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目的 对去纤剂(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。方法 应用国际Cochane协作网的系统评价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)进行了系统评价。结果 至1998年底,国内外共有8个已完成的RCT,仅3个(共包括182例病人)有关Ancrod的RCT符合本研究的纳入标准。Ancrod与早期病死率的显著降低有关[5.6％ v 16％;机会比(OR)0.33;95％可信区间(CI)0.13～0.85;2P=0.02] ,提示用Ancrod每治疗100例病人可避免约10例早期死亡。Ancrod组和对照组均无严重颅内外出血的病例发生。远期病死率或残废率在Ancrod组有降低的趋势但无统计学意义。至2000年底,另2个RCT发表了结果,一个RCT待发表。结论 根据目前资料3小时内使用Ancrod显示有益。但对去纤剂尚不能作出最后结论,近期更新的Cochrane系统评价将提供更为详细的研究进展资料。
Objective To objectively and impartially evaluate the efficacy and safety of defibrillators (snake venom enzyme) in the treatment of acute ischemic stroke. METHODS: The systematic reviews of worldwide randomized controlled trials (RCTs) of defibrillators in the treatment of acute ischemic stroke were conducted using a systematic review of the international Cochane network. Results By the end of 1998, there were 8 completed RCTs at home and abroad, and only 3 (including 182 patients) RCTs for Ancrod met the inclusion criteria of this study. Ancrod was associated with a significant reduction in early mortality [5.6% v 16%; odds ratio (OR) 0.33; 95% CI 0.13 to 0.85; 2P = 0.02], suggesting that ancrod treatment of 100 patients could be avoided About 10 cases of early death. Ancrod group and control group were no serious cases of intracranial hemorrhage. Long-term mortality or disability rate in the Ancrod group has a decreasing trend but not statistically significant. By the end of 2000, the other two RCTs published the results, one RCT to be published. Conclusion The use of Ancrod within 3 hours based on the current data suggests that it is beneficial. However, defibrillators can not make a final conclusion, the recent updated Cochrane systematic review will provide more detailed information on the progress of the study.