摘要：

目的: 探讨奥法妥木单抗治疗视神经脊髓炎谱系疾病(NMOSDs)的疗效及安全性。方法: 纳入2022年4月至2023年3月郑州大学第一附属医院采用奥法妥木单抗治疗方案的25例NMOSDs患者，分为定期给药组(A组，12例)及按CD19⁺B细胞百分比给药组(B组，13例)，计算用药前和用药1年时年化复发率(ARR)、复发例数、复发次数和时间、复发症状，采用扩展残疾状态量表(EDSS)评估神经功能，记录用药期间药物不良反应。结果: 奥法妥木单抗治疗1年时3例(12%)复发，A组1例患者复发2次，分别为用药后1和5个月；B组2例患者复发，1例复发2次，为用药后2和6个月，1例复发1次，为用药后2个月。两组用药1年时与用药前仅ARR变化幅度差异具有统计学意义(F = 29.061，P = 0.000)，A组用药1年时ARR较用药前下降(t = 13.215，P = 0.001)，B组用药1年时ARR亦较用药前下降(t =19.259，P = 0.000)。有8例出现注射部位疼痛、3例注射后发热、1例注射后头痛，其中1例诊断为细菌性脑膜炎；14例感染新型冠状病毒，其中1例因新型冠状病毒感染致肺炎入住重症监护病房；均无残疾、死亡等严重不良反应，EDSS评分均未增加。结论: 奥法妥木单抗定期给药或依据CD19⁺B细胞百分比给药均可减少患者复发风险，改善EDSS评分；早期与糖皮质激素联用需警惕感染风险。

关键词: 视神经脊髓炎, 奥法妥木单抗(非MeSH词), 复发, 药物相关性副作用和不良反应

Abstract:

Objective: To investigate the efficacy and neuromyelitis optica spectrum disorders (NMOSDs). Methods: The clinical data of 25 patients with NMOSDs hospitalized in The First Affiliated Hospital of Zhengzhou University from April 2022 to March 2023 and treated with ofatumumab were retrospectively analyzed. They were divided into 2 groups, Group A with 12 cases receiving regular medication, and Group B with 13 cases receiving medication based on the percentage of CD19⁺B lymphocytes. Annual relapse rate (ARR), the number of relapses, the frequency and time of relapses, and the symptoms of relapses were calculated before and at one year of medication. The neurological function was assessed by Expanded Disability Status Scale (EDSS) before and at one year of medication. The adverse drug reactions were recorded during medication. Results: After one year treatment with ofatumumab, 3 patients (12%) experienced recurrence. One patient in Group A experienced recurrence twice, one month and 5 months after treatment, respectively. At the second recurrence, the percentage of CD19⁺B lymphocytes was 2.80%. Two patients in Group B experienced recurrence, one patient relapsed twice at 2 and 6 months after medication. The percentage of CD19⁺B lymphocytes was 0.80% and 0.21%, respectively; another patient relapsed once at 2 months after medication. At the time of recurrence, the percentage of CD19⁺B lymphocytes was 0.70%. There was a statistically significant difference in ARR before and after one year treatment (F = 29.061, P = 0.000). After one year's treatment, the ARR of Group A (t = 13.215, P = 0.001) and Group B (t = 19.259, P = 0.000) was decreased than before. There were 8 cases of the injection site pain, 3 cases of fever after injection, and one case of headache after injection. There were no serious adverse reactions such as disability and death, and EDSS scores were not increased. Conclusions: Continuous administration of ofatumumab every 3 months or based on the percentage of CD19⁺B lymphocyte can reduce recurrence. Combination with corticosteroids should be alert to the risk of infection.

Key words: Neuromyelitis optica, Ofatumumab (not in MeSH), Recurrence, Drug-related side effects and adverse reaction