Kataoka Kensuke, Taniguchi Hiroyuki, Kondoh Yasuhiro, Nishiyama Osamu, Kimura Tomoki, Matsuda Toshiaki, Yokoyama Toshiki, Sakamoto Koji, Ando Masahiko
Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
Department of Respiratory Medicine and Allergy, Tosei General Hospital, Seto.
Chest. 2015 Aug;148(2):436-443. doi: 10.1378/chest.14-2746.
Acute exacerbation (AE) of idiopathic pulmonary fibrosis (IPF) presents as episodes of acute respiratory worsening closely associated with endothelial damage and disordered coagulopathy. Recombinant human soluble thrombomodulin (rhTM) regulates the coagulation pathway mainly by reducing thrombin-mediated clotting and enhancing protein C activation. We investigated the efficacy of rhTM for the treatment of patients with AE-IPF.
This historical control study comprised 40 patients with AE-IPF. Twenty patients treated with rhTM (0.06 mg/kg/d) for about 6 days (rhTM group) and 20 patients treated without rhTM (control group) were evaluated. The predictors of 3-month mortality (logistic regression model) were evaluated.
There was no difference in baseline characteristics between the control group and the rhTM group. Three-month mortality of the rhTM group and control group was 30.0% and 65.0%, respectively. In univariate analysis, C-reactive protein and rhTM therapy were significant determinants for 3-month survival. In multivariate analysis, rhTM therapy (OR, 0.219; 95% CI, 0.049-0.978; P = 0.047) was an independent significant determinant for 3-month survival.
We found that rhTM therapy improved 3-month survival of AE-IPF. The results observed here warrant further investigation of rhTM in randomized control trials.
特发性肺纤维化（IPF）的急性加重（AE）表现为急性呼吸功能恶化发作，与内皮损伤和凝血功能障碍密切相关。重组人可溶性血栓调节蛋白（rhTM）主要通过减少凝血酶介导的凝血和增强蛋白C活化来调节凝血途径。我们研究了rhTM治疗AE-IPF患者的疗效。
这项历史对照研究纳入了40例AE-IPF患者。对20例接受rhTM（0.06mg/kg/d）治疗约6天的患者（rhTM组）和20例未接受rhTM治疗的患者（对照组）进行了评估。评估了3个月死亡率的预测因素（逻辑回归模型）。
对照组和rhTM组的基线特征无差异。rhTM组和对照组的3个月死亡率分别为30.0%和65.0%。在单因素分析中，C反应蛋白和rhTM治疗是3个月生存的重要决定因素。在多因素分析中，rhTM治疗（OR，0.219；95%CI，0.049-0.978；P = 0.047）是3个月生存的独立重要决定因素。
我们发现rhTM治疗可提高AE-IPF患者的3个月生存率。此处观察到的结果值得在随机对照试验中对rhTM进行进一步研究。
