中药复方干预亚健康随机对照试验的系统评价

Compound Chinese medicine for the intervention of sub-health: a systematic review of randomized controlled trials

目的:评价中药复方干预亚健康的有效性和安全性,为临床干预亚健康提供证据。方法:通过检索Cochranelibrary,MEDLINE,EMBASE,CBM和CNKI数据库(截至2008年12月),全面搜集有关中药复方干预亚健康的随机对照试验,并对文献进行筛选,资料提取和质量评价,质量评价参照Cochrane handbook 5.0标准,数据分析采用Revman 5.0。结果:有8篇文献(合计1487例患者)纳入系统评价。由于纳入研究间临床异质性较大,不能进行定量合并分析,只做描述性分析:4个研究采用了有效率指标,95%可信区间均在右侧;6个涉及躯体症状研究的95%可信区间均在左侧,1个采用HRV指标和2个涉及生活质量改善状况研究的95%可信区间均在右侧。8篇文献中只有一篇提到不良反应,不良反应主要表现为口干和便干,与对照组不良反应比较无统计学差异(P>0.05)。结论:基于以上研究分析,中药复方干预亚健康在改善特异症状和生活质量方面有显著疗效,但由于中药复方干预亚健康的随机对照研究开展较少,纳入研究质量较低,其有效性和安全性有待进一步深入研究。

Objective ： To evaluate the efficacy and safety of compound Chinese medicine for the intervention of sub - health. Methods：Cochrane systematic review method was applied, MEDLINE, EMBASE, CBM, CNKI and Coehrane Centre Controlled Trials Register were searched, and most of the randomized controlled trials＇（RCTs） of compound Chinese medicine for the interven- tion Of sub - health were collected. Randomized controlled trials about compound Chinese medicine for the intervention of sub - health would be included irrespective of any language. Data were extracted by 2 reviewers. The quality of each trial was assessed according to the Cochrane Reviewers＇ Handbook 5. O. O. Statistical software （ RevMan 5.0 ） provided by the Cochrane Collaboration was applied. Results ：Eight RCTs involving 1487 patients were included in this systematic review. The methodological quality of the trials was low. Because of the significant clinical heterogeneity between included trials, we just did descriptive analysis without meta -analysis： 95% confidence interval of six studies is in right ,the others is in left. Conclusion ：Based on current evidence compound Chinese medicine had a significant effect on the improvement of sub - health symptoms and life quality with few ad- verse eventsl However,there was still lack of high quality evidence because of low methodological quality of clinical trials.