Kathryn Gaebel, Gord Blackhouse, Kaitryn Campbell, Diana Robertson, Feng Xie, Nazila Assasi, Colin Chalk, Mitchell Levine, Ron Goeree
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引用次数: 0
Abstract
Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an acquired immune-mediated inflammatory disorder that targets the myelin sheaths of the peripheral nervous system. Intravenous immunoglobulin (IVIg) is a blood product containing immunoglobulin G pooled from many human donors. In fall 2008, CIDP became an approved indication for IVIg in the United States and Canada.
Objective: To evaluate the clinical effectiveness and safety of IVIg for the treatment of CIDP through a systematic review of published randomized controlled trials.
Methods: We searched the MEDLINE (1996-2009, including in-process and other non-indexed citations), Embase (1996-2009) and other databases through the Ovid interface. We applied a methodological filter to limit retrieval to controlled clinical trials, meta-analyses and systematic reviews, and health technology assessments. Retrieval was limited to studies involving humans, and no language restrictions were employed. We pooled extracted data to estimate the effect size of IVIg treatment based on the random-effects model.
Results: We identified 9 unique randomized controlled trials. Of these, 3 compared IVIg therapy with an active comparator (plasma exchange, plasma exchange using extracorporeal immunoadsorption, oral prednisolone, respectively); the other 6 trials had placebo controls. No incremental benefit was seen in terms of primary outcomes for comparisons of IVIg therapy and an active comparator. Data from 4 of the 6 placebo-controlled trials were included in a meta-analysis. A significant improvement in disability (i.e., reduction in disability score) was found, with a standardized mean difference of 0.65 (95% confidence interval [CI] 0.23 to 1.08) in favour of IVIg. A pooled analysis of the proportion of patients with a response to treatment, as defined by the investigators of each of the trials, resulted in a risk ratio of 2.74 (95% CI 1.80 to 4.15) favouring IVIg.
Interpretation: IVIg therapy was statistically superior to placebo in reducing disability and impairment among patients with CIDP. The effectiveness of IVIg was similar to that of the alternative treatment strategies of plasma exchange and oral prednisolone.
背景:慢性炎症性脱髓鞘性多根神经病变(CIDP)是一种以周围神经系统髓鞘为靶点的获得性免疫介导的炎症性疾病。静脉注射免疫球蛋白(IVIg)是一种血液制品,含有来自许多人类献血者的免疫球蛋白G。2008年秋季,CIDP在美国和加拿大被批准为IVIg的适应症。目的:通过对已发表的随机对照试验进行系统评价,评价IVIg治疗CIDP的临床有效性和安全性。方法:通过Ovid界面检索MEDLINE(1996-2009年)、Embase(1996-2009年)等数据库。我们采用了方法学筛选方法,将检索限制在对照临床试验、荟萃分析和系统评价以及卫生技术评估中。检索仅限于涉及人类的研究,并且没有使用语言限制。我们汇集了提取的数据,以估计基于随机效应模型的IVIg治疗的效应大小。结果:我们确定了9个独特的随机对照试验。其中,3例比较了IVIg治疗与活性比较物(血浆置换、体外免疫吸附血浆置换、口服强的松龙);另外6项试验采用安慰剂对照。在比较IVIg治疗和活性比较物的主要结果方面,没有看到增加的益处。6项安慰剂对照试验中的4项数据被纳入meta分析。研究发现,IVIg对残疾有显著改善(即残疾评分降低),标准化平均差异为0.65(95%可信区间[CI] 0.23至1.08)。对每项试验的研究人员定义的对治疗有反应的患者比例进行汇总分析,结果显示支持IVIg的风险比为2.74 (95% CI 1.80至4.15)。解释:IVIg治疗在减少CIDP患者的残疾和损害方面在统计学上优于安慰剂。IVIg的有效性与血浆置换和口服强的松龙的替代治疗策略相似。