中成药在孕妇中使用的安全性研究  

Study on the safety of Chinese patent medicine used in pregnancy

作　　者：张瑞丽[1] 王景红[1] 苏爽[1] 梅娜[1] 郑金凤[1] 夏坤[1] 宗志勇[1] 

机构地区：[1]中国中医科学院望京医院药学部,北京100102

出　　处：《临床药物治疗杂志》2017年第9期38-41,共4页Clinical Medication Journal

基　　金：2016年北京药学会临床药学研究项目

摘　　要：目的:编制孕妇安全使用中成药手册,为医师、药师提供用药参考。方法:对望京医院200种中成药的说明书、2015版《中国药典》和2010版《临床用药须知》中孕妇用药信息的标注情况及其孕妇禁忌成分进行梳理、分析,挖掘中成药在孕妇用药中的安全隐患,初步提出孕妇安全使用中成药的建议。结果:200份中成药说明书中有113份明确标注了有效孕妇用药信息,其中"孕妇禁用"55种、"孕妇慎用"33种、"孕妇忌用"25种;参考2015版《中国药典》和2010版《临床用药须知》,增加孕妇禁用30种、孕妇慎用7种;通过对中成药所含孕妇禁忌成分进行分析,增加孕妇禁用15种、孕妇慎用13种;筛选出38个孕妇使用相对安全的品种。结论:200种常用中成药多是孕妇禁忌品种,在使用中有一定的安全隐患,编制孕妇安全使用中成药手册,对提高孕妇使用中成药安全性,提升药学服务质量具有重要意义。Objective： To draw up a Chinese patent medicine（CPM） manual for pregnancy and provide medication safety information to physicians and pharmacists. Methods： We investigated and analyzed drug information for pregnancy from instructions, Chinese Pharmacopoeia（2015 Edition）, and Clinical Application Guidelines（2010 edition） of 200 CPMs. Contraindications and potential safety problems for pregnancy of these CPMs were explored, and relevant medication suggestions were made. Results： Drug information for pregnancy were marked in the instructions in 113 CPMs, where ＇prohibited＇ were marked with 55 CPMs, ＇caution＇ were marked with 33 CPMs, and ＇contraindication＇ were marked with 25 CPMs. According to Chinese Pharmacopoeia（2015 Edition） and Clinical Application Guidelines（2010 edition）, 30 CPMs were marked as ＇administrated with prohibited＇ and 7 CPM were marked as ＇administrated with caution＇. Furthermore, 15 CPMs were marked as ＇prohibited＇ and 13 CPM were marked as ＇caution＇ due to containing contraindicated composition for pregnancy. Thirty eight CPMs were selected as relatively safe medication. Conclusion： Most of 200 CPMs were contraindicated for pregnant women, and there was certain security danger in CPM utilization. CPM manual for pregnancy might play an important role in enhancing safety application of CPM and improving quality of pharmaceutical care.

关 键 词：中成药 孕妇 安全性研究 药学服务 

分 类 号：R969[医药卫生—药理学]