妇产科用米索前列醇片安全性风险分析及思考

Risks posed by misoprostol tablets used in obstetrics and gynecology

目的分析妇产科用米索前列醇片的安全性风险,为临床合理用药提供参考。方法对2015年1月1日至2019年10月31日我国药品不良反应监测数据库和自建库起至2021年12月31日国内外文献数据库中不良反应报告及国内风险控制措施等相关资料进行整理与分析。结果和结论米索前列醇片不良反应一般较轻,大多数不需要特殊处理,但需警惕比较严重的不良反应。医疗机构应严格按照说明书使用本品,关注本品的严重不良反应。药品生产企业应加强企业药品不良反应监测与评价的主体责任,及时完善药品说明书安全性信息,必要时应主动开展上市后安全研究。

Objective To analyze the risk to safety posed by misoprostol tablets used in obstetrics and gynecology in China in order to provide reference for clinical rational drug use.Methods The individual cases of adverse drug reactions reported in China adverse drug reaction database between January 1,2015 and October 31,2019 were analyzed,domestic and foreign literature published from the inception of the database to December 31,2021 was retrieved,and precautions taken in China were outlined.Results and Conclusion The adverse reactions of misoprostol tablets are generally mild,and most of them do not require special treatment.But more serious adverse reactions are worthy of attention.Medical institutions should use misoprostol tablets strictly in accordance with the instructions and be alert to the serious adverse reactions.Drug manufacturers should make more effort to monitor and evaluate adverse drug reactions of their products,improve the safety information in drug instructions and take the initiative to carry out post-marketing safety studies when necessary.