摘要
目的 从《中华传染病杂志》18年来发表的文献中鉴定出临床研究并对其评价,以了解我国传染病临床防治研究的基线和水平。方法 对《中华传染病杂志》创刊至2000年共18卷12期,采用手工检索逐期逐页由鉴定、筛选临床试验并填表登记,随机对照试验(randomized controlled trial,RCT)及对照临床试验(controlled clinical trial,CCT)的定义严格按照《Cochrane协作网手册》1997年版执行。结果18年间共发表214篇临床研究,其中,RCT67篇(双盲RCT5篇,多中心协作RCT8篇),占31.3％,CCT67篇,占31.3％,无对照的临床治疗研究80篇,占37.4％。RCT所用样本含量平均(X±SD)为103.0±70.2例(范围17～296例)。按每5年一个时段统计(1998-2000年3年为一个时段),RCT所占比例逐渐增加,1983-1987为22.9％(11/48),1988-1992为29.2％(14/48),1993-1997占41.9％(26/62),1998-2000年占28.6％(16/56)。214篇临床研究的主要病种有,病毒性肝炎(65篇)、肾综合征出血热(19篇)、伤寒(11篇)、细菌感染(13篇)、细菌性痢疾(5篇)、流行性乙型脑炎(3篇)、寄生虫病(9篇)。结论 我国传染病临床研究的水平尚有待提高,应尽可能采用RCT设计;多中心、大规模的协作研究值得提倡。
Objective To know about the base line and quality of clinical prophylaxis and treatment study on communicable diseases in China, by identifying and assessing the clinical studies published in Chinese Journal of Infectious Diseases for 18 years. Method Handsearching page by page to identify and register the clinical studies from the journal, the definition of randomised controlled trial (RCT) and controlled clinical trial (CCT) strictly according to the Cochrane Collaboration Handbook (1997). Results There were totally 214 clinical studies during the 18 years, including 67 RCTs, 67 CCTs and 80 Non-CCTs. The average sample size of the RCTs was 103.0 ± 70.2 (range from 17 to 296). Counted by every 5 years period (3 years period from 1998 to 2000), the proportion of RCTs in clinical studies was increasing steadily. The proportion were 22.9% from 1983 to 1987 (11/48), 29.2% from 1988 to 1992 (14/48), 41 .9% from 1993 to 1997 (26/62) , 28.6% from 1998 to 2000 (16/56) respectively. The main diseases studied in 214 clinical studies include: virus hepatitis (65 studies), hcmorrhagic fever with renal syndrome (19 studies), typhoid fever (11 studies), bacterial infection (13 studies), bacillary dysentery (5 studies), epidemic encephalitis B (3 studies) and parasitosis (9 studies) .Conclusion RCT study design should be applied as much as possible. The quality of clinical studies on communicable diseases in China remains to be improved. Multi-center and large-scale collaborative study is worthy to advocate.
