国内、外左炔诺孕酮紧急避孕药药品说明书的比较和分析  

Comparison and Analysis on Instructions for Foreign and Domestic Levonorgestrel Emergency Contraception

作　　者：朱向珺[1,2] 李瑛[1,2] 

机构地区：[1]国家人口计生委计划生育药具不良反应监测中心 [2]江苏省计划生育科学技术研究所,南京市210036

出　　处：《中国药房》2010年第9期842-844,共3页China Pharmacy

基　　金：国家"十一五"科技支撑计划课题"避孕药具上市后监测和风险再评价研究"(2006BAI15B07)

摘　　要：目的:为规范左炔诺孕酮紧急避孕药药品说明书提供参考。方法:对目前我国市场上所使用的左炔诺孕酮紧急避孕药药品说明书的内容与国家相关规定进行比较,同时与国外说明书的内容进行对比,分析目前我国左炔诺孕酮紧急避孕药药品说明书中存在的问题。结果:目前我国左炔诺孕酮紧急避孕药药品说明书中存在的主要问题包括没有规定用药人群、没有明确使用次数和用药间隔、未对左炔诺孕酮紧急避孕药的不良反应提供足够的提示、缺少相关药学研究数据等。结论:目前我国市场上左炔诺孕酮紧急避孕药药品说明书存在缺项、漏项及用药安全性提示不足的情况,建议相关部门和企业对此类药品说明书进行修改和完善。OBJECTIVE： To provide reference for the standardization of the instruction of levonorgestrel emergency contraception. METHODS： Instruction of levonorgestrel emergency contraception in the market was compared with the national regulations and foreign instruction of the same kind of productions in order to discover the problems in domestic specification. RESULTS： The major problems of domestic instruction of levonorgestrel emergency contraception included instructions without population limits, unclear frequency and interval of drug use, without attention to ADR of levonorgestrel emergency contraception, lack of pharmacy research data. CONCLUSIONS： The problems existing in domestic instruction of levonorgestrel emergency contraception are shortage of items and warnings of drug safety. Related administration departments and enterprises are suggested to modify and perfect the instruction of levonorgestrel emergency contraception.

关 键 词：左炔诺孕酮 紧急避孕药 药品说明书 

分 类 号：R95[医药卫生—药学]