中国药物评价2016，Vol.33Issue(4)：231-234,245,5.
我国药品说明书中儿童用药标示情况研究
Study on the Labeling Contents of Drug Instructions for Children in China
摘要
Abstract
Objective:To assess the existing problems on labeling contents of drug instructions for children in China, which may be help to promote the improvement and standardization of contents of labeling contents.Methods:The major Chinese database were searched,the study on the labeling contents of drug instructions for children were included.The related data were analyzed by STATA13.0 software,at the same time,subgroup analysis was performed by dosage forms.Results:36 studies were included with a total sample size of 13213.The Meta-analysis showed that for all related items,the missing rate of [pharmacological toxicology],[clinical trials] and “the safety of medicines using” is all very high.The rate of [ pharmacokinetics] without annotation is 61%.The description of [ drug interac-tions] and [ drug overdose] unclear are 24%and 36%.The rate of [ contraindications] with clear annotation is less than 5%,for [ pre-cautions] is just 33%.The [usage and dosage] such as annotations were not clear or follow the doctor's advice,the rate are 17% and 14%respectively.The rate of usage and dosage with no dose of children using is 21%.Conclusion:The labeling contents of drug instruc-tions for children were missing or insufficient,which may be affect the safety of using medicines for children.关键词
药品说明书/儿童用药/标示问题/Meta分析Key words
Drug instructions/Children/Labeling Problems/Meta-analysis分类
医药卫生引用本文复制引用
张雅婷,杨佳卉,唐佳,黄鹏,沈克非,田金徽..我国药品说明书中儿童用药标示情况研究[J].中国药物评价,2016,33(4):231-234,245,5.基金项目
甘肃省循证医学与临床转化重点实验室开放基金；兰州大学中央高校基本科研业务专项资金资助 （）
