重复免疫吸附治疗新冠后肌痛性脑脊髓炎/慢性疲劳综合征及β2-肾上腺素能受体自身抗体升高患者的疗效：一项前瞻性队列研究
Efficacy of repeated immunoadsorption in patients with post-COVID myalgic encephalomyelitis/chronic fatigue syndrome and elevated β2-adrenergic receptor autoantibodies: a prospective cohort study.
作者信息
Stein Elisa, Heindrich Cornelia, Wittke Kirsten, Kedor Claudia, Rust Rebekka, Freitag Helma, Sotzny Franziska, Krüger Anne, Tölle Markus, Grabowski Patricia, Scheibenbogen Carmen, Kim Laura
机构信息
Institute of Medical Immunology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, Berlin, 13353, Germany.
Experimental and Clinical Research Center and Neuro Science Clinical Research Center, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt Universität zu Berlin, Berlin Institute of Health, Charitéplatz 1, Berlin, 10117, Germany.
出版信息
Lancet Reg Health Eur. 2024 Dec 12;49:101161. doi: 10.1016/j.lanepe.2024.101161. eCollection 2025 Feb.
BACKGROUND
Since the pandemic, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become the leading trigger for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Evidence indicates that autoimmunity plays an important pathophysiological role. We aimed to evaluate the effectiveness of IA treatment in post-COVID ME/CFS patients.
METHODS
This pre-post study included 20 post-coronavirus disease 2019 (COVID) ME/CFS patients found to have elevated β2 adrenergic autoantibodies (β2 AR-AB) between October 2022 and October 2023. Patients, with a median disease duration of 22 months (IQR: 15-31), were treated with five immunoadsorption sessions at Charité - Universitätsmedizin Berlin, Germany. Seven were male and 13 female, with a median age of 40 years (IQR: 36-51). The primary end point was the change in the Short Form (36) Health Survey physical functioning domain (SF36 PF) from baseline to four weeks post immunoadsorption. Key symptoms were assessed via questionnaires over six months. Handgrip strength and EndoPAT® measurements were used to evaluate muscle fatigue and vascular dysfunction. Seven patients who worsened after an initial response received a second cycle.
FINDINGS
The treatment was generally well tolerated, reducing total immunoglobulin G by 79% (: 73-84%) and β2 AR-AB by 77% (: 58-95%). Patients demonstrated a mean increase in the SF36 PF of 17.75 points (: 13.41-26.16), with the greatest improvement occurring between months two and three, and significant gains maintained through month six. 14/20 (70%) patients were categorized as responders with an increase in the SF36 PF of ≥ ten points. Further lasting improvements were reported in fatigue, post-exertional malaise, pain, cognitive, autonomic, and immunological symptoms. Female patients had increased repeat handgrip strength at month six.
INTERPRETATION
Immunoadsorption may improve symptoms in post-COVID ME/CFS patients. The beneficial effects of IgG depletion suggest a significant role for autoantibodies and disturbed B-cell function in the condition's pathophysiology.
FUNDING
Funded by The Federal Ministry of Education and Research and the Weidenhammer Zöbele Research Foundation.
背景
自疫情大流行以来，严重急性呼吸综合征冠状病毒2（SARS-CoV-2）已成为肌痛性脑脊髓炎/慢性疲劳综合征（ME/CFS）的主要诱发因素。有证据表明，自身免疫在其病理生理过程中起着重要作用。我们旨在评估免疫吸附疗法（IA）对新冠后ME/CFS患者的疗效。
方法
这项前后对照研究纳入了20例2019冠状病毒病（COVID）后ME/CFS患者，这些患者在2022年10月至2023年10月期间被发现β2肾上腺素能自身抗体（β2 AR-AB）升高。患者的疾病中位持续时间为22个月（四分位间距：15 - 31个月），在德国柏林夏里特大学医学中心接受了5次免疫吸附治疗。其中7例为男性，13例为女性，中位年龄为40岁（四分位间距：36 - 51岁）。主要终点是从基线到免疫吸附后四周，简短健康调查问卷身体功能领域（SF36 PF）的变化。通过问卷在六个月内评估关键症状。使用握力和EndoPAT®测量来评估肌肉疲劳和血管功能障碍。7例最初有反应后病情恶化的患者接受了第二个疗程。
研究结果
该治疗总体耐受性良好，使总免疫球蛋白G降低了79%（范围：73 - 84%），β2 AR-AB降低了77%（范围：58 - 95%）。患者的SF36 PF平均增加了17.75分（范围：13.41 - 26.16），最大改善出现在第2个月至第3个月之间，并且显著改善一直持续到第6个月。20例患者中有14例（70%）被归类为反应者，SF36 PF增加≥10分。在疲劳、运动后不适、疼痛、认知、自主神经和免疫症状方面也有进一步的持续改善。女性患者在第6个月时重复握力增加。
解读
免疫吸附可能改善新冠后ME/CFS患者的症状。免疫球蛋白G减少的有益效果表明自身抗体和紊乱的B细胞功能在该疾病的病理生理过程中起重要作用。
资金来源
由联邦教育与研究部和魏登哈默·策贝勒研究基金会资助。
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