90种中成药说明书中妊娠禁忌证及儿童用药标注情况调查分析

目的了解中成药药品说明书中妊娠禁忌证以及儿童用药标注存在的问题并提出建议。方法收集长江航运总医院使用的90种中成药说明书,参考2015年版《中华人民共和国药典》(一部)及2015年版《临床用药须知》中药成方制剂卷中妊娠禁用、忌用、慎用药材和饮片,依据《中华人民共和国药典》及2015年版《临床用药须知》中"注意"项,对比分析药品说明书中妊娠禁忌及儿童用药标注存在的问题。结果90种中成药药品说明书中有妊娠禁忌标注仅47份,缺乏的为43种,标注率52.2%,仅3种药品说明书与《中华人民共和国药典》《临床用药须知》妊娠禁忌标注一致;有儿童用法用量提示5种,缺乏儿童用法用量提示85种,标注率和缺标率分别为6%,94%,仅2种药品说明书儿童用药用量提示与《中华人民共和国药典》《临床用药须知》中儿童用药用量标注一致。结论该院大部分中成药药品说明书妊娠禁忌以及儿童用药标注缺省严重,中成药不能简单以是否含有妊娠禁忌成分作为评估孕期用药宜忌;中成药的妊娠及儿童应用信息还需要更多的临床数据和循证药学数据支持。

Investigation and Analysis of Pregnancy Contraindications and Pediatric Medication Information Labelling in 90 Kinds of Package Inserts of Chinese Patent Medicine

Objective To investigate the labelling problems of pregnancy contraindications and pediatric medication in the package inserts of Chinese patent medicine(CPM),and to put forward the suggestions.Methods A total of 90 package inserts of CPM in General Hospital of Yangtze River Shipping were collected.Referring to the prohibited,contraindicated and caution materials and decoction pieces in Chinese pharmacopoeia(part 1,2015 edition),based on"note"item in Chinese pharmacopoeia and clinical application guidelines(2015 edition),problems existing in pregnancy contraindication and pediatric medication information labeling of package inserts were compared and analyzed.Results Among 90 package inserts of CPM,only 47 of them were labeled as pregnancy contraindications,and 43 of them were lacking.The rate of labelling was 52.2%.Meanwhile,there were 5 package inserts of CPM have pediatric medication,and 85 of them were lacking,in which the labeling lack rate were 6%and 94%,respectively.Above all,only 3 kinds of pregnancy contraindications and 2 kinds of pediatric medication were consistent with the labeling in Chinese Pharmacopoeia and Clinical Application Guidelines.Conclusion Most CPM have serious absence labels among pregnancy contraindications and pediatric medication.Pregnancy contraindications of CPM cannot be simply taken as an indication and contraindications to evaluate pregnancy medication.More clinical data and evidence-based pharmaceutical data are needed to support pregnancy and child medication information of CPM.