Pub Date : 2021-07-26DOI: 10.18203/2319-2003.IJBCP20212761
Noopur Verma, S. Verma, S. Dayal, M. Gupta
Background: Tinea corporis and cruris is said to be recurrent when there is relapse of sign and symptoms after 6 weeks of cure. Recently, there has been increase in cases of recurrent tinea corporis and cruris, with atypical lesions. This study was done to establish efficacy and safety of different terbinafine regimens against recurrent tinea corporis and cruris.Methods: Sixty patients with clinically and mycologically diagnosed recurrent tinea corporis and cruris were enrolled and divided into three groups. Group A was administered oral terbinafine 500 mg once daily for 2 weeks, group B was given terbinafine 250 mg once daily for double duration i.e., 4 weeks, and group C was given standard treatment which is 250 mg once daily for 2 weeks. Physician assessment four-point scale (PA4PS) and KOH wet mount were assessed for clinical and mycological efficacy. Biochemical laboratory parameters (liver function tests and kidney function tests) and adverse drug reactions were assessed for safety.Results: At the end of 6 weeks, reduction in PA4PS from baseline was 46.5%, 95.8%, and 20.4% in groups with double dose, double duration and standard therapy respectively with statistically significant (p<0.05) improvement in group with double duration. Mycological cure at the end of 4 weeks was 80%, 100% and 50%. There was no safety concern in any of the groups.Conclusions: Double duration of terbinafine was found to be more efficacious and safer.
{"title":"Efficacy and safety of different terbinafine regimens in patients of recurrent tinea corporis and cruris","authors":"Noopur Verma, S. Verma, S. Dayal, M. Gupta","doi":"10.18203/2319-2003.IJBCP20212761","DOIUrl":"https://doi.org/10.18203/2319-2003.IJBCP20212761","url":null,"abstract":"Background: Tinea corporis and cruris is said to be recurrent when there is relapse of sign and symptoms after 6 weeks of cure. Recently, there has been increase in cases of recurrent tinea corporis and cruris, with atypical lesions. This study was done to establish efficacy and safety of different terbinafine regimens against recurrent tinea corporis and cruris.Methods: Sixty patients with clinically and mycologically diagnosed recurrent tinea corporis and cruris were enrolled and divided into three groups. Group A was administered oral terbinafine 500 mg once daily for 2 weeks, group B was given terbinafine 250 mg once daily for double duration i.e., 4 weeks, and group C was given standard treatment which is 250 mg once daily for 2 weeks. Physician assessment four-point scale (PA4PS) and KOH wet mount were assessed for clinical and mycological efficacy. Biochemical laboratory parameters (liver function tests and kidney function tests) and adverse drug reactions were assessed for safety.Results: At the end of 6 weeks, reduction in PA4PS from baseline was 46.5%, 95.8%, and 20.4% in groups with double dose, double duration and standard therapy respectively with statistically significant (p<0.05) improvement in group with double duration. Mycological cure at the end of 4 weeks was 80%, 100% and 50%. There was no safety concern in any of the groups.Conclusions: Double duration of terbinafine was found to be more efficacious and safer.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"21 6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82913949","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 : 2021-07-26DOI: 10.18203/2319-2003.IJBCP20212931
A. Jacob, C. Thomas, Anay Deore, P. Deshpande
Background: Drug-drug interactions (DDIs) contribute majorly to hospital admissions, treatment failures, avoidable medical complications and subsequent healthcare costs. Thus, we employ a mechanistic approach to prospectively investigate the incidence of potential DDIs in the psychiatric patients in a clinical setting.Methods: In this prospective, observational, multi centred study conducted for a span of 6 months, psychiatric inpatients (≥18 years) prescribed with 2 or more medications daily for any medical illness were included. The secured prescriptions of the inpatients selected in accordance to the inclusion criteria were then assessed for DDIs using Micromedex(TM) as a standard.Results: Of the total 400 enrolled participants, 383 (95%) of them showed at least one pDDI regardless of the severity. An average of 7.33 interactions per patient was also deduced. A high prevalence of pDDIs totalling to 2900 was recorded in our study with an average of 7.33 interactions per patient. Most of the interactions were of major (56.52%) and moderate severity (39.07) followed by contraindicated (2.55) and minor (1.83). Cardiovascular system (41.77%) had the highest potential to be affected due to the pDDIs identified. Trihexyphenidyl, haloperidol, promethazine, amisulpride, risperidone, divalproex, trifluoperazine, olanzapine and clozapine where among the most commonly encountered drugs in these interactions.Conclusions: A high prevalence of pDDIs totalling to 2900 was recorded in our study with an average of 7.33 interactions per patient. A significant association of the pDDIs with variables such as age, gender, diagnosis and total number of drugs used was identified. More studies are required to explore the overall pattern of DDIs in psychiatric patients along with their levels and correlation with different risk factors. Careful monitoring and documentation are necessary to prevent further complications thereby improving the therapeutic outcome.
{"title":"Appraisal and discernment of prevalent drug-drug interactions in patients with psychiatric disorders","authors":"A. Jacob, C. Thomas, Anay Deore, P. Deshpande","doi":"10.18203/2319-2003.IJBCP20212931","DOIUrl":"https://doi.org/10.18203/2319-2003.IJBCP20212931","url":null,"abstract":"Background: Drug-drug interactions (DDIs) contribute majorly to hospital admissions, treatment failures, avoidable medical complications and subsequent healthcare costs. Thus, we employ a mechanistic approach to prospectively investigate the incidence of potential DDIs in the psychiatric patients in a clinical setting.Methods: In this prospective, observational, multi centred study conducted for a span of 6 months, psychiatric inpatients (≥18 years) prescribed with 2 or more medications daily for any medical illness were included. The secured prescriptions of the inpatients selected in accordance to the inclusion criteria were then assessed for DDIs using Micromedex(TM) as a standard.Results: Of the total 400 enrolled participants, 383 (95%) of them showed at least one pDDI regardless of the severity. An average of 7.33 interactions per patient was also deduced. A high prevalence of pDDIs totalling to 2900 was recorded in our study with an average of 7.33 interactions per patient. Most of the interactions were of major (56.52%) and moderate severity (39.07) followed by contraindicated (2.55) and minor (1.83). Cardiovascular system (41.77%) had the highest potential to be affected due to the pDDIs identified. Trihexyphenidyl, haloperidol, promethazine, amisulpride, risperidone, divalproex, trifluoperazine, olanzapine and clozapine where among the most commonly encountered drugs in these interactions.Conclusions: A high prevalence of pDDIs totalling to 2900 was recorded in our study with an average of 7.33 interactions per patient. A significant association of the pDDIs with variables such as age, gender, diagnosis and total number of drugs used was identified. More studies are required to explore the overall pattern of DDIs in psychiatric patients along with their levels and correlation with different risk factors. Careful monitoring and documentation are necessary to prevent further complications thereby improving the therapeutic outcome.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75443827","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 : 2021-07-26DOI: 10.18203/2319-2003.ijbcp20212933
L. Balasundaram, Bharatraj Kidambi, Surya Singaravelu
With 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.
{"title":"Thorough QT/QTc (TQT) study","authors":"L. Balasundaram, Bharatraj Kidambi, Surya Singaravelu","doi":"10.18203/2319-2003.ijbcp20212933","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212933","url":null,"abstract":"With 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.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"85 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81457588","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 : 2021-07-26DOI: 10.18203/2319-2003.ijbcp20212919
P. Yashaswini, A. Geetha, K. Ravi
Background: Oxidative stress plays major role in diabetes mellitus (DM), abnormal high free radicals decline antioxidant defence mechanism can lead to damage of cellular organelles and enzymes, increased lipid peroxidation and insulin resistance leads to development of complications. Supplementation of antioxidants protects free radical induced damage and further complications. The objective was to evaluate the efficacy and safety of metformin versus metformin with vitamin C and E on glycaemic parameters in newly diagnosed type 2 diabetes mellitus (T2DM).Methods: 60 newly diagnosed T2DM patients were randomized into two groups of 30 in each to receive metformin (500 mg BD) alone in group A versus metformin (500 mg BD)+vitamin C (500 mg OD)+vitamin E (400 mg OD) in group B for 12 weeks. Efficacy was measured by improvement in glycaemic (FBS fasting blood sugar, PPBS postprandial blood sugar and HbA1c glycosylated haemoglobin) parameters at week 4, 8 and 12 from baseline. Safety was assessed by monitoring treatment emergent adverse effects.Results: The baseline characteristics were comparable between the two groups. There was a significant reduction of glycaemic parameters seen in both the groups from baseline to week 12 (p<0.001) but the difference was not statistically significant between the two groups (p>0.05). No significant adverse effects were noted.Conclusions: Both the groups are effective in improving glycaemic indices and supplementation of vitamins along with metformin as compared to metformin alone with no significant adverse effect. Hence, daily consumption of vitamins may be beneficial in decreasing blood glucose in patients with T2DM and thus reducing the risk of complications.
{"title":"A comparative study of efficacy and safety of anti-oxidants as an add-on therapy to metformin on glycemic parameters in newly diagnosed type 2 diabetes mellitus patients at a tertiary care hospital","authors":"P. Yashaswini, A. Geetha, K. Ravi","doi":"10.18203/2319-2003.ijbcp20212919","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212919","url":null,"abstract":"Background: Oxidative stress plays major role in diabetes mellitus (DM), abnormal high free radicals decline antioxidant defence mechanism can lead to damage of cellular organelles and enzymes, increased lipid peroxidation and insulin resistance leads to development of complications. Supplementation of antioxidants protects free radical induced damage and further complications. The objective was to evaluate the efficacy and safety of metformin versus metformin with vitamin C and E on glycaemic parameters in newly diagnosed type 2 diabetes mellitus (T2DM).Methods: 60 newly diagnosed T2DM patients were randomized into two groups of 30 in each to receive metformin (500 mg BD) alone in group A versus metformin (500 mg BD)+vitamin C (500 mg OD)+vitamin E (400 mg OD) in group B for 12 weeks. Efficacy was measured by improvement in glycaemic (FBS fasting blood sugar, PPBS postprandial blood sugar and HbA1c glycosylated haemoglobin) parameters at week 4, 8 and 12 from baseline. Safety was assessed by monitoring treatment emergent adverse effects.Results: The baseline characteristics were comparable between the two groups. There was a significant reduction of glycaemic parameters seen in both the groups from baseline to week 12 (p<0.001) but the difference was not statistically significant between the two groups (p>0.05). No significant adverse effects were noted.Conclusions: Both the groups are effective in improving glycaemic indices and supplementation of vitamins along with metformin as compared to metformin alone with no significant adverse effect. Hence, daily consumption of vitamins may be beneficial in decreasing blood glucose in patients with T2DM and thus reducing the risk of complications.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86969503","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 : 2021-07-26DOI: 10.18203/2319-2003.ijbcp20212928
A. Shah, Neeta Banzal, C. Mehta, Anupama S. Desai
Background: The discussion around COVID-19 vaccines has been in the limelight ever since the announcement was made for mass vaccination campaign in India. Less is known about undergraduate medical students’ perception and willingness towards getting COVID-19 vaccination. The aim of the study was to assess reasons for the apprehension if present towards taking the COVID-19 vaccines among medical students and to spread awareness about the ongoing issue.Methods: This was a prospective, cross sectional, survey-based study which was conducted at Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India. Questionnaire was distributed among medical students during lectures and exam going students were sent Google form link. Data collection was done from February to March 2021, and 550 students submitted the forms.Results: While 34.9% students had taken the vaccine voluntarily, category I (acceptance group); 18.2% students were initially hesitant to take the vaccine, but later took it, category II (hesitant group); the frequency increased to 46.9% students who are still hesitant and have not taken the vaccine, category III (refusal group). Top reasons for hesitancy were: concern regarding adverse events (69%), safety (60%) and lack of scientific data (27%) provided for the vaccines.Conclusions: This study revealed that there was lack of knowledge and positive attitude towards the COVID-19 vaccines among the non-vaccinated students. This evaluation has guided the importance and the need of targeted educational program to address the knowledge gap.
{"title":"Assessment of COVID-19 vaccine hesitancy among undergraduate medical students of a tertiary care teaching hospital, Surat: a source of profound concern","authors":"A. Shah, Neeta Banzal, C. Mehta, Anupama S. Desai","doi":"10.18203/2319-2003.ijbcp20212928","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212928","url":null,"abstract":"Background: The discussion around COVID-19 vaccines has been in the limelight ever since the announcement was made for mass vaccination campaign in India. Less is known about undergraduate medical students’ perception and willingness towards getting COVID-19 vaccination. The aim of the study was to assess reasons for the apprehension if present towards taking the COVID-19 vaccines among medical students and to spread awareness about the ongoing issue.Methods: This was a prospective, cross sectional, survey-based study which was conducted at Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India. Questionnaire was distributed among medical students during lectures and exam going students were sent Google form link. Data collection was done from February to March 2021, and 550 students submitted the forms.Results: While 34.9% students had taken the vaccine voluntarily, category I (acceptance group); 18.2% students were initially hesitant to take the vaccine, but later took it, category II (hesitant group); the frequency increased to 46.9% students who are still hesitant and have not taken the vaccine, category III (refusal group). Top reasons for hesitancy were: concern regarding adverse events (69%), safety (60%) and lack of scientific data (27%) provided for the vaccines.Conclusions: This study revealed that there was lack of knowledge and positive attitude towards the COVID-19 vaccines among the non-vaccinated students. This evaluation has guided the importance and the need of targeted educational program to address the knowledge gap.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87022843","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 : 2021-07-26DOI: 10.18203/2319-2003.ijbcp20212924
Suganthi S. Ramachandran, V. Kumar, S. Dwivedi, Vishwajeet Singh, Pooja Gupta
Background: This study aimed to compare the effect of regular coffee and decaffeinated coffee on psychomotor performance in healthy volunteers during post-lunch period.Methods: In this randomized double-blind cross-over study, adult healthy volunteers were given hot coffee (3 g each of regular or decaffeinated coffee) during post-lunch period. Psychomotor functions (critical flicker-fusion frequency (CFF), choice reaction time (CRT) and error count in hand-steadiness test (HST)), blood pressure and heart rate were measured pre-lunch, pre-coffee (1-hour post-lunch) and 1-hour post-coffee consumption. Subjective ratings of sleepiness and mood were also assessed during post-lunch sessions.Results: The mean age of the participants (n=16) was 27.4±2.7 years with a male: female ratio of 7:9. There was no significant deterioration in psychomotor performance post-lunch when compared to pre-lunch on both the days. The mean CFF, CRT, errors committed in HST and cardiovascular parameters did not differ significantly between regular coffee and decaffeinated groups during post-lunch sessions. There was no significant difference in values of cardiovascular parameters as well as subjective ratings of sleep and mood between two groups.Conclusions: In healthy adult individuals’ consumption of both regular coffee and decaffeinated coffee during the post-lunch period did not affect psychomotor performance.
{"title":"The post-lunch effect of regular and decaffeinated coffee on psychomotor performance: a randomized double-blind cross-over study","authors":"Suganthi S. Ramachandran, V. Kumar, S. Dwivedi, Vishwajeet Singh, Pooja Gupta","doi":"10.18203/2319-2003.ijbcp20212924","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212924","url":null,"abstract":"Background: This study aimed to compare the effect of regular coffee and decaffeinated coffee on psychomotor performance in healthy volunteers during post-lunch period.Methods: In this randomized double-blind cross-over study, adult healthy volunteers were given hot coffee (3 g each of regular or decaffeinated coffee) during post-lunch period. Psychomotor functions (critical flicker-fusion frequency (CFF), choice reaction time (CRT) and error count in hand-steadiness test (HST)), blood pressure and heart rate were measured pre-lunch, pre-coffee (1-hour post-lunch) and 1-hour post-coffee consumption. Subjective ratings of sleepiness and mood were also assessed during post-lunch sessions.Results: The mean age of the participants (n=16) was 27.4±2.7 years with a male: female ratio of 7:9. There was no significant deterioration in psychomotor performance post-lunch when compared to pre-lunch on both the days. The mean CFF, CRT, errors committed in HST and cardiovascular parameters did not differ significantly between regular coffee and decaffeinated groups during post-lunch sessions. There was no significant difference in values of cardiovascular parameters as well as subjective ratings of sleep and mood between two groups.Conclusions: In healthy adult individuals’ consumption of both regular coffee and decaffeinated coffee during the post-lunch period did not affect psychomotor performance.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82974818","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 : 2021-06-22DOI: 10.18203/2319-2003.ijbcp20212379
K. Saxena, S. Srivastava
Background: Majority of the patients first contact the family physicians (FP) for treatment. If adverse drug reaction (ADR) occurs necessary measures are taken and ADR managed but usually not reported. The present study was conducted to assess knowledge, attitude and practice of reporting of ADR among family physicians.Methods: The study was a prospective cross-sectional questionnaire based study. The correctly filled forms from 90 family physicians were analysed based on 20 questions (knowledge 10, attitude 5, and practice 5).Results: Majority of family physicians were aware regarding the occurrence of ADR and 59% of them were aware that all ADR should be reported. Most of (71%) the physicians do not know there is ADR reporting form. Majority of them (93%) are aware that reporting of ADR is necessary that will increase patient safety (92%). About 78% of physician were aware that ADR can be reported by any of health care professional. However, about 71% do not know how to report and where to report ADR. Only few of them (19%) have reported ADR.Conclusions: The family physicians of Surat have adequate knowledge about pharmacovigilance and aware that ADR should be reported. However, most of them have not reported any ADR due to various reasons.
{"title":"Assessment of knowledge, attitude and practice of reporting of adverse drug reaction among family physicians in Surat city","authors":"K. Saxena, S. Srivastava","doi":"10.18203/2319-2003.ijbcp20212379","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212379","url":null,"abstract":"Background: Majority of the patients first contact the family physicians (FP) for treatment. If adverse drug reaction (ADR) occurs necessary measures are taken and ADR managed but usually not reported. The present study was conducted to assess knowledge, attitude and practice of reporting of ADR among family physicians.Methods: The study was a prospective cross-sectional questionnaire based study. The correctly filled forms from 90 family physicians were analysed based on 20 questions (knowledge 10, attitude 5, and practice 5).Results: Majority of family physicians were aware regarding the occurrence of ADR and 59% of them were aware that all ADR should be reported. Most of (71%) the physicians do not know there is ADR reporting form. Majority of them (93%) are aware that reporting of ADR is necessary that will increase patient safety (92%). About 78% of physician were aware that ADR can be reported by any of health care professional. However, about 71% do not know how to report and where to report ADR. Only few of them (19%) have reported ADR.Conclusions: The family physicians of Surat have adequate knowledge about pharmacovigilance and aware that ADR should be reported. However, most of them have not reported any ADR due to various reasons.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76975072","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 : 2021-06-22DOI: 10.18203/2319-2003.ijbcp20212380
Shilpa Shukla, Arkapal Bandyopadhyay, Sumit Kumar, G. Vardhan, B. Goel, C. Choudhary, R. Kant, P. Dhamija
Background: Chronic neuropathic pain, caused by a lesion or disease of the somatosensory nervous system is a common debilitating condition in clinical practice. Pregabalin and Amitriptyline are most commonly used drugs for its management. The aim of the study was to study the safety of Pregabalin and Amitriptyline in chronic neuropathic pain.Methods: Prospective observational study at Department of Medicine and Orthopaedics at All India Institute of Medical Sciences, Rishikesh. Newly diagnosed patients of neuropathic pain who were prescribed either Pregabalin or Amitriptyline were included in the study. Patients were followed up telephonically or during routine visits for a period of 3 months after initiation of any of these drugs. Appropriate measures of central tendency were used to describe demographic and clinical parameters and Correlation test was used between different variables and occurrence of adverse drug reactions.Results: 317 patients were prescribed these drugs. A total of 276 ADRs were observed (128 with Pregabalin and 148 with Amitriptyline). Central nervous system symptoms like sedation and dizziness were most commonly present in both the groups. Diabetes mellitus (47.1%) was most common etiology for neuropathic pain. Causality assessment showed probable association with Amitriptyline (n=140) and Pregabalin (n=118). Majority of ADRs with Amitriptyline group (49.32%) were moderate in severity whereas it was mild with Pregabalin (59.7%). A weak positive correlation (R=0.273) was seen with number of ADRs occurrence and total drug exposure in patients taking Pregabalin whereas a weak negative correlation (R=-0.623) was seen in Amitriptyline treated group.Conclusions: Safety profile of Pregabalin was better than Amitriptyline in the present study. The study findings must be replicated in larger patient population and for a prolonged duration for better understanding of the pattern of adverse drug reactions.
{"title":"Painful neuropathy: comparative observational analysis of safety profile of pregabalin and amitriptyline","authors":"Shilpa Shukla, Arkapal Bandyopadhyay, Sumit Kumar, G. Vardhan, B. Goel, C. Choudhary, R. Kant, P. Dhamija","doi":"10.18203/2319-2003.ijbcp20212380","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212380","url":null,"abstract":"Background: Chronic neuropathic pain, caused by a lesion or disease of the somatosensory nervous system is a common debilitating condition in clinical practice. Pregabalin and Amitriptyline are most commonly used drugs for its management. The aim of the study was to study the safety of Pregabalin and Amitriptyline in chronic neuropathic pain.Methods: Prospective observational study at Department of Medicine and Orthopaedics at All India Institute of Medical Sciences, Rishikesh. Newly diagnosed patients of neuropathic pain who were prescribed either Pregabalin or Amitriptyline were included in the study. Patients were followed up telephonically or during routine visits for a period of 3 months after initiation of any of these drugs. Appropriate measures of central tendency were used to describe demographic and clinical parameters and Correlation test was used between different variables and occurrence of adverse drug reactions.Results: 317 patients were prescribed these drugs. A total of 276 ADRs were observed (128 with Pregabalin and 148 with Amitriptyline). Central nervous system symptoms like sedation and dizziness were most commonly present in both the groups. Diabetes mellitus (47.1%) was most common etiology for neuropathic pain. Causality assessment showed probable association with Amitriptyline (n=140) and Pregabalin (n=118). Majority of ADRs with Amitriptyline group (49.32%) were moderate in severity whereas it was mild with Pregabalin (59.7%). A weak positive correlation (R=0.273) was seen with number of ADRs occurrence and total drug exposure in patients taking Pregabalin whereas a weak negative correlation (R=-0.623) was seen in Amitriptyline treated group.Conclusions: Safety profile of Pregabalin was better than Amitriptyline in the present study. The study findings must be replicated in larger patient population and for a prolonged duration for better understanding of the pattern of adverse drug reactions. ","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87758134","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 : 2021-06-22DOI: 10.18203/2319-2003.ijbcp20212378
Disha Patel, Chetankumar R. Acharya
Background: Tuberculosis is major cause of death in India. Analysis of heart rate variability is one of the most popular methods of autonomic nervous system evaluation. Shorter MDR-TB regimen drugs affect both central nervous system as well as peripheral nervous system. Existing research suggests that active pulmonary tuberculosis causes ANS dysfunction. So, by HRV measurement impact of shorter MDR-TB regimen drugs on autonomic dysfunction can be correlated. Aim of the current investigation was to evaluate effect of shorter MDR-TB regimen drugs on cardiac autonomic regulation in MDR-TB patients with respect to heart rate variability as a parameter.Methods: Fifty newly diagnosed MDR-TB patients of either gender on shorter MDR- TB regimen were enrolled in this study after taking consent. After 20 minutes rest, ECG was taken by “physiopac digital polygraph” software for 5 minutes. Two follow-up HRV assessments were done on 2nd month and 4th or 6th month of treatment. HRV was calculated by root mean square deviation of successive differences between adjacent RR intervals (RMSSD) and low frequency and high frequency ratio.Results: Repeated measures ANOVA showed no statistically significant difference in HRV parameters between baseline, 2 months and 6 months groups. So, sympathetic and parasympathetic modulation in terms of HRV remains unchanged during treatment of MDR-TB with shorter MDR-TB regimen drugs.Conclusions: Shorter MDR-TB regimen drugs don’t have any significant impact on HRV in MDR- TB patients, No correlation was observed between HRV and heart rate in MDR-TB patients.
{"title":"Impact of shorter MDR tuberculosis regimen drugs on heart rate variability in MDR tuberculosis patients at tertiary care hospital","authors":"Disha Patel, Chetankumar R. Acharya","doi":"10.18203/2319-2003.ijbcp20212378","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212378","url":null,"abstract":"Background: Tuberculosis is major cause of death in India. Analysis of heart rate variability is one of the most popular methods of autonomic nervous system evaluation. Shorter MDR-TB regimen drugs affect both central nervous system as well as peripheral nervous system. Existing research suggests that active pulmonary tuberculosis causes ANS dysfunction. So, by HRV measurement impact of shorter MDR-TB regimen drugs on autonomic dysfunction can be correlated. Aim of the current investigation was to evaluate effect of shorter MDR-TB regimen drugs on cardiac autonomic regulation in MDR-TB patients with respect to heart rate variability as a parameter.Methods: Fifty newly diagnosed MDR-TB patients of either gender on shorter MDR- TB regimen were enrolled in this study after taking consent. After 20 minutes rest, ECG was taken by “physiopac digital polygraph” software for 5 minutes. Two follow-up HRV assessments were done on 2nd month and 4th or 6th month of treatment. HRV was calculated by root mean square deviation of successive differences between adjacent RR intervals (RMSSD) and low frequency and high frequency ratio.Results: Repeated measures ANOVA showed no statistically significant difference in HRV parameters between baseline, 2 months and 6 months groups. So, sympathetic and parasympathetic modulation in terms of HRV remains unchanged during treatment of MDR-TB with shorter MDR-TB regimen drugs.Conclusions: Shorter MDR-TB regimen drugs don’t have any significant impact on HRV in MDR- TB patients, No correlation was observed between HRV and heart rate in MDR-TB patients.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"466 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83019351","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 : 2021-06-22DOI: 10.18203/2319-2003.ijbcp20212376
S. Johar, D. Jaybhaye, S. Chandra, P. Mishra
Background: Clinical research is a component of medical and health research that facilitates valuable knowledge regarding diagnosis, prevention as well as treatment of a disease. Nowadays, the practise of medicine is evidence-based and combining medical education with clinical research provides a channel for translating scientifically advanced knowledge into better public health. The aim of the study was to assess knowledge (K), attitude (A), and practices (P) about clinical research among post graduate medical students.Methods: After obtaining institutional ethics committee approval, a cross-sectional and questionnaire-based study was conducted. A pre-structured and validated KAP questionnaire comprising of 25 questions (knowledge-15, attitude-5 and practices-5) was shared online through google forms with post graduate students. The responses to the questions were later marked correct or incorrect. The data was collected and compiled using Microsoft excel and expressed in percentage (%). Data analysis was performed using SPSS version 25.0.Results: 102 students responded to the questionnaire completely. Out of which males (55.9%) pre-dominated and majority of the PG students belonged to I year accounting for 40.2%. About 61.76% PG students were aware about a clinical research unit in the college. Majority of the students acknowledged the necessity of conducting clinical research and exhibited good knowledge about key concepts of clinical trials. Even responses to questions pertaining to attitude towards clinical research were also majorly positive. On the contrary, more than 90% students had neither attended any workshop on ICH-GCP guidelines nor registered their academic study under clinical trial registry of India. However, 73.5% of them expressed their willingness to participate in a clinical trial in future.Conclusions: Although, assessment of knowledge and attitudes about clinical research among post graduate students showed positive results but discrepancies were observed in its practise. As such, this necessitates incorporation of clinical research activities into existing medical education system.
{"title":"Evaluation of knowledge, attitude and practices of postgraduate medical students towards clinical research in a tertiary care teaching hospital","authors":"S. Johar, D. Jaybhaye, S. Chandra, P. Mishra","doi":"10.18203/2319-2003.ijbcp20212376","DOIUrl":"https://doi.org/10.18203/2319-2003.ijbcp20212376","url":null,"abstract":"Background: Clinical research is a component of medical and health research that facilitates valuable knowledge regarding diagnosis, prevention as well as treatment of a disease. Nowadays, the practise of medicine is evidence-based and combining medical education with clinical research provides a channel for translating scientifically advanced knowledge into better public health. The aim of the study was to assess knowledge (K), attitude (A), and practices (P) about clinical research among post graduate medical students.Methods: After obtaining institutional ethics committee approval, a cross-sectional and questionnaire-based study was conducted. A pre-structured and validated KAP questionnaire comprising of 25 questions (knowledge-15, attitude-5 and practices-5) was shared online through google forms with post graduate students. The responses to the questions were later marked correct or incorrect. The data was collected and compiled using Microsoft excel and expressed in percentage (%). Data analysis was performed using SPSS version 25.0.Results: 102 students responded to the questionnaire completely. Out of which males (55.9%) pre-dominated and majority of the PG students belonged to I year accounting for 40.2%. About 61.76% PG students were aware about a clinical research unit in the college. Majority of the students acknowledged the necessity of conducting clinical research and exhibited good knowledge about key concepts of clinical trials. Even responses to questions pertaining to attitude towards clinical research were also majorly positive. On the contrary, more than 90% students had neither attended any workshop on ICH-GCP guidelines nor registered their academic study under clinical trial registry of India. However, 73.5% of them expressed their willingness to participate in a clinical trial in future.Conclusions: Although, assessment of knowledge and attitudes about clinical research among post graduate students showed positive results but discrepancies were observed in its practise. As such, this necessitates incorporation of clinical research activities into existing medical education system.","PeriodicalId":13901,"journal":{"name":"International Journal of Basic & Clinical Pharmacology","volume":"7 1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78350353","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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