中成药治疗冠心病随机对照试验方法学质量评价

目的评价复方丹参滴丸、复方丹参片、速效救心丸、通心络胶囊与硝酸异山梨酯治疗冠心病心绞痛随机对照试验(randomized controlled trial,RCT)质量。方法检索电子数据库并筛选出符合纳入标准的RCT。采用Jadad评分量表、M评分量表、CONSORT2010、CONSORT for herbal medicine评价报告质量。利用R统计软件对RCT质量与其基本特征(作者数量、发表年限、样本量、疗程)之间的Kendall相关性进行分析计算。结果 88篇RCT报告纳入研究分析。各评价标准得分中位数(平均值,95%可信区间)分别为Jadad评分量表2.00(2.09,[1.81,2.37])、M评分量表4.00(3.52,[2.95,4.09])、CONSORT201015.00(15.39,[13.87,16.91])和CONSORT for herbal medicine19.00(19.06,[17.16,20.96])。Jadad得分>2的高质量报告只有9.1%(8/88)。纳入研究的RCT质量与提取出的基本特征未呈显著相关。结论中成药对比硝酸异山梨酯治疗冠心病心绞痛RCT的质量1997-2009年没有显著改善。需要努力提高RCT的设计实施与报告质量。

Assessment of the Quality of Randomized Controlled Trials in Treating Coronary Heart Disease by Chinese Patent Medicine

Objective To assess the quality of randomized controlled trials(RCTs) on Compound Danshen Dripping Pill,Compound Danshen Tablet,Suxiao Jiuxin Pill,Tongxinluo Capsule,and isosorbide dinitrate(ISDN) in treating coronary heart disease angina.Methods RCT reports were retrieved from CNKI,Wanfang Data,PubMed,China Master Theses Full-text Database,Chinese Electronic Periodical Services,Social Sciences Citation Index,Science Direct,Cambridge Journals Online,and EBM Reviews.Qualities of RCTs were assessed according to Jadad scale,M scale,CONSORT 2010,and CONSORT for herbal medicine.Kendall correlations between basic study characteristics and qualities of included RCTs were analyzed using R statistical software.Results Eighty-eight RCTs were included.The medians(means,95% CIs) were 2.00(2.09,[1.81,2.37]) for the Jadad scale,4.00(3.52,[2.95,4.09]) for the M scale,15.00(15.39,[13.87,16.91]) for the CONSORT 2010,and 19.00(19.06,[17.16,20.96]) for the CONSORT for herbal medicine.Only 9.09%(8/88) of RCTs were of high quality(Jadad score>2).These RCT quality measures were not correlated with individual items of reporting,such as sample sizes and follow-up periods.Conclusions The quality of RCTs on Chinese patent medicine compared with ISDN was not improved from 1997 to 2009.It is urgent to improve the design of RCTs and the report quality.