中医药治疗心力衰竭临床随机对照试验文献的方法学评价

Methodological Evaluation of Randomized Controlled Trials for Treatment of Heart Failure in Chinese Medical Literatures

目的评价中医药治疗心力衰竭临床随机对照试验(RCTs)文献的质量。方法根据Cochrane系统评价手册,机检调查1999年—2009年近10年国内生物医学期刊发表的有关中医药治疗心衰RCTs文献,调查内容包括研究对象选择、样本大小、纳入排除标准、随机化方法、盲法、组间可比性、干预措施、中医证型、统计学处理、疗效评价、不良反应、依从性、退失访病例及随访等。结果共纳入RCTs文献169篇。研究对象有明确纳入标准的有34篇(20.11%),有排除标准的47篇(27.81%)。无一篇文献说明样本量估算方法。只有15.38%(26/169)的文献对随机法进行了具体的描述,仅有1篇RCTs采取了随机分配隐藏,3.55%(6/169)的RCTs采取了盲法,有4.14%(7/169)的文献报道了失访与退出病例,Jadad质量评分显示高质量的文献仅有6篇。结论中医药治疗心衰的RCTs质量还不够高。主要表现为随机分组方法没有说明或应用错误,随机分配隐藏没有得到足够重视,盲法使用过低,忽视依从性、病例脱落、随访情况的分析,中小样本试验多,鲜见多中心、大样本试验研究,且样本量没有具体的估算方法,组间基线资料统计不全,疗效评价标准不够统一。

Objective To assess the quality of randomized controlled trials （RCTs） for heart failure published in Chinese medical journals. Methods According to Cochrane system evaluation manual,the Chinese biomedical journals in 1999 to 2009 were machine- searched and 169 RCTs for heart failure were identified. Chin Journal of Heart failure, Chin J of New Drugs and Clinical Remedies, Chin J of Endocrine and metabolic,Chin J Integrated Trad Western Med,and Chin J Internal Med on Emergency Treatment were in- cluded. Results In the recent 10 years,the numbers of RCTs were 169 trials. There were 20.11~//00 with inclusion criteria for subject selection and 27.81~ with exclusion criteria. No one literature showed estimation method. There were 15.38 ~//0 had the random de- scription and only one piece of RCTs adopted random distribution. Blindness was used in 6 RCTs. There were 4.14 % RCT to report lost to follow- up and exit. High quality documents by Jadad quality score had only six trials. Conclusions The quality of TCM RCTs trial for heart failure should further improve.