中药临床治疗试验质量的调查──314篇文献评阅结果

Quality of Clinical Trials of Chinese Herbal Drugs a Review of 314 Published Papers

本文抽查三种不同级别中医杂志上已发表的中药临床试验文献。采用规范方法对各文献进行评阅和分析。从对照、随机等与中药试验质量关系较大的因素看，中西医结合杂志所报道的试验质量最好、某全国性中医杂志其次、某省级中医杂志较差。另外，与８０年代初比较，各杂志文献上反映的中药临床试验质量似有一定改善，但与试验标准比较，仍具有差距。

The study was based on a review of clinical trials for herbal drugs published in various journals.Three journals selected were Chinese Journal of Integrated Traditional and Western Medicine(JITWM),Journal of Traditional Chinese Medicine(JTCM),and a provincial Journal of Traditional Medicine(JTM).In order to reflect different levels of the journal,each paper of the clinical trials of herbal drugs in the above-mentioned journals during the survey years,1991,1987 and 1980(or 1981)was reviewed using a standard checklist and quantified through a score system.A total of 314 paper were reviewed, in which 179 in 1991,82 in 1987,and 53 in 1980 and 1981.Controlled trials were found in 86% of JITWM,40.8% of JTCM,and 26.8% of JTM in 1991.Although there was an increased trend in the use or randomized trials,it still showed a lower proportion,respectively 52.9% in JITWM,36.0% in JTCM,and 11.1% in JTM.We found that the quality of clinical trials in JITWM was the first,JTCM the second,JTM the third and showed a gradually improved trend with time.