五苓散及其加减方临床对照研究文献的质量评价*

[目的]评价五苓散及其加减方临床对照研究文献的质量,为提高该方的临床研究水平提供证据.[方法]计算机检索中国知网、维普、万方、中国生物医学文献数据库、wiley、pubmed,检索时间截至2007年1月.对纳入所有五苓散及其加减方治疗肝硬化、高脂血症、小儿秋季腹泻、中心性浆液性视网膜病变、心力衰竭的临床对照研究文献进行质量评价.[结果]合格文献52篇,其中心力衰竭有15篇,小儿秋季腹泻有12篇,中心性浆液性视网膜病变有9篇,肝硬化腹水有9篇,高脂血症有7篇;采用随机对照有34篇(65.38%),明确说明了随机分配方法有5篇(9.62%),应用盲法有2篇(3.85%),说明病例退出情况有2篇(3.85%);说明基线资料的可比性有35篇(67.31%),说明统计学分析方法有24篇(46.15%),使用分析表格有29篇(55.77%);所有文献均未设立随机方案的隐藏和样本估算.[结论]五苓散及其加减方临床对照试验的研究质量,近年来逐渐提高,但尚存在一些不足.应该加大对上述5类病种的临床研究力度.

Qualitative evaluation on clinical controlled study of literatures on Wuling powder and Its modified formula

[Objection] To evaluate the quality in clinical controlled study on literatures of Wuling powder and its modified formula and provide the evidence for enhancing clinical research level of Wuling powder.[Methods] The corresponding literatures from the CNKI,Vip,Wanfang,CBM,Wiley and Pubmed database were searched till the January of 2007.The qualitative evaluation of clinical controlled study on these literatures about Wuling powder and its modified formula was carried out.The diseases included were hepatic cirrhosis,hyperlipemia,pedo-rotavirus enteritis,central serous retinopathy and heart failure.[Results] The qualified literatures was fifty-two chapters which included heart failure (fifteen chapters),hyperlipemia (seven chapters),pedo-rotavirus enteritis (twelve chapters),central serous retinopathy (nine chapters) and hepatic cirrhosis (nine chapters).Thirty-four chapters belonged to random control literatures (65.38%).The selected literatures included five chapters with random allocation method (9.62%),two chapters with blind method (3.85%),two chapters with explaining case exit condition (3.85%),thirty-five chapters with explaining comparability of baseline data (67.31%),twenty-four chapters with explaining statistics analysis method (46.15%),twenty-nine chapters with analytical table (55.77%).All the literatures didn't establish random scheme conceal and sample estimation.[Conclusion] The research quality of Wuling powder and its modified formula is more and more increasing in its clinical controlled study on literatures.We should enhance clinical research level of five related disease.