Hughes R A, Raphaël J C, Swan A V, van Doorn P A
Department of Neuroimmunology, Guy's, King's and St Thomas' School of Medicine, Guy's Hospital, London, UK, SE1 9RT.
Cochrane Database Syst Rev. 2001(2):CD002063. doi: 10.1002/14651858.CD002063.
Guillain-Barré syndrome is a potentially serious, acute, paralysing, probably autoimmune disease caused by inflammation of the peripheral nerves. Recovery has been shown to be speeded by plasma exchange which replaces the patient's own plasma with a plasma substitute. Intravenous immunoglobulin purified from donated blood is beneficial in other autoimmune diseases and is easier to administer.
To determine the efficacy of intravenous immunoglobulin in comparison with no treatment or other treatments for treating Guillain-Barré syndrome and to determine the most efficacious dose.
Search of the Cochrane Neuromuscular Disease Group register using Guillain-Barré syndrome and acute polyradiculoneuritis as the search terms, bibliographies of trials and contact with their authors and other experts.
Randomised and quasi-randomised trials.
Two reviewers examined the titles and abstracts of all the papers retrieved by the search, extracted the data onto forms designed for this review, and independently assessed the quality of the trials.
The only trial comparing intravenous immunoglobulin with supportive treatment was inadequate to establish its value. Another Cochrane systematic review has shown that plasma exchange (PE) hastens recovery. Plasma exchange has become the gold standard against which other treatments need to be compared. We found three randomised trials that compared intravenous immunoglobulin with PE. We were able to combine the results of the two largest trials in a metaanalysis involving 398 patients. The primary outcome measure in this review was the change in a 7 grade disability scale four weeks after randomisation. The weighted mean difference of this measure was not significant, being only 0.11 (95% CI -0.14 to 0.37) of a disability grade more improvement in the intravenous immunoglobulin group than the PE group. There were also no significant differences in other outcome measures, including time to walk unaided, mortality, and proportion of patients unable to walk without aid after a year but some of these outcome measures were only available for one trial. We also reviewed one trial involving 249 patients which compared PE followed by intravenous immunoglobulin with PE alone and another involving 37 patients which compared immunoabsorption followed by intravenous immunoglobulin with immunoabsorption alone. Neither revealed any significant differences between the regimens with and without intravenous immunoglobulin. We did not discover any dose ranging studies of intravenous immunoglobulin except for one that is ongoing.
REVIEWER'S CONCLUSIONS: There are no adequate trials to determine whether intravenous immunoglobulin is more beneficial than placebo. Intravenous immunoglobulin and plasma exchange have a similar ability to speed the recovery from Guillain-Barré syndrome. Giving intravenous immunoglobulin after plasma exchange is not significantly better than plasma exchange alone. Randomised trials are needed to decide whether intravenous immunoglobulin helps in mild Guillain-Barré syndrome or in disease which has lasted more than two weeks. Randomised trials also need to establish the optimal dose.
吉兰 - 巴雷综合征是一种潜在严重的急性麻痹性疾病,可能是由周围神经炎症引起的自身免疫性疾病。血浆置换可通过用血浆替代品替换患者自身血浆来加速恢复。从献血中纯化的静脉注射免疫球蛋白对其他自身免疫性疾病有益且更易于给药。
确定静脉注射免疫球蛋白与不治疗或其他治疗方法相比治疗吉兰 - 巴雷综合征的疗效,并确定最有效的剂量。
使用吉兰 - 巴雷综合征和急性感染性多发性神经炎作为检索词,检索Cochrane神经肌肉疾病组登记库,查阅试验的参考文献并与作者及其他专家联系。
随机和半随机试验。
两名评价员检查了检索到的所有论文的标题和摘要,将数据提取到为本评价设计的表格上,并独立评估试验质量。
唯一一项比较静脉注射免疫球蛋白与支持治疗的试验不足以确定其价值。另一项Cochrane系统评价表明血浆置换(PE)可加速恢复。血浆置换已成为其他治疗方法需要与之比较的金标准。我们发现三项随机试验比较了静脉注射免疫球蛋白与血浆置换。我们能够将两项最大试验的结果合并进行一项涉及398例患者的荟萃分析。本评价的主要结局指标是随机分组后四周7级残疾量表的变化。该指标的加权平均差异不显著,静脉注射免疫球蛋白组比血浆置换组在残疾等级上仅多改善0.11(95%CI -0.14至0.37)。其他结局指标也无显著差异,包括独立行走时间、死亡率以及一年后仍需辅助才能行走的患者比例,但其中一些结局指标仅在一项试验中可用。我们还查阅了一项涉及249例患者的试验,该试验比较了血浆置换后静脉注射免疫球蛋白与单纯血浆置换,以及另一项涉及37例患者的试验,该试验比较了免疫吸附后静脉注射免疫球蛋白与单纯免疫吸附。两项试验均未显示加用和未加用静脉注射免疫球蛋白的治疗方案之间有任何显著差异。除一项正在进行的试验外,我们未发现任何静脉注射免疫球蛋白的剂量范围研究。
尚无足够的试验来确定静脉注射免疫球蛋白是否比安慰剂更有益。静脉注射免疫球蛋白和血浆置换在加速吉兰 - 巴雷综合征恢复方面能力相似。血浆置换后给予静脉注射免疫球蛋白并不比单纯血浆置换显著更好。需要进行随机试验来确定静脉注射免疫球蛋白是否对轻症吉兰 - 巴雷综合征或病程超过两周的疾病有帮助。还需要随机试验来确定最佳剂量。