一项B细胞监测下减量利妥昔单抗治疗视神经脊髓炎谱系病的前瞻性研究  

The efficacy and safety of reduced-dosage rituximab in the treatment of neuromyelitis optica spectrum disorders under B cell monitoring-A prospective study

作　　者：李园园[1] 俞海[2] 王笑竹 沈月平[4] 古彦铮[3] 田璟鸾 方琪[1,3] 陈向军[2] 薛群[1,3] LI Yuanyuan;YU Hai;WANG Xiaozhu(Department of Neurology,First Affiliated Hospital of Soochow University,Suzhou,Jiangsu 215006,China)

机构地区：[1]苏州大学第一附属医院神经内科,江苏苏州215006 [2]复旦大学华山医院神经内科,上海200040 [3]苏州大学第一附属医院江苏省临床免疫学重点实验室临床免疫学研究所,江苏苏州215006 [4]苏州大学流行病学与卫生统计学系,江苏苏州215006

出　　处：《中风与神经疾病杂志》2021年第4期345-348,共4页Journal of Apoplexy and Nervous Diseases

基　　金：江苏省科技计划重点项目(社会发展),BE2019666;苏州市临床重点病种诊疗技术专项项目,(LCZX201702)。

摘　　要：目的观察B细胞监测下减量利妥昔单抗方案治疗视神经脊髓炎谱系病(NMOSD)患者的疗效及安全性。方法收集2016年12月-2019年6月苏州大学附属第一医院神经内科规律随访的35例NMOSD患者临床资料,分为B细胞监测下减量利妥昔单抗组、硫唑嘌呤组及环磷酰胺组,比较治疗前后扩展残疾状态量表评分差值、未复发的可能性、药物不良反应等指标。结果(1)RTX组比AZA组治疗前后EDSS评分下降水平明显,具有统计学意义(P<0.05);(2)RTX组和CTX组的复发风险明显低于AZA组,差异有统计学意义(Log-rankχ^(2)=9.147,P=0.01);(3)RTX组总不良事件发生比例较CTX组少,RTX组激素停药率高于AZA组和CTX组(P<0.05),差异具有统计学意义;(4)RTX组平均用药间隔时间7.00(6.0,10.0)m。结论B细胞监测下减量利妥昔单抗方案治疗NMOSD总体安全、有效,可延长用药间隔,减少患者的用药费用支出。Objective To investigate the efficacy and safety of a reduced-dosage rituximab(RTX)treatment regimen for neuromyelitis optica spectrum disorders(NMOSD)under B cell monitoring.Method Clinical data from 35 patients with NMOSD who were regularly followed up in the Department of Neurology of the First Affiliated Hospital of Soochow University from December 2016 to June 2019 were collected.They were divided into rituximab reduction group under B cell monitoring,azathioprine group and cyclophosphamide group.Differences in the indexes including the Expanded Disability Status Scale(EDSS)score,possibility of no recurrence,and adverse drug reactions were used to evaluate the efficacy and safety of the three treatment regimens.Results(1)The EDSS score of the RTX group was significantly lower than that of the AZA group before and after treatment(P<0.05).(2)The relapse risk of the RTX and CTX groups was significantly lower than that of the AZA group(Log-rankχ^(2)=9.147,P=0.01).(3)The proportion of total adverse events in the RTX group was less than that in the CTX group.The glucocorticoids withdrawal rate in the RTX group was higher than that of the AZA group and the CTX group(P<0.05),and the difference was statistically significant.(4)The mean interval of treatment in RTX group was 7.00(6.0,10.0)months.Conclusion The reduced-dose rituximab regimen under B cell monitoring is generally safe and effective in the treatment of NMOSD,which can prolong the medication interval and reduce the medication expenses of patients.

关 键 词：视神经脊髓炎谱系病 利妥昔单抗 B细胞监测 疗效评价 安全性分析 

分 类 号：R744.52[医药卫生—神经病学与精神病学]