【摘要】 目的 评价利妥昔单抗在神经系统免疫疾病中超说明书用药的循证医学/药学证据，分析其用药安全性，为临床合理用药提供参考。方法 回顾性收集2020年至2024年神经内科超说明书使用利妥昔单抗的病例40例，根据循证医学/药学证据评价超说明书用药情况，分析用药后不良反应的发生情况。结果 40例病例中，临床诊断为自身免疫性脑炎的有20例（占50.0%），临床诊断为视神经脊髓炎谱系疾病的有16例（占40.0%），临床诊断为抗髓鞘少突胶质细胞糖蛋白免疫球蛋白G抗体相关疾病的有2例（占5.0%）。40例病例利妥昔单抗超说明书用药的Micromedex证据推荐等级均为4～5级。40例病例中有14例病例发生了不良反应（发生率为35.0%），主要为血液系统反应、输液反应和继发感染。结论 利妥昔单抗在神经系统免疫疾病中的超说明用药循证医学/药学证据比较充分，但仍存在一定安全性风险。应规范利妥昔单抗在神经系统免疫疾病中的超说明书用药，以促进临床合理用药。更多还原

【Abstract】 AIM To evaluate the evidence-based medicine/pharmacy evidence for the off-label use of rituximab in neuroimmune diseases, analyze its safety profile, and provide a reference for rational clinical medication. METHODS Retrospective analysis and evidence-based evaluation of off-label drug use in 40 inpatients using rituximab were conducted in the neurology department of a hospital from 2020 to 2024. The occurrence of adverse reactions in patients after medication was analysed. RESULTS Among the 40 patients, 20 patients(50.0%) were diagnosed with autoimmune encephalitis, 16 patients(40.0%) with neuromyelitis optica spectrum disorders, and 2 patients(5.0%) with anti-myelin oligodendrocyte glycoprotein immunoglobulin G antibody-associated disorders. The off-label use of rituximab in all 40 patients was classified as level 4 to 5 according to the Micromedex evidence recommendation. Among the 40 patients, 14 patients(35.0%) experienced adverse reactions, mainly hematological reactions, infusion reactions, and secondary infections. CONCLUSION The evidence-based medicine/pharmacy evidence for the off-label use of rituximab in neuroimmune diseases is relatively sufficient. Nevertheless, certain security risks still exist. The off-label use of rituximab in neuroimmune diseases should be standardized to promote rational clinical medication.更多还原