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首页> 外文期刊>Stroke: A Journal of Cerebral Circulation >Low-dose recombinant tissue-type plasminogen activator enhances clot resolution in brain hemorrhage: the intraventricular hemorrhage thrombolysis trial.
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Low-dose recombinant tissue-type plasminogen activator enhances clot resolution in brain hemorrhage: the intraventricular hemorrhage thrombolysis trial.

机译：低剂量重组组织型纤溶酶原激活剂可增强脑出血中的血凝块分解：脑室内出血溶栓试验。

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BACKGROUND AND PURPOSE: Patients with intracerebral hemorrhage and intraventricular hemorrhage have a reported mortality of 50% to 80%. We evaluated a clot lytic treatment strategy for these patients in terms of mortality, ventricular infection, and bleeding safety events, and for its effect on the rate of intraventricular clot lysis. METHODS: Forty-eight patients were enrolled at 14 centers and randomized to treatment with 3 mg recombinant tissue-type plasminogen activator (rtPA) or placebo. Demographic characteristics, severity factors, safety outcomes (mortality, infection, bleeding), and clot resolution rates were compared in the 2 groups. RESULTS: Severity factors, including admission Glasgow Coma Scale, intracerebral hemorrhage volume, intraventricular hemorrhage volume, and blood pressure were evenly distributed, as were adverse events, except for an increased frequency of respiratory system events in the placebo-treated group. Neither intracranial pressure nor cerebral perfusion pressure differed substantially between treatment groups on presentation, with external ventricular device closure, or during the active treatment phase. Frequency of death and ventriculitis was substantially lower than expected and bleeding events remained below the prespecified threshold for mortality (18% rtPA; 23% placebo), ventriculitis (8% rtPA; 9% placebo), symptomatic bleeding (23% rtPA; 5% placebo, which approached statistical significance; P=0.1). The median duration of dosing was 7.5 days for rtPA and 12 days for placebo. There was a significant beneficial effect of rtPA on rate of clot resolution. CONCLUSIONS: Low-dose rtPA for the treatment of intracerebral hemorrhage with intraventricular hemorrhage has an acceptable safety profile compared to placebo and historical controls. Data from a well-designed phase III clinical trial, such as CLEAR III, will be needed to fully evaluate this treatment.
机译：背景与目的：脑出血和脑室内出血的患者据报道死亡率为50％至80％。我们从死亡率，心室感染和出血安全事件及其对脑室内血栓溶解率的影响方面评估了这些患者的血栓溶解治疗策略。方法：在14个中心招募了48位患者，并随机接受3 mg重组组织型纤溶酶原激活剂（rtPA）或安慰剂的治疗。比较两组的人口统计学特征，严重性因素，安全性结果（死亡率，感染，出血）和血块消退率。结果：除了安慰剂治疗组的呼吸系统事件发生频率增加外，包括入院格拉斯哥昏迷量表，脑出血量，脑室内出血量和血压在内的严重性因素以及不良事件均平均分布。在就诊时，外部心室装置关闭时或在积极治疗阶段，各治疗组之间的颅内压和脑灌注压均无显着差异。死亡和心室炎的发生频率大大低于预期，出血事件仍低于死亡率的预定阈值（rtPA 18％;安慰剂23％），室炎（rtPA 8％;安慰剂9％），症状性出血（rtPA 23％; 5％）安慰剂，具有统计学意义; P = 0.1）。 rtPA的平均给药时间为7.5天，安慰剂为12天。 rtPA对血凝块分解速率有显着的有益作用。结论：与安慰剂和历史对照相比，小剂量rtPA治疗脑出血合并脑室内出血具有可接受的安全性。需要精心设计的III期临床试验（如CLEAR III）中的数据来全面评估该治疗方法。

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