在慢性炎症性脱髓鞘性多发性神经病患者中，长期静脉注射免疫球蛋白（Gamunex® 10%）治疗期间的疲劳、抑郁和产品耐受性。
Fatigue, depression, and product tolerability during long-term treatment with intravenous immunoglobulin (Gamunex® 10%) in patients with chronic inflammatory demyelinating polyneuropathy.
机构信息
Charité - Universitätsmedizin Berlin, Neurocure Clinical Research Center Berlin, Charitéplatz 1, 10117, Berlin, Germany.
Jüdisches Krankenhaus Berlin, Heinz-Galinski-Straße 1, 13347, Berlin-Mitte, Germany.
出版信息
BMC Neurol. 2023 May 26;23(1):207. doi: 10.1186/s12883-023-03223-5.
INTRODUCTION/AIMS: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is characterized by progressive weakness and sensory loss, often affecting patient's ability to walk and perform activities of daily living independently. Furthermore, patients often report fatigue and depression which can affect their quality of life. These symptoms were assessed in CIDP patients receiving long-term intravenous immunoglobulin (IVIG) treatment.
METHODS
GAMEDIS was a multi-center, prospective, non-interventional study in adult CIDP patients treated with IVIG (10%) and followed for two years. Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Hughes Disability Scale (HDS), Fatigue Severity Scale (FSS), Beck Depression Inventory II (BDI), Short Form-36 health survey (SF-36) and Work Productivity and Activity Impairment Score Attributable to General Health (WPAI-GH) were assessed at baseline and quarterly. Dosing and treatment intervals, changes in outcome parameters, and adverse events (AEs) were analyzed.
RESULTS
148 evaluable patients were followed for a mean of 83.3 weeks. The mean maintenance IVIG dose was 0.9 g/kg/cycle (mean cycle interval 38 days). Disability and fatigue remained stable throughout the study. Mean INCAT score: 2.4 ± 1.8 at baseline and 2.5 ± 1.9 at study end. HDS: 74.3% healthy/minor symptoms at baseline and 71.6% at study end. Mean FSS: 4.2 ± 1.6 at baseline and 4.1 ± 1.7 at study end. All patients reported minimal/no depression at baseline and throughout. SF-36 and WPAI-GH scores remained stable. Fifteen patients (9.5%) experienced potentially treatment-related AEs. There were no AEs in 99.3% of infusions.
DISCUSSION
Long-term treatment of CIDP patients with IVIG 10% in real-world conditions maintained clinical stability on fatigue and depression over 96 weeks. This treatment was well-tolerated and safe.
介绍/目的：慢性炎症性脱髓鞘性多发性神经病（CIDP）的特征是进行性无力和感觉丧失，常影响患者独立行走和日常生活活动的能力。此外，患者常报告疲劳和抑郁，这会影响他们的生活质量。这些症状在接受长期静脉注射免疫球蛋白（IVIG）治疗的 CIDP 患者中进行了评估。
方法
GAMEDIS 是一项多中心、前瞻性、非干预性研究，纳入了接受 IVIG（10%）治疗的成年 CIDP 患者，并随访了两年。在基线和每季度评估炎症性神经病病因和治疗（INCAT）残疾评分、休斯残疾量表（HDS）、疲劳严重程度量表（FSS）、贝克抑郁量表 II（BDI）、36 项简明健康调查（SF-36）和归因于一般健康的工作生产力和活动障碍评分（WPAI-GH）。分析了剂量和治疗间隔、结局参数的变化以及不良事件（AE）。
结果
148 例可评估患者的平均随访时间为 83.3 周。平均维持性 IVIG 剂量为 0.9 g/kg/周期（平均周期间隔 38 天）。残疾和疲劳在整个研究过程中保持稳定。平均 INCAT 评分：基线时为 2.4±1.8，研究结束时为 2.5±1.9。HDS：基线时为 74.3%健康/轻度症状，研究结束时为 71.6%。平均 FSS：基线时为 4.2±1.6，研究结束时为 4.1±1.7。所有患者在基线时和整个研究过程中均报告轻微/无抑郁。SF-36 和 WPAI-GH 评分保持稳定。15 例患者（9.5%）发生了潜在与治疗相关的 AE。99.3%的输注中无 AE。
讨论
在真实环境条件下，CIDP 患者接受 IVIG 10%的长期治疗，96 周以上维持疲劳和抑郁的临床稳定。这种治疗耐受良好且安全。
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