葛根素治疗冠心病心绞痛的临床研究文献评价

Quality Assessment of Clinical Studies on Puerarin for Angina Pectoris

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 196 6年至 2 0 0 3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 2 0 2篇 ,纳入 138篇 ,其中随机对照研究 10 6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 2 4篇。 12 6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。

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.