论文部分内容阅读
目的：了解《中华传染病杂志》创刊至１９９７年发表的有关传染病临床试验中的随机对照试验（ＲＣＴ），以建立中国有关传染病治疗的ＲＣＴ基线资料。方法：逐页手检《中华传染病杂志》自创刊（１９８３）到１９９７年共１５卷６０期杂志，根据“Ｃｏｔｈｒａｎｅ协作网手册１９９７”对ＲＣＴ和对照临床试验（ＣＣＴ）的定义，严格检定ＲＣＴ和ＣＣＴ。结果：１５年中，该杂志共发表１０１篇临床试验，４８篇为ＲＣＴ，占４７５％。其中，双盲ＲＣＴ５篇。以５年时间段划分，ＲＣＴ比例为：１９８３～１９８７年４０９（９／２２），１９８８～１９９２年３８２％（１３／３４，２篇为双盲ＲＣＴ），１９９３～１９９７年５７８％（２６／４５，双盲ＲＣＴ３篇）。４８篇ＲＣＴ中主要研究的传染病有病毒性肝炎（１６篇）、肾综合征出血热（９篇）、伤寒（５篇）、细菌感染（４篇）、细菌性痢疾（３篇）、流行性脑膜炎（３篇）、华支睾吸虫病（３篇）。结论：中国有关传染病临床试验的质量有待进一步提高，临床试验设计应当多采用ＲＣＴ和双盲法。
Objectives: To understand the randomized controlled trials (RCTs) in the clinical trial of infectious diseases published since “China Infectious Diseases Journal” started in 1997 to establish the baseline data of RCTs on the treatment of infectious diseases in China. Methods: According to the definitions of RCT and controlled clinical trial (CCT) in “Cothrane Cooperative Handbook 1997”, we screened RCT strictly according to the manual of “Chinese Journal of Infectious Diseases” (1983-1997) And CCT. Results: In 15 years, the journal published a total of 101 clinical trials, 48 were RCT, accounting for 47 5%. Among them, double-blind RCT5 articles. According to the five-year time-series, the proportions of RCTs were 40 9 (9/22) from 1983 to 1987, 38 2% from 1988 to 1992 (13/34 and 2 were double-blind RCTs) 8% (26/45, double-blind RCT3 articles). The main infectious diseases studied in 48 RCTs were viral hepatitis (16 articles), hemorrhagic fever with renal syndrome (9 articles), typhoid fever (5 articles), bacterial infection (4 articles), bacillary dysentery (3 articles), epidemic Meningitis (3), Clonorchis sinensis (3). Conclusion: The quality of clinical trial of infectious diseases needs to be further improved in China. RCT and double-blind method should be used more in clinical trial design.