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为了对去纤制剂(蛇毒酶)治疗急性缺血性卒中的疗效和安全性进行客观公正的评价,我们应用国际Cochane协作网的方法对全世界关于去纤制剂治疗急性缺血性卒中的随机对照试验(RCT)进行了Meta-分析,结果表明:至1997年底,国内外共有8个已完成的和3个正在进行的RCT。已完成的RCT中,仅3个(共包括182例病人)关于Ancrod的RCT符合本研究的纳入标准。Ancrod与早期死亡率的显著降低有关[5.6%v16%;机会比(OR)033;95%可信区间(CI)0.13-0.85;2P=0.02],提示用Ancrod治疗100例病人可避免约10例早期死亡。Ancrod组无明显颅内外出血的病例发生。远期死亡或残废率在Ancrod组有降低的趋势但无统计学意义。结论:因病例太少,目前尚不能作肯定结论,Ancrod似有前途但需大样本的RCT予以证实。3个正在进行的RCT(北美、欧洲、中国各一个,共约3000例病人)将为去纤制剂(蛇毒酶)治疗急性缺血性卒中的疗效和安全性评价提供更多的资料。
In an objective and fair evaluation of the efficacy and safety of defibrinated agents (snake venom enzyme) in the treatment of acute ischemic stroke, we used the International Cochane Collaboration to evaluate the worldwide use of defibrinated agents in the treatment of acute ischemic stroke Meta-analysis of RCTs showed that by the end of 1997, there were 8 completed and 3 ongoing RCTs at home and abroad. Of the completed RCTs, only 3 (182 patients in total) RCTs for Ancrod met the inclusion criteria for this study. Ancrod was associated with a significant reduction in early mortality [5.6% v16%; odds ratio (OR) 0.33; 95% confidence interval (CI) 0.13-0.85; 2P = 0.02] Treatment of 100 patients with Ancrod avoids about 10 early deaths. Ancrod group no obvious intracranial hemorrhage cases. Long-term mortality or disability rate in the Ancrod group decreased but not statistically significant. CONCLUSIONS: Due to the small number of cases, it is not yet possible to conclude that Ancrod seems to be promising with RCTs that require large samples. Three ongoing RCTs, one in North America, one in Europe and one in China, with a total of about 3,000 patients, will provide additional information on the efficacy and safety of defibrinated agents (snake venom enzyme) in the treatment of acute ischemic stroke.