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Tolerability and Safety Profile of a New Brand-Generic Product of Glatiramer Acetate in Iranian Patients with Relapsing-Remitting Multiple Sclerosis: An Observational Cohort Study

机译:醋酸格拉替雷新品牌通用产品在患有复发缓解型多发性硬化症的伊朗患者中的耐受性和安全性概况:一项观察性队列研究

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摘要

BackgroundThe aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month period. A noninterventional cohort study was conducted on 185 patients. The patients had a confirmed and documented diagnosis of relapsing-remitting multiple sclerosis as defined by the Revised McDonald Criteria (2010), were ambulatory with a Kurtzke Expanded Disability Status Scale score of 0 to 5.5, and their treatment by glatiramer acetate 40 mg/mL was just started.
机译:背景本研究的目的是评估品牌通用醋酸格拉替雷在12个月内复发缓解型多发性硬化症患者中的安全性,耐受性和疗效。一项针对185名患者的非干预队列研究。根据修订的McDonald Criteria(2010)定义,患者已确诊并记录有复发缓解型多发性硬化症的诊断,正在非门诊治疗,Kurtzke扩展残疾状态量表评分为0到5.5,接受醋酸格拉替雷治疗40 mg / mL才刚刚开始。

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