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Spectrum of practice in the routine management of cervical dystonia with abobotulinumtoxinA: findings from three prospective open-label observational studies

机译:肉毒杆菌毒素A常规治疗宫颈肌张力障碍的实践范围:三项前瞻性开放性观察研究的发现

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Background Cervical dystonia is a heterogeneous disorder with several possible presentations, for which first-line therapy is often botulinum toxin (BoNT). In routine clinical practice the success of each BoNT injection is dependent on several variables, including individual presentation and injection technique. Large multicenter, observational studies provide important information on individualized administration strategies that cannot be otherwise ascertained from controlled clinical trials. In this meta-analysis of patient level data, we aimed to evaluate the clinical characteristics of patients with cervical dystonia undergoing routine treatment with botulinum toxin, specifically abobotulinumtoxinA. We also aimed to characterize current abobotulinumtoxinA injection techniques and parameters and to explore international differences in patient presentation and treatment. Methods This was a meta-analysis of baseline data from three prospective, international, multicenter, observational studies (NCT01314365, NCT00833196 and NCT01753349) of botulinum toxin treatment for the routine management of adult cervical dystonia. Results Data presented illustrate the significant heterogeneity of CD presentation in routine practice. Most subjects presented with a complex pattern of dystonic movements and the majority had additional components of shoulder elevation, tremor and/or jerk. Dosing was generally in accordance with that recommended in the abobotulinumtoxinA prescribing information, although the range of dosing also indicates that injections are tailored to individual presentation. Sub-group analyses at the country level revealed distinct differences in injection practice. Conclusions This meta-analysis is based on the largest dataset of subjects with cervical dystonia studied to date. The heterogeneity revealed in our baseline findings support the need to develop consistent, practical and comprehensive best practice guidelines.
机译:背景颈肌张力障碍是一种异质性疾病,有几种可能的表现,一线治疗通常是肉毒杆菌毒素(BoNT)。在常规的临床实践中,每次BoNT注射的成功取决于多个变量,包括个体表现和注射技术。大型的多中心,观察性研究提供了关于个性化给药策略的重要信息,而这些信息无法从对照临床试验中确定。在这种对患者水平数据的荟萃分析中,我们旨在评估接受肉毒杆菌毒素(特别是abobotulinumtoxinA)常规治疗的宫颈肌张力障碍患者的临床特征。我们还旨在表征当前的肉毒杆菌毒素A注射技术和参数,并探讨患者表现和治疗方面的国际差异。方法这是对肉毒杆菌毒素治疗三项前瞻性,国际,多中心,观察性研究(NCT01314365,NCT00833196和NCT01753349)进行的基线数据的荟萃分析,用于成人宫颈肌张力障碍的常规治疗。结果提供的数据说明了CD演示在常规实践中的显着异质性。大多数受试者表现出复杂的肌张力运动,而大多数受试者还有肩部抬高,震颤和/或抽搐等其他症状。尽管剂量范围也表明注射剂是针对个体出现量身定制的,但剂量通常与阿博毒素蛋白A处方信息中推荐的剂量一致。国家一级的子组分析显示了注射实践的明显差异。结论这项荟萃分析基于迄今为止研究的最大的宫颈肌张力障碍受试者数据集。我们的基线发现揭示的异质性支持需要制定一致,实用和全面的最佳实践指南。

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