葛根素治疗冠心病心绞痛的临床研究文献评价

目的了解葛根素治疗冠心病心绞痛的临床研究现状,并评价其能否为临床应用提供高质量的依据.方法按文内所述检索策略,计算机检索1966年至2003年10月在国内外公开发表的有关葛根素治疗冠心病心绞痛的所有文献,并对所纳入的文献按国际临床流行病学标准进行分析.结果共检索到文献202篇,纳入138篇,其中随机对照研究106篇,但仅有1篇属高质量研究;有对照未随机分组的研究8篇;无对照的系列病例观察研究24篇.126篇有诊断标准,10篇有纳入标准,3篇为半随机分配,1篇为双盲,4篇为单盲,无随访研究,117篇报告了不良反应.结论目前葛根素治疗冠心病心绞痛临床研究的方法学质量尚低,还不能为临床应用提供可靠的依据.

Ouality Assessment of Clinical Studies on Puerarin for Angina Pectoris

Objective To investigate the current situation of clinical studies on puerarin for angina pectoris and assess whether it is adequate to provide evidence for clinical practiice.. Methods We collected all the published clinical studies on puerarin for angina pectoris from 1966 to October 2003, and assessed all the included reports according to international clinical epidemiological standard. Results 106 RCTs, 8 non-randomized controlled studies and 24 case series were included and analyzed. 126 studies reported diagnosis criteria, 10 desccribed inclusion criteria;3 studies were quasi-random, 1 double blind, 4 single blind;no study reported follow-up;117 studies reported adverse effects. Conclusion Currently the quality of studies on puerarin for angina pectoris is not good enough to provide reliable evidence for clinical practice.