从循证医学角度分析《中华烧伤杂志》2000-2004年发表的临床试验论文

目的了解我国烧伤专业临床试验研究的现状，进一步提高论文的学术水平。方法按照循证医学（EBM）的标准，对《中华烧伤杂志）2000--2004年刊登的临床试验论文进行回顾性检索及综合分析，以评价其质量。结果临床试验论文共计89篇，其中随机对照试验（RCT）43篇占48．3％，临床对照试验（CCT）46篇占51．7％，RCT论文呈逐年增多趋势，而CCT论文波动较大。采用盲法试验的论文5篇，占5．6％；有明确纳入、排除标准的论文53篇，占59．6％；64篇论文未提供分组的基线资料比较情况，占71．9％；10篇论文在统计分析时仅给出了P值，未说明采取何种统计学方法，占11．2％；仅有2篇论文提及随访、失访情况，占2．2％，但未详细报道结果；10篇论文对不良反应进行了报道，占11．2％；对混杂干扰因素进行分析说明的论文有5篇，占5．6％；无一篇论文对样本含量的估计以及随机化方法进行说明。结论我国烧伤领域部分论文在科研设计、伦理学思考方面尚存在不足，有待进一步改进和提高。

Analysis of the quality of papers dealing with clinical trails in "Chinese Journal of Burns" during 2000 ～ 2004 by the standard of evidence-based medicine

Objective To investigate the quality of reports of clinical results concerning burn injury, in order to raise the standard of clinical study of burn care in accordance to the standard of evidence-based medicine ( EBM) , with the aim of improving clinical research in burn care of this country. Methods All the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard. Results There were 89 papers about clinical trials published in the past 5 years, in which 43 (48. 3% ) of the studies were carried out with random control trials ( RCT) , and 46 (51. 7% ) were clinical control trials (CCT). RCT papers increased year by year, while the number of CCT papers fluctuated greatly. The disparity in the quality of research was found as follows. In all the RCT and CCT papers, blinded research was adopted only in 5 papers (5. 6% ). Strict diagnostic standard including inclusion and exclusion standards were reported in 53 articles(59. 6% ). The comparison with baselines was not provided in 64 articles (71.9% ). P value was given in 10 papers but statistical method was not mentioned (11.2% ). Follow-up visits and lost information were only recorded in 2 articles, but no detailed follow-up visiting data were provided. Side effects were reported in 10 articles ( 11.2% ). There were analysis and explanation of mixed interfering factors only in 5 papers (5. 6% ). There was no explanation of the evaluation of sample size in any one paper. Conclusion In summary, the literature concerning clinical studies published in CJB in the past five years has become more extensive. However, the present study indicates that many clinical trials are not designed and ethical consideration is often missing. Therefore, it is deemed imperative to improve the quality of the clinical studies by improving the planning of the protocols of the study and statistical analysis of the research results in future.