和第三代探针对慢性牙周炎患者临床参数的准确性。材料和方法:本随机对照临床研究在印度卡纳塔克邦Davangere的Bapuji牙科学院和医院牙周病科进行，纳入30例慢性牙周炎患者，随机分为三组，每组10例患者。这项研究进行了八个月，从2001年2月到2001年10月。采用常规牙周探针、真压敏(TPS)探针和佛罗里达探针对患者进行检查。前10名患者按ⅰ、ⅱ、ⅲ顺序使用探针，后10名患者按ⅱ、ⅲ、ⅰ顺序使用探针，后10名患者按ⅲ、ⅰ、ⅱ顺序使用探针，以避免因审查员对临床参数的记忆而产生偏倚。记录的临床参数为菌斑指数(PI) (Silness and Loe 1964)、牙龈指数(GI) (Loe and Silness 1963)、探诊出血指数(BOP) (Ainamo and Bay 1975)、探诊袋深度(PPD)和临床依恋水平(CAL)。在基线时，所有临床参数由两名校准的检验员(即检验员1和检验员2)记录。检查员- 1连续第1、第2、第3、第4周记录术后所有临床参数。统计分析采用配对t检验、单因素方差分析(ANOVA)、学生极差检验和Karl Pearson相关系数检验计算和比较被测者间和被测者内变异。结果:本研究纳入的30例患者中，男性22例，女性8例。患者的平均年龄为45.16±1.33岁。术后(第4周)PI、GI均值分别为0.16±0.21、0.22±0.21，在不同时间间隔内均有统计学意义。第4周结束时，Williams牙周探针、TPS探针和Florida探针测得的探牙深度分别降至4.2±0.4 mm、3.9±0.4 mm和3.5±0.4 mm。第4周结束时，使用Williams牙周探针、TPS探针和Florida探针测量的CAL分别降至7.0±0.6 mm、6.6±0.5 mm和6.1±0.6 mm。结论:TPS探针、Williams探针和Florida探针记录临床参数的准确性依次递减，具有优势
{"title":"Evaluation of First, Second and Third Generation Probe after Phase I Therapy in Chronic Periodontitis PatientsA Randomised Clinical Study","authors":"Salma Raja, J. R. James, Tamilselvan Kumar, JP Mohan Raj, S. Divya, P. Fairlin, G. Rajkumar, M. Beulah","doi":"10.7860/jcdr/2023/60170.17948","DOIUrl":"https://doi.org/10.7860/jcdr/2023/60170.17948","url":null,"abstract":"Introduction: Periodontitis manifested by the presence of periodontal pocket depth and loss of attachment level is detected and measured by using periodontal probes. Various generations of probes have been discovered and are used to measure the pocket depth. There has been a huge difference in the accuracy of different generations of probe. Aim: To compare the interprobe accuracy of first, second and third generations of probe on clinical parameters in patients with chronic periodontitis. Materials and Methods: This randomised comparative clinical study was conducted at the Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India and included 30 chronic periodontitis patients, randomly allocated into three groups with each group consisting of 10 patients. The study was conducted over a period of eight months, from February 2001 to October 2001. Conventional periodontal probe, True Pressure Sensitive (TPS) probe and Florida probe were used to examine the patients. The probes were used in sequence of I, II and III for first 10 patients, II, III and I for next 10 patients and III, I and II for the last 10 patients to avoid bias due to examiner memory of clinical parameters. The recorded clinical parameters were Plaque Index (PI) (Silness and Loe 1964), Gingival Index (GI) (Loe and Silness 1963), Bleeding On Probing (BOP) index (Ainamo and Bay 1975), Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). At baseline, all the clinical parameters were recorded by two calibrated examiners i.e., Examiner-1 and Examiner-2. Examiner-I recorded all the clinical parameters postoperatively at Ist, IInd, IIIrd and IVth consecutive weeks. The statistical analysis was done using paired t-test, One-way Analysis of Variance (ANOVA), studentised range test and Karl Pearson’s correlation coefficient test for calculation and comparison of interexaminer and intraexaminer variability. Results: Among the 30 patients included in the present study, 22 were males and eight were females. The mean age of the patients involved in the study was 45.16±1.33 years. The mean value of PI and GI showed a statistically significant reduction at different intervals with a value of 0.16±0.21 and 0.22±0.21 postoperatively (4th week). The probing depths measured using Williams periodontal probe, TPS probe and Florida probe were reduced to 4.2±0.4 mm, 3.9±0.4 mm and 3.5±0.4 mm, respectively at the end of 4th week. The CAL measured using Williams periodontal probe, TPS probe and Florida probe were reduced to 7.0±0.6 mm, 6.6±0.5 mm and 6.1±0.6 mm, respectively at the end of 4th week. Conclusion: The TPS probe, Williams probe, and Florida probe showed their superiority regarding the accuracy of recording clinical parameters in the decreasing order respectively","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"66 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76530358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.7860/jcdr/2023/56291.17889
Sonal S. Mehta, A. Chaturvedi
Introduction: Progesterone is the treatment of choice for support of the luteal phase of controlled ovarian stimulation cycles in women undergoing an Assisted Reproductive Technology (ART) treatment. Available progesterone preparations include oral, vaginal and oil-based Intramuscular (i.m.) formulations. Oral formulation has poor bioavailability whereas vaginal formulations cause side-effects such as vaginal discharge and/ or local irritation. Oil-based progesterone formulations for i.m. use are associated with discomfort and pain at the injection site. Hence, a novel aqueous-based progesterone formulation for i.m./Subcutaneous (s.c.) was developed to avoid the local tolerability issues of the existing parenteral formulations. Aim: To assess single-dose Pharmacokinetics (PK) and relative bioavailability of i.m. (test-1; T1) or s.c. (test-2; T2) administration of novel aqueous progesterone formulation with i.m. (reference; R) administration of oil-based progesterone formulation. Materials and Methods: In this open-label, three-sequence, three-period, single-dose, cross-over study, 51 healthy human postmenopausal female subjects between 45 to 65 years of age were included. The study was conducted at Lambda Therapeutic Research Limited, Ahmedabad, Gujarat, India, between 21 May 2018 to 06 July 2018. Subjects were randomised to a single 25 mg dose of T1, T2 or R in three-periods (Period-I: T1, R, T2; Period-II: T2, T1, R; Period-III: R, T2, T1) with ≥18 days washout period. Blood samples were collected at prespecified time points in each period and analysed using validated liquid chromatography with tandem mass spectrometry. PK parameters {maximum plasma concentration (Cmax), time to reach Cmax (Tmax), area under the plasma concentration vs. time curve (AUC0-t), AUC from time 0 to ∞ (AUC0-∞), plasma half-life (t1/2)} were calculated from the plasma concentration vs. time profile by non compartmental model. The total study duration was about 47 days (11 hours prior to the drug administration in Period-I until the last ambulatory sample in Period-III). All patients provided written informed consent form and an approval from the Conscience-Independent Ethics Committee (CIEC) was taken. Descriptive statistics were calculated and reported for PK parameters for baseline corrected and uncorrected data. Results: Of 72 screened patients, 51 patients were included for the PK and statistical analysis. The mean±SD age of the patients was 55.1±4.67 years. The baseline corrected PK data shows that in T1, T2 and R arms, mean (range) Tmax were 1.00 (0.50– 1.75), 1.00 (0.75–1.75) and 8.00 hours (1.00–12.00), mean±SD t ½ (h) were 15.43±5.81, 15.27±6.68 and 19.80±6.35; mean±SD Cmax (ng/mL) were 101.91±73.07, 51.67±14.81 and 18.89±7.89, and mean±SD AUC0-t (ng/mL) were 385.10±89.29, 349.63±64.41 and 371.50±56.25, respectively. Similarly, the AUC0-∞ was also comparable in all three arms. The baseline uncorrected data were also in line with baseline corrected data. For AU
{"title":"Comparison of the Pharmacokinetics, Bioequivalence and Safety of Aqueous Progesterone Formulation Administered as either Intramuscular or Subcutaneous Injection versus Oil-based Progesterone Formulation Administered as Intramuscular Injection: A Randomised Study","authors":"Sonal S. Mehta, A. Chaturvedi","doi":"10.7860/jcdr/2023/56291.17889","DOIUrl":"https://doi.org/10.7860/jcdr/2023/56291.17889","url":null,"abstract":"Introduction: Progesterone is the treatment of choice for support of the luteal phase of controlled ovarian stimulation cycles in women undergoing an Assisted Reproductive Technology (ART) treatment. Available progesterone preparations include oral, vaginal and oil-based Intramuscular (i.m.) formulations. Oral formulation has poor bioavailability whereas vaginal formulations cause side-effects such as vaginal discharge and/ or local irritation. Oil-based progesterone formulations for i.m. use are associated with discomfort and pain at the injection site. Hence, a novel aqueous-based progesterone formulation for i.m./Subcutaneous (s.c.) was developed to avoid the local tolerability issues of the existing parenteral formulations. Aim: To assess single-dose Pharmacokinetics (PK) and relative bioavailability of i.m. (test-1; T1) or s.c. (test-2; T2) administration of novel aqueous progesterone formulation with i.m. (reference; R) administration of oil-based progesterone formulation. Materials and Methods: In this open-label, three-sequence, three-period, single-dose, cross-over study, 51 healthy human postmenopausal female subjects between 45 to 65 years of age were included. The study was conducted at Lambda Therapeutic Research Limited, Ahmedabad, Gujarat, India, between 21 May 2018 to 06 July 2018. Subjects were randomised to a single 25 mg dose of T1, T2 or R in three-periods (Period-I: T1, R, T2; Period-II: T2, T1, R; Period-III: R, T2, T1) with ≥18 days washout period. Blood samples were collected at prespecified time points in each period and analysed using validated liquid chromatography with tandem mass spectrometry. PK parameters {maximum plasma concentration (Cmax), time to reach Cmax (Tmax), area under the plasma concentration vs. time curve (AUC0-t), AUC from time 0 to ∞ (AUC0-∞), plasma half-life (t1/2)} were calculated from the plasma concentration vs. time profile by non compartmental model. The total study duration was about 47 days (11 hours prior to the drug administration in Period-I until the last ambulatory sample in Period-III). All patients provided written informed consent form and an approval from the Conscience-Independent Ethics Committee (CIEC) was taken. Descriptive statistics were calculated and reported for PK parameters for baseline corrected and uncorrected data. Results: Of 72 screened patients, 51 patients were included for the PK and statistical analysis. The mean±SD age of the patients was 55.1±4.67 years. The baseline corrected PK data shows that in T1, T2 and R arms, mean (range) Tmax were 1.00 (0.50– 1.75), 1.00 (0.75–1.75) and 8.00 hours (1.00–12.00), mean±SD t ½ (h) were 15.43±5.81, 15.27±6.68 and 19.80±6.35; mean±SD Cmax (ng/mL) were 101.91±73.07, 51.67±14.81 and 18.89±7.89, and mean±SD AUC0-t (ng/mL) were 385.10±89.29, 349.63±64.41 and 371.50±56.25, respectively. Similarly, the AUC0-∞ was also comparable in all three arms. The baseline uncorrected data were also in line with baseline corrected data. For AU","PeriodicalId":15483,"journal":{"name":"JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH","volume":"25 1","pages":""},"PeriodicalIF":0.2,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76565228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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