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利妥昔单抗治疗多发性硬化症患者的疗效和安全性:沙特阿拉伯麦加一家三级中心的观察性研究。

Efficacy and safety of rituximab in patients with multiple sclerosis: An observational study at a tertiary center in Makkah, Saudi Arabia.

机构信息

From the Department of Neurology (Almatrafi, Babakkor, Irfan, Samkari, Alzahrani), from Research centre (Mohorjy), King Abdullah Medical City, Makkah, from Punjab Institute of Cardiology (Zahoor), Lahore, Pakistan.

出版信息

Neurosciences (Riyadh). 2022 Apr;27(2):65-70. doi: 10.17712/nsj.2022.2.20210122.

Abstract

OBJECTIVES

To assess the efficacy and safety of rituximab for multiple sclerosis (MS) treatment in terms of reduction in clinical relapses, magnetic resonance imaging (MRI) activity, Expanded Disability Status Scale (EDSS) score and adverse events.

METHODS

This is a retrospective cross-sectional study conducted at King Abdullah Medical City, from January 2017 to August 2021, involving patients with MS given rituximab, with 1-year follow-up. Clinical parameters were noted pre- and post-treatment to determine efficacy; adverse events were noted to analyze safety. A paired samples t-test was used to compare responses pre- and post-treatment. A -value<0.05 was considered significant.

RESULTS

Among 31 patients, 6 (19.4%) had progressive MS, and 25 (80.6%) had relapsing-remitting MS (mean disease duration=8.12±5.65 years). The annual relapse rate reduced from 1.67±0.97 to 0.06±0.25 (<0.001), the EDSS score from 3.16±2.14 to 2.80±2.28 (=0.141) and the MRI activity score from 1.84±1.03 to 1.03±0.18 (<0.001). Only one patient had enhancing lesion activity post-treatment. The commonest side effect was urinary tract infection (25.8%). Only 2 patients discontinued the drug.

CONCLUSION

Rituximab is an efficient drug in reducing the annual relapse rate and MRI activity of patients with MS, with few tolerable side effects not leading to drug discontinuation or any lethal outcome.

摘要

目的

评估利妥昔单抗治疗多发性硬化症(MS)的疗效和安全性,包括降低临床复发率、磁共振成像(MRI)活动、扩展残疾状况量表(EDSS)评分和不良事件。

方法

这是一项回顾性横断面研究,于 2017 年 1 月至 2021 年 8 月在阿卜杜拉国王医疗城进行,涉及接受利妥昔单抗治疗的 MS 患者,随访时间为 1 年。治疗前后记录临床参数以确定疗效;记录不良事件以分析安全性。采用配对样本 t 检验比较治疗前后的反应。P 值<0.05 认为差异具有统计学意义。

结果

在 31 名患者中,6 名(19.4%)为进展型 MS,25 名(80.6%)为复发缓解型 MS(平均病程=8.12±5.65 年)。年复发率从 1.67±0.97 降至 0.06±0.25(<0.001),EDSS 评分从 3.16±2.14 降至 2.80±2.28(=0.141),MRI 活动评分从 1.84±1.03 降至 1.03±0.18(<0.001)。仅 1 名患者治疗后出现增强病变活动。最常见的副作用是尿路感染(25.8%)。仅 2 名患者停止用药。

结论

利妥昔单抗是一种有效的药物,可降低 MS 患者的年复发率和 MRI 活动度,副作用少,可耐受,不会导致停药或任何致命后果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b9/9257910/ff54b0d47530/Neurosciences-27-2-65_page_4_1.jpg

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