Ishizuka Tamotsu, Hisada Takeshi, Hatori Motoaki, Koike Akio, Hanabuchi Kikuo, Matsuzaki Shinichi, Kamide Yosuke, Utsugi Mitsuyoshi, Aoki Haruka, Yoshino Reiko, Yanagitani Noriko, Koga Yasuhiko, Ono Akihiro, Kaira Kyoichi, Sunaga Noriaki, Dobashi Kunio, Tsuburai Takahiro, Akiyama Kazuo, Yamada Masanobu, Suzuki Kazuhiro, Mori Masatomo
Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15 Showa-machi, Maebashi, 371-8511, Japan,
Inflamm Res. 2014 Sep;63(9):789-96. doi: 10.1007/s00011-014-0753-1. Epub 2014 Jul 8.
An open-label, non-randomized, single-arm study was performed to investigate the safety and efficacy of high-dose leukocytapheresis (pulse LCAP) for refractory asthma.
Six patients who fulfilled the ATS workshop criteria for refractory asthma were enrolled and completed this clinical study.
After 4 weeks of observation, pulse LCAP using a large LCAP filter, Cellsorba(®) CS-180S, was performed twice with a 1-week interval at a target dose of 5 L per treatment session.
The clinical response was assessed by monitoring the peak expiratory flow rate (PEFR) twice a day. The asthma control test (ACT) was used to evaluate the condition of asthma symptoms. The fraction of exhaled nitric oxide (FeNO) as a biomarker for eosinophilic airway inflammation was measured using a chemiluminescence analyzer.
PEFR in the morning or the evening and the sum total of the score on the ACT were increased after two consecutive sessions of pulse LCAP. FeNO decreased after pulse LCAP.
The results suggest the efficacy of pulse LCAP for refractory asthma.
开展了一项开放标签、非随机、单臂研究,以调查高剂量白细胞去除术(脉冲白细胞去除术,pulse LCAP)治疗难治性哮喘的安全性和有效性。
招募了6名符合美国胸科学会(ATS)难治性哮喘研讨会标准的患者,并完成了这项临床研究。
在观察4周后,使用大型白细胞去除术过滤器Cellsorba(®) CS-180S进行脉冲白细胞去除术,每次治疗目标剂量为5升,每隔1周进行2次。
通过每天监测两次呼气峰值流速(PEFR)来评估临床反应。使用哮喘控制测试(ACT)评估哮喘症状状况。使用化学发光分析仪测量呼出一氧化氮分数(FeNO)作为嗜酸性气道炎症的生物标志物。
连续两次脉冲白细胞去除术后,早晨或晚上的PEFR以及ACT评分总和均有所增加。脉冲白细胞去除术后FeNO降低。
结果表明脉冲白细胞去除术治疗难治性哮喘有效。