International Journal of Basic & Clinical Pharmacology
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A randomized, double-blind, parallel, placebo-controlled study to evaluate efficacy and safety of a synergistic multi-herbal extract blend KaraHeart™ in supporting healthy cholesterol levels
Get PDFBackground: Hyperlipidemia is a condition involving abnormally high levels of lipids in the blood. Hyperlipidemia is a major risk factor for cardiovascular diseases and refers to either high levels of triglycerides (TGL) or cholesterol. Herbal supplements have been used in the management of cholesterol levels in Ayurveda, a complete medical system originating in India. KaraHeart™ is a multi-herbal extract synergistic blend that may help in the management of healthy cholesterol levels. The current study tested the efficacy, tolerability, and safety of KaraHeart™ versus a placebo in the management of cholesterol levels of patients with mild hyperlipidemia.Methods: This was a randomized, double-blind, parallel, and placebo-controlled study. A total of 100 patients were divided into two groups. One group was given KaraHeart™ and the other group was given a placebo for 120 days. Treatment results were assessed by checking the lipid profile parameters such as total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very-low-density lipoprotein (VLDL), and TGL.Results: The study found that the herbal supplement KaraHeart™ significantly reduced levels of LDL, VLDL, TGL, and total cholesterol, while increasing the levels of HDL in the blood. Additionally, the study concluded that KaraHeart™ was safe to use.Conclusions: KaraHeart™ was shown to be safe and effective in the management of cholesterol levels
A systematic review on metformin rational pharmacotherapeutics
Get PDFThis systematic review of the different and wide-ranged studies on metformin rational pharmacotherapeutics was performed, for a better comprehension of multi-centre maintenance of rational pharmacotherapeutic aspects in the regular anti-diabetic treatment prescribed to the new type II diabetic patients. This systematic review contributed 3729 refined and relevant medical records, among total 4570 records obtained from the study databases search, thus providing a refined qualitatively synthesised conclusive medical research study literature, on metformin rational pharmacotherapeutics
Is pregabalin better than gabapentin in treatment of neuropathic pain? An observation-based study at tertiary care centre of North India
Get PDFBackground: The present study was undertaken to assess the efficacy of pregabalin and gabapentin in treatment of neuropathic pain at a government tertiary care hospital of Uttar Pradesh, India. Due to indiscriminate use of drugs for treatment of neuropathic pain, selection of an effective drug is need of hour.Methods: Out of 130 patients, 62 patients were given pregabalin and 68 were given gabapentin. Douleur Neuropathique 4 questionnaire (DN4) which was used to diagnose patients of neuropathic pain. Efficacy of drug was based on their capability to decrease neuropathic pain at regular intervals.Results: On comparing the efficacy of drugs by their ability to decrease neuropathic pain, there was a significant difference when comparing pregabalin and gabapentin, pregabalin being statistically significant than gabapentin.Conclusions: On the basis present study efficacy of pregabalin 300 mg once daily brought better improvement of symptoms and sign than that of gabapentin 600 mg administered once daily dose. So pregabalin is a better drug than gabapentin
Hemovigilance: a momentous step to blood safety
Get PDFHemovigilance is a series of monitoring procedures that cover the entire transfusion chain, from blood and its component collection to recipient follow-up, collecting and collecting information about unexpected or adverse effects resulting from the therapeutic use of unstable blood products. It is designed to be evaluated, and to prevent their occurrence and recurrence. The Haemovigilance program in developed countries is associated with IHN and has voluntary reporting requirements. In France, Germany and Switzerland, the hemodynamic system is regulated by supervisors. It is one of the blood manufacturers in Japan, Singapore and South Africa. In the Netherlands and the United Kingdom within the Medical Society; in Canada, regulated by health authorities. Intensive blood exercise program to ensure patient safety and promote public health begins on December 10, 2012 in Phase 1 in collaboration with National Institute of Biological Sciences under MOHFW for the first time in India it was done. HvPI is responding very well, as most medical colleges and laboratories have already registered and are beginning to provide data on side effects. The HvPI Unit produces educational materials in the form of publishing the Haemovigilance newsletter, information, education and communication (IEC) literature, and conducts an academic CME and awareness program on Haemovigilance throughout the year in India. The provocation is to understand not only the feedback of the internet, but even the sociology of human networks. Guaranteeing the reliability, responsiveness, and feedback of each alert is also important. Blood products are an important area of PvPI for reporting and recording post-transfusion ADRs of blood / blood products. To work efficiently, a lean mechanism and proper coordination with standardized tools at all levels is needed
COVID-19 impact on the prevalence of PIMS in elderly patients according to STOPP/ START criteria: a record base study
Get PDFBackground: Polypharmacy, contribute to an increased risk of adverse drug reaction morbidity, and mortality, and increases the length of hospital stay, hospital revisits and readmissions. We aimed to evaluate the prevalence and trends of polypharmacy and potentially inappropriate medications in elderly patients with version 2. STOPP/START criteria, and assess the severity of adverse drug events in patients with PIMs.Methods: This is a retrospective, record-based study of over-the-counter, and potentially inappropriate medications in the prescriptions of patients (>60 years). PIMs have been identified and further investigated to determine any adverse effects. If harm occurred, the severity of an adverse effect was rated using a modified Hartwig and Siegel scale. The causality of the events was assessed by using Naranjo's scale.Results: Out of 583 patients polypharmacy and excessive polypharmacy were found in 36.0%, and 42.8% of pre-admission medications. The most common over-the-counter (OTC) drugs were hydrocortisone (39.86%), ranitidine (21.62%), bisacodyl (14.86%), and diphenhydramine (12.84%). A statistically significant positive correlation was seen between age and the number of drugs prescribed (r2=0.16), while a non-significant positive correlation was found between sex, length of stay (LOS), and the number of drugs prescribed (r2 =0.0002, r2 =0.001). Common PIMs related incidence reported include Insulin (regular) 31.25% (N=20), Trihexyphenidyl (THP) 18.75%, zolpidem 12.5%, acetylsalicylic acid 9.3%, pantoprazole 52 7.81%, furosemide 7.8%, hydrocortisone 6.25%, and glimepiride 6.25%. Total of 130 ADRs 50% were mild, 28.4% were moderate, and 21.5% were severe. Out of 130 incidents, 64.6% were preventable, 22.3% were probably preventable, and 13.0% were not preventable. A total of 50.0% recovered completely from the ADRs, 33.0% had been recovering, 12.3% recovered with a squeal, 2.3% could not recover and 2.3% had been fatal.Conclusions: The study shows high uses of OTC and PIMs and PGx in elderly patients; which encourage intent need to develop awareness and action plans
Determination of resistance pattern of bacteriostatic antimicrobial drugs by analysis of blood culture reports
Get PDFBackground: Determination of each isolated bacterium from blood culture and pattern of antimicrobial sensitivity has an important role epidemiologically in a region and can assist physicians in the determination of primary antimicrobial agents. In this study, schema of resistance of bacteriostatic antimicrobials in blood culture is evaluated. Determination of resistance pattern of bacteriostatic antimicrobial drugs by analysis of blood culture report.Methods: A retrospective analysis of microbiological blood culture and antibiotics sensitivity results have been done. A total of 120 laboratory culture results were selected randomly during the observational period. These all-blood culture reports were analyzed for bacteriostatic antimicrobial resistance pattern.Results: The 41 bacterial isolates were obtained from 120 blood culture reports, 24.39% (10) were gram positive and 75.60% (31) were gram-negative. The most frequently isolated gram-negative organisms were K. pneumoniae (34.14%) followed by Pseudomonas (12.19%), E. coli (12.19%). The most frequently isolated gram-positive organism was staphylococcus aureus. All isolates showed less resistance to bacteriostatic antibiotics like clindamycin, chloramphenicol, co-trimoxazole, doxycycline, linezolid, tetracycline, nitrofurantoin, erythromycin, tigecycline.Conclusions: S. aureus, E. coli and Klebsiella spp. pseudomonas aeruginosa were the leading causes of septicaemia or any type of infection in our study finding. These bacteria isolates were highly resistant to bactericidal antimicrobials. But bacteriostatic antimicrobial has shown less resistance compared to bactericidal
Pharmacokinetic availability of proteolytic enzymes after oral administration: a narrative review of the literature
Get PDFOrally administered serine and cysteine proteolytic enzymes are used extensively in the therapy of various inflammatory conditions. However, due to their protein nature, there have been concerns about these enzymes undergoing digestion or biotransformation in the gut and the resultant amount of active enzyme reaching blood circulation and at the site of inflammation. Research has shown that orally administered serine and cysteine proteases are able to pass through the mucosal barrier of the gastrointestinal tract and reach the blood and lymph as intact, high molecular weight and physiologically active forms. These have been studied in in vitro, animal models and further confirmed in human studies. Despite high inter-individual variability, the maximum plasma levels of the free proteases follow dose linearity. They circulate bound to plasma anti-proteases and are detectable in clinically significant concentrations. Targeted studies also indicate that paracellular transport mechanism may play a significant role in the absorption of these molecules. We present a summary of the existing knowledge from these studies
A study on the knowledge, attitude and practice of junior doctors to adverse drug event reporting in a tertiary care hospital, Manipur
Get PDFBackground: The aim of the present study is to find out the ways to improve the status of adverse drug effect (ADE) reporting to the pharmacovigilance centres.Methods: The present study is a cross-sectional study with purposive sampling. Descriptive statistics is used for analysing the data from the questionnaire using frequencies and percentages.Results: The response on the questionnaire was 77.7%. The 90 participants knew the definition of ADE. The 91 participants want to report the ADEs of newly marketed drugs. Only 70 participants know about the existence of PvPI. The 80 participants did not consider all OTC drugs to be safe. 95 participants opined that all Herbal and non-allopathic drugs are not safe. The 69 participants replied that no ADE monitoring centre was available in SHIJA hospitals and research institute Pvt. Ltd. Though 90 participants knew the definition of ADE, only 85.1% of them considered to report it as a professional obligation. Maximum ADEs are seen with skin, paediatric and elderly patients as opined by 57.4% of the participants. Varied opinions of occurrence of ADEs according to the participants with polypharmacy was 70.3% and with foods and drinks was 40.6%. Although 85.1% participants have the attitude of reporting ADE, only 63.4% participants have good clarity when reporting and filling the ADE forms with careful observation of the risks and behaviour of the patients.Conclusions: To promote ADE reporting, a regular awareness cum sensitization programme coupled with CME program is necessary at various levels of health-care providers
Cinemeducation: a teaching-learning tool to teach professionalism and ethics in medical undergraduates
Get PDFBackground: The study was undertaken in II year medical students to sensitize and make student competent for professionalism and ethics to maintain respect for patients, colleagues and society and role of Informed Consent in a clinical trial using Cinema-education Methods: A brief lecture about professionalism and ethics and hands-on training to write reflections was conducted. During session, the knowledge gained and attitudes were checked by pre-test questionnaire. In the Session the students were shown short movie clips that portray on professionalism and ethics which highlight doctor patient relationship in context of maintaining respect of patient, colleagues and society and ethical aspects of informed consent in a clinical trial. The Post session was assessed by a role play, post-test, feedback and reflection writing and analyzed using content and narrative analysis.Results: Respect towards patients and co-workers and taking informed consent were the positive reflections while treating patients as a subject and giving incomplete information about the trial were pointed out as negative aspect of the movie clip. Majority of the students agreed that cinemeducation had cleared doubts, gave better understanding, stimulated their interest and motivated to learn about professionalism and Ethics. Through role play as assessment the students were able to correctly pick up the scenario, identify the issues related to the role play and were able to give solution to the problem portrayed.Conclusions: Cinemeducation is an indispensable teaching learning tool to understand about patients feelings, role of communication and to teach empathy, ethical aspects in patient care
A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital
Get PDFBackground: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. Identification of ADRs and their reporting pattern can provide useful information for their prevention. Hence this study was done to see the pattern of reported ADRs in Patna Medical College and Hospital, Patna in a 3 months of study.Methods: It was an observational and retrospective study carried out between July 2022 to September 2022. Both outpatients and inpatients were included in the study. The ADRs in the form of Individual Case Safety Reports (ICSRs) were sent to the nearby adverse drug reaction monitoring centre (AMC).Results: The occurrence of ADRs was more common in females (56.25%) as compared to males (43.75%). Patients of age-group 21-40 years (40.625%) were most commonly involved. Medicine department (34.375%) reported the maximum percentage of ADRs. Antimicrobials (37.50%) was the most common drug-group causing ADRs. Maximum reported ADRs (81.25%) were probable, 9.375% were possible, 6.25% were certain, while 3.125% were unlikely with the suspected drug as per Naranjo scale.Conclusions: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital setup elsewhere, along with a few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use