Dyck P J, Litchy W J, Kratz K M, Suarez G A, Low P A, Pineda A A, Windebank A J, Karnes J L, O'Brien P C
Department of Neurology, Mayo Clinic, Rochester, MN 55905.
Ann Neurol. 1994 Dec;36(6):838-45. doi: 10.1002/ana.410360607.
Chronic inflammatory demyelinating polyradiculoneuropathy is a paralytic syndrome, causing considerable disability and even death. In controlled clinical trials, plasma exchange prevented or ameliorated neurological deficits, but the efficacy of immune globulin infusion remains unproved. Also unknown is whether immune globulin infusion is as effective, or more effective, than plasma exchange and what dosages and frequencies are best. In this observer-blinded study, using some objective end points not subject to bias (e.g., summated compound muscle action potential), 20 patients with progressive or static polyneuropathy were randomly assigned to receive either of the two treatments for 6 weeks, followed by a washout period, and then were assigned to receive the other treatment. Plasma exchange (twice a week for 3 weeks then once a week for 3 weeks) and immune globulin infusion (0.4 gm/kg once a week for 3 weeks, then 0.2 gm/kg once a week for the next 3 weeks) were used. End points assessed before and after treatment schedules were neurological disability score; muscle weakness of the neurological disability score; summated compound muscle action potentials of ulnar, median, and peroneal nerves; summated sensory nerve action potentials of ulnar and sural nerves; and vibratory detection threshold of the great toe using CASE IV. Observers were masked as to treatment used. Of 20 patients, 13 received both treatments whereas 4 did not worsen sufficiently to receive the second treatment--1 patient left the study during and 2 after the first treatment to receive unscheduled treatment elsewhere.(ABSTRACT TRUNCATED AT 250 WORDS)
慢性炎症性脱髓鞘性多发性神经根神经病是一种麻痹综合征,可导致严重残疾甚至死亡。在对照临床试验中,血浆置换可预防或改善神经功能缺损,但免疫球蛋白输注的疗效尚未得到证实。免疫球蛋白输注是否与血浆置换一样有效或更有效,以及最佳剂量和频率是多少也尚不清楚。在这项观察者盲法研究中,使用一些不受偏倚影响的客观终点(如复合肌肉动作电位总和),将20例进行性或静止性多发性神经病患者随机分为两组,接受两种治疗中的一种,为期6周,随后是洗脱期,然后再接受另一种治疗。采用了血浆置换(每周两次,共3周,然后每周一次,共3周)和免疫球蛋白输注(每周一次,0.4克/千克,共3周,然后在接下来的3周里每周一次,0.2克/千克)。在治疗方案前后评估的终点包括神经功能残疾评分;神经功能残疾评分中的肌肉无力;尺神经、正中神经和腓总神经的复合肌肉动作电位总和;尺神经和腓肠神经的感觉神经动作电位总和;以及使用CASE IV测量的大脚趾振动检测阈值。观察者对所采用的治疗方法不知情。20例患者中,13例接受了两种治疗,而4例病情没有充分恶化,无需接受第二种治疗——1例患者在第一次治疗期间离开研究,2例在第一次治疗后离开,去其他地方接受非计划治疗。(摘要截短于250字)