文章摘要
姚响文,连林涛,杨晓.105 份口服降糖药品说明书信息采样分析[J].中国药事,2019,33(10):1193-1197
105 份口服降糖药品说明书信息采样分析
Sampling Analysis of Package Inserts of 105 Oral Hypoglycemic Drugs
投稿时间:2019-05-28  
DOI:10.16153/j.1002-7777.2019.10.017
中文关键词: 口服降糖药  药品说明书  采样分析
英文关键词: oral hypoglycemic drugs  drug package inserts  sampling analysis
基金项目:
作者单位E-mail
姚响文 山东省烟台市中医医院, 烟台 264000  
连林涛 山东省烟台市中医医院, 烟台 264000  
杨晓 山东省烟台市中医医院, 烟台 264000 xiaoyangzhu@126.com 
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中文摘要:
      目的:为进一步提高国产口服降糖药药品说明书质量、促进药品说明书监管工作科学化、系统化、规范化提供参考。方法:收集、比较105份国产和进口口服降糖药药品说明书,比较各项目标注情况,并对26份不同厂家国产二甲双胍药品说明书进行比较分析。结果:105份药品说明书项目标注存在不同程度的差异,进口药品说明书在孕妇及哺乳期妇女用药、儿童用药、老年用药、药物过量、警告、临床试验6个项目标注率均高于国产药品说明书,内容相对完善;26份国产二甲双胍药品说明书的项目标注也存在差异,说明书质量参差不齐。结论:国产药品说明书质量还有待进一步提高,需要多方共同努力,才能保证药品说明书的科学、严谨、规范,保证患者合理安全用药。
英文摘要:
      Objective: To provide references for further improving the quality of domestic oral hypoglycemic drug package inserts and promoting the scientific, systematic and standardized supervision of drug package inserts. Methods: 105 domestic and imported oral hypoglycemic drug package inserts were collected and compared. Item labelings were compared and drug package inserts of 26 domestic metformin from different manufacturers were compared and analyzed. Results: The item labelings of 105 drug package inserts were different in varying degrees. The labeling rate of imported drug package inserts for the following 6 items, such as drugs used by pregnant and lactating women, drugs used by children, drugs used by the elderly, drug overdose, warnings and clinical trials were higher than that of the domestic drug package inserts. The contents are more perfect than the instructions of domestic drugs. There were also differences in item labelings among 26 domestic metformin package inserts, indicating that the quality of package inserts was uneven. Conclusion: The quality of domestic drug package inserts needs to be further improved, and joint efforts are needed to ensure the scientific, rigorous and standardized drug package inserts and to ensure the rational and safe drug use of patients.
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