Benefit profile of recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis.
Benefit profile of recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis.
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DOI：
10.1186/s13054-015-0810-3
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发表时间：
2015-03-03
期刊：
影响因子：
--
通讯作者：
Shimazu T
中科院分区：
文献类型：
--
作者：
Yoshimura J;Yamakawa K;Ogura H;Umemura Y;Takahashi H;Morikawa M;Inoue Y;Fujimi S;Tanaka H;Hamasaki T;Shimazu T
重组人可溶性血栓调节蛋白（rhTM）的安全性和有效性已得到证实，在IIb期随机对照试验中有希望的证据表明对涉及凝血功能障碍的严重脓毒症患者有效。然而，尚未阐明rhTM的获益特征。本研究的目的是探索根据急性生理学和慢性健康评价（APACHE）II和序贯器官衰竭评估（SOFA）评分确定的疾病严重程度较高的患者是否会从rhTM给药中获益。这是一项在三家日本三级转诊医院进行的多中心回顾性队列研究的事后亚组分析。脓毒症引起的弥散性血管内凝血（DIC）患者需要呼吸机管理。我们根据疾病严重程度将患者分为几个层次，通过APACHE II和SOFA评分确定，使用分类和回归树获得生存数据。使用调整倾向模型的考克斯回归分析分析干预效应（表示为风险比（HR）），以检测rhTM对住院死亡率影响的亚组异质性。参与者是162例脓毒症诱导的DIC患者;其中68例接受rhTM治疗，94例未接受。调整失衡后，rhTM给药与高危患者死亡率降低显著相关（APACHE II：24 - 29; HR：0.281; 95%置信区间（CI）：0.093 - 0.850; P = 0.025）。在极高风险亚组中观察到类似的非显著性趋势（APACHE II：≥30; HR：0.529; 95% CI：0.202至1.387; P = 0.195），但在中度风险患者亚组中不明显（APACHE II：<24; HR：0.814; 95% CI：0.351至1.884; P = 0.630）。在SOFA评分分析中观察到类似的趋势（中度风险子集（SOFA：<11），P = 0.368;高风险子集（SOFA：≥11），P = 0.042）。根据基线APACHE II和SOFA评分，在脓毒症诱导的DIC和高死亡风险中观察到rhTM治疗的生存获益。
The safety and efficacy of recombinant human soluble thrombomodulin (rhTM) have been demonstrated, with promising evidence suggestive of efficacy for patients with severe sepsis involving coagulopathy in a phase IIb randomized controlled trial. However, the benefit profiles of rhTM have not been elucidated. The purpose of this study was to explore whether patients with greater disease severity, determined according to the Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores, would experience treatment benefit from rhTM administration. This was a post hoc, subgroup analysis of a multicenter retrospective cohort study conducted in three Japanese tertiary referral hospitals. Patients with sepsis-induced disseminated intravascular coagulation (DIC) who required ventilator management were included. We stratified patients into several strata according to disease severity, determined by APACHE II and SOFA scores, using classification and regression trees for survival data. Intervention effects, expressed as hazard ratios (HR), were analyzed using Cox regression analysis adjusted for a propensity model to detect subgroup heterogeneity of the effects of rhTM on in-hospital mortality. Participants were 162 patients with sepsis-induced DIC; 68 of these patients received rhTM and 94 did not. After adjusting for imbalances, rhTM administration was significantly associated with reduced mortality in high-risk patients (APACHE II: 24 to 29; HR: 0.281; 95% confidence interval (CI): 0.093 to 0.850; P = 0.025). A similar nonsignificant tendency was observed in the very high-risk subset (APACHE II: ≥30; HR: 0.529; 95% CI: 0.202 to 1.387; P = 0.195) but was not evident in the moderate-risk subset of patients (APACHE II: <24; HR: 0.814; 95% CI: 0.351 to 1.884; P = 0.630). A similar tendency was observed in analysis of SOFA scores (moderate-risk subset (SOFA: <11), P = 0.368; high-risk subset (SOFA: ≥11), P = 0.042). Survival benefit was observed with rhTM treatment in sepsis-induced DIC and high risk of death according to baseline APACHE II and SOFA scores.
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影响因子：
158.5
作者：
Abraham, E;Laterre, P;Macias, WL
通讯作者：
Macias, WL
影响因子：
158.5
作者：
Ranieri, V. Marco;Thompson, B. Taylor;Williams, Mark D.
通讯作者：
Williams, Mark D.
影响因子：
38.9
作者：
Yamakawa, Kazuma;Ogura, Hiroshi;Fujimi, Satoshi;Morikawa, Miki;Ogawa, Yoshihito;Mohri, Tomoyoshi;Nakamori, Yasushi;Inoue, Yoshiaki;Kuwagata, Yasuyuki;Tanaka, Hiroshi;Hamasaki, Toshimitsu;Shimazu, Takeshi
通讯作者：
Shimazu, Takeshi
影响因子：
8.8
作者：
Vincent, Jean-Louis;Ramesh, Mayakonda K.;Kaul, Inder
通讯作者：
Kaul, Inder
影响因子：
8.8
作者：
Gando, S;Iba, T;Shimazaki, S
通讯作者：
Shimazaki, S