瓜蒌薤白类方治疗胸痹(冠心病)随机对照试验文献的质量评价

Quality Evaluation on Literatures of Randomized Controlled Trial of "Chest Stuffiness" (Coronary Heart Disease) Treated with the Associated Prescriptions of Gualou and Xiebai

目的对瓜蒌薤白类方治疗胸痹(冠心病)随机对照文献进行研究质量的评价和分析。方法选择1994年1月—2009年5月国内发表的瓜蒌薤白类方治疗胸痹(冠心病)的随机对照文献,根据临床流行病学/DME原则和方法,采用中医古代经典临床文献证据分级研究的文献评价表,从诊断及纳入和排除标准、基线资料、随机化方法、盲法、试验措施、疗效判定标准、统计学分析、不良反应等多个方面进行分析评价。结果共纳入文献86篇,其中仅有4篇(4.65%)采用双盲法,9篇(10.47%)对随机化方法进行了简单描述,79篇(91.86%)说明基线可比性,81篇(94.19%)报告了疾病诊断标准,33篇(38.37%)说明了采用的统计学方法,60篇(69.77%)有纳入标准,27篇(31.40%)有排除标准,有效对照41篇(47.67%),安慰剂对照仅1篇(1.16%),25篇(29.07%)报告了不良反应情况,85篇(98.84%)有疗效判定标准。进一步分析提示,文献报道的随机化方法信息较少,很少采用盲法且报道信息不详。结论瓜蒌薤白类方在胸痹(冠心病)治疗中应用广泛,但方法学如随机方案的实施、样本量的计算、统计学方法及不良反应检测等方面质量较低,论文撰写水平有待提高。

Objective To evaluate the quality of literatures on randomized controlled trial of chest stuffiness（coronary heart disease,CHD） treated with Gualou and Xiebai prescriptions.Methods According to the principles and ways of clinical epidemiology/DME,＂Table of quality evaluation on clinical research literatures for TCM ancient classicals＂was adopted for literatures of randomized controlled trial of chest stuffiness（CHD） treated with the associated prescriptions of Gualou and Xiebai,diagnostic criteria,inclusion and exclusioncriteria,randomization method,blind method,result report,statistical method,adverse drug reaction.Results There were 86 literatures included the evaluation.There were only 4 literatures（4.65%） to adopt double-blind method,9 literatures（10.47%） to depict the randomization method,79 literatures（91.86%） to illustrate the comparability of baseline,81 literatures（94.19%） to include diagnostic criteria,33 literatures（38.37%） to use statistical method,60 literatures（69.77%） to include inclusion criteria,27 literatures（31.40%） to include exclusion criteria,41 literatures（47.67%） to adapt effective contrast control,1 literature（1.16%） to adopt placebo contrast control,25 literatures（29.07%） to explain drug adverse reaction,85 literatures（98.84%） to show curative effect determinant criteria.The further analysis presented that there was few information about randomization method in these literatures.There were seldom literatures to adopt blind method and to report the details of the data.Conclusion The associated prescriptions of Gualou and Xiebai were applied widely to treat chest stuffiness.But there were only a few reports to adapt the randomization method,and to calculate sample size,depict statistical method and to report the adverse reaction.The quality of articles should be improved.