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一项关于在塞浦路斯的多发性硬化症患者中使用利妥昔单抗治疗的回顾性观察性研究。

A retrospective observational study of rituximab treatment in multiple sclerosis patients in Cyprus.

机构信息

Neurology Clinic C, The Cyprus Institute of Neurology and Genetics , Nicosia , Cyprus.

The Cyprus School of Molecular Medicine , Nicosia , Cyprus.

出版信息

Postgrad Med. 2019 Sep;131(7):486-489. doi: 10.1080/00325481.2019.1649975. Epub 2019 Jul 30.

Abstract

: The objective of this study was to evaluate the efficacy and safety of rituximab (RTX) treatment given off-label to Cypriot patients with multiple sclerosis (MS). : Clinical data from 30 MS patients ever treated with off-label RTX until mid-2018 at the Cyprus Institute of Neurology and Genetics were retrospectively collected and reviewed. The heterogeneous patient cohort included patients with relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Outcome data (relapse rate and EDSS progression) as well as adverse effects for patients with a follow-up period of >12 months (n = 13) were recorded. : Following RTX administration, all patients with RRMS remained relapse free and had a stable or slightly improved EDSS score (mean EDSS before treatment = 6, mean EDSS at 12 months = 4.75). Patients with SPMS had a significant reduction in their relapse rate and a stabilization or slight improvement of their EDSS scores (mean EDSS before treatment = 6.25, mean EDSS at 12 months = 5.5). Only one of the patients with PPMS had a follow-up period of >12 months and his EDSS score remained unchanged. Rituximab infusions were generally well tolerated; there were only seven grade 3 or 4 adverse events recorded. : Our results are in agreement with larger retrospective studies in which it was demonstrated that RTX was well tolerated and effective in treating RRMS and SPMS patients by reducing relapse rate and stabilizing disease.

摘要

本研究旨在评估利妥昔单抗(RTX)在未经批准的情况下用于治疗塞浦路斯多发性硬化症(MS)患者的疗效和安全性。回顾性收集并审查了截至 2018 年年中在塞浦路斯神经病学和遗传学研究所接受过未经批准的 RTX 治疗的 30 名 MS 患者的临床数据。异质患者队列包括复发缓解型多发性硬化症(RRMS)、原发性进展型多发性硬化症(PPMS)和继发性进展型多发性硬化症(SPMS)患者。记录了随访时间>12 个月(n=13)的患者的转归数据(复发率和 EDSS 进展)以及不良反应。在接受 RTX 治疗后,所有 RRMS 患者均未复发,且 EDSS 评分稳定或略有改善(治疗前 EDSS 平均值为 6,治疗后 12 个月 EDSS 平均值为 4.75)。SPMS 患者的复发率显著降低,EDSS 评分稳定或略有改善(治疗前 EDSS 平均值为 6.25,治疗后 12 个月 EDSS 平均值为 5.5)。仅有 1 例 PPMS 患者的随访时间>12 个月,其 EDSS 评分保持不变。RTX 输注总体上耐受性良好;仅记录到 7 例 3 级或 4 级不良事件。我们的结果与更大规模的回顾性研究一致,这些研究表明,RTX 通过降低复发率和稳定疾病,在治疗 RRMS 和 SPMS 患者方面耐受性良好且有效。

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