Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial.
Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial.
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DOI：
10.1136/bmjopen-2016-012850
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发表时间：
2016-12-30
期刊：
影响因子：
2.9
通讯作者：
Kimura A
中科院分区：
文献类型：
--
作者：
Hagiwara A;Tanaka N;Uemura T;Matsuda W;Kimura A
确定重组人血栓调节蛋白（rhTM）治疗是否能增加严重败血症诱导的弥散性血管内凝血（DIC）患者的生存率。单中心、开放标签、随机对照试验。单一三级医院。92例严重败血症诱发DIC患者。DIC评分≥4（根据日本急性医学会的定义）的患者被诊断为DIC。采用信封法进行随机化。治疗组（rhTM组，n=47）在入院后24小时内（第0天）静脉注射rhTM，对照组（n=45）除深静脉血栓形成和肺栓塞外，不接受任何抗凝剂。 在第0天（入院）、第1、2、3、5、7和10天收集数据。主要结局是28天和90天的生存率。 次要终点包括DIC评分、血小板计数、D-二聚体、抗凝血酶III和C反应蛋白水平以及序贯器官衰竭评估（SOFA）评分的变化。所有分析均基于意向治疗进行。对照组和rhTM组的28天存活率分别为84%和83%（p=0.745，对数秩检验）。对照组和rhTM组的90天生存率分别为73%和72%（p=0.94，对数秩检验）。同时，rhTM组DIC（<4）的恢复率显著高于对照组（p=0.001，对数秩检验）。第3天和第5天，rhTM组d-二聚体水平较基线的相对变化显著低于对照组。rhTM治疗降低了严重败血症诱导的DIC患者的D-二聚体水平，促进了DIC的恢复。然而，该治疗并未改善该队列的生存率。UMIN000008339.
To determine whether treatment with recombinant human thrombomodulin (rhTM) increases survival among patients with severe septic-induced disseminated intravascular coagulation (DIC). Single-centre, open-label, randomised controlled trial. Single tertiary hospital. 92 patients with severe septic-induced DIC. Patients with DIC scores ≥4, as defined by the Japanese Association of Acute Medicine, were diagnosed with DIC. The envelope method was used for randomisation. The treatment group (rhTM group, n=47) was intravenously treated with rhTM within 24 hours of admission (day 0), and the control group (n=45) did not receive any anticoagulants, except in cases of deep venous thrombosis and pulmonary embolism. Data were collected on days 0 (admission), 1, 2, 3, 5, 7 and 10. The primary outcome was survival at 28 and 90 days. The secondary end points comprised changes in DIC scores, platelet counts, d-dimer, antithrombin III and C reactive protein levels, and Sequential Organ Failure Assessment (SOFA) scores. All analyses were conducted on an intent-to-treat basis. The 28-day survival rates were 84% and 83% in the control and rhTM groups, respectively (p=0.745, log-rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p=0.94, log-rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p=0.001, log-rank test). Relative change from baseline of d-dimer levels was significantly lower in the rhTM group than in the control group, on days 3 and 5. rhTM treatment decreased d-dimer levels and facilitated DIC recovery in patients with severe septic-induced DIC. However, the treatment did not improve survival in this cohort. UMIN000008339.