Clinique Neuro-Lévis, Lévis, Québec, Canada.
Clinique Neuro-Rive Sud, Greenfield Park, Québec, Canada.
Can J Neurol Sci. 2021 Sep;48(5):676-684. doi: 10.1017/cjn.2020.275. Epub 2020 Dec 21.
Symptoms of cervical dystonia (CD) can vary in severity and cause significant pain. OnabotulinumtoxinA is an approved treatment for CD. This study assessed health-related quality of life (HRQoL) in patients with CD who received multiple onabotulinumtoxinA treatments.
This prospective, observational standard-of-care study was conducted at multiple neurology centers in Québec, Canada. Patients reported the health impact of CD using the Cervical Dystonia Impact Profile (CDIP)-58, before and after up to eight onabotulinumtoxinA treatments. Other measures included the Cervical Dystonia Severity Rating Scale by physician, employment status using the Work Productivity Questionnaire and pain using the Pain Numeric Rating Scale (PNRS). Adverse events (AEs) were recorded.
Sixty-two patients were enrolled (safety population, n = 61; modified efficacy population, n = 58). Participants were mostly females who were employed; most (79.3%) had torticollis. In all, 21/62 patients (33.9%) discontinued the study. At the final visit, there was a statistically significant (p < 0.001) improvement in all eight CDIP-58 subscales, particularly head and neck symptoms (-31.0) and psychosocial functioning (-28.2). Employment increased from baseline (55%) to the end of the study (64%), and there was improvement in work productivity. There was a significant (p < 0.0001) reduction in pain measured by the PNRS, from -0.5 post-treatment 1 to -2.4 at end of study. AEs (neck pain, muscular weakness, dysphagia, nausea) were consistent with onabotulinumtoxinA use.
These real-world data indicate that after repeated, long-term use, onabotulinumtoxinA continues to be a safe and effective treatment for CD, improving HRQoL and work productivity.
颈肌张力障碍(CD)的症状严重程度可能不同,会引起严重疼痛。肉毒毒素 A 是一种已被批准用于治疗 CD 的药物。本研究评估了接受多次肉毒毒素 A 治疗的 CD 患者的健康相关生活质量(HRQoL)。
这是一项在加拿大魁北克省多个神经病学中心进行的前瞻性、观察性的标准护理研究。患者使用颈肌张力障碍影响量表(CDIP)-58 报告 CD 的健康影响,在接受多达 8 次肉毒毒素 A 治疗前后进行报告。其他措施包括医生使用的颈肌张力障碍严重程度评分量表、使用工作生产力问卷评估的就业状况和疼痛使用数字疼痛评分量表(PNRS)。记录不良反应(AE)。
共纳入 62 名患者(安全性人群,n=61;改良疗效人群,n=58)。参与者主要为女性,有工作;大多数(79.3%)患有斜颈。共有 21/62 名患者(33.9%)退出了研究。在最后一次就诊时,所有 8 项 CDIP-58 子量表均有统计学显著(p < 0.001)改善,尤其是头颈部症状(-31.0)和心理社会功能(-28.2)。就业率从基线(55%)上升到研究结束时(64%),工作生产力也有所提高。PNRS 测量的疼痛有显著(p < 0.0001)降低,从治疗后 1 时的-0.5 降至研究结束时的-2.4。AE(颈部疼痛、肌肉无力、吞咽困难、恶心)与肉毒毒素 A 的使用一致。
这些真实世界的数据表明,在重复、长期使用后,肉毒毒素 A 仍然是 CD 的安全有效治疗方法,可改善 HRQoL 和工作生产力。