中国急性脑卒中随机对照试验证据现状与趋势分析

Analysis of acute stroke trials conducted in China's Mainland in the past 17 years

目的 了解中国大陆急性脑卒中随机对照治疗试验（RCTs）的现状与发展趋势,为未来国内临床试验设计及指南制定提供参考依据.方法 通过电子检索国内外8个数据库,纳入1996年1月至2013年5月国内外发表的中国大陆急性脑卒中（缺血性脑卒中、脑出血、蛛网膜下腔出血）随机对照治疗试验,对所纳入的试验进行质量分析.结果 共纳入试验13 493个.17年来发表的RCTs呈递增趋势.研究的卒中类型分别为缺血性脑卒中（63.9%,8623/13 493）,脑出血（30.8%,4157/13 493）,蛛网膜下腔出血（5.3%,713/13 493）.纳入的试验中,多中心随机对照试验共52个,占0.4%（52/13 493）;61.5%（32/52）为药物试验,其中西药占65.6%（21/32）,中药34.4%（11/32）;非药物研究38.5%（20/52）,其中物理疗法 8个,手术7个,针灸5个;样本量为500例以上的多中心随机安慰剂对照试验仅有3个.采用安慰剂对照的多中心药物RCT有13个,采用双盲双模拟阿司匹林对照的多中心试验1个.采用了分组隐藏的非药物RCT有3个.主要结局采用了远期终点指标的多中心药物试验和非药物试验各2个.结论 近17年来,中国大陆急性脑卒中治疗措施的临床试验发表数量增长明显,但有安慰剂对照或分组隐藏的多中心随机对照试验数量仍非常有限,提高急性脑卒中治疗试验的设计与实施质量需引起更多重视.

Objective To evaluate the current status and trend of acute stroke randomized controlled trials （RCTs） in China's Mainland. Methods Acute stroke RCTs were retrieved from 8 databases published in Chinese or English language from January 1996 to May 2013. Those with transient ischemic attack （TIA） or traumatic hemorrhage were excluded. Methodological items were referred to the Cochrane Collaboration＇s tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measures. The data were processed by SPSS 16. 0. Data were summarized as frequency （ and % ） or median and interquartile range. Difference in proportions was assessed with X2 test. Results A total of 13 493 RCTs were identified. The number of acute stroke RCTs increased by years, but only 52 multi-center RCTs were published. There were 13 multi-center placebo controlled drug trims. Among them, only 3 had a sample size of over 500 cases. In multi-center non-drug trials, only 3 used allocation concealment. The studied types of stroke included ischemic stroke （63.9%, 8623/13 493 ）, intracerebral hemorrhage （30. 8%, 4157/13 493） and subarachnoid hemorrhage （5.3%, 713/13 495）. There were 61.5% （32/ 52） multi-center drug trials, including 65.6% （21/32） in Western drug treatment and 34.4% （11/32） in traditional Chinese medicine. There were 38. 5% （20/52）non-drug trials including 8 physical therapy, 7 surgery and 5 acupuncture treatment. There were 2 multi-center placebo controlled drug trials and 2 multicenter non-drug trials used mortality/disability for assessing outcome measures over a follow-up period of 90 clays or more. Conclusion In the past 17 years in China's Mainland, the number of acute stroke RCTs has increased dramatically, but the high-quality trials are scarce. The future acute stroke trials should pay more attention to true randomization, blinding and better patient outcome measures.