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静脉注射免疫球蛋白治疗吉兰-巴雷综合征。

Intravenous immunoglobulin for Guillain-Barré syndrome.

作者信息

Hughes Richard A C, Swan Anthony V, van Doorn Pieter A

机构信息

MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, London, UK.

出版信息

Cochrane Database Syst Rev. 2012 Jul 11(7):CD002063. doi: 10.1002/14651858.CD002063.pub5.

Abstract

BACKGROUND

Guillain-Barré syndrome (GBS) is an acute, paralysing, inflammatory peripheral nerve disease. Intravenous immunoglobulin (IVIg) is beneficial in other autoimmune diseases. This is an update of a review first published in 2001 and previously updated in 2003, 2005, 2007 and 2010. Other Cochrane systematic reviews have shown that plasma exchange (PE) significantly hastens recovery in GBS compared with supportive treatment alone, and that corticosteroids alone are ineffective.

OBJECTIVES

To determine the efficacy of IVIg for GBS.

SEARCH METHODS

We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 August 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3), MEDLINE (January 1966 to August 2011) and EMBASE (January 1980 to August 2011). We checked the bibliographies in reports of the randomised trials and contacted the authors and other experts in the field to identify additional published or unpublished data.

SELECTION CRITERIA

Randomised and quasi-randomised trials of IVIg compared with no treatment, placebo treatment, PE, or other immunomodulatory treatments in children and adults with GBS of all degrees of severity. We also included trials in which IVIg was added to another treatment.

DATA COLLECTION AND ANALYSIS

Two authors independently selected papers, extracted data and assessed quality. We collected data about adverse events from the included trials.

MAIN RESULTS

In this review, seven trials with a variable risk of bias compared IVIg with PE in 623 severely affected participants. In five trials with 536 participants for whom the outcome was available, the mean difference (MD) of change in a seven-grade disability scale after four weeks was not significantly different between the two treatments: MD of 0.02 of a grade more improvement in the intravenous immunoglobulin than the plasma exchange group; 95% confidence interval (CI) 0.25 to -0.20. There were also no statistically significant differences in the other measures considered. Three studies including a total of 75 children suggested that IVIg significantly hastens recovery compared with supportive care.In one trial involving 249 participants comparing PE followed by IVIg with PE alone, the mean grade improvement was 0.2 (95% CI -0.14 to 0.54) more in the combined treatment group than in the PE alone group; not clinically significantly different, but not excluding the possibility of significant extra benefit. Another trial with 37 participants comparing immunoabsorption followed by IVIg with immunoabsorption alone did not reveal significant extra benefit from the combined treatment.Adverse events were not significantly more frequent with either treatment, but IVIg is significantly much more likely to be completed than PE.Small trials in children showed a trend towards more improvement with high-dose compared with low-dose IVIg, and no significant difference when the standard dose was given over two days rather than five days.

AUTHORS' CONCLUSIONS: A previous Cochrane review has shown that PE hastens recovery compared with supportive treatment alone. There are no adequate comparisons of IVIg with placebo in adults, but this review provides moderate quality evidence that, in severe disease, IVIg started within two weeks from onset hastens recovery as much as PE. Adverse events were not significantly more frequent with either treatment but IVIg is significantly much more likely to be completed than PE. Also, according to moderate quality evidence, giving IVIg after PE did not confer significant extra benefit. In children, according to low quality evidence, IVIg probably hastens recovery compared with supportive care alone. More research is needed in mild disease and in patients whose treatment starts more than two weeks after onset. Dose-ranging studies are also needed.

摘要

背景

吉兰 - 巴雷综合征(GBS)是一种急性、导致瘫痪的炎性周围神经疾病。静脉注射免疫球蛋白(IVIg)在其他自身免疫性疾病中有益。这是一篇综述的更新版,该综述首次发表于2001年,此前于2003年、2005年、2007年及2010年进行过更新。其他Cochrane系统评价表明,与单纯支持治疗相比,血浆置换(PE)能显著加速GBS的恢复,且单独使用皮质类固醇无效。

目的

确定IVIg治疗GBS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(2011年8月15日)、Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆2011年第3期)、MEDLINE(1966年1月至2011年8月)和EMBASE(1980年1月至2011年8月)。我们检查了随机试验报告中的参考文献,并联系了该领域的作者及其他专家,以识别其他已发表或未发表的数据。

入选标准

在所有严重程度的儿童和成人GBS患者中,将IVIg与未治疗、安慰剂治疗、PE或其他免疫调节治疗进行比较的随机和半随机试验。我们还纳入了将IVIg添加到另一种治疗中的试验。

数据收集与分析

两位作者独立选择论文、提取数据并评估质量。我们从纳入的试验中收集了不良事件的数据。

主要结果

在本综述中,七项偏倚风险各异的试验将623名重度患者的IVIg与PE进行了比较。在五项有536名参与者且可获得结果的试验中,两种治疗在四周后七级残疾量表变化的平均差异(MD)无显著差异:静脉注射免疫球蛋白组比血浆置换组在等级上多改善0.02;95%置信区间(CI)为0.25至 -0.20。在其他所考虑的指标上也无统计学显著差异。三项共纳入75名儿童的研究表明,与支持性护理相比,IVIg能显著加速恢复。在一项涉及249名参与者的试验中,比较血浆置换后静脉注射免疫球蛋白与单纯血浆置换,联合治疗组的平均等级改善比单纯血浆置换组多0.2(95%CI -0.14至0.54);虽无临床显著差异,但不排除有显著额外益处的可能性。另一项有37名参与者的试验比较免疫吸附后静脉注射免疫球蛋白与单纯免疫吸附,未发现联合治疗有显著额外益处。两种治疗的不良事件发生频率均无显著增加,但静脉注射免疫球蛋白比血浆置换更有可能完成治疗。儿童中的小型试验显示,高剂量IVIg比低剂量IVIg有更多改善的趋势,且标准剂量分两天而非五天给药时无显著差异。

作者结论

之前的Cochrane综述表明,与单纯支持治疗相比,血浆置换能加速恢复。在成人中,IVIg与安慰剂没有充分的比较,但本综述提供了中等质量的证据,即在严重疾病中,发病两周内开始使用IVIg与血浆置换一样能加速恢复。两种治疗的不良事件发生频率均无显著增加,但静脉注射免疫球蛋白比血浆置换更有可能完成治疗。此外,根据中等质量的证据,在血浆置换后给予静脉注射免疫球蛋白未带来显著额外益处。在儿童中,根据低质量证据,与单纯支持性护理相比,静脉注射免疫球蛋白可能加速恢复。在轻度疾病以及发病两周后开始治疗的患者中还需要更多研究。也需要进行剂量范围研究。

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