13家医疗机构儿科常用中成药说明书信息及标注情况分析  

Information and Annotation in Instructions of Commonly Used Chinese Patent Medicine in Pediatrics of 13 Medical Institutions

作　　者：马津京[1] 张艳菊[1] 胡利华[1] 胡泊洋[1] 陈博[1] 李颖[2] 金婷婷 易鹏飞[3] 席云鹏 Ma Jinjing;Zhang Yanju;Hu Lihua;Hu Boyang;Chen Bo;Li Ying;Jin Tingting;Yi Pengfei;Xi Yunpeng(National Center for Children’s Health,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China;Shenyang Children’s Hospital,Liaoning Shenyang 110032,China;Jiangxi Provincial Children’s Hospital,Jiangxi Nanchang 330006,China;Children’s Hospital of Shanxi,Shanxi Taiyuan 030013,China)

机构地区：[1]国家儿童医学中心,首都医科大学附属北京儿童医院,北京100045 [2]沈阳市儿童医院,辽宁沈阳110032 [3]江西省儿童医院,江西南昌330006 [4]山西省儿童医院,山西太原030013

出　　处：《儿科药学杂志》2021年第11期22-26,共5页Journal of Pediatric Pharmacy

基　　金：北京市中医管理局第二批中药骨干人才培养项目,京中医科字[2018]213号。

摘　　要：目的:通过调查13家医疗机构儿科门急诊常用中成药说明书及信息标注情况,分析儿科常用中成药说明书中存在的问题,并提出相关建议。方法:根据13家医疗机构儿科常用的340种中成药信息,对功能主治、剂型、辅料、含毒性药物、儿童用法用量等项目进行统计分析。结果:340种中成药中,31.76%为儿童专用药。以清热、化痰、止咳平喘类中药使用最多,且以口服剂型居多。明确标注辅料信息的中成药构成比为46.18%;含毒性成分中成药为34.12%。用法用量按儿童年龄段明确标注的占31.76%。结论:儿科常用中成药说明书存在儿童用药及安全性信息标注不全的情况,为确保中成药在儿科临床应用的有效性和安全性,应充分考虑儿童群体的特殊性。Objective:By investigating the information and annotation in instructions of commonly used Chinese patent medicine in pediatric outpatient and emergency department in 13 medical institutions,to analyze the problems in the instructions of commonly used Chinese patent medicine in pediatrics and put forward the relevant suggestions.Methods:According to the information of 340 kinds of commonly used Chinese patent medicine in pediatrics of 13 medical institutions,the items of function and indications,dosage forms,excipients,toxic ingredients,children’s usage and dosage were statistically analyzed.Results:Of the 340 kinds of traditional Chinese patent medicine,31.76%were developed only for children.Heat clearing,phlegm reducing,cough and asthma relieving drugs took the lead,and most of them were in oral dosage forms.The proportion of Chinese patent medicine clearly marked with information of excipients was 46.18%,the proportion of Chinese patent medicine with toxic ingredients was 34.12%.The usage and dosage were clearly marked according to the age group of children,accounting for 31.76%.Conclusion:There are incomplete annotation of pediatric medication and safety information in the instructions of commonly used Chinese patent medicine in pediatrics.In order to ensure the effectiveness and safety of the clinical application of Chinese patent medicine in pediatrics,the special characteristics of pediatrics should be fully considered.

关 键 词：儿科 中成药 说明书 标注 

分 类 号：R969.3[医药卫生—药理学]