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• 药品评价-循证医学研究 • 上一篇    下一篇

我国药品说明书中儿童用药标示情况研究

张雅婷,杨佳卉,唐佳,黄鹏,沈克非,田金徽   

  1. 兰州大学循证医学中心,兰州大学基础医学院,,,,,
  • 收稿日期:2016-07-18 修回日期:2016-07-18 出版日期:2016-08-25 发布日期:2016-08-25
  • 基金资助:
    ]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(lzujbky-2015-170;lzujbky-2014-18)

Study on the labeling contents of drug instructions for Children in China

  1. Evidence-based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Gansu Lanzhou,Evidence-based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Gansu Lanzhou,Evidence-based Medicine Center,School of Basic Medical Scienc
  • Received:2016-07-18 Revised:2016-07-18 Online:2016-08-25 Published:2016-08-25

摘要: 目的:采用Meta分析方法分析我国药品说明书中儿童用药标示情况,以便为进一步完善与规范我国药品说明书中儿童用药内容提供依据。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儿童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36个研究,总样本量为13213。Meta分析结果显示,药品说明书中儿童用药相关项标示中,【药理毒理】、【临床试验】、“用药安全”相关等缺项严重,【药效药动学】整体未标注率为61%,【药物相互作用】和【药物过量】标注为“尚不明确”者分别为24%、36%。【禁忌】项明确标注者不足5%,【注意事项】明确标注率仅为33%。【用法用量】项中,标注为“遵医嘱”、“尚不明确”者分别为17%、14%,未提及儿童用药剂量者为21%。结论:我国药品说明书中儿童用药内容存在不完整或标示不够准确等问题,这可能会影响儿童用药安全。

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 the labeling contents of drug instructions for Children were included. The related data were analyzed by STATA 13.0 software,at the same time,subgroup analysis was performed by dosage forms.Results: Thirty-six 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 interactions and drug overdose unclear are 24% and 36%.The rate of contraindications with clear annotation is less than 5%,for precautions is just 33%. The usage and dosage such as annotations were not clear or follow the doctor"s advice,the rate are 17% and14%. The rate of usage and dosage with no dose of children using is 21%.Conclusion: The labeling contents of drug instructions for Children were missing or insufficient, which may be affect the safety of using medicines for children.