新药临床桥接试验的文献计量分析

Bibliometric analysis of bridging study of new drugs

目的检索国内外与桥接试验相关的文献资料,了解桥接试验的研究进展和现状。方法检索截止至2015年3月Pubmed、Embase、Web of Science以及中国知网数据库,用End Note X7整理,对文献类型、发表年份、第一作者、研究机构、发表期刊、被引频次、样本量和研究内容进行计量分析。结果共纳入外文文献98篇,中文文献8篇。第一篇文献于1993年发表,自1998年关于桥接试验的文献波动增加。发文量最多的是美国,发表最多的期刊是生物药剂统计学杂志,发表最多的研究机构是加利福尼亚临床试验中心,最高被引120次。具体样本量在50以下的文献超过一半。研究内容涉及种族敏感性、桥接研究的类型及桥接策略的模式等。结论桥接试验被广泛关注,但仍需更多临床研究数据以待更深入的探索。

Abjective To retrieve domestic and international literatures about bridging study, and understand the recent progress and current situation.Methods PubMed, Embase, Web of Science and CNKI were searched to collect all the literatures connected with bridging studies from the beginning to March,2015.Endnote X7 was used to sort out and sum-marize.The type of literature, published year, first author, research in-stitution, published journal, cited frequency, sample size and research contents were analyzed with bibliometric methods.Results A total of 98 foreign articles and 8 Chinese articles were included.The first paper was published in 1993, and then the number rose wavelike since ICH E5 was published in 1998.The top one journal who published the most articles is journal of biopharmaceutical statistics, and the top one research institu-tion who published the most articles is California Clinical Trials.Among them, the most frequently cited paper was cited up to 120 times.The sample size under 50 was more than half of the totality.Ethnic sensitivi-ty, type of bridging research and pattern of bridging strategy were fre-quently involved.Conclusion Bridging study is being paid more atten-tion to, but we still need more data of clinical trial to conduct deep explo-ration.