Dalvi Prashant S, Singh Anil, Trivedi Hiren R, Mistry Suresh D, Vyas Bhadresh R
Department of Pharmacology, MP Shah Medical College, Jamnagar 361 008, Gujarat, India.
J Pharmacol Pharmacother. 2011 Apr;2(2):100-3. doi: 10.4103/0976-500X.81901.
To monitor and evaluate the pattern of ADRs to oseltamivir in pediatric population suffering from H1N1 influenza at a tertiary care hospital.
Children offered oseltamivir for treatment and chemoprophylaxis were monitored for adverse events by direct questioning for symptoms and clinical examination on day 5 and day 10. Assessment of neurological events was done by asking the parents or guardians regarding development of specific symptoms. Adverse events obtained were analyzed for severity, causality and age-group wise.
Out of 191 children (median age, 3 years), 69 (36.1%) developed ADRs. Most common symptoms were vomiting (16.2%) followed by diarrhea (12.0%), ear disorders (8.9%), and insomnia (6.8%). The incidence of neuropsychiatric symptoms was 12.6% which were mild-to-moderate on severity scale. There was no significant difference in the incidence of adverse events between children less than 1 year and other age groups.
Oseltamivir is well tolerated in Indian children with suspected or confirmed H1N1 influenza. Our study also indicates safety of oseltamivir in infants.
在一家三级护理医院监测和评估甲型H1N1流感患儿使用奥司他韦后的不良反应模式。
通过在第5天和第10天直接询问症状和进行临床检查，对接受奥司他韦治疗和化学预防的儿童的不良事件进行监测。通过询问父母或监护人特定症状的发生情况来评估神经事件。对获得的不良事件进行严重程度、因果关系和年龄组分析。
在191名儿童（中位年龄3岁）中，69名（36.1%）出现了不良反应。最常见的症状是呕吐（16.2%），其次是腹泻（12.0%）、耳部疾病（8.9%）和失眠（6.8%）。神经精神症状的发生率为12.6%，严重程度为轻至中度。1岁以下儿童与其他年龄组之间的不良事件发生率没有显著差异。
疑似或确诊甲型H1N1流感的印度儿童对奥司他韦耐受性良好。我们的研究还表明奥司他韦对婴儿是安全的。
