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一项研究静脉注射免疫球蛋白对慢性炎症性脱髓鞘性多发性神经根神经病疗效的新型试验设计。

A novel trial design to study the effect of intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy.

作者信息

Thompson N, Choudhary P, Hughes R A, Quinlivan R M

机构信息

Department of Neurology, UMDS, London, UK.

出版信息

J Neurol. 1996 Mar;243(3):280-5. doi: 10.1007/BF00868527.

Abstract

Using a novel trial design, we prospectively examined the effect of intravenous immunoglobulin in seven patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in a double-blind, placebo-controlled cross-over study. We suggest that the commonly used manual muscle testing and Rankin scale are not sufficiently sensitive to measure changes in CIDP and should not be used as isolated outcome measures. We propose a timed 10-m walk, the Nine-Hole Peg Test, the Hammersmith Motor Ability Score, and myometry as alternative measures which are valid, reliable and sensitive. Our trial design permitted the measurement of a treatment response in three responders despite different patterns of disability typical of the broad clinical picture seen in CIDP.

摘要

采用一种新颖的试验设计,我们在一项双盲、安慰剂对照的交叉研究中,前瞻性地研究了静脉注射免疫球蛋白对7例慢性炎症性脱髓鞘性多发性神经根神经病(CIDP)患者的疗效。我们认为,常用的徒手肌力测试和Rankin量表对测量CIDP的变化不够敏感,不应作为单独的结局指标。我们建议采用定时10米步行试验、九孔插钉试验、哈默史密斯运动能力评分和肌测量法作为有效的、可靠的和敏感的替代指标。尽管CIDP患者临床表现多样,残疾模式不同,但我们的试验设计仍能够测量出3例有治疗反应患者的治疗反应。

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