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不同剂量利妥昔单抗治疗难治性全身乙酰胆碱受体型重症肌无力的疗效和安全性:一项荟萃分析。

Efficacy and safety of different dosages of rituximab for refractory generalized AChR myasthenia gravis: A meta-analysis.

机构信息

Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin 300052, China.

Department of Clinical Laboratory, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.

出版信息

J Clin Neurosci. 2021 Mar;85:6-12. doi: 10.1016/j.jocn.2020.11.043. Epub 2021 Jan 2.

Abstract

BACKGROUND

Rituximab (RTX) is a mouse-human chimeric anti-CD20 monoclonal antibody and has been increasingly used for preventing relapses in myasthenia gravis (MG). However, the appropriate dose for maximizing the beneficial effects in refractory MG with acetylcholine receptor (AChR) autoantibody is a long-standing and critical debating question.

METHODS

We performed a meta-analysis to evaluate the efficacy and safety of the different doses of RTX in 260 refractory AChR-MG patients.

RESULTS

The AChR-MG patients were divided into low or routine RTX dose groups. An overall proportion of 77% (p = 0.000) AChR-MG patients demonstrated improved clinical status as indicated by the Myasthenia Gravis Foundation of America post-intervention scale (MGFA-PIS). There were 77.1% patients showed improved clinical status in lower dose of RTX group (p = 0.000) and 76.8% in routine protocol group (p = 0.000). Although we found there was no significant difference in the proportion of AChR-MG patients with improved clinical status or adverse reactions between the two groups, adverse reactions might be lower in the lower dose RTX group.

CONCLUSION

Most of refractory MG patients with anti-AChR autoantibody were well responsive and tolerated to RTX treatment. Repeated application of lower dose of RTX was effective and might be more appropriate for refractory AChR-MG patients with potential lower side effects.

摘要

背景

利妥昔单抗(RTX)是一种鼠-人嵌合抗 CD20 单克隆抗体,已越来越多地用于预防重症肌无力(MG)的复发。然而,对于乙酰胆碱受体(AChR)自身抗体阳性的难治性 MG,最大化其有益效果的合适剂量是一个长期存在的、具有争议的问题。

方法

我们进行了一项荟萃分析,以评估不同剂量 RTX 在 260 例难治性 AChR-MG 患者中的疗效和安全性。

结果

AChR-MG 患者分为低剂量或常规 RTX 剂量组。总体而言,77%(p=0.000)的 AChR-MG 患者的临床状态得到改善,这一结果通过美国重症肌无力基金会干预后量表(MGFA-PIS)得到了证实。低剂量 RTX 组中,77.1%的患者临床状态得到改善(p=0.000),常规方案组中,76.8%的患者临床状态得到改善(p=0.000)。尽管我们发现两组间在改善临床状态或不良反应的 AChR-MG 患者比例方面无显著差异,但低剂量 RTX 组的不良反应可能较低。

结论

大多数抗 AChR 自身抗体阳性的难治性 MG 患者对 RTX 治疗反应良好且可耐受。重复应用低剂量 RTX 是有效的,对于潜在不良反应较低的难治性 AChR-MG 患者可能更为合适。

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