From the Department of Neurology (M.G., B.T.A.d.G., M.S., J.G.J.H., C.G.F., I.S.J.M.), School of Mental Health and Neuroscience, and Department of Clinical Epidemiology and Medical Technology Assessment (S.M.J.v.K.), Maastricht University Medical Center+; Department of Rehabilitation Adelante/Maastricht University Medical Center+ (M.S.), the Netherlands; and Department of Neurology (I.S.J.M.), Curaçao Medical Center, Willemstad, Curaçao.
Neurology. 2021 May 18;96(20):e2534-e2545. doi: 10.1212/WNL.0000000000011919. Epub 2021 Mar 25.
This is the first double-blind randomized controlled trial evaluating the efficacy and safety of IV immunoglobulin (IVIG) vs placebo in patients with idiopathic small fiber neuropathy (I-SFN).
Between July 2016 and November 2018, 60 Dutch patients with skin biopsy-proven I-SFN randomly received a starting dose of IVIG (2 g/kg body weight) or matching placebo (0.9% saline). Subsequently, 3 additional infusions of IVIG (1 g/kg) or placebo were administered at 3-week intervals. The primary outcome was a 1-point change in Pain Intensity Numerical Rating Scale score at 12 weeks compared to baseline.
Thirty patients received IVIG, and 30 received placebo. In both groups, 29 patients completed the trial. In 40% of patients receiving IVIG, the mean average pain was decreased by at least 1 point compared to 30% of the patients receiving placebo ( = 0.588, odds ratio 1.56, 95% confidence interval 0.53-4.53). No significant differences were found on any of the other prespecified outcomes, including general well-being, autonomic symptoms, and overall functioning and disability.
This randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN.
ClinicalTrials.gov Identifier: NCT02637700, EudraCT 2015-002624-31.
This study provides Class I evidence that for patients with painful I-SFN, IVIG did not significantly reduce pain compared to placebo.
这是首个评估静脉注射免疫球蛋白（IVIG）与安慰剂治疗特发性小纤维神经病（I-SFN）患者的疗效和安全性的双盲随机对照试验。
2016 年 7 月至 2018 年 11 月，60 名荷兰经皮肤活检证实的 I-SFN 患者随机接受起始剂量的 IVIG（2g/kg 体重）或匹配的安慰剂（0.9%生理盐水）治疗。随后，在 3 周间隔内给予另外 3 次 IVIG（1g/kg）或安慰剂输注。主要结局是与基线相比，12 周时疼痛强度数字评分量表评分变化 1 分。
30 名患者接受 IVIG 治疗，30 名患者接受安慰剂治疗。在两组中，29 名患者完成了试验。在接受 IVIG 的患者中，40%的患者平均疼痛至少降低了 1 分，而接受安慰剂的患者中为 30%（=0.588，优势比 1.56，95%置信区间 0.53-4.53）。在任何其他预定的结局上，均未发现显著差异，包括总体健康状况、自主症状以及整体功能和残疾。
这项随机对照试验表明，IVIG 治疗对有疼痛性 I-SFN 的患者的疼痛没有显著影响。
NCT02637700，EudraCT 2015-002624-31。
这项研究提供了 I 级证据，表明对于有疼痛性 I-SFN 的患者，与安慰剂相比，IVIG 并未显著减轻疼痛。
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