摘要
目的:采用Meta分析方法分析我国中药药品说明书的用药标示情况,为进一步完善和规范中药药品说明书用药的标示。方法:全面、系统检索主要中文数据库中有关我国中药药品说明书的用药标示情况的研究,采用STATA 13.0软件对用药标示指标进行合并分析,并对中药不同剂型进行亚组分析。结果:共纳入51个研究,Meta分析结果显示,中药药品说明书的相关项标示中,【药代动力学】、【药理毒理】、【药物相互作用】、【孕妇及哺乳期用药】、【老年用药】和【儿童用药】标注率分别为4%、23.8%、1.6%、9.7%、4.8%和7.8%。结论:我国中药药品说明书的用药内容标示存在缺项或标示不准确现象,可能会影响中药用药安全。
Objective： To analyze the existing problems of the labeling contents of drug instructions for traditional Chinese medicines in order to promote and standardize contents of labeling contents. Methods： The major Chinese databases were searched, the studies of labeling contents of drug instructions for traditional Chinese medicines were included. The related data were analyzed by STATA13.0 software, at the same time, subgroup analysis was performed by dosage forms. Results： 51 studies were included. The Meta-analysis showed that for all related items, the rate of pharmacokinetics, pharmacology and toxicology and drug interactions was 4% ,23.8% and 1.6%, respectively, at the same time, the rate of medication for the old, children, and pregnant women and during lactation was 4. 8%, 7. 8% and 9. 7%, respectively. Conclusion：The labeling contents of traditional Chinese medicines in some package inserts were missing or insufficient, which affects the safety of using traditional Chinese medicines.
出处
《中国药物评价》
2016年第5期443-447,共5页
Chinese Journal of Drug Evaluation
基金
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)
关键词
药品说明书
中药
标示问题
META分析
Package Insert
Traditional Chinese medicines
Labeling Problems
Meta-analysis
