国内消化病学领域临床随机对照试验方法学的评价

Mathodological evaluation of reporting of clinical randomized controlled trials in the field of digestive diseases in China

目的了解国内消化系疾病随机对照试验（RCT）的方法学现状。方法手工检索并调查1999年-2008年间在《中华消化杂志》上发表的临床RCT论文，并根据国际标准对RCT进行方法学评价及分析。结果在3298篇研究论文中临床RCT文章共92篇，占文章总数的2．8％，样本含量从18～5241例不等，有明确纳入标准及排除标准的有61篇（66．3％），16篇（17．4％）具体交代了随机分组的方法，22篇（23．9％）有双盲设计，58篇（63．0％）对分组基线情况进行了比较，73篇（79．3％）具体叙述了统计学方法，仅有7篇（5．7％）被认定为严格设计的RCT。结论临床RCT的数量和质量远远不能满足临床实践的需要。应提倡严格科学设计的多中心、大样本前瞻性临床RCT研究。

Objective To estimate the current quality of the reporting of randomized controlled trials （RCTs） related to digestive diseases in China. Methods All the papers related to RCTs published in Chinese Journal of Digestion from 1999 to 2008 were hand-searched by professional staff then evaluated and analyzed them according to the international reference standard. Results In the 3298 issues of the recent ten years, there were 92 research papers of RCTs which was accounting for 2.8%. The sample size ranged from 18 to 5241. Sixty-one （66.0%） trials included the exact standard of internalize and exclusion. Sixteen （17.4%） trails told the specific method of random allocation and 22（23.9%） were double-blinded. Fifty-eight （63.0%） trials compared the baseline condition of each groups. Seventy-three（79.3%） trails showed the specific approach of statistic. In the end, only 7（5. 7%） trails were identified as the strictly-designed RCTs. Conclusions The quantity and quality of the clinical RCTs can not satisfy the demand of clinical practice. Strictly-scientific designed, multi- centered, large sample prospective clinical RCT should be advocated.