935例银杏叶制剂药品不良反应分析  

Analysis of 935 cases of ADR/ADE reports of ginkgo biloba preparation

作　　者：刘雅楠[1] 雷凯[1] 尹先国 赵丽 刘东[1] LIU Ya-nan;LEI Kai;YIN Xian-guo;ZHAO Li;LIU Dong(Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China;Hubei Center for ADR Monitoring, Wuhan 430071, China)

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030 [2]湖北省药品不良反应监测中心,湖北武汉430071

出　　处：《中国药物应用与监测》2017年第2期107-110,共4页Chinese Journal of Drug Application and Monitoring

摘　　要：目的:分析银杏叶制剂导致不良反应(ADR)的规律及特点,为临床合理应用该药提供理论参考。方法:采用回顾性分析的方法,对2012年1月–2014年12月期间湖北省药品不良反应监测中心数据库中收集到的935例银杏叶制剂导致的ADR报告进行分析。分别从患者的年龄与性别、用药方法与剂量、ADR发生时间、ADR累及系统/器官和临床表现等方面进行统计分析。结果:935例银杏叶制剂导致的ADR中,男女发生比例为1:1.35,且在各个年龄段均有分布,中老年患者中例数较多;所导致的不良反应以中枢及外周神经系统损害(23.30%)、胃肠系统损害(19.90%)、皮肤及其附件损害(17.52%)、心血管系统损害(17.01%)和全身性损害(12.92%)为主;存在超说明书规定剂量用药的现象;严重ADR 21例。结论:银杏叶制剂所致ADR的原因包括不合理的使用剂量、给药速率等,同时也与患者自身身体状况相关。建议临床在使用该药时应参考患者的不良反应史,控制使用剂量和给药速率,及时治疗已发生的不良反应,确保临床用药的安全有效。Objective:To analyze the rule and characteristics of ginkgo biloba preparation,to provide references for clinical se.Methods:Using retrospective studies,935cases of ADR/ADE reports collected by Hubei Center for ADR Monitoring from anuary2012to December2014were analyzed according to patients'age and gender,dosage and administration,occurrence time,theinvolvement system and manifestation,nature and causality evaluation and so on.Results:From the analysis of935cases of ADR/ADE reports of ginkgo biloba preparation,the ratio of male to female was1:1.35,female were more than male,and the ADR/ADE eports appeared in all age groups,especially old people;the mainly involvement system contained central and peripheral nervous ystem damage(23.30%),gastrointestinal system damage(19.90%),skin and appendages damage(17.52%),cardiovascular damage17.01%),systemic damage(12.92%);off-label drug use existed in some cases.A total of21severe ADR/ADE cases were reported.onclusion:The ADR/ADE reports of ginkgo biloba preparation were mainly caused by incorrect dosage,administration rate and o on.The health condition of patients also must be taken into account.To reduce the occurrence of ADR/ADE and ensure the safety f clinical use,it is necessary to refer to patients'ADR/ADE history,control the dosage of utilize and provide timely treatment for DR in clinical use.

关 键 词：银杏叶制剂 药品不良反应 临床应用 

分 类 号：R95[医药卫生—药学]