Treatment effects of recombinant human soluble thrombomodulin in patients with severe sepsis: a historical control study.
Treatment effects of recombinant human soluble thrombomodulin in patients with severe sepsis: a historical control study.
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DOI：
10.1186/cc10228
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发表时间：
2011
期刊：
影响因子：
--
通讯作者：
Shimazu T
中科院分区：
文献类型：
--
作者：
Yamakawa K;Fujimi S;Mohri T;Matsuda H;Nakamori Y;Hirose T;Tasaki O;Ogura H;Kuwagata Y;Hamasaki T;Shimazu T
脓毒症时凝血系统与炎症反应之间的串扰可引起器官损伤，随后出现多器官功能障碍综合征，甚至死亡。因此，抗凝治疗有望对严重败血症的治疗有益。重组人可溶性凝血调节蛋白（rhTM）与凝血酶结合使凝血失活，凝血酶-rhTM复合物激活蛋白C产生活化蛋白C。本研究旨在探讨rhTM治疗脓毒症诱导的弥散性血管内凝血（DIC）的疗效。本研究纳入65例需要通气治疗的败血症性DIC患者。所有患者均符合严重脓毒症的标准和国际血栓与止血学会对明显DIC的标准。最初45例患者不给予rhTM治疗（对照组），随后连续20例患者给予rhTM治疗（0.06 mg/kg/天），为期6天（rhTM组）。主要结局指标为28天死亡率。采用逐步多变量Cox回归分析评估哪些自变量与死亡率相关。采用重复测量方差分析比较两组患者连续天数的序贯器官衰竭评估（SOFA）评分。Cox回归分析显示，rhTM组28天死亡率显著低于对照组（校正风险比为0.303；95%可信区间为0.106 ~ 0.871;P = 0.027）。rhTM组SOFA评分较对照组显著降低（P = 0.028）。事后检验中，与对照组相比，rhTM组SOFA评分在第1天迅速下降（P < 0.05）。我们发现rhTM可以改善脓毒症诱导的DIC患者的器官功能障碍。rhTM对脓毒症致DIC病理生理的影响有待进一步的临床研究。
Cross-talk between the coagulation system and inflammatory reactions during sepsis causes organ damage followed by multiple organ dysfunction syndrome or even death. Therefore, anticoagulant therapies have been expected to be beneficial in the treatment of severe sepsis. Recombinant human soluble thrombomodulin (rhTM) binds to thrombin to inactivate coagulation, and the thrombin-rhTM complex activates protein C to produce activated protein C. The purpose of this study was to examine the efficacy of rhTM for treating patients with sepsis-induced disseminated intravascular coagulation (DIC). This study comprised 65 patients with sepsis-induced DIC who required ventilatory management. All patients fulfilled the criteria of severe sepsis and the International Society on Thrombosis and Haemostasis criteria for overt DIC. The initial 45 patients were treated without rhTM (control group), and the following 20 consecutive patients were treated with rhTM (0.06 mg/kg/day) for six days (rhTM group). The primary outcome measure was 28-day mortality. Stepwise multivariate Cox regression analysis was used to assess which independent variables were associated with mortality. Comparisons of Sequential Organ Failure Assessment (SOFA) score on sequential days between the two groups were analyzed by repeated measures analysis of variance. Cox regression analysis showed 28-day mortality to be significantly lower in the rhTM group than in the control group (adjusted hazard ratio, 0.303; 95% confidence interval, 0.106 to 0.871; P = 0.027). SOFA score in the rhTM group decreased significantly in comparison with that in the control group (P = 0.028). In the post hoc test, SOFA score decreased rapidly in the rhTM group compared with that in the control group on day 1 (P < 0.05). We found that rhTM administration may improve organ dysfunction in patients with sepsis-induced DIC. Further clinical investigations are necessary to evaluate the effect of rhTM on the pathophysiology of sepsis-induced DIC.
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