Objective: Adverse drug reactions have not been as thoroughly studied in children as they have in adults. Extrapolation of efficacy, dosing regimens, and ADRs from adult data are inappropriate owing to developmental changes in physiology and drug handling. There is a lack of local data regarding the potential risk of ADRs in pediatric patients. Objective of this study is to identify the adverse drug reaction (ADR) profile in pediatric patients.
Methods: In this cross-sectional study, 450 children attending the pediatric inpatient and outpatient department were selected, and the CDSCO reporting form for suspected ADR reporting forms was collected from those who had any adverse events by the consulting pediatrician. Later, this form was analyzed for the details for ADRs and assessed for causality, severity, and preventability using Naranjo’s algorithm, Hartwig and Siegel scale, and modified Schumock and Thornton scale of adverse drug reactions.
Results: The cross-sectional study revealed a prevalence of 12.89%. Antibiotics caused more ADRs than any other group of drugs. Dermatological ADRs were the most common. Most ADRs were not preventable and were of moderate severity. The causality assessment showed that most ADRs were possible category.
Conclusion: The ADRs are often unrecognized. We need more strict monitoring for early detection, treatment, and more importantly prevention of these events in the future. For that, more awareness programs, CMEs and teamwork are extremely important among the caregivers.
Background: To study the spectrum, incidence and severity of toxicity among Multiple Myeloma patients receiving Thal-Dex in South Indian population.Methods: Between November 2005 and November 2005, 25 adult patients with previously- untreated Multiple Myeloma were assigned to receive Thal-Dex at Regional Cancer Centre, Trivandrum. During chemotherapy, patients were followed-up to detect the development of any toxicity symptoms. The toxicities recorded, were graded according to the criteria of the World Health Organization toxicity-guidelines.Results: In the 25 patients who received Thal-Dex, peripheral neuropathy, infection and constipation were significantly seen, while gastrointestinal toxicities were seen to a lesser extent, and haematological toxicities were low.Conclusions: The Thal-Dex regimen was tolerated well by majority of the patients and showed favourable toxicity profile, reiterating its acceptability as a front line antimyeloma regimen
Background: The assessment of severity in acute pancreatitis is very important as 20% of cases can progress to serious life-threatening events. Several multifactorial scoring systems are widely used; but they are too cumbersome to use in daily clinical practice. A single test which has a predictive power of prognostication is serum C-reactive protein.Aims: To assess the relative accuracy of serum C-reactive protein and Ranson's scoring system in predicting the severity of acute pancreatitis. To evaluate the accuracy of serum C-reactive protein in monitoring the clinical course of the disease Materials and Methods: it is a prospective study done on all patients admitted in the institution over a period of one year, who were diagnosed with acute pancreatitis. Results: A total of 42 patients were studied. Thirty patients had mild acute pancreatitis and 12 had severe. Ranson's criteria predicted 16 patients to have severe pancreatitis, whereas only 8 cases turned out to be severe. CRP estimation predicted 14 to be severe, of which, 10 patients had a severe outcome. Ranson's criteria showed a sensitivity of 66.6%; specificity of 73.3% and accuracy of 71.4; whereas, serum CRP showed a sensitivity of 83.3; specificity of 86.6% and accuracy of 85.7%. Conclusion: Serum CRP shows a higher prognostic sensitivity and accuracy than Ranson's scoring system. CRP as a single parameter can be used to predict the development of complications in acute pancreatitis. It is a good early marker for the severity of acute pancreatitis. The CRP value at the end of the first week is useful in monitoring the clinical course.
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