国内外第三代芳香化酶抑制剂药品说明书的对比分析

Comparative Analysis of Domestic and Foreign Instructions of the Third-generation Aromatase Inhibitors

目的:为进一步规范第三代芳香化酶抑制剂药品说明书提供参考。方法:依据《药品说明书和标签管理规定》和《化学药品和生物制品说明书规范细则》及其他参考资料,对国内、外第三代芳香化酶抑制剂药品说明书的各项内容进行统计,并对不良反应、注意事项、药物相互作用、药理毒理、药动学、修改次数等进行对比、分析。结果与结论:与第三代芳香化酶抑制剂的3份进口药品说明书比较,10份国产药品说明书的整体结构、基本项目标注完整,但存在部分项目标注简单或部分缺失,不良反应、注意事项、药物相互作用、药理毒理、药动学等关键项目标注不够详细,更新不及时等问题。建议药品监督管理部门加强对国产药品生产企业规范和完善药品说明书的相关项目标注的管理,保障临床用药安全、有效。

OBJECTIVE：To provide reference for further standardizing the instructions of domestic third-generation aromatase inhibitors（AIs）. METHODS：According to Instruction and Label Management Regulations,Chemical Drugs and Biological Products Instruction Detail Rules and other references,the domestic and foreign instructions of third-generation AIs were analyzed comparatively in terms of ADR,precautions,drug interaction,pharmacology and toxicology,pharmacokinetics and the modification times,etc. RESULTS CONCLUSIONS：Compared with 3 foreign AIs instructions,the instructions of 10 domestic AIs were relatively complete in structure and items,but the key projects were not marked in detail,including ADR,precautions,drug interaction,pharmacology and toxicology and pharmacokinetics. At the same time,the instruction of domestic AIs were not timely revised. It is suggested to strengthen standardizing domestic pharmaceutical producing enterprise and perfecting item labelling management of drug instructions so as to guarantee safe and effective use of drugs in the clinic.