国内_外左炔诺孕酮紧急避孕药药品说明书的比较和分析_朱向珺.pdfVIP

·药品监督· 国内、外左炔诺孕酮紧急避孕药药品说明书的比较和分析Δ ＊ # 朱向 ，李 瑛（国家人口计生委计划生育药具不良反应监测中心/ 江苏省计划生育科学技术研究所，南京市 210036） 中图分类号 R95 文献标识码 C 文章编号 1001- 0408（2010）09- 0842- 03 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。 关键词 左炔诺孕酮；紧急避孕药；药品说明书 Comparison and Analysis on Instructions for Foreign and Domestic Levonorgestrel Emergency Contracep- tion ZHU Xiang-jun ，LI Ying （Contraceptives ADR Monitoring Center ，National Population and Family Planning Commission ，Jiangsu Institute of Family Planning Research ，Nanjing 210036，China ） ABSTRACT OBJECTIVE ：To provide reference for the standardization of the instruction of levonorgestrel emergency contracep- tion. 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 short- age of items and warnings of drug safety. Related administration departments and enterprises are suggested to modify and perfect the instruction of levonorgestrel emergency contraception. KEY WORDS Levonorgestrel ；Emergency contraception ；Instruction 紧急避孕药品是在觉察到避孕方法失败或无防护措施性