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静脉注射免疫球蛋白(IVIG)治疗吉兰-巴雷综合征(GBS)患者的疗效和安全性:一项系统评价。

Efficacy and safety of intravenous immunoglobulin retreatment amongst Guillain-Barré syndrome patients who poorly responded to initial IVIG cycle: a systematic review.

机构信息

Department of Physiology, College of Medicine, University of the Philippines-Manila, Manila, Philippines.

Department of Internal Medicine, Medical Center Manila, Manila, Philippines.

出版信息

Acta Neurol Belg. 2024 Aug;124(4):1237-1250. doi: 10.1007/s13760-024-02518-9. Epub 2024 Mar 30.

Abstract

INTRODUCTION

Small cross-sectional studies and case reports observed improvement after administration of second IVIG dose (SID) amongst Guillain-Barré Syndrome (GBS) patients not responsive to initial IVIG cycle. Nevertheless, recent clinical trial and larger observational studies did not find any positive effects of SID. Instead, an increased risk of thromboembolism and mortality was noted. The conclusions of these studies however were not robust as confounding and selection bias were present.

METHODOLOGY

Two neurologists conducted the search process (KBA and MBP) using the following terms in Medline: [(" Guillain-Barré Syndrome"[MeSH Terms] or GBS or Acute Motor Axonal Neuropathy or Acute Motor Axonal Neuropathy or Acute Inflammatory Demyelinating Polyneuropathy) AND (Poorly Responsive or Poor Prognosis or Progressive)] AND [("Intravenous Immunoglobulin"[MeSH Terms] or IVIG or IGIV) AND (second dose or retreatment or SID)].

RESULTS

Only 7 articles were included in this review. In terms of primary outcomes, although the cross-sectional study found improvement in GBS DS score at 4 weeks (Median GBS DS: 3 vs 5, p = 0.033) and the 2 case series observed improvement after SID, no significant differences between the control and intervention groups were found in the cohort [Early SIV OR: 0.7 (95% CI 0.16-3.04), Late SIV OR: 0.66 (CI: 0.18-2.5)] and clinical trial studies (Adjusted OR: 1.4 (95% CI:0.6-3.3, p = 0.45). Moreover, 4 patients who died in the clinical trial were from the intervention group.

CONCLUSION

Based on studies with research designs of higher quality, SID is not effective in the management of GBS patients who poorly responded to initial IVIG. Nevertheless, an adequately powered, randomized, double-blinded, placebo-controlled clinical trial, using GBS-DS of 3 and above after first IVIG dose should be done to effectively establish the efficacy and safety of SID as intervention for this cohort of patients.

摘要

简介

小型横断面研究和病例报告观察到,在初始 IVIG 周期后,对初始 IVIG 无反应的格林-巴利综合征(GBS)患者给予第二剂 IVIG(SID)后有改善。然而,最近的临床试验和更大的观察性研究并没有发现 SID 的任何积极影响。相反,观察到血栓栓塞和死亡率增加。然而,这些研究的结论并不稳健,因为存在混杂和选择偏倚。

方法

两名神经病学家(KBA 和 MBP)使用 Medline 中的以下术语进行了搜索过程:[(“格林-巴利综合征”[MeSH 术语]或 GBS 或急性运动轴索性神经病或急性运动轴索性神经病或急性炎症性脱髓鞘性多发性神经病)和(反应不佳或预后不良或进行性)]和 [(“静脉内免疫球蛋白”[MeSH 术语]或 IVIG 或 IGIV)和(第二剂量或再治疗或 SID)]。

结果

本综述仅纳入了 7 篇文章。就主要结局而言,尽管横断面研究发现 SID 后 4 周时 GBS-DS 评分有所改善(中位数 GBS-DS:3 与 5,p=0.033),且 2 项病例系列观察到 SID 后有所改善,但队列研究中对照组和干预组之间没有发现显著差异[早期 SIV OR:0.7(95%CI 0.16-3.04),晚期 SIV OR:0.66(CI:0.18-2.5)]和临床试验研究(调整 OR:1.4(95%CI:0.6-3.3,p=0.45)。此外,临床试验中死亡的 4 名患者来自干预组。

结论

基于质量更高的研究设计的研究,SID 在治疗对初始 IVIG 无反应的 GBS 患者方面无效。然而,应该进行一项足够大的、随机的、双盲的、安慰剂对照的临床试验,使用首次 IVIG 剂量后 GBS-DS 为 3 及以上,以有效地确定 SID 作为该患者群体的干预措施的疗效和安全性。

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