抵当汤及其加减方临床对照研究文献的系统评价*

目的]评价国内抵当汤及其加减方的临床对照研究文献的真实性和相关内容,为进一步提高研究者临床研究设计水平和质量提供理论依据.方法]全面广泛收集抵当汤及其加减方临床研究文献,按照临床流行病学和循证医学的原则,采用统一编制的“抵当汤及其加减方文献质量评价信息采集表“,对1980-2007年发表的抵当汤及其加减方临床研究文献进行质量评价.结果]检索到符合纳入标准的临床对照试验文献17篇,省市级研究机构有7项,市级以下医疗与研究机构有10项;10篇报告了疾病诊断标准;有5篇叙述纳入标准,有5篇叙述排除标准;仅有5篇文献对随机化方法进行了描述;有14篇文献有疗效判定标准;有3篇研究报告了不良反应情况;提及基线资料可比性的有12篇.结论]抵当汤及其加减方的临床研究文献逐年增加,特别是近年来研究者更多采用了随机对照方法,并报告了不良反应情况,但设计中仍存在不足,研究质量有待进一步提高.

System evaluation of didang decoction and its variation formula on the clinical control study literatures

Objection] To evaluate validity and effective on clinical control study literatures of Didang decoction and its variation formula and provide theory evidence for enhancing clinical research designing level and quality.Methods] To carry out quality evaluation on clinical control study literatures of Didang decoction and its variation formula from 1980 to 2007.Results] To retrieval seventeen valid literatures that consistented with selected standard of clinical control trial literatures.Conclusion] The literatures of Didang decoction introduced randomly contrast method and reported adverse effect.But there was some deficient in the clinical design.The treatment scope of Didang decoction were cerebral apoplexy,early diabetic nephropathy,unstable angina pectoris,etc.The mainly treatment scope was cerebral apoplexy.