慢性胃炎中医药研究文献的数据分析及质量评价研究

目的：评价我国关于中医药治疗慢性胃炎的临床随机对照试验文献的质量。方法：检索中国知网（CNKI）、中文科技期刊数据库（VIP）,纳入凡文中有＂随机＂字样或＂随机分组＂＂随机对照＂的慢性胃炎为目标疾病的研究,并对其质量进行评价,检索年限从1999年至2008年。结果：共检索出1088篇文献,其中排除非随机对照文献12篇,将1076篇文献纳入分析。1）仅有119篇文献说明了分配序列产生的方法,而其中分配序列产生方法恰当的有64篇;2）文献中说明分配的隐藏方法的仅3篇文献,在这3篇文献中分配被充分隐藏的仅2篇;3）对干预措施实施盲法的文章有4篇,而对分配的干预措施盲法足够的有2篇;4）5篇文献报告了未完成的病例数,仅1篇文献进行了意向治疗分析;5）选择性结果的文献为351篇,725篇文献无选择性结果报告;6）没有使研究处于风险的其他问题的文献共22篇。结论：目前,我国慢性胃炎的中医药临床研究中,高质量的RCT文献量较少,中医药临床研究的整体水平有待提高。RCT还没有真正的应用于中医临床研究。

Data Analysis and Quality Assessment on the Studies of Traditional Chinese Medicine for Chronic Gastritis

Objective： To assess the quality of published randomized controlled trials on traditional Chinese medicine（ TCM） treating chronic gastritis. Methods： Studies on treating chronic gastritis with the terms of＂random＂or＂randomized＂,＂randomized controlled＂ published form 1999 to 2008 were retrieved on CNKI and VIP. Results： Among the retrieved 1088 studies,12 non-randomized ones were excluded,and the remaining 1076 papers were accorded with the inclusion criteria. 1） There were only 119 articles describing the allocation method,and the appropriate allocation method was described in 64 of them. 2） Only 3 articles described allocation conceal- ment,and two of them adopted sufficient allocation concealment. 3） Four studies mentioned the blind method of intervention,and two of them studies noted double-blind. 4） Five studies reported the number of unfinished cases,and only one study finished intention-to-treat. 5） There were altogether 351 literatures reporting selective results,and 725 ones were non-selective results report. 6） There were only 22 articles without the problems which would lead studies to be at risk. Conclusion： Till now,it was lack of high-quality RCT literatures in the clinical research of chronic gastritis treated with TCM,therefore,the overall level of Chinese medicine clinical researches needs to be improved. RCT has not been truly used in Chinese medicine clinical research.