近10年针刺干预缺血性中风临床研究文献质量分析

目的:评价1999-2008年针刺干预缺血性中风临床研究文献的质量。方法:收集1999-2008年针刺干预缺血性中风临床随机对照(RCT)试验,并以Cochrane系统评价员手册4.2版推荐的质量评价标准为基础评价纳入研究文献的质量,并对相关的疗效评价进行分析。结果:1999-2008年间共有83篇针刺干预缺血性中风临床RCT研究,16篇(19.3%)简要提到了随机方法,其中8篇(9.6%)详细描述了具体随机的步骤;有1篇文献实施了双盲,且具体描述了双盲的方法;总共有5篇(6.0%)文献报道了退出及失访病例情况,9篇文献(10.9%)提到了不良反应的观察问题;疗效评价方面,应用依次排在前5位的量表分别是95年第四届脑血管病会议通过的脑卒中临床神经功能缺损程度评分标准(95CSS,32/83,38.5%)、1986年第三次脑血管病会议通过的脑血管病疗效评价标准(86CSS,14/83,15.8%)、改良bathel指数(13/83,15.6%)、中风病诊断与疗效评价标准(10/83,12%)以及Fugl-Meyer量表(8/83,9.6%);有44篇文献(53%)以治疗末总有效率为主要终点结局指标,4篇文章(4.8%)报道了治疗期末的残疾发生率。结论:近10年我国针刺干预缺血性中风RCT文献质量不容乐观,在研究设计、对照组的选择以及临床结果报告方面有待进一步改善,相关疗效评价体系不够健全,应该加强RCT各个环节的监控,同时根据临床研究特点和需要建立科学的多维疗效评价体系。

Evaluation of the Quality of Reports on Acupuncture for Ischemic Stroke in Recent ten Years

Objective：To assess the methodological quality of RCT on acupuncture for ischemic stroke in recent ten years. Methods：With the searching terms including acupuncture, ischemic stroke, treatment, etc, the database of the CBM （ 1999 - 2008） ,TCMLRS（ 1999 - 2008 ） and CMCC （ 1999 - 2008 ） were searched from their date of start publication. Chinese medical journals and relevant academic conference proceedings were hand searched as well. Several items in included trials were assessed, including methodology, diagnostic criteria, inclusion/exclusion criteria, acupuncture/control interventions, outcome measures and follow - up, etc. Results：Among the 83 included trials ,5 trials were high - quality. China Stroke Scale of 1995 ,China Stroke Scale of 1986,Modified Bathel Index,Standard of diagnose and curative effect evaluation for stroke and Fugl - Meyer Index were often evalu- ated as outcome measures. Among the 83 trials,5 reported the follow -up outcomes and 9 mentioned adverse events. Conclusion： There was scare high quality trial on acupuncture for ischemic stroke w in China. The outcome measures in trials published in China by now can not evaluate the outcomes of acupuncture for ischemlc accurately. To study designs, advantages of trials oversea can be used for reference. We should build an unified ,scientific, multi - angle evaluated system for acupuncture on ischemic stroke.