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慢性炎症性脱髓鞘性多发性神经根神经病的血浆置换疗法

Plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy.

作者信息

Mehndiratta Man Mohan, Hughes Richard A C

机构信息

Department of Neurology, G.B. Pant Hospital, New Delhi, India.

出版信息

Cochrane Database Syst Rev. 2012 Sep 12(9):CD003906. doi: 10.1002/14651858.CD003906.pub3.

DOI:10.1002/14651858.CD003906.pub3
PMID:22972066
Abstract

BACKGROUND

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an uncommon progressive or relapsing paralysing disease caused by inflammation of the peripheral nerves. If the hypothesis that it is due to autoimmunity is correct, removal of autoantibodies in the blood by plasma exchange should be beneficial.

OBJECTIVES

To evaluate the efficacy of plasma exchange in CIDP.

SEARCH METHODS

We searched the Cochrane Neuromuscular Disease Group Specialized Register (14 May 2012), CENTRAL (2012, Issue 4), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), CINAHL Plus (January 1937 to May 2012) and LILACS (January 1982 to May 2012). We also scrutinised the bibliographies of the trials, and contacted the trial authors and other disease experts.

SELECTION CRITERIA

Randomised controlled trials (RCTs) or quasi-RCTs in participants of any age comparing plasma exchange with sham treatment or no treatment.

DATA COLLECTION AND ANALYSIS

Two authors selected the trials, extracted the data and assessed risk of bias independently. Where possible data were combined according to the methods of the Cochrane Neuromuscular Disease Review Group.

PRIMARY OUTCOME MEASURE

one cross-over trial including 18 participants showed two (95% confidence interval (CI) 0.8 to 3.0) points more improvement after four weeks on an 11-point disability scale with plasma exchange (10 exchanges over four weeks) than with sham exchange. Rapid deterioration after plasma exchange occurred in eight of 12 who had improved.

SECONDARY OUTCOME MEASURES

when the results of this trial and another with 29 participants treated in a parallel group design trial were combined, there were 31 points (95% CI 16 to 45, maximum score 280) more improvement in an impairment scale after plasma exchange (six exchanges over three weeks) than after sham exchange. There were significant improvements in both trials in an electrophysiological measure, the proximally evoked compound muscle action potential, after three or four weeks. Non-randomised evidence indicates that plasma exchange induces adverse events in 3% to 17% of procedures. These are sometimes serious. A trial showing no significant difference in the benefit between plasma exchange and intravenous immunoglobulin has been included in the Cochrane review of intravenous immunoglobulin for this condition.

AUTHORS' CONCLUSIONS: Moderate to high quality evidence from two small trials showed that plasma exchange provides significant short-term improvement in disability, clinical impairment and motor nerve conduction velocity in CIDP but rapid deterioration may occur afterwards. Adverse events related to difficulty with venous access, use of citrate and haemodynamic changes are not uncommon. More research is needed to identify agents which will prolong the beneficial action of plasma exchange.

摘要

背景

慢性炎性脱髓鞘性多发性神经根神经病(CIDP)是一种由周围神经炎症引起的罕见的进行性或复发性麻痹性疾病。如果其病因是自身免疫这一假说正确,那么通过血浆置换去除血液中的自身抗体应该是有益的。

目的

评估血浆置换治疗CIDP的疗效。

检索方法

我们检索了Cochrane神经肌肉疾病组专业注册库(2012年5月14日)、Cochrane系统评价数据库(2012年第4期)、医学期刊数据库(1966年1月至2012年5月)、EMBASE数据库(1980年1月至2012年5月)、护理学与健康领域数据库(1937年1月至2012年5月)以及拉丁美洲和加勒比卫生科学数据库(1982年1月至2012年5月)。我们还仔细查阅了试验的参考文献,并联系了试验作者和其他疾病专家。

选择标准

纳入任何年龄参与者的随机对照试验(RCT)或半随机对照试验,比较血浆置换与假治疗或不治疗的效果。

数据收集与分析

两位作者独立选择试验、提取数据并评估偏倚风险。尽可能根据Cochrane神经肌肉疾病综述组的方法合并数据。

主要结局指标

一项纳入18名参与者的交叉试验显示,在11分的残疾量表上,经过四周(四周内进行10次置换)的血浆置换后比假置换改善了2分(95%置信区间(CI)0.8至3.0)。在12名病情改善的患者中,有8名在血浆置换后病情迅速恶化。

次要结局指标

当将该试验与另一项采用平行组设计、纳入29名参与者的试验结果合并时,在损伤量表上,血浆置换(三周内进行6次置换)后比假置换改善了31分(95%CI 16至45,最高分为280分)。在两项试验中,经过三或四周后,电生理指标近端诱发复合肌肉动作电位均有显著改善。非随机证据表明,3%至17%的血浆置换操作会引发不良事件。这些不良事件有时很严重。一项显示血浆置换与静脉注射免疫球蛋白在疗效上无显著差异的试验已被纳入Cochrane关于静脉注射免疫球蛋白治疗该疾病的综述中。

作者结论

两项小型试验提供的中等至高质量证据表明,血浆置换能使CIDP患者的残疾、临床损伤和运动神经传导速度在短期内得到显著改善,但之后可能会迅速恶化。与静脉通路困难、使用柠檬酸盐和血流动力学变化相关的不良事件并不少见。需要更多研究来确定能延长血浆置换有益作用的药物。

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