用多粘菌素 B 固定纤维柱（PMX）直接血液灌流治疗特发性肺纤维化急性加重：一项前瞻性多中心队列研究。

IF 2.4 Q2 RESPIRATORY SYSTEM Respiratory investigation Pub Date : 2025-01-01 DOI:10.1016/j.resinv.2024.11.017

Shinji Abe , Arata Azuma , Yoshinobu Saito , Hiroki Hayashi , Takeru Kashiwada , Toru Tanaka , Tomohisa Baba , Akimasa Sekine , Hideya Kitamura , Ryo Okuda , Satoshi Ikeda , Takashi Ogura

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引用次数: 0

摘要

背景：特发性肺纤维化急性加重期（AE-IPF）的预后极差：特发性肺纤维化急性加重期（AE-IPF）的预后极差。然而，最近的临床报告表明，用多粘菌素 B-固定化纤维柱（PMX）直接进行血液灌流治疗可能对 AE-IPF 患者有益。这项多中心前瞻性研究旨在探讨 PMX 治疗 AE-IPF 的有效性和安全性：我们在日本的两家医疗机构对接受 PMX 治疗的 AE-IPF 患者进行了前瞻性研究。每位患者接受 2-3 次 PMX 治疗，目标疗程为 6-24 小时，主要终点是 PMX 治疗后第 28 天的存活率：PMX治疗后第28天患者的存活率为65%[95%置信区间（CI）：40.3-81.5%]。研究中95% CI的下限高于40%的存活率，而40%是之前报道的接受常规治疗的AE-IPF存活率的上限。PMX 治疗 12 周后患者的存活率为 50%（95% CI：27.1%-69.2%）。肺泡和动脉血氧张力之差以及动脉血氧分压/吸入氧分压的变化随着PMX疗程次数的增加而改善，在第二次PMX疗程结束时观察到显著改善。PMX 的安全性在临床上是可以接受的：这项前瞻性多中心研究表明，PMX治疗对AE-IPF患者是安全的，并可改善他们的氧合和预后。

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Direct hemoperfusion with polymyxin B immobilized fiber column (PMX) treatment for acute exacerbation of idiopathic pulmonary fibrosis: A prospective multicenter cohort study

Background

The prognosis of acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is extremely poor. However, recent clinical reports suggest that direct hemoperfusion with polymyxin B-immobilized fiber column (PMX) treatment may have beneficial effects in patients with AE-IPF. The aim of this multicenter prospective study was to investigate the effectiveness and safety of PMX treatment in AE-IPF.

Methods

We conducted a prospective study of patients with AE-IPF treated by PMX at two institutions in Japan. Each patient received 2–3 sessions of PMX treatment with a target duration of 6–24 h. The primary endpoint was the survival rate at day 28 after the PMX treatment.

Results

The survival rate of the patients on day 28 after PMX treatment was 65% [95% confidence interval (CI): 40.3–81.5%]. The lower limit of 95% CI in the study was higher than the survival rate of 40%, which was the upper limit of the survival rate in AE-IPF receiving conventional treatments, as reported previously. The survival rate of the patients 12 weeks after PMX was 50% (95% CI: 27.1–69.2%). The changes in the difference between alveolar and arterial oxygen tension and the partial pressure of arterial oxygen/fraction of inspired oxygen improved as the number of PMX sessions increased, and significant improvements were observed at the end of the second PMX session. The safety of PMX was clinically acceptable.