丹红注射液治疗冠心病心绞痛随机对照试验报告质量评价

Quality Assessment of Randomized Controlled Trials Involving Danhong Injection for Angina of Coronary Heart Disease

目的评价丹红注射液治疗冠心病心绞痛随机对照试验的报告质量,同时期望能为提高中药注射剂临床研究质量提供借鉴。方法计算机检索CBM、CNKI、VIP、PubMed、CCTR和e National Research Register,并辅以手工检索,全面收集2002～2010年7月国内外公开发表的有关丹红注射液治疗冠心病心绞痛的随机对照试验。按照Cochrane协作网推荐的评价方法对纳入研究进行方法学质量评价,按照CONSORT项目进行研究报告质量评价。同时采用Jadad评分量表进行质量评价。结果共纳入104篇文献进行质量评价。Jadad评分结果显示:9篇(8.7%)2分,87篇(83.6%)1分,8篇(7.7%)0分。按CONSORT标准:仅1篇(0.96%)RCT报告描述了随机方法,没有RCT报告详述如何执行随机,无采用安慰剂对照的文献报道,仅有3篇文献(2.9%)报道了终点指标,1篇(0.96%)实施单盲,2篇(1.9%)采用双盲,54篇(51.9%)进行了具体统计量计算,5篇(4.8%)报告提供了随访记录,无文献报道阴性结果及等效结果,74篇(71.2%)报道了不良事件,均未进行样本含量计算、意向性分析和分层分析,无多中心的文献研究报道,均未报道进行临床审批和知情同意情况。结论现有丹红注射液治疗冠心病心绞痛随机对照试验报告质量存在不同程度的方法学问题,在随机方案实施、样本量计算、统计学方法、报告随访、失访及不良反应等方面均存在诸多不足,影响了对丹红注射液疗效的真实评价。建议今后进行中药注射液临床随机对照试验设计和报告时应参考CONSORT条目,并基于中医辨证论治的理论开展病证结合的临床试验形式,尤其需重视中药注射液不良反应的临床观察,以便更有益于临床安全用药,保障患者权益。

Objective To investigate the quality of randomized controlled trials（RCTs） involving Danhong Injection for angina of coronary heart disease,and to provide references for improving the quality of clinical research on Chinese medicine（CM） injection.Methods The RCTs published from 2002 to July 2010 about Danhong Injection for angina of coronary heart disease were searched.The methodological quality of the literatures was evaluated according to the methods recommended by the Cochrane Collaboration,and the reporting quality was assessed by means of the Jadad scale and the CONSORT checklist.Results A total of 104 RCTs were included.The assessment result of Jadad scale showed： nine RCTs（8.7%） scored two,87（83.6%） scored one,and the other 8（7.7%） scored zero.According to the standard of CONSORT,only 1 RCT（0.96%） described the random method;no literatures explained how to execute randomization and use placebo control;3 RCTs（2.9%） reported endpoint outcome;1（0.96%） RCT performed single blind;2（1.9%） RCTs performed double blind;54（51%） RCTs calculated statistic values;5（4.8%） RCTs reported follow-up;no RCT reported equivalent results or negative results;74（71.2%） RCTs reported adverse events;no RCTs conducted sample size estimation,intention-to-treat analyses and stratified analyses;no RCTs were multicenter trials;and no RCTs recorded the accreditation and the informed consent.Conclusion The quality of RCTs about Danhong Injection for angina of coronary heart disease is still low in methodological aspects such as randomization,estimation of sample size,statistic methods,reporting of follow-up and non-follow-up,and adverse reactions,which has influences on the real evaluation of the effect of Danhong Inection.It is suggested that the future RCTs on CM injection should be conducted with references of CONSORT statement,that a clinical mode of integration of disease and syndrome should be applied according to the treatment theory based on syndrome differentiation,and that more attention should be paid to the clinical observation on adverse reactions of CM injection,so as to be helpful for safe medication and patients＇ right protection.