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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >A Systematic Review of Randomized Evidence for Fibrinogen-Depleting Agents in Acute Ischemic Stroke
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A Systematic Review of Randomized Evidence for Fibrinogen-Depleting Agents in Acute Ischemic Stroke

机译:对急性缺血性卒中中纤维蛋白酶引发剂的随机证据进行系统综述

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Objective: To assess the efficacy and safety of fibrinogen-depleting agents (snake venom extracts) in the treatment of acute ischemic stroke. Methods: A systematic review of all the relevant randomized controlled trials (RCTs) was performed. RCTs were identified from the Cochrane Stroke Group's Specialized Trial Register, additional electronic and hand searching, and personal contact with pharmaceutical companies. We included all completed and unconfounded truly or quasi-randomized trials in patients with ischemic stroke comparing fibrinogen depleting agents with control started within 14 days of the stroke onset. The Peto method was used for analysis. Results: Eight completed and two ongoing RCTs have been identified so far, Only three trials using ancrod (182 patients) met the inclusion criteria. Ancrod was associated with a significant reduction in early deaths (5.6% v 16%; odds ratio [OR], 0.33; 95% confidence interval [CI], 0.13 to 0.85; 2P - .02) suggesting that treatment of 100 patients would avoid about 10 early deaths. The frequency of asymptomatic intracranial hemorrhage shown by computed tomography was similar between ancrod-treated and control groups (7.6% v 9.6%; OR, 0.78; 95% CI, 0.26 to 2.33; IP - .65). No major intracranial or extracranial hemorrhages or recurrent ischemic strokes occurred in the ancrod-allocated patients. There were nonsignificant trends in favor of ancrod in death from any cause (OR, 0.57; 95% CI, 0.27 to 1.23; 2P = .15) and death or disability (OR, 0.52; 95% CI, 0.26 to 1.03; 2P - .06) at the end of trial follow-up. Conclusions: There were too few patients and outcome events to draw reliable conclusions from the present data. Although ancrod-like agents appeared promising, their routine use cannot be recommended at the moment. Two ongoing trials (including about 1,000 patients in total) will provide more data. Future trials should test simpler fixed-dose regimens to allow better generalizabil-ity.
机译:目的:评估纤维蛋白原消耗剂(蛇毒液提取物)治疗急性缺血性卒中的疗效和安全性。方法:对所有相关随机对照试验(RCT)进行系统审查。从Cochrane Stroke Group的专门试验登记,额外的电子和手搜索以及与制药公司的个人接触来确定RCT。我们包括所有已完成的,并且在缺血性卒中患者中均已完成,令人满意的真正或准随机试验将纤维蛋白原耗尽剂与对照开始于行程发作的14天内开始。 PETO方法用于分析。结果:八项已完成,迄今已识别出两台正在进行的RCT,只有三次使用AnCrod(182名患者)的试验达到纳入标准。 ancrod与早期死亡的显着降低有关(5.6%v 16%;差距[或],0.33; 95%置信区间[Ci],0.13至0.85; 2p - .02)表明避免治疗100名患者大约10个早期死亡。通过计算断层扫描显示的无症状颅内出血的频率在疾病治疗和对照组(7.6%V.6%;或,0.78; 95%CI,0.26至2.33; IP - .65)之间相似。在ANCROD分配的患者中没有发生任何主要的颅内或颅内出血或复发性缺血性卒中。从任何原因(或0.57%CI,0.27至1.23; 2p = .15)和死亡或残疾(或0.52; 95%CI,0.26至1.03; 2p - .06)在试验后续行动结束时。结论:患者和结果事件太少,从目前的数据中得出可靠的结论。虽然ancrod样的药剂出现了很有希望,但目前无法建议他们的常规使用。两项持续的试验(包括约1,000名患者)将提供更多数据。未来的试验应测试更简单的固定剂量方案,以允许更好的Generalizabil-ity。

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