阿苯达唑上市后安全性再评价报告  

Re-evaluation of the Safety of Albendazole in Post-marketing

作　　者：郑荣远[1] 朱振国[1] 杨学志[1] 殷为勇[1] 王新施[1] 曹立亚[2] 吴晔[2] 任经天[2] 

机构地区：[1]温州医学院附属第一医院浙江省神经药物流行病学研究中心,浙江温州325000 [2]国家食品药品监督管理局药品评价中心

出　　处：《药物流行病学杂志》2008年第1期13-16,共4页Chinese Journal of Pharmacoepidemiology

基　　金：国家食品药品监督管理局药品评价中心资助项目

摘　　要：目的:评价阿苯达唑(ADZ)上市后用药的安全性,提出风险管理、合理用药的建议。方法:检索国内外医药文献数据库,收集1994～2005年间的与ADZ安全性评价相关的数据信息,用流行病学方法对ADZ不良反应的报告文献、病例资料进行调查,并作统计分析。结果:共收集ADZ临床治疗文献190篇,不良反应214例。儿童和老年患者多发,以神经系统和皮肤损害所占比例最高,如脑炎综合征、药疹等。结论:ADZ用药人群存在治疗风险,严重不良反应可致死、致残;应加强ADZ的风险管理,规范用药。保障用药安全。Objective ： To evaluate the safety of albendazole in post-marketing and provide some suggestions for its risk management and rational use. Method： All the cases related to ADRs of albendazole were collected, and the articles of case reported and case series analyzed were searched out from the Medical and Pharmaceutical Database in Chinese or English from 1994 to 2004. Then the case materials and articles were recorded, gathered, investigated and summarized. They were analyzed with the methods of literature survey and epidemiology. Result： It was found that 190 articles about clinical use of albendazole and 214 cases of serious adverse drug reaction （ SADR ） was reported. SADR might easily attack children and old people, and SADR of ADZ such as encephalitis syndrome and drug eruption were primarily seen in the nervous system and skin reaction. Conclusion： The risks existed in the population who took ADZ as anthelmintic, and those SADRs were rare and could induce disability or death ; The risk management of ADZ and rational use of ADZ should be enhanced.

关 键 词：阿苯达唑 不良反应 脑炎综合征 安全性评价 

分 类 号：R978.63[医药卫生—药品]