{"title":"Anecdotal and experimental observation of putative onco-regressive factors in urine: The need for detailed further investigation.","authors":"Ashok D B Vaidya","doi":"10.4103/ijp.ijp_270_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_270_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"5 1","pages":"295-296"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A novel ultra-performance liquid chromatography detection method development and validation for paclitaxel and its major metabolite in human plasma.","authors":"Vikas Kumar,Gyan Vardhan,Amit Sehrawat,Shailendra Handu,Puneet Dhamija","doi":"10.4103/ijp.ijp_557_23","DOIUrl":"https://doi.org/10.4103/ijp.ijp_557_23","url":null,"abstract":"BACKGROUNDPaclitaxel is a promising anticancer drug for patients with ovarian, breast, lung, gastrointestinal, genitourinary, prostate, and head-and-neck cancers. Paclitaxel follows nonlinear pharmacokinetics. The major metabolite of paclitaxel is 6-alpha-hydroxy paclitaxel, mediated by CYP2C8, while metabolism to two of its minor metabolites, 3'-p-hydroxypaclitaxel and 6a, 3'- p-dihydroxypaclitaxel, is catalyzed by CYP3A4. Therapeutic drug monitoring of paclitaxel could be a promising approach to improve the efficacy and safety of paclitaxel correct personalized doses and improve the overall benefit-risk ratio. A novel and highly sensitive chromatographic method for the detection of paclitaxel and its metabolite has been proposed that allows quantification in human plasma with 100% accuracy in terms of recovery without significant intraday or interday variations.MATERIALS AND METHODSThe present study was planned following bioanalytical method validation guidance according to the U.S. Food and Drug Administration requirements. The validation of the analytical procedure was performed as per ICH Q2(R1) guidelines. It was done to assure the reliability of the results obtained for various parameters such as linearity, accuracy, precision, limit of detection (LOD), limit of quantification, robustness, stability, and system suitability.RESULTSThe specificity of the method was established by ensuring no interference with peak obtained from paclitaxel and 6-alpha-hydroxy paclitaxel. LOD was found to be 0.05 and 0.033 while the limit of quantitation was 0.14 and 0.099 for paclitaxel and 6-alpha-hydroxy paclitaxel, respectively. Median (±interquartile range) accuracy for paclitaxel and 6-alpha-hydroxy paclitaxel was found to be 102.73 (±13.581) and 100.87 (±7.573), respectively.CONCLUSIONThis novel method of simultaneous detection of paclitaxel and its major metabolite 6-alpha-hydroxy paclitaxel demonstrated significant resolution and was sensitive enough for its quantification in human plasma.","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"4 1","pages":"253-259"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Can baxdrostat revamp resistant hypertension status in India?","authors":"Elisha Paikray,Satyajit Mohapatra","doi":"10.4103/ijp.ijp_141_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_141_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"25 1","pages":"293-294"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prospective, randomized, placebo-controlled, two-arm study to evaluate the efficacy of coadministration of garlic as a hydrogen sulfide donor and tadalafil in patients with erectile dysfunction not responding to tadalafil alone – A pilot study","authors":"Gajanan Shripad Bhat, Anuradha Shastry","doi":"10.4103/ijp.ijp_310_23","DOIUrl":"https://doi.org/10.4103/ijp.ijp_310_23","url":null,"abstract":"<h3>OBJECTIVE: </h3>\u0000<p>The objective is to evaluate the efficacy of coadministration of garlic (as a hydrogen sulfide [H<sub xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">2</sub>S] donor) and tadalafil for patients with ED using a placebo-controlled, prospective, randomized, two-arm pilot study in patients responding poorly to tadalafil alone.</p>\u0000<h3>MATERIALS AND METHODS: </h3>\u0000<p>The patients with complaints of ED (with normal penile Doppler) who failed to maintain sustained improvement in erectile function with tadalafil were recruited after excluding those with comorbidities. The study sample was randomized into two groups. Group A received garlic 5 g twice a day orally and Group B received a placebo twice daily orally for 4 weeks. Both groups continued tadalafil 5 mg in the night for 4 weeks. Their erectile function was assessed at the beginning and at the end of 4 weeks using the International Index of Erectile Function (IIEF-EF), erectile function domain and compared. A value of <em xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">P</em> ≤ 0.05 was considered statistically significant.</p>\u0000<h3>RESULTS: </h3>\u0000<p>Nineteen patients in Group A (mean age 37.5 ± 10.6 years) and 16 patients in Group B (mean age 39.6 ± 9.6 years) participated in the pilot study conducted from May 2022 to August 2022. The participants treated with garlic (as an H<sub xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">2</sub>S donor) as a coadministrant had statistically significant improvement in IIEF-EF score (<em xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">P</em> ≤ 0.0001) at the end of 4 weeks compared to placebo.</p>\u0000<h3>CONCLUSIONS: </h3>\u0000<p>Garlic (as an H<sub xmlns:mrws=\"http://webservices.ovid.com/mrws/1.0\">2</sub>S donor) as adjunctive therapy was beneficial in our study participants responding poorly to tadalafil alone.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"40 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
B Sindhoora,Vandana Singh,Sathish Kumar Mungamuri,Dinesh Kumar Bharatraj
{"title":"Pharmacological benefits of durva swaras (Cynodon dactylon L. Pers.) administration in APAP-induced liver injury model of mice - Assessment by metabolic and inflammatory markers.","authors":"B Sindhoora,Vandana Singh,Sathish Kumar Mungamuri,Dinesh Kumar Bharatraj","doi":"10.4103/ijp.ijp_133_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_133_24","url":null,"abstract":"OBJECTIVELiver derangement underlies the development of metabolic syndrome in perimenopause. Previously, we have observed that durva swaras (DS) improved metabolic-associated fatty liver disease (MAFLD) and abnormal liver enzymes (aspartate aminotransferase and alanine aminotransferase) along with other complications of menopause in ovariectomized rats. We aimed to decipher the hepatoprotective mechanisms of DS in acetaminophen (APAP)-induced liver injury model, which is analogous to the pathophysiology of MAFLD.MATERIALS AND METHODSMale Swiss albino mice were distributed into three groups at random. Group I (Control) was administered with vehicle (distilled water) for 7 days. Group II (APAP) received vehicle for the first 6 days and APAP (350 mg/kg - single dose) on the 7th day. Group III (APAP + D) received test compound DS (quality complied) at a dose of 133 mg/kg for 6 days and APAP (350 mg/kg - single dose) on the 7th day. Subsequently, blood and liver tissues were subjected to biochemical, ultrastructural, and gene expression analysis.RESULTSDS pretreatment protected the liver from APAP-induced disruption of sinusoids and necrosis. DS prevented the elevation of liver enzymes - AST and ALT induced by APAP. Importantly, DS inhibited the APAP-elicited increase in messenger ribonucleic acid levels of hepatic nuclear factor-kappa beta (NF-κB) and pro-inflammatory cytokines, namely interleukin-1 beta, interleukin 6, and tumor necrosis factor-alpha. Moreover, DS activated gene expression of nuclear factor erythroid 2-related factor 2 and liver-X-receptor-alpha (LXR-α) to combat the liver damage.CONCLUSIONDS hinders APAP-induced liver damage by activating LXR-α and inhibiting the NF-κB-associated pro-inflammatory cytokine gene expression. These observations confirm the protective role of DS in metabolic dysfunction-associated liver conditions.","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"6 1","pages":"260-267"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142206518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Judhajit Maiti, Gerry George Mathew, V. Jayaprakash, S. Sreedhar
{"title":"Anti-tubercular treatment-induced granulomatous acute interstitial nephritis","authors":"Judhajit Maiti, Gerry George Mathew, V. Jayaprakash, S. Sreedhar","doi":"10.4103/ijp.ijp_19_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_19_24","url":null,"abstract":"<p>This case emphasizes the value of meticulous observation and regular follow-up of patients receiving rifampicin therapy. The prognosis for complete improvement in renal function in such cases was excellent, with prompt recognition and discontinuation of rifampicin. Teaching patients about these possible adverse effects and encouraging immediate reporting of signs and symptoms are likely to be beneficial because acute kidney injury can manifest itself very quickly after rifampicin is started. Even if renal failure can happen with any dose of rifampicin, primary physicians must have awareness about patients on intermittent or irregular therapy and those who have previously used this medication. It is challenging to determine the prevalence of adverse reactions to common antibiotics where a state- or country-wide reporting system is absent. Along with withdrawal of the causative agent patients were treated with corticosteroids (0.5–1 mg/kg/day) for an average period of 4–12 weeks showing significant recovery of renal function.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"11 1","pages":""},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy, safety, and cost-effectiveness of biosimilars of bevacizumab in näive patients with diabetic macular edema.","authors":"Shalini Virani,Akshay Bhatiwal,Parveen Rewri","doi":"10.4103/ijp.ijp_58_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_58_24","url":null,"abstract":"OBJECTIVESAnti-vascular endothelial growth factor (VEGF) therapy restores retinal architecture and enhances vision in diabetic macular edema (DME). Bevacizumab is an off-label anti-VEGF drug that effectively treats DME. The safety and efficacy of bevacizumab biosimilars, which are more affordable than the original medication, still need to be established. This study aimed to assess the cost-effectiveness, efficacy, and safety of biosimilars for treating patients with naïve DME across various price ranges that are accessible in the Indian market.MATERIALS AND METHODSTwo biosimilars, BevaciRelTM (Reliance Life Sciences Pvt. Ltd.) and ZyBev (Cadila Healthcare Limited), were compared to their original, Avastin (Roche Products [India] Pvt. Ltd.), in a randomized, control study. Three end-notes were used to assess safety and efficacy: persistence, improvement, and adverse events. Cost-effective analysis was carried out using a decision-tree analysis model.RESULTSThis study included 69 (59%) men and 54 (41%) women with naïve DME. The cohort had an average log MAR visual acuity of 0.87 ± 0.22, and the central retinal thickness at baseline on OCT was 398.5 ± 37.61 μm. The visual acuity showed a similar improvement, and there was a decrease in central retinal thickness as observed on OCT across the groups. The incremental cost-effectiveness ratio was 10.8.CONCLUSIONSThe biosimilars of bevacizumab are safe and efficacious in treating DME in a cost-effective manner.","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"185 1","pages":"248-252"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mugundan Uma Maheshwari, Muhasaparur Ganesan Rajanandh
{"title":"From antiviral to anticancer: Exploring efavirenz's potential against breast cancer.","authors":"Mugundan Uma Maheshwari, Muhasaparur Ganesan Rajanandh","doi":"10.4103/ijp.ijp_332_24","DOIUrl":"10.4103/ijp.ijp_332_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"361-362"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Metformin-induced eyelid myokymia.","authors":"Marya Ahsan, Deba Jalal Nizami","doi":"10.4103/ijp.ijp_284_24","DOIUrl":"10.4103/ijp.ijp_284_24","url":null,"abstract":"<p><strong>Abstract: </strong>Metformin, an insulin-sensitizer, is used in the treatment of polycystic ovarian syndrome (PCOS) in obese women as it helps in weight loss and regularizes the menstrual cycle. However, impaired absorption of Vitamin B12 due to metformin has also been hypothesized. Here, we report the case of a 39-year-old woman prescribed metformin for PCOS, presenting with an unusual symptom of eyelid myokymia. She developed distressing unilateral eyelid twitching, not responsive to conservative management or oral methylcobalamin. She was a nonsmoker, nonalcoholic, and nor caffeine-abuser. Other confounding factors such as stress, sleep deprivation, or eye strain were not evident. The only significant finding was borderline low Vitamin B12 levels. The symptoms subsided on discontinuation of metformin and reappeared when metformin was reintroduced. Although eyelid myokymia is a self-limiting benign condition, it can also be triggered by drugs and affect the quality of life. Practitioners should monitor Vitamin B12 levels during metformin therapy to prevent adverse effects.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"358-360"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698286/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The role of very low-dose prophylaxis in severe hemophilia patients.","authors":"Sunita Aggarwal, Anshul Tomar, Kapil Kumar, Ankitesh Kumar, Suresh Kumar, Sandeep Garg, Naresh Kumar, Sudipta Nandi","doi":"10.4103/ijp.ijp_333_24","DOIUrl":"10.4103/ijp.ijp_333_24","url":null,"abstract":"<p><strong>Introduction: </strong>Very low-dose prophylaxis of antihemophilic factor (AHF) in hemophilia involves administration of minimal amounts of clotting factor concentrates, typically below standard doses, to maintain baseline levels and reduce bleeding episodes. This method uses smaller, more frequent doses to balance bleeding prevention and cost-effectiveness. Close monitoring ensures adequate protection while avoiding overtreatment, offering a tailored, cost-effective approach to improve the quality of life (QoL) of the hemophiliacs.</p><p><strong>Aim: </strong>The study aims to study the bleeding risks in patients with severe hemophilia who are on very low-dose AHF prophylaxis. It also seeks to assess the annual consumption of AHF in the hemophiliacs. In addition, the research will determine the QoL in both groups using the social functioning (SF)-36 questionnaire,evaluate patient compliance with the prophylactic regimen, and check functional disability using the Functional Independence Score in Hemophilia (FISH).</p><p><strong>Materials and methods: </strong>The patients selected for the study were diagnosed with cases of hemophilia and were planned for any surgical procedure. The study was a cross-sectional study lasting 12 months. Patients over 13 years were included and patients with any other bleeding tendencies were excluded from the study.</p><p><strong>Results: </strong>The differences found in the study, were significant in terms of annual bleed rate (ABR), amount of AHF consumed, SF-36, and FISH scores.</p><p><strong>Conclusion: </strong>Our study found that very low-dose prophylaxis significantly reduced the ABR in hemophilia patients. Functional independence worsened in the control group but remained stable in the test group, which showed significant improvements in SF-36 domains. The test group had no inhibitor development and showed a decline in severe bleeds, proving the efficacy and superiority of low-dose prophylaxis over on-demand therapy.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"312-316"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}