Abe Shinji, Azuma Arata, Saito Yoshinobu, Hayashi Hiroki, Kashiwada Takeru, Tanaka Toru, Baba Tomohisa, Sekine Akimasa, Kitamura Hideya, Okuda Ryo, Ikeda Satoshi, Ogura Takashi
Department of Respiratory Medicine, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjyuku-ku, Tokyo, 160-0023, Japan.
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi Bunkyo-ku, Tokyo, 113-8603, Japan.
Respir Investig. 2025 Jan;63(1):102-108. doi: 10.1016/j.resinv.2024.11.017. Epub 2024 Dec 12.
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.
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.
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.
This prospective multicenter study suggests that PMX treatment is safe for patients with AE-IPF and may improve their oxygenation and prognosis.
特发性肺纤维化急性加重(AE - IPF)的预后极差。然而,近期临床报告表明,采用多粘菌素B固定纤维柱直接血液灌流(PMX)治疗可能对AE - IPF患者有益。这项多中心前瞻性研究的目的是探讨PMX治疗AE - IPF的有效性和安全性。
我们在日本的两家机构对接受PMX治疗的AE - IPF患者进行了一项前瞻性研究。每位患者接受2 - 3次PMX治疗,目标持续时间为6 - 24小时。主要终点是PMX治疗后第28天的生存率。
PMX治疗后第28天患者的生存率为65%[95%置信区间(CI):40.3 - 81.5%]。该研究中95%CI的下限高于先前报道的接受传统治疗的AE - IPF患者生存率上限40%。PMX治疗12周后患者的生存率为50%(95%CI:27.1 - 69.2%)。随着PMX治疗次数的增加,肺泡与动脉血氧分压差值及动脉血氧分压/吸入氧分数的变化有所改善,在第二次PMX治疗结束时观察到显著改善。PMX的安全性在临床上是可接受的。
这项前瞻性多中心研究表明,PMX治疗对AE - IPF患者是安全的,可能改善其氧合及预后。