Stroke:缺血性卒中:r-tPA是否合用阿加曲班差异巨大

2017-07-06 易湛苗 环球医学资讯

2017年6月,发表在《Stroke》的一项由美国科学家进行的随机、多中心ARTSS-2试验发现缺血性卒中患者中,重组组织型纤溶酶原激活剂(r-tPA)合用阿加曲班不增加症状性颅内出血的风险,且增加获得有利结局的可能性。

2017年6月,发表在《Stroke》的一项由美国科学家进行的随机、多中心ARTSS-2试验发现缺血性卒中患者中,重组组织型纤溶酶原激活剂(r-tPA)合用阿加曲班不增加症状性颅内出血的风险,且增加获得有利结局的可能性。

背景和目的:研究人员进行了一项随机探索性研究,以评估阿加曲班(一种直接凝血酶抑制剂)+r-tPA治疗缺血性卒中患者的安全性和获得有利结局的可能性。

方法:使用常规剂量r-tPA治疗的患者不接受血管内治疗,随机分配到不使用阿加曲班组或使用阿加曲班组(100 μg/kg推注),随后在48小时输注1μg/kg/min(低剂量)或3μg/kg/min(高剂量)。安全性指标是症状性颅内出血的发生率。临床获益(90天时改良Rankin量表评分0~1分)的可能性使用conservative Bayesian Poisson模型评估(中性先验概率集中在相对风险,1.0;95%先验间隔,0.33~3.0)。

结果:90名患者被随机分配:29名仅使用r-tPA、30名使用r-tPA+低剂量阿加曲班、31名使用r-tPA+高剂量阿加曲班。对照组,低剂量与高剂量组的症状性颅内出血的比率相似:分别为3/29(10%)、4/30(13%)和2/31(7%)。90天时,6名(21%)仅使用r-tPA、9名(30%)使用低剂量和10名(32%)使用高剂量阿加曲班的患者的改良Rankin量表评分为0~1分。低剂量、高剂量、低剂量或高剂量阿加曲班的改良Rankin量表评分为0~1分的相对风险(95%置信区间)分别是1.17(0.57~2.37)、1.27(0.63~2.53)和1.34(0.68~2.76)。在低、高、低或高剂量组,合用阿加曲班优于仅使用r-tPA的概率分别为67%、74%和79%。

结论:在使用r-tPA治疗的患者中,合用阿加曲班与症状性颅内出血风险增加不相关,且为有效性试验提供了证据。

原始出处:
Barreto AD, Ford GA, Shen L,, et al. Randomized, Multicenter Trial of ARTSS-2 (Argatroban With Recombinant Tissue Plasminogen Activator for Acute Stroke).Stroke. 2017 Jun;48(6):1608-1616. doi: 10.1161/STROKEAHA.117.016720. Epub 2017 May 15.

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    2017-11-07 yahu
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    2017-08-20 循证小兵

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