中国药品说明书外用法研究的现状调查与分析

Survey and analysis of studies on off-label use in China

目的:调查中国药品说明书外用法的研究现状。方法:计算机检索PubMed,CNKI,SinoMed,WanFang Data,检索时限均从建库至2014年4月,纳入药品说明书外用法的观察性研究论文,统计论文发表情况,并进行文献研究内容分析。结果:共纳入39篇文献,文献发表情况方面,中国自2008年起发表药品说明书外用法相关研究,自2011年起发表英文文献,文献来源地主要集中于北京、四川、广东,涉及33家单位,总引用频次为97次,总下载频次4679次,药师发表的论文占79.49%。研究内容方面,36篇(92.31%)为单一中心研究,34篇(87.18%)为处方或医嘱的调查分析。药物类别以儿科用药为主(14篇,35.90%)。37篇(94.87%)均根据CFDA公布的药品说明书作为药品说明书外用法判断依据。结论:中国药品说明书外用法的研究发展迅速,但在观察主体、研究类型、研究方向和药物类别方面均存在局限性,尚需建立规范化的药品说明书外用法的判定依据。

Objective： To investigate the current situation of studies on off-label use in China. Methods： PubMed, CNKI, SinoMed and WanFang Data were searched through to April 2014 for observational studies on off-label use. Study characteristics and outcomes were extracted and analyzed. Results： In total, 39 studies were included. China began to publish studies on off-label use since 2008, and the first English paper was reported in 2011. The authors involving in 33 institutions were mainly from Beijing, Sichuan and Guangdong provinces. The totally frequency of citation added up to 97 while download times were 4 679. The proportion of studies published by pharmacists reached 79.49%. As for the main contents, 36 reports （92.31%） belonged to single-center studies, and 34 （87.18%） reports focused on prescriptions or doctor＇s advice. Furthermore, there are 14 papers （35.90%） posted pediatric drugs, and 37 papers （94.87%） referred drug directions approved by CFDA as eligibility criteria to determine whether it was off-label use or not. Conclusion： Though studies on off- label use have been developing rapidly in China, there are still tremendous limitations in such aspects as researchers, types of studies, study focus and drug classes, as well as standard eligibility criteria for off-label use.