168例百乐眠胶囊不良反应文献分析  

Literature Analysis of 168 Adverse Drug Reactions Induced by Bailemian Capsule

作　　者：彭丽丽[1] 范燕[1] 刘巍[1] 郭雪[1] 胡军[1] PENG Lili;FAN Yan;LIU Wei;GUO Xue;HU Jun(Centre for Drug Reevaluation,CFDA,Beijing 100022,China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100022

出　　处：《中国药物警戒》2018年第11期674-676,681,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项(2015ZX09501004-001-001):基于SRS系统的动态;长效中药风险信号早期发现研究;国家中医药管理局中医药行业科研专项(201507004-4-2):基于流行病学调查的何首乌肝损伤人群特征研究

摘　　要：目的分析百乐眠胶囊的不良反应文献,为临床合理用药提供参考。方法通过检索2006～2017年中国知网(CNKI)、万方医学网数据库和维普中文期刊全文数据库,对收录的百乐眠胶囊不良反应文献进行筛选和分析。结果临床应用文献29篇,涉及病例报道168例;女性患者数量为男性的1.54倍,32～65岁患者居多,不良反应多表现为胃肠系统损害、精神及神经系统损害、皮肤及其附件损害,表现有恶心、口干、便秘、食欲下降、乏力、过度镇静、药疹等,有肝功能异常的个案报告。结论应注意百乐眠胶囊的安全用药,规范和完善百乐眠胶囊药品说明书中安全性内容,以促进药品的合理应用,保证患者用药安全。Objective To analyze the literatures on clinical application and adverse drug reactions(ADRs)induced by Bailemian capsule,so as to provide reference for its rational use in clinic.Methods The literatures on the clinical application and ADRs of Bailemian capsule were retrieved in CNKI,Wangfang data and VIP Chinese full-text database.The related literatures were screened out and analyzed.Results29available literatures were retrieved where168cases with adverse drug reactions were reported.Female patients were1.54times that of male patients,the most of patients were32to65years old,the ADRs were mainly gastrointestinal disorders,liver and biliary disorders,psychiatric and neurological disorders,skin and appendages disorders,including nausea,mouth dry,constipation,appetite decreased,sedation excessive,drug eruption etc,and there has been an individual case safety report about the hepatic function abnormal.Conclusion We should strengthen the safe application of Bailemian capsule,standardize and improve the drug labelling,promote the rational use of drug and guarantee the safety of patients.

关 键 词：百乐眠胶囊 临床应用 药品不良反应 

分 类 号：R994.11[医药卫生—毒理学]