Bril Vera, Katzberg Hans, Donofrio Peter, Banach Marta, Dalakas Marinos C, Deng Chunqin, Hanna Kim, Hartung Hans-Peter, Hughes Richard A C, Latov Norman, Merkies Ingemar S J, van Doorn Pieter A
Department of Neurology, University Health Network, Toronto, Ontario, Canada.
Muscle Nerve. 2009 Apr;39(4):448-55. doi: 10.1002/mus.21236.
Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) received immune globulin intravenous, 10% caprylate/chromatography purified (IGIV-C, Gamunex; n=59) or placebo (n=58) every 3 weeks for up to 24 weeks (first period) in a randomized, double-blind, parallel-group, response-conditional, crossover study. Motor and sensory nerves were assessed at baseline and endpoint/week 24. A nonsignificant trend toward improvement in the proximal amplitude of the most severely affected motor nerve was observed with IGIV-C (0.69+/-1.86 mV) versus placebo (0.47+/-2.29 mV), and a greater improvement of 1.08+/-2.15 mV with IGIV-C versus 0.46+/-2.03 mV with placebo (P=0.089) was observed with exclusion of data from Erb's point stimulation. Greater improvements from baseline favoring IGIV-C were observed for 127/142 electrophysiologic parameters. The averaged motor amplitudes from all motor nerves significantly improved with IGIV-C versus placebo [treatment difference, 0.62 mV; 95% confidence interval (CI), 0.05, 1.20; P=0.035], and conduction block decreased significantly (treatment difference, -5.54%; 95% CI, -10.43, -0.64; P=0.027), particularly in the lower limbs. Overall, the data suggest that IGIV-C improves electrophysiologic parameters in CIDP.
在一项随机、双盲、平行组、反应条件性、交叉研究中,慢性炎性脱髓鞘性多发性神经病(CIDP)患者每3周接受一次静脉注射免疫球蛋白,10%辛酸/层析纯化(IGIV-C,Gamunex;n = 59)或安慰剂(n = 58),持续24周(第一阶段)。在基线和终点/第24周评估运动和感觉神经。与安慰剂组(0.47±2.29 mV)相比,IGIV-C组(0.69±1.86 mV)观察到最严重受累运动神经近端波幅有改善但无统计学意义的趋势;排除Erb点刺激的数据后,IGIV-C组改善幅度为1.08±2.15 mV,安慰剂组为0.46±2.03 mV(P = 0.089),观察到IGIV-C组改善更明显。在142项电生理参数中,有127项从基线开始的改善更有利于IGIV-C组。与安慰剂相比,IGIV-C组所有运动神经的平均运动波幅显著改善[治疗差异,0.62 mV;95%置信区间(CI),0.05,1.20;P = 0.035],传导阻滞显著降低(治疗差异,-5.54%;95% CI,-10.43,-0.64;P = 0.027),尤其是在下肢。总体而言,数据表明IGIV-C可改善CIDP患者的电生理参数。