国外大样本针灸临床试验研究文献质量评价

Evaluation on Quality of Large Sample Clinical Trials of Acupuncture in Foreign Countries

本研究以MEDLINE和EMBASE数据库为基础,对国外近年来(1996年-2012年)开展的大样本(500例以上)针灸临床试验研究文献进行监测,对其文献质量进行评价。按照临床循证医学的原则和方法,从10个方面进行总结。经过对37篇国外研究文献进行质量评价研究发现,文献发表的国家相对集中在德国、美国等发达国家,文献质量及研究水平参差不齐,例如不少文献忽略了诊断标准、脱失病例分析、随访、样本含量估算以及卫生经济学评价及不良反应报告等,还有一些研究的纳入、排除标准不明确等。而属于多中心、随机对照且样本量在1 000例以上、试验设计相对全面的高质量文献报道值得我们的重视与借鉴,借此来取长补短,发挥优势,以提高我国针灸临床试验研究的水平。

Following retrieving articles about foreign large sample clinical trials of acupuncture（more than 500cases）from MEDLINE and EMBASE databases（1996-2012）by using keywords of＂acupuncture＂and＂clinical trial＂,aquality analysis was carried out independently by two researchers.A total of 1 373 papers were collected and 37 were considered to meet our preformulated standards in accordance with the principles and methods of evidence-based medicine.Majority of these 37 articles were from some advanced countries including Germany,USA,Japan,Demark,Australia,et al.Their paper quality and research quality are varied including the methodology,standards for diagnosis,inclusive and exclusive criteria,follow-up survey,economic effectiveness,adverse effects,acupoint application and syndrome differentiation of traditional Chinese medicine.Of the 37 papers,17are multiple center clinical trials,18 are one center clinical trials,and 2are not clear.Our Chinese researchers should pay more attention to foreign well-designed,large example,randomized controlled clinical trials and draw their matured experience and strong points to compensate our weak points and to improve our levels in clinical study on acupuncture treatment of clinical disorders.