低剂量利妥昔单抗治疗难治性重症肌无力的有效性和安全性  

Study on efficacy and safety of low-dose regimens of rituximab for refractory myasthenia gravis

作　　者：王彦改[1] 智博洋 朱文佳[3] 白向荣[1] 褚燕琦[1] WANG Yangai;ZHI Boyang;ZHU Wenjia;BAI Xiangrong;CHU Yanqi(Department of Pharmacy,Xuanwu Hospital Capital Medical University,Beijing 100053,China;Department of Clinical Pharmacy,School of Pharmaceutical Sciences,Beijing 100069,China;Department of Neurology,Xuanwu Hospital Capital Medical University,Beijing 100053,China)

机构地区：[1]首都医科大学宣武医院药学部,北京100053 [2]首都医科大学药学院临床药学系,北京100069 [3]首都医科大学宣武医院神经内科,北京100053

出　　处：《临床药物治疗杂志》2025年第3期74-77,89,共5页Clinical Medication Journal

基　　金：中国研究型医院学会评价专委会临床重点药品的使用监测和评价研究专项(Y2023FH-YWPJ03-206)。

摘　　要：目的评估低剂量利妥昔单抗注射液治疗难治性重症肌无力(RMG)的疗效和安全性。方法通过回顾性自身前后对照研究的方式,比较治疗前后RMG患者重症肌无力定量评分表(QMG)评分、激素用量、日常生活能力评定量表(MG-ADL)评分变化。结果共纳入17例利妥昔单抗注射液治疗的RMG患者,治疗后QMG评分由12(7,14)分降至6(5,6)分,差异有统计学意义(P<0.05),激素用量由20(15,30)mg降至7.5(0,15)mg,ADL评分由4(2,5)分降至1(0,2)分。1例患者在治疗后出现了乙肝再激发,在接受抗病毒治疗后表面抗原转阴。2例患者出现了输液相关不良反应。结论利妥昔单抗注射液可以改善RMG患者肌无力症状,减少激素用量,但使用过程需要关注患者HBV再激发及输注反应。Objective To evaluate the efficacy and safety of low-dose rituximab off-label treatment for the treatment of refractory myasthenia gravis.Methods The change of quantitative myasthenia gravis(MG)score(QMG),prednisone dosage and quality of daily life(MG-ADL)score were used as observational outcomes.Results A total of 17 patients with refractory MG who recevied rituximab therapy were included in this retrospective study.At the end of the study,it showed that the median QMG score decreased from 12(7,14)to 6(5,6)(P=0.008),and the median steroids dosage decreased from 20(15,30)mg to 7.5(0,15)mg while the median ADL score decreased from 4(2,5)to 1(0,2).In terms of safety,one patient experienced hepatitis B reactivation after RTX treatment,and the HbsAg turned to negative after receiving anti-virus treatment.Two patients had infusion-related adverse reactions.Conclusion This study found that the myasthenia symptoms of patients with refractory myasthenia gravis improved and the dosage of prednisone decreased after the treatment with low-dose rituximab,but it is necessary to pay attention to the risk of hepatitis B rechallenge and infusion reactions in patients.

关 键 词：难治性重症肌无力 利妥昔单抗 重症肌无力定量评分 乙型肝炎病毒再激发 

分 类 号：R979.5[医药卫生—药品] R946.1[医药卫生—药学]