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首页> 外文期刊>Critical care medicine >A randomized, double-blind, placebo-controlled, phase 2b Study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation
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A randomized, double-blind, placebo-controlled, phase 2b Study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation

机译：一项随机，双盲，安慰剂对照的2b期研究，用于评估重组人可溶性血栓调节蛋白ART-123在脓毒症和疑似弥散性血管内凝血患者中的安全性和有效性

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Objectives:: To determine the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with suspected sepsis-associated disseminated intravascular coagulation. design:: Phase 2b, international, multicenter, double-blind, randomized, placebo-controlled, parallel group, screening trial. setting:: Two hundred and thirty-three ICUs in 17 countries. patients:: All adult patients admitted with sepsis and suspected disseminated intravascular coagulation as assessed using a modified International Society on Thrombosis and Hemostasis score. interventions:: Patients were randomized to receive IV ART-123 (0.06 mg/kg/d) for 6 days or placebo, in addition to standard of care. The primary endpoint was reduction in mortality. Secondary endpoints included reversal of overt disseminated intravascular coagulation and reduction in disease severity. Measurements and main results:: A total of 750 patients were randomized, nine of whom did not receive the allocated treatment so that 371 patients received ART-123 and 370 received placebo. There were no meaningful differences between the two groups in any of the baseline variables. Twenty-eight-day mortality was 17.8% in the ART-123 group and 21.6% in the placebo group (Cochran-Mantel-Haenszel two-sided p value of 0.273 in favor of ART-123, which met the predefined statistical test for evidence suggestive of efficacy). There were no statistically significant differences in event-free and alive days between the two groups. d-dimer, prothrombin fragment F1.2 and TATc concentrations were lower in the ART-123 group than in the placebo group. There were no differences between the two groups in organ function, inflammatory markers, bleeding or thrombotic events or in the development of new infections. In post hoc analyses, greatest benefit from ART-123 was seen in patients with at least one organ system dysfunction and an international normalized ratio greater than 1.4 at baseline. conclusions:: ART-123 is a safe intervention in critically ill patients with sepsis and suspected disseminated intravascular coagulation. The study provided evidence suggestive of efficacy supporting further development of this drug in sepsis-associated coagulopathy including disseminated intravascular coagulation. Future study should focus on using ART-123 in the subgroup of patients most likely to respond to this agent.
机译：目的：确定重组血栓调节蛋白（ART-123）在怀疑与脓毒症相关的弥散性血管内凝血的患者中的安全性和有效性。设计：： 2b期，国际，多中心，双盲，随机，安慰剂对照，平行组，筛选试验。设置：： 17个国家/地区的233个ICU。患者：根据改良的国际血栓形成与止血协会评分评估，所有患有败血症并怀疑弥散性血管内凝血的成年患者。干预措施：除了标准的护理外，患者随机接受6天内的静脉抗病毒治疗ART-123（0.06 mg / kg / d）或安慰剂。主要终点是降低死亡率。次要终点包括明显的弥散性血管内凝血逆转和疾病严重性降低。测量和主要结果：总共750例患者被随机分组​​，其中9例未接受分配的治疗，因此371例接受ART-123的患者和370例接受了安慰剂的患者。两组之间的任何基线变量之间都没有有意义的差异。 ART-123组的28天死亡率为17.8％，安慰剂组为21.6％（Cochran-Mantel-Haenszel的双面p值为0.273，支持ART-123，符合预先确定的统计学检验证据）暗示疗效）。两组的无活动天数和存活天数在统计学上无显着差异。 ART-123组的d-二聚体，凝血酶原片段F1.2和TATc的浓度低于安慰剂组。两组在器官功能，炎症标志物，出血或血栓形成事件或新发感染方面无差异。在事后分析中，在至少一个器官系统功能障碍且基线时国际标准化比率大于1.4的患者中，ART-123获益最大。结论：ART-123是脓毒症和疑似弥散性血管内凝血的危重患者的安全干预措施。这项研究提供了证据支持这种药在脓毒症相关性凝血病（包括弥散性血管内凝血）中进一步发展的功效。未来的研究应集中在最有可能对该药物产生反应的患者亚组中使用ART-123。

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