重组血栓调节蛋白治疗特发性间质性肺炎急性加重期预后不良患者的疗效：SETUP 试验的二次分析。
Efficacy of recombinant thrombomodulin for poor prognostic cases of acute exacerbation in idiopathic interstitial pneumonia: secondary analysis of the SETUP trial.
机构信息
Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.
Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Suita City, Osaka, Japan.
出版信息
BMJ Open Respir Res. 2020 May;7(1). doi: 10.1136/bmjresp-2020-000558.
BACKGROUND
Acute exacerbation (AE) in idiopathic pulmonary fibrosis and other idiopathic interstitial pneumonias (IIPs) are poor prognostic events although they are usually treated with conventional therapy with corticosteroids and immunosuppressants. Previously, we demonstrated the safety and efficacy of recombinant human soluble thrombomodulin (rhTM) for AE-IIP in the SETUP trial. Here, we aimed to clarify the efficacy of rhTM for poor-prognosis cases of AE-IIP.
METHODS
In this study, we included 85 patients, in whom fibrin degradation product (FDP)/d-dimer was evaluated at AE, from the 100 patients in the SETUP trial. The AE-IIP patients in the rhTM arm (n=39) were diagnosed using the Japanese criteria from 2014 to 2016 and treated with intravenous rhTM for 6 days in addition to the conventional therapy. The AE-IIP patients in the control arm (n=46) were treated with the conventional therapy without rhTM between 2011 and 2013. The subjects were classified into higher and lower FDP/d-dimer groups based on the Japanese Association for Acute Medicine Disseminated Intravascular Coagulation scoring system. A multivariate Cox proportional hazard regression analysis with stepwise selection was performed to reveal the prognostic factors of AE-IIP.
RESULTS
We developed a prognostic scoring system using two significant prognostic factors, higher FDP/d-dimer at AE and prednisolone therapy before AE, with 3 and 2 points assigned for each parameter, respectively. The prognostic scores ranged from 0 to 5. Survival of AE-IIP patients with a prognostic score=0 was significantly better than that of patients with score ≥2. Survival was improved with the rhTM therapy (p<0.05) in the poor prognostic cases (score ≥2), but not in the good prognostic cases (score=0).
CONCLUSIONS
Treatment with rhTM might improve survival in AE-IIP cases with poor prognoses.UMIN000014969, date: 28 August 2014.
背景
特发性肺纤维化和其他特发性间质性肺疾病（IIP）的急性加重（AE）是预后不良的事件，尽管它们通常采用常规的皮质类固醇和免疫抑制剂治疗。此前，我们在 SETUP 试验中证明了重组人可溶性血栓调节蛋白（rhTM）治疗 AE-IIP 的安全性和有效性。在这里，我们旨在阐明 rhTM 对 AE-IIP 预后不良病例的疗效。
方法
本研究纳入了 SETUP 试验中的 100 例患者中 85 例在 AE 时评估纤维蛋白降解产物（FDP）/D-二聚体的患者。rhTM 组（n=39）的 AE-IIP 患者根据 2014 年至 2016 年的日本标准诊断，并在常规治疗的基础上额外接受静脉内 rhTM 治疗 6 天。对照组（n=46）的 AE-IIP 患者在 2011 年至 2013 年期间未接受 rhTM 常规治疗。根据日本急性医学弥漫性血管内凝血评分系统，将患者分为 FDP/D-二聚体较高和较低的两组。采用逐步选择的多变量 Cox 比例风险回归分析来揭示 AE-IIP 的预后因素。
结果
我们使用 AE 时较高的 FDP/D-二聚体和 AE 前泼尼松治疗这两个有意义的预后因素，分别为每个参数分配 3 分和 2 分，建立了一个预后评分系统。评分范围从 0 到 5。AE-IIP 患者的预后评分=0 的生存明显优于评分≥2 的患者。rhTM 治疗（p<0.05）改善了预后不良病例（评分≥2）的生存，但对预后良好病例（评分=0）无改善。
结论
rhTM 治疗可能改善 AE-IIP 预后不良病例的生存。UMIN000014969，日期：2014 年 8 月 28 日。
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