Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan.
Department of Internal Medicine, Kichijoji Asahi Hospital, Tokyo, Japan.
Mod Rheumatol. 2023 Nov 1;33(6):1125-1136. doi: 10.1093/mr/roac137.
We conducted a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of intravenous immunoglobulin (IVIg) in patients with glucocorticoid-refractory neuropathy associated with microscopic polyangiitis.
Patients received immunoglobulin or placebo intravenously for 5 consecutive days at baseline and after 4 weeks. The IVIg and placebo groups received IVIg and placebo, respectively, after 8 weeks. The primary and major secondary end-points were the least squares mean of the change in the manual muscle test (MMT) sum score after 8 and 4 weeks, respectively.
A total of 37 patients were randomised into two groups (IVIg [19] and placebo [18]). The least squares mean for the change in the MMT sum score was 9.02 for IVIg and 6.71 for placebo (difference 2.32, 95% confidence interval -2.60 to 7.23, p = .345) after 8 weeks and 6.81 and 2.83 (difference 3.99, 95% confidence interval -1.22 to 9.19, p = .129), respectively, after 4 weeks. There were no new safety concerns for IVIg.
MMT sum scores improved with IVIg compared with placebo after 8 weeks of dosing and two courses of treatment, but the differences were not statistically significant, and the results showed no clear efficacy of IVIg in this patient population. No new safety concerns were raised.
我们进行了一项 3 期、多中心、随机、双盲、安慰剂对照、平行组试验，以评估静脉注射免疫球蛋白（IVIg）在与显微镜下多血管炎相关的糖皮质激素难治性神经病患者中的疗效和安全性。
患者在基线和 4 周后连续 5 天接受免疫球蛋白或安慰剂静脉注射。在 8 周后，IVIg 和安慰剂组分别接受 IVIg 和安慰剂。主要和次要次要终点分别为 8 周和 4 周后手动肌肉测试（MMT）总和评分变化的最小二乘均数。
共有 37 名患者被随机分为两组（IVIg [19]和安慰剂 [18]）。在 8 周后，MMT 总和评分的变化最小二乘均数为 IVIg 组的 9.02 和安慰剂组的 6.71（差值为 2.32，95%置信区间-2.60 至 7.23，p=0.345），在 4 周后，分别为 6.81 和 2.83（差值为 3.99，95%置信区间-1.22 至 9.19，p=0.129）。IVIg 没有新的安全性问题。
与安慰剂相比，IVIg 在 8 周和两疗程治疗后 MMTS 总和评分有所改善，但差异无统计学意义，结果表明 IVIg 对该患者人群无明显疗效。没有提出新的安全性问题。
