我国药品说明书中孕妇及哺乳期妇女用药标示情况分析

Analysis of the Labeling Contents of Drug Instructions for Pregnant Women and Lactating Women in China

目的:采用Meta分析方法分析我国药品说明书中孕妇及哺乳期妇女用药标示情况,为完善与规范我国药品说明书中孕妇及哺乳期妇女用药内容的标示。方法:全面、系统检索主要中文数据库中有关我国药品说明书中孕妇及哺乳期妇女用药标示情况的研究,采用STATA13.0软件对相关指标进行合并分析,并对药物不同剂型等指标进行亚组分析。结果:共纳入13个研究,Meta分析结果显示,药品说明书中孕妇及哺乳期妇女用药相关项标示中,标注为"禁用"的标注率为25%,无标注者为23%。【药代药动学】、【用法用量】、【注意事项】(包括禁忌)未标注率分别高达82%、84%和63%。【药物相互作用】标注"尚无资料"者占本研究统计的100%。结论:我国部分药品说明书中孕妇及哺乳期妇女用药内容存在缺项或标示不准确现象,严重影响孕妇及哺乳期妇女用药安全。

Objective： To analyze the existing problems of the labeling contents of drug instructions for pregnant women and lactating women in China by Meta-analysis,in order to improve and standardize contents of labeling contents. M ethods： The major Chinese databases were searched,the studies of labeling contents of drug instructions for pregnant women and lactating women were included. The related data were analyzed by STATA 1 3. 0 software,at the same time,subgroup analysis was performed by dosage forms. Results： 1 3 studies were included. The Meta-analysis showed that for all related items,the rate of the usage and dosage such as annotations was [forbidden] to use is 2 5 %,the rate of it without annotation is 2 3 %. The rates of [pharmacokinetics],[usage and dosage],[precautions ]（ contraindications） without annotation are 8 2 %,8 4 % and 6 3 %. The rate of[drug interactions] with no information of pregnant and lactating women using is 100%. Conclusion： The labeling contents drug instructions for pregnant women and lactating women in China were missing or insufficient,which may be affect the safety of using medicines for them.