International Journal of Basic & Clinical Pharmacology
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A case of phenobarbitone induced Stevens-Johnson syndrome-toxic epidermal necrolysis along with its causality assessment
Get PDFStevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse drug reaction, which are mainly caused by drugs; and these are usually associated with high degree of morbidity and mortality. They are characterized by mucocutaneous tenderness and typically haemorrhagic erosions, erythema and more or less severe epidermal detachment as blisters and areas of denuded skin. High risk drugs for the development of SJS-TEN include phenobarbitone, phenytoin, carbamazepine, lamotrigine, nevirapine, NSAIDs, allopurinol, and cotrimoxazole. A 33 years old female patient came to skin and venereal diseases (VD) outpatient department (OPD) with complaints of painful skin lesions. She was apparently symptom free 15 days back. Then she took tablet phenobarbitone 60 mg, BD as her anti-epileptic treatment. After 12-13 days of taking the drug, she developed erythematous papules associated with itching over her both forearm, face, chest, abdomen, back and lower limbs bilaterally which rapidly progressed to fluid-filled blisters that ruptured to form painful erosions and desquamation of skin all over the body. The patient was managed by withdrawal of phenobarbitone and conservatively, and the patient recovered successfully. The causality of phenobarbitone in this reaction was “probable” as per Naranjo scale. Seriousness of the reaction was “prolonged hospitalization”. Phenobarbitone is one of the most common causative agents of SJS and TEN. The main stay of treatment is immediate withdrawal of causative agent along with supportive care
Kaposi's sarcoma in a different concept from HIV-AIDS: report of a case in a patient with Behçet's disease and immunomodulatory drugs
Get PDFKaposi's sarcoma (KS) is a malignant vascular neoplasm that typically appears opportunistically in patients with acquired immunodeficiency syndrome (AIDS); it can also arise in organ transplanted subjects and exceptionally in carriers of autoimmune diseases, such as Behçet's disease. A 23-year-old man with Behçet's disease who debuts with clinically and histologically compatible dermatosis with KS. Conclusions. KS is not exclusive to HIV-AIDS, it also prevails in situations of primary or secondary immunocompromision that favor its appearance, as is the case of Behçet's Disease and its immunomodulatory therapy.
A study on the effectiveness of nicotine and counselling in tobacoo smoking cessation
Get PDFBackground: Effectiveness of pharmacotherapy and counselling has been suggested by various research workers in smoking cessation, but studies show variable results with pharmacotherapy. Also efficacy of counselling and pharmacological intervention differs from centre to centre. So we conducted this study, to observe the role of counselling and nicotine gums in our setup.Methods: 86 smokers willing to quit smoking were enrolled. Baseline counselling was provided at the time of enrolment, then at 1 week, 1 month, 3 months and at 6 months. Telephonic counselling was given to those who did not come for face to face counselling. Nicotine gums were prescribed for 3 months duration. At the end of 12 months, follow up outcome was measured.Results: At 1 week 24% smokers, at 1 month 23%, at 3 months 12% and at 6 months 33% smokers attended face to face counselling session. At 1 week 66%, at 1 month 57%, at 3 months 63% and at 6 months 59% smokers received telephonic counselling. Nicotine gums were used by only 76% smokers. Out of those who used nicotine gums, only 3% used gums for 3 months duration and 97% stopped prematurely. Among those who used gums, 29% experienced side effects. Total 22 (26%) smokers stopped smoking at 12 months.Conclusions: Less number of smokers coming for follow up counselling visits, suggest lack of motivation. Alternative counselling, like telephonic counselling, was much more accepted and was found to be helpful. Acceptance of nicotine gums was very less which also shows the lack of motivation. Abstinence rate of 26% shows that counselling and nicotine gums help in quitting smoking
The bromelain and rutoside advantage in systemic enzyme therapy: pharmacological basis of combination with trypsin
Get PDFInflammation involves various interlinked pathways and processes. In its uncontrolled form, inflammation results in variety of diseased sates. Current therapy for inflammatory diseases is limited to steroidal and non-steroidal anti-inflammatory drugs (NSAIDs). But these are associated with safety concerns and have a deleterious effect on wound healing. Proteolytic enzymes, also called proteases, which are naturally occurring substances derived from animal or plant sources, are believed to be effective and safer alternatives to the conventional medications. Combined with the bioflavonoid rutoside, the proteases trypsin and bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions. Their individual mechanisms of action and the advantages of combining bromelain and rutoside with trypsin has been discussed. The combination not only covers a wider range of processes involved in inflammation, but they also complement each other’s actions and provide a more well-rounded control of the inflammatory processes
Taxanes induced hypersensitivity reactions in cancer chemotherapy patients reported at adverse drug reaction monitoring centre at a tertiary care hospital
Get PDFBackground: Cancer chemotherapy involves highly complex regimens using antineoplastic agents like taxanes (paclitaxel, docetaxel) etc. Taxanes cause hypersensitivity reactions (HSRs) like redness, rashes, dyspnoea, severe anaphylaxis and death. In this study, adverse drug reactions (ADRs) associated with taxanes are described & analysed on their severity and preventability. The present study aims to analyse and determine the prevalence of ADRs, especially HSRs in patients treated with taxanes.Methods: After getting IEC approval, the present study is done retrospectively by assessing the HSRs in suspected ADR reporting forms from December 2019 to February 2022 in ADR monitoring centre (AMC) in the Department of Pharmacology at Kurnool Medical College, Kurnool. Descriptive statistics used to analyse patient demography, frequency, various carcinomas under treatment & organ involved, causality assessment using WHO-UMC Scale and Naranjo's Algorithm, severity assessment using modified Hartwig & Siegel’s scale and preventability by modified Schumock & Thornton scale.Results: A total of 258 ADRs were recorded, of which 30 cases reported HSRs with taxanes-paclitaxel (22) and docetaxel (8). The most commonly occurred HSR is shortness of breath. Naranjo’s algorithm showed 52.5% possible (score 1-4) HSRs. WHO-UMC causality assessment scale showed 56.4% as probable HSRs. Modified Hartwig & Siegel severity scale showed 46.6% moderate (level 3). Modified Schumock and Thornton scale showed 76.9% as not preventable.Conclusions: Chemotherapy-related ADRs among cancer patients urges the oncologists to be actively involved in ADR reporting, in the need of the hour in order to mitigate, avoid their occurrence and reducing morbidity and mortality, when practiced with diligence
Evaluation of knowledge, attitude and practice towards drug-drug interactions among postgraduates in tertiary care hospital, Kurnool
Get PDFBackground: Drug-drug interactions (DDIs) are changes in a drug’s effects due to concurrent use of another drug. Clinically significant interactions lead to undesired adverse effects, therapeutic failure, toxicity or may even cause death of the patients. The Aim is to evaluate the Knowledge, Attitude and Practice of Postgraduates regarding DDIs and implementation of educational program may enhance patient’s safety.Methods: A cross-sectional study was conducted among postgraduates in all clinical departments of Government general hospital, Kurnool in the month of October 2021. Pre-validated questionnaire was used to assess the KAP. It contains demographic data, knowledge and practice questions related to DDIs and attitude towards the preferable sources of drug interaction information. Data analysis was done by using SPSS version 26.Results: Out of 220 questionnaires distributed, 126 postgraduates submitted with complete answers(n=126). Overall response rate is 57%. By using the Bloom’s cut-off points, most of the respondents (43.5%) had low level of knowledge towards DDIs. Even respondents with high knowledge level (19%) are not practicing the drug interaction screening during the admission of patients. Majority of PGs with low level knowledge agreed to ask doctors than pharmacist about DDIs and prefer to search for DDIs using reference book than online mode as the source of drug information.Conclusions: In my study, most of the respondents had insufficient knowledge to prevent life threatening DDI’s. So, there is a need to increase medical educational program regarding the importance of screening and assessing of DDI’s before prescribing medicines
An analysis of studies on non-small cell lung cancer registered on clinical trials registry of India
Get PDFBackground: Lung cancer is the most common cancer in males, of which non-small cell type is more prevalent. It is an active area of research owing to the limited available treatment modalities with several studies registered on CTRI. Objectives of current study was to analyse randomized control trials for non-small cell lung cancer registered on clinical trial registry India.Methods: Studies registered on CTRI were reviewed in this registry-based audit using the keywords lung cancer and non-small cell lung cancer. Parameters such as type of study, nature of intervention, phase of study, primary and secondary endpoints used, etc, were analysed and summarised using descriptive statistics in Microsoft Excel 365.Results: Out of 230 trials for lung cancer, 121 studied non-small cell lung cancer, of which 103 studies (85.1%) were interventional studies. Most common intervention under study was drug 97 studies (94.2%) followed by radiation 4 studies (3.3%). Majority of trials were phase 3, 48 trials (39.7%) and only 4 (3.3%) studies were phase 1. Five most common primary and secondary endpoints observed were survival, response rate, safety, pharmacokinetic data & quality of life. Maximum patients were in the advanced stage of cancer(52.1%) and pemetrexed (9.9%) was the most common drug used.Conclusions: We observed an increasing trend in studies registered on CTRI, with maximum studies in phase 3 with patients in the advanced stage of cancer having overall survival as the endpoint
Bisphosphonates-what’s new?
Get PDFBisphosphonates are chemical-related to pyrophosphate. The oxygen atom in pyrophosphate is substituted by a carbon atom in these compounds, resulting in a P-C-P bond. They are potent antiresorptive medicines because they have a strong inhibitory effect on osteoclasts. It lowers fracture risk by reducing bone turnover, increasing bone mineral density, and decreasing fracture risk in the lumbar spine and hip. Bisphosphonates are strongly attracted to bone surfaces, where they accumulate, primarily at remodeling sites. They are rarely associated with systemic side effects due to their selectivity in action. Irritation of the upper gastrointestinal tract is the most common side effect. A strong third-generation bisphosphonate, zoledronate, is currently approved to treat postmenopausal-induced osteoporosis. This review mainly focuses on the mechanism of action, therapeutic uses, and its adverse effects
Effect of angiotensin receptor neprilysin inhibitor in patients of heart failure with reduced ejection fraction with reduced ejection fraction with cardiorenal syndrome type-1
Get PDFBackground: Heart failure is recognized as one of the most common indications for hospitalization. The dysfunction of either the heart or the kidneys affect the functioning of each other and thus play an important role in the quality of life.Methods: This study is a Prospective interventional Cohort study over a period of 18 months in 125 patients. The patients were divided into two broad treatment groups. The primary end point of the study was to quantify the response of ARNI for renal recovery in patients of cardio-renal syndrome and improvement in cardiovascular parameters by measuring the change in urine output, estimated glomerular filtration rate, serum creatinine, change in weight of the patients, control of blood pressure and change in left ventricular ejection fraction. The secondary end-points were evaluated during the 60 days follow up period post admissions.Results: Cardio-renal syndrome was seen in 39% of the patients. On screening e-GFR was 91±14 and 49±8 for group 1and 2 respectively, the median age, UACR was 59 years ,1.0 mg/mmol respectively for both the groups and 19% had micro albuminuria. ACEIs had more reports of hyperkalemia (8/32, 25%), and greater deterioration of renal parameters (10/32, 34%) needing discontinuation of the drug in some patients. Patients also developed cough (6/32, 20%) needing replacement with ARBs. ARNI group developed more hypotension (6/31, 20%). In all cardiovascular and renal end points except UACR, ARNI showed better recovery profile in CRS-1patients including diabetics.Conclusions: This study showed beneficial effects of ARNI in heart failure patients with cardio-renal syndrome.
A rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals
Get PDFBackground: Pefloxacin is a newer broad-spectrum bactericidal fluoroquinolone antibiotic, with superior antibacterial activity in vivo against pathogenic ocular gram-negative and anaerobic microorganisms and better pharmacokinetic properties. The objective of this clinical research study was the rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals.Methods: The 43 bacterial conjunctivitis patients were prescribed topical pefloxacin 0.3% ophthalmological drops, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days. The pharmacovigilance safety appraisal was performed by monitoring the occurrence of adverse drug reactions, like, transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness, and recording in Adverse Event Case Report Forms, on days 0, 3, 5, 7, 10, 15, 30, and on further follow-ups.Results: In this study, the safety assessment showed that only 1 patient had ocular discomfort in the eye. The occurrence of adverse effects was statistically non-significant. Thus, 0.3% pefloxacin ophthalmological drops treatment was safe and tolerable, among all 43 patients.Conclusions: Therefore, pefloxacin is a safe ocular antibiotic for treating bacterial conjunctivitis, with adequate drug tolerability exhibited by the patients