《华西医学》15年临床试验文献评价

Evaluation of Clinical Trials Published in West China Medical Journal in the Past 15 Years

目的 :鉴定出《华西医学》从 1986年至 2 0 0 0年间发表的临床试验论著中的随机对照试验 (RCT ,ran domizedcontrolledtrial)、半随机对照试验 (CCT ,controlledclinicaltrial)和对其评价 ,并向中国Cochrane中心输送基线资料。设计 :现况调查。研究地点 :四川大学华西医院图书馆。对象 :《华西医学》 1986年 (创刊 )～ 2 0 0 0年共 15卷 ,无缺漏 (原名《华西医讯》于 1989年改刊名为《华西医学》)。方法 :逐期逐页手工检索 ,鉴定、筛选临床试验并填写手检登记表 ,根据“Cochrane协作网手册 1997”对RCT和CCT的定义严格鉴定RCT和CCT。结果 :在 15年中 ,该杂志共发表 3939篇文献 ,其中临床试验总共为 5 80篇 ,RCT为 16 9篇占 2 9 1%,CCT为 93篇占 16 0 %。以 5年时间段划分 ,RCT的比例为 :1986～ 1990年为 13 6 %(2 3/ 16 9) ,1991～ 1995年为 2 8 4 %(4 8/16 9) ,1996～ 2 0 0 0年为 5 8 0 %(98/ 16 9) ,RCT所占比例每年逐渐增加 (P <0 0 5 )。在RCT中有 2 2篇采用盲法(13 0 %)。RCT所选取平均样本含量 ( X±SD)为 86 0± 79 3例 (其范围为 12～ 5 6 6例 )。 2 6 2篇RCT和CCT的研究病种主要有 :呼吸系统的疾病 2 7篇 ,消化系统的疾病 31篇 ,心脑血管的疾病 32篇 ,泌尿生殖系统 (含妇产科 )的疾病 2 6?

Objective:To identify the randomized controlled trials and controlled clinical trials in West China Medical Journal from 1986 to 2000,and offer the basic data to Chinese Cochrane center.Design:Cross-sectional study.Site:The Library of West China Hospital of Sichuan University.Methods:Handsearching page by page to identify and register the clinical trials from the journal,the definition of randomised controlled trial(RCT)and controlled clinical trials(CCT)strictly according to the Cochrane Collaboration Handbook(1997).Results:There were 3939 articles published in total,and 580 clinical trials were identified in which RCTs were 169(29.1%),and CCTs 93(16.0%).The proportion of RCTs were increased by every three-year,i.e.,13.6%(23/169)in 1986-1990,28.4%(48/169)in 1991-1995,and 58.0%(98/169)in 1996-2000.Among the RCTs,22 papers used blind method(13.0%).The average sample size(±SD)was 86.0±79.3(range from 12 to 566).Conclusion:with the development of epidemiology and the rising of EBM,the quantity of clinical trials published in West China Medicine Journal was increased gradually and their quality was improved.However,there are still problems,such as methods of randomization unclear,improper sample size,and blinding less used.The quality of clinical trials needs improving.