Neuromuscular Diseases Clinic, International Center for Neurological Restoration, Habana, Cuba.
Division of Neuromuscular Diseases Clinic, Abel Santamaria Cuadrado University Hospital, Pinar del Río, Cuba.
Drug Dev Res. 2021 Aug;82(5):707-715. doi: 10.1002/ddr.21798. Epub 2021 Feb 15.
Multiple sclerosis (MS) is an autoimmune neurodegenerative disease that affects the central nervous system. It is the second cause of neurological disability in young adults. The exact cause of the disease remains unknown and there is no curative treatment. It is imperative to evaluate the efficacy of newest, biotechnological products modifying the disease. This study was designed to evaluate the use of interferon beta 1a (Rebif®) in patients with relapsing remitting MS treated at International Center for Neurological Restoration. Thirty-one patients with relapsing remitting MS, between 10 and 65 years of age, four males and 27 females, were treated with Rebif® three times per week during 1 year. The safety of the treatment was evaluated based on the adverse events and the efficacy based on the disability scale score, the number of attacks and the number of lesions at magnetic resonance imaging (MRI). The public clinical trial is registered in Cuba (Number B-10-030-L03). Adverse effects occurred in 75% of the cases, but they were mild. A significant reduction in the number of attacks, the disability scale score and the number of lesions at MRI were observed in patients with relapsing remitting MS treated with Rebif®. The use of interferon beta 1a showed safety and efficacy in the treatment of patients with relapsing remitting MS.
多发性硬化症(MS)是一种影响中枢神经系统的自身免疫性神经退行性疾病。它是导致年轻人神经功能障碍的第二大原因。该病的确切病因仍不清楚,也没有治愈方法。评估最新生物技术产品对疾病的疗效至关重要。本研究旨在评估在国际神经康复中心接受治疗的复发性缓解型多发性硬化症患者使用干扰素β 1a(Rebif®)的效果。
31 名年龄在 10 至 65 岁之间的复发性缓解型多发性硬化症患者(4 名男性和 27 名女性)接受 Rebif®每周三次治疗,为期 1 年。根据不良反应评估治疗的安全性,根据残疾量表评分、发作次数和磁共振成像(MRI)上的病变数量评估疗效。该公开临床试验在古巴注册(编号 B-10-030-L03)。
75%的患者出现不良反应,但均为轻度。Rebif®治疗的复发性缓解型多发性硬化症患者的发作次数、残疾量表评分和 MRI 上的病变数量均显著减少。干扰素β 1a 的使用在复发性缓解型多发性硬化症患者的治疗中显示出安全性和疗效。