International Journal of Basic & Clinical Pharmacology
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Thorough QT/QTc (TQT) study
Get PDFWith a number of drugs entering the market, cardiac safety remains a cause of major concern for the regulatory authorities, before approval. The incidence of drug induced arrhythmia with non-cardiovascular drugs is low, however the result is fatal, hence much focus is being given to assess the pro-arrhythmic potential of a drug. The arrhythmogenic risk of the drug is higher if the patient is on polypharmacy or has other risk factors such as an electrolyte imbalance or an underlying structural heart disease. QT prolongation can be either due to congenital causes such as Long QT syndromes (LQTS) which include Romano-Ward syndrome, Jervell and Lange-Nielson syndrome or can be acquired, which is mainly due to drugs. Several drugs such as terfenadine, astemizole, cisapride and grepafloxacin have been withdrawn from the market due to QT prolongation and development of a fatal ventricular arrythmia - torsades de pointes (TdP). This has led to implementation of guidelines to assess cardiac safety. The pro-arrhythmic risk can be assessed using thorough QT/QTc studies or exposure response modelling of intensive ECGs. This article will give an overall view of the use of QT/QTc interval as a biomarker for cardiac safety and the current guidelines for thorough QT/QTc studies which are mainly done to assess the pro-arrhythmic potential of a non-anti-arrhythmic drug
Use of proton pump inhibitors in dialysis unit in tertiary care hospital: a pharmaco-epidemiological study
Get PDFBackground: Proton pump inhibitors (PPI) are generally thought to be safer drug with fewer adverse effects. Though this class of the drug is thought to be well tolerated, a detail study about actual use of these agents in nephrology department is still awaited in many parts of India. There had been case reports and case series which were reporting PPIs producing acute interstitial nephritis progressing to acute renal failure. The risk of PPI treatment in haemodialysis patients remains unexplored. The aim of the study was to evaluate a drug utilization of PPI in patient undergoing haemodialysis procedure.Methods: In this study every day visit to the dialysis units of the hospitals was carried out. After taking consent from the patients, the information from the case-report form was noted like; age, sex, diagnosis, laboratory reports and drug prescried. No personally identifiable information about patient or physician was collected. After this an interview of patients was taken.Results: In this study, out of 126 patients 76.6% were male and 23.4% were female. Out of these 126 patients 88.89% patients were on PPI. Nearly 54% were using PPI for more than six months. Nearly 29% patients were using PPI for more than 12 months.Conclusions: As many case-reports and studies are suggesting, there is co-relation of PPI and acute interstitial nephritis from this study we suggest that especially in nephrology unit patients’, more caution must be exercised while using PPI
A perspective review of deadly viral diseases: An era of viruses
Get PDFThis review article overviewed briefly about the era of deadly viruses. Humans have been combating viruses since before our species had even evolved into its recent form. In some cases of viral infections, vaccines and antiviral drugs have allowed us to treat infections from spreading broadly, and have facilitated to patient recover. But it is far from over to fight the viruses. In recent decades, a number of viruses have sprung from animals to humans and have caused massive outbreaks, claiming thousands of lives such as the virus that led to the 2014-2016 Ebola outbreak in West Africa kills up to 90% of the population, making it the deadliest member of the Ebola family. But there are some viruses that are equally deadly, and some are even more deadly. Some viruses, including the novel coronavirus currently undergoing global outbreaks, have a low mortality rate but still pose a serious health risk as we have no means of access to the health facilities and scarcity of resources and infrastructure. Here we are reporting such type of ten deadly viruses. those have infected humans within last 50 years
Advancing indigenous fruits consumption to promote self-management in ill-health: a critical narrative review
Get PDFMost African communities consume various edible fruits, which are important to their well-being. Some of these edible fruits are indigenous and were well-known to the rural communities. These indigenous fruits can be collected from the wild or planted in home gardens and also as intercrops with staple crops. Some indigenous fruits, wild collection is still practiced, especially in parts of eastern, western and southern Africa. However, some fruits are still imported. A casual verbal survey indicated that many people in the general population do not know that actual differences in nutritional values between these fruits. Therefore, this study was a critical review of some fruits using the USDA database. Results show, for instance, that guava has over 250% vitamin C relative to orange. Avocado yields more calories than banana and this is very likely due to the fat/fibre ratio difference. Further, the imported cucumber and watermelon do not seem to have any advantage over the indigenous products. It concluded that the hidden potential of these indigenous fruits needs to be advanced and exploited to improve their consumption as they play a pivotal role in health economics of healthy dietary habit and self-management of ill-health
A questionnaire-based knowledge, attitude and practice study to determine the awareness of pharmacovigilance among the health care professionals in a tertiary care hospital of West Bengal
Get PDFBackground: Pharmacovigilance programs have been introduced to keep an eye on adverse drug reactions and safe use of drugs. All Healthcare professionals (HCPs) should report each and every adverse events which they come across. Pharmacovigilance programme of India is running actively since 2010 but India contributes only 2% of Adverse drug reactions (ADR’s) reported worldwide. There is need to monitor awareness of HCP’s about pharmacovigilance to achieve the goals. Such studies from peripheries of Eastern India are lacking. The aim of the study was to assess the knowledge, attitude and practice and overall awareness among HCP’s about pharmacovigilance and to understand actual barriers of ADR reporting.Methods: A cross-sectional questionnaire-based study was done in Burdwan Medical College and Hospital. Ninety-nine HCP’s completed the pre-designed questionnaire. There were 15 questions to assess the awareness and cause(s) of underreporting. Data were analysed using appropriate statistical software.Results: We analysed data of 67 doctors and 32 nurses. We found, 67.2% doctors and 59.4% nurses knew definition of pharmacovigilance. About half HCP’s had knowledge about existing pharmacovigilance committee in our hospital. Almost all HCP’s felt ADR reporting is necessary. Surprisingly 88.1% doctors and 46.9% nurses experienced ADR at least once but 25.4% and 3.1% reported them respectively. For knowledge and practice related questions, correct responses were significantly higher for doctors. Most common discouraging factors regarding ADR reporting were, didn’t know how to report (52.5%) where to report (41.4%).Conclusions: Attitude of HCP’s towards pharmacovigilance activities was appreciable and combining it with periodic sensitizing programs, and training sessions will increase the knowledge, clear doubts about ADR reporting and improve the awareness about pharmacovigilance
Effect of nephroprotective Ficus dalhousiae bark extract on gentamicin induced with combination of benzoic acid nephrotoxicity in rats
Get PDFBackground: The Ficus dalhousiae plant (Anjeer family) is. Its important parts-leaves, stem, bark and root are. The current study is design to effect of Ficus dalhousiae bark extract on gentamicin (GM) induced with combination of benzoic acid (BA) nephrotoxicity in rats.Methods: In acute toxicity studies animals are fasted before being dosed; kept overnight. Depending on the time interval. The beginning dose will be chosen from one of four predetermined levels: 5, 50, 300, or 2000 mg/kg of body weight. The animals are evaluated for 4 and 48 hours. In nephroprotective studies we are taken 30 rats which will be divided into 5 groups. proceed group by group like-control with normal saline, BA (100 mg/kg/body weight, IP) daily, hydroalcoholic extract of Ficus dalhousiae (200 mg/kg/body weight, PO) and simultaneously administered GM (100 mg/kg/body weight, IP) daily for 9 days. And we are doing difference types of estimations, like-blood urea, uric acid and serum creatinine.Results: Ficus dalhousiae bark extract on BA action on serum creatinine and urea levels in rats given GM. When compared to control rats, eight days of GM treatment resulted in significantly higher serum creatinine and urea levels. However, BA pretreatments have significantly improved serum creatine and urea (p<0.001) to reduce GM-induced nephrotoxicity (p<0.01, resp.).Conclusions: Ficus dalhousiae has significant nephroprotective activity in nephroprotective studies, acute toxicity activity and various such type of estimations like- blood urea, uric acid and creatinine
A multivariate comparative clinical pharmacotherapeutic efficacy and chronopharmacovigilance assessment study of ofloxacin, one of the commonplace, TGFβ1 inducing and telomerase impairing fluoroquinolones, in treating acute gastroenteritis, chronic obstructive pulmonary disease, new drug-sensitive tuberculosis, recurrent mixed cutaneous infections, and post-surgical refractory wound infections, among the global patients, with heterogenous pharmacogeographic and pharmacogenomic constitution
Get PDFBackground: Ofloxacin has an inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, IL-8, TNFa; and a superinducing effect on IL-2. Ofloxacin has profound bactericidal, anti-tubercular, anti-leprotic, anti-viral including anti-coronavirus, anti-fungal, anti-protozoal, comedolytic, anti-comedogenic, anti-inflammatory, immunomodulatory, and anti-malignant: pro-apoptotic and anti-proliferative potential, including TGFb1 targeted G2 phase cell cycle arrest and telomerase activity impairment. Objectives of the study were a comparative clinical pharmacotherapeutic efficacy and chronopharmacovigilance assessment study, of ofloxacin, one of the commonplace TGFb1 inducing and telomerase impairing fluoroquinolones, in treating heterogenous global patients, suffering from different diseases.Methods: A prospective, multivariate study of 100 patients, allotted into group A (acute gastroenteritis) =20, group B (chronic obstructive pulmonary disease) =20, group C (new drug-sensitive tuberculosis) =20, group D (recurrent mixed cutaneous infections) =20, and group E (post-surgical refractory wound infections) =20, was prescribed ofloxacin 200-400 mg twice daily, according to required prescribed regimens. A comparative pharmacotherapeutic efficacy assessment was made from the complete recovery time-periods, including the residual recovery time-periods. The chronopharmacovigilance assessment was made by adverse effects occurrence monitoring during treatment period or follow-up, with an Adverse Event Case Report Form. Results: The residual recovery time-periods, in group A=0 days, group B=2 days, group E=3 days, group D=3 days, and group C=7 days. Adverse effects were not statistically significant, with a predictable chronopharmacovigilance illustration.Conclusions: The pharmacotherapeutic efficacy of ofloxacin was more for treating group A, followed by group B, followed by group E and group D, and finally followed by group C. Ofloxacin was safe, without any pharmacogenomic or pharmacogeographic heterogeneity related fluctuation
Comparing the effect of statins on hepatic fibrosis induced by carbon tetrachloride in Wistar rats
Get PDFBackground: The clinical studies have shown contrary results regarding hepatoprotective effect of statins. However, antifibrotic properties of statins in in vitro and in vivo experimental models have been demonstrated. The purpose of this study was to assess and compare the effect of statins on serum liver enzymes and their antifibrotic effects.Methods: Forty two rats were divided into 7 groups (I to VII) (n=6). Liver toxicity was induced by injecting carbon tetrachloride (1 ml/kg). Control groups received corn oil (0.1 ml/100 gm) and carboxy methyl cellulose (0.50%) respectively. Group III to VII received carbon tetrachloride (CCl4) for 6 weeks and then groups IV, V, VI and VII received simvastatin (10 mg/kg), atorvastatin (15 mg/kg), rosuvastatin (2 mg/kg) and silymarin (50 mg/kg) for another 8 weeks respectively. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) levels were estimated in all the groups at baseline, 6 weeks and 14 weeks. At 14 weeks, histopathology of liver was done in all groups.Results: At 14 weeks, all the test groups (IV, V and VI) showed a significant decrease in serum ALT, AST and ALP levels as compared to control (p<0.05) and group III (p<0.05). On intergroup comparison, liver enzymes in rats in group VI (rosuvastatin) and group V (atorvastatin) were decreased more in comparison to group IV (simvastatin) but the difference was not statistically significant except for AST levels where the difference was significant between the statins. There was decrease in hepatic fibrosis by statins with rosuvastatin being superior followed by atorvastatin and simvastatin.Conclusions: In the present study statins decreased the serum AST, ALT and ALP levels and histopathological changes were reversed by statins in CCl4 induced hepatotoxic models
Efficacy of leeching (Ta‘līq al-‘Alaq) in patients with vitiligo (baras): a comprehensive case study
Get PDFVitiligo is a hypomelanotic skin disorder in white patches appear on the skin surface and also involve the hair. The disease is idiopathic, acquired and effects 1-4 percent of the world population. It is belived that there is immunologic influence in the pathogenesis of vitiligo and there is evidence of early cell death in vitiligo melanocytes related to their increased sensitivity to oxidative stress. In Ayurveda the vitiation of three doshas results deraignment of rasa, rakta, mamsa and medadhuta which results in vitiligo patches on skin. In Unani System of Medicine (USM) the deraignment of body humours result in the Fasad-e-Ikhlat which results in the Baras (vitiligo). Since both in Ayurveda and USM leech has been used for various dermatalogicalailments including vitiligo. In this study leeching (hirudotherapy) were done in vitiligo patients of both sexes with single and multiple patches and successful results were observed
Lasmiditan: the first neurally acting anti-migraine drug
Get PDFLasmiditan is the first neurally acting drug for the treatment of acute migraine. It is a highly selective, orally acting 5-HT1F agonist that was approved in November 2019, for the acute treatment of migraine in adults, with or without aura, by USFDA. Lesmiditan may help in terminating the acute attack of migraine by inhibiting the central and peripheral neuronal activity and the release of CGRP