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机构地区:[1]上海医科大学临床药理研究所,上海医科大学儿科医院
出 处:《中国临床药理学杂志》1996年第1期39-45,共7页The Chinese Journal of Clinical Pharmacology
摘 要:采用医院集中监测方法,对1662名住院患儿进行为期一年的药物不良反应(ADRs)流行病学研究。监测期共有257人发生药物不良反应290次,发生率为15.46%(257/1662)。196次为中、重度不良反应,215次属A型不良反应。运用标准化评定法进行因果关系评价,肯定的药物不良反应有81次,占39.31%。激素及抗肿瘤药为最常见的易致药物。累及肾脏及皮肤的不良应比例较高,分别占18.28%和16.21%。用药种数、住院天数、原发疾病以及肝肾功能均与药物不良反应的发生有关。本课题为我国儿童药物不良反应的发生状况提供了一个较为完整而客观的药物流行病学报告,以促进和提高儿童用药安全性。An intensive pediatric hospital monitoring over a period of one year(Nov.1991Oct. 1992) was performed in Pediatric Hospital, Shanghai Medical University.During the given period,1662 hospitalized Patients were monitored.There were 290 verified ADRs identified in 257 patients(incidence=15.46%),196 ADRs were characterized as moderate or severe, and 215 were classified as type A reactions. Causality assessment using standardized algorithm revealed that definite causality was established in 81(39.31%)of total ADRs. The most common therapeutic classes involved were corticosteroids and antineoplastics.Renal and dermatologic manifestations accounted for 18.28% and 16.21% of the ADRs respectively.The number of drugs administered, duration of hospitalization.disease severity, and liver or kidney function were closely related to ADRs. The study has provided data for the pharmacoepidemiological report of the ADRs in pediatric patients.
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