复方丹参滴丸治疗冠心病心绞痛随机对照试验的质量评价

目的调查复方丹参滴丸治疗冠心病心绞痛随机对照试验(RCT)的现状,并评价其能否为临床应用提供高质量证据。方法计算机检索1994~2005年l2月国内外公开发表的有关复方丹参滴丸治疗冠心病心绞痛的RCT,采用Jadad评分量表、CONSORT标准和其他自拟评价指标进行质量评价。结果共纳入115篇RCT,其中1篇3分,6篇2分,106篇1分,2篇0分。无RCT执行分配隐藏。按CONSORT标准,仅4篇(3.5%)RCT描述了如何产生随机顺序,其中2篇为半随机,没有RCT报道如何执行随机,有1篇(0.9%)RCT采用安慰剂对照,1篇(0.9%)报道了终点指标,9篇(7.8%)实施单盲,4篇(3.5%)采用双盲,11篇(9.6%)进行了具体统计量计算,2篇(1.7%)提供了随访记录,1篇(0.9%)报道了阴性结果,25篇(21.7%)报道不良事件,均未进行样本含量计算、意向性分析(ITT)和分层分析,属于多中心的仅有1篇(0.9%),均未进行伦理审批和知情同意。描述了中医证型的有27篇(23.5%),所有试验均未采用模拟剂。结论目前复方丹参滴丸治疗冠心病心绞痛临床研究的方法学和报告质量尚低,还不能为临床应用提供可靠的依据。

Quality Assessment of Clinical Studies on Compound Salvia Pellet (CSP) for Angina Pectoris

Objective To investigate the current situation of randomized controlled trials (RCTs) on compound salvia pellet (CSP) for angina pectoris and assess whether there is adequate evidence for clinical practice. Methods We collected all the published clinical studies on CSP for angina pectoris from 1994 to December 2005, and assessed each included report using the Jadad scale ,the revised CONSORT statement and other self-edited items. Results We finally identified 115 RCTs. Among which , 1 scored 3 points, 6 scored 2 points, 106 scored 1 points and 2 socred 0 points. No RCT performed allocation concealment according to the CONSORT criteria, only 4 RCTs (3.5%) described the generation of the randomization sequence, among which 2 were quasi-randomized. No RCT provided randomization implementation ,1 RCT (0.9%) carried out placebo control, 1 RCT (0.9%) reported endpoint, 9 RCTs (7.8%) adopted single blinding ,4 RCTs (3.5%) reported double blinding ,11 RCTs (9.6%) calculated statistical values, 2 RCTs (1.7%) provided the record of follow-up ,1 RCT (0.9%) reported negative outcome ,25 RCTs (21.8%) described adverse events, no RCT described how the sample size was estimated , and how an intent-to-treat (ITT) analysis and correlation analysis were reported, 1 RCT (0.9%) was multi-center, no RCT completed ethical approval and informed consent, 27 RCTs (23.5%) described syndrome type of TCM. Conclusion Currently, the methodology and reporting of studies on CSP for angina pectoris are not good enough to provide reliable evidence for clinical practice.