Pharmaceutical Department, JA Hiroshima General Hospital at Jigozen, Hatsukaiti-shi, Hiroshima, Japan.
Division of Emergency and Critical Care Medicine, JA Hiroshima General Hospital at Jigozen, Hatsukaiti-shi, Hiroshima, Japan.
Shock. 2019 Feb;51(2):174-179. doi: 10.1097/SHK.0000000000001148.
Recombinant human-soluble thrombomodulin (rhTM) is a novel class therapeutic agent for managing disseminated intravascular coagulation. The progression of severe respiratory failure may be related to intra-alveolar coagulation/fibrinolytic disorders. We aimed to determine the efficacy of rhTM in treating sepsis patients with severe respiratory failure.
We performed a retrospective observational study using an existing dataset collected from 42 intensive care units (ICUs) in Japan. Of 3,195 patients with severe sepsis or septic shock from the dataset, we selected sepsis patients with severe respiratory failure, and compared patient outcomes based on the administration of rhTM (rhTM group and no rhTM group). Propensity score analysis was performed between the two groups. Outcomes of interest were ICU mortality, hospital mortality, and ventilator-free days (VFDs).
In this study, 1,180 patients (rhTM, n = 356; no rhTM, n = 824) were analyzed. After adjusting for baseline imbalances with propensity score matching, the survival-time analysis revealed a significant difference between the two groups (hazard ratio, 0.654; 95% confidence interval, 0.439-0.974, P = 0.03). ICU mortality was lower in the rhTM group (rhTM: 22.1% [33/149] vs. no rhTM: 36.2% [54/149], P = 0.01). Hospital mortality was also lower in the rhTM group (35.6% [53/149] vs. 49.7% [74/149], P = 0.02). VFDs trended to be higher in the rhTM group than the no rhTM group (12.8 ± 10.1 days vs. 10.6 ± 10.6 days, P = 0.09).
Administration of rhTM was positively correlated with a reduction in mortality in sepsis patients with severe respiratory failure.
重组人可溶性血栓调节蛋白（rhTM）是一种用于治疗弥漫性血管内凝血的新型治疗药物。严重呼吸衰竭的进展可能与肺泡内凝血/纤维蛋白溶解紊乱有关。我们旨在确定 rhTM 治疗严重呼吸衰竭的败血症患者的疗效。
我们使用来自日本 42 个重症监护病房（ICU）的现有数据集进行了回顾性观察性研究。在该数据集中，有 3195 例严重败血症或败血症性休克患者，我们选择了严重呼吸衰竭的败血症患者，并根据 rhTM 的使用情况（rhTM 组和无 rhTM 组）比较了患者的结局。对两组进行倾向评分分析。感兴趣的结局是 ICU 死亡率、医院死亡率和无呼吸机天数（VFDs）。
在这项研究中，分析了 1180 例患者（rhTM 组，n=356；无 rhTM 组，n=824）。通过倾向评分匹配调整基线不平衡后，生存时间分析显示两组之间存在显著差异（风险比，0.654；95%置信区间，0.439-0.974，P=0.03）。rhTM 组的 ICU 死亡率较低（rhTM：22.1%[33/149] vs. 无 rhTM：36.2%[54/149]，P=0.01）。rhTM 组的医院死亡率也较低（rhTM：35.6%[53/149] vs. 无 rhTM：49.7%[74/149]，P=0.02）。rhTM 组的 VFDs 趋势高于无 rhTM 组（12.8±10.1 天 vs. 10.6±10.6 天，P=0.09）。
rhTM 的给药与严重呼吸衰竭的败血症患者死亡率降低呈正相关。
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