Han Yi, Stevens Andrea L, Dashtipour Khashayar, Hauser Robert A, Mari Zoltan
WG Consulting, 200 Fifth Avenue, New York, NY, 10010, USA.
Faculty of Medical Offices, School of Medicine, Loma Linda University, 11370 Anderson, Suite B-100, Loma Linda, CA, 92354, USA.
J Neurol. 2016 Apr;263(4):772-80. doi: 10.1007/s00415-016-8050-2. Epub 2016 Feb 25.
A systematic pair-wise comparison of all available botulinum toxin serotype A and B treatments for cervical dystonia (CD) was conducted, as direct head-to-head clinical trial comparisons are lacking. Five botulinum toxin products: Dysport(®) (abobotulinumtoxinA), Botox(®) (onabotulinumtoxinA), Xeomin(®) (incobotulinumtoxinA), Prosigne(®) (Chinese botulinum toxin serotype A) and Myobloc(®) (rimabotulinumtoxinB) have demonstrated efficacy for managing CD. A pair-wise efficacy and safety comparison was performed for all toxins based on literature-reported clinical outcomes. Multi-armed randomized controlled trials (RCTs) were identified for inclusion using a systematic literature review, and assessed for comparability based on patient population and efficacy outcome measures. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was selected as the efficacy outcome measurement for assessment. A mixed treatment comparison (MTC) was conducted using a Bayesian hierarchical model allowing indirect comparison of the interventions. Due to the limitation of available clinical data, this study only investigated the main effect of toxin treatments without explicitly considering potential confounding factors such as gender and formulation differences. There was reasonable agreement between the number of unconstrained data points, residual deviance and pair-wise results. This research suggests that all botulinum toxin serotype A and serotype B treatments were effective compared to placebo in treating CD, with the exception of Prosigne. Based on this MTC analysis, there is no significant efficacy difference between Dysport, Botox, Xeomin and Myobloc at week four post injection. Of the adverse events measured, neither dysphagia nor injection site pain was significantly greater in the treatment or placebo groups.
由于缺乏直接的头对头临床试验比较，因此对所有可用的A型和B型肉毒杆菌毒素治疗颈部肌张力障碍（CD）进行了系统的两两比较。五种肉毒杆菌毒素产品：Dysport（阿扑肉毒杆菌毒素A）、Botox（保妥适，肉毒杆菌毒素A）、Xeomin（因卡肉毒杆菌毒素A）、衡力（中国A型肉毒杆菌毒素）和Myobloc（兰瑞肽素B）已证明对治疗CD有效。基于文献报道的临床结果，对所有毒素进行了两两疗效和安全性比较。通过系统的文献综述确定纳入多组随机对照试验（RCT），并根据患者群体和疗效结果指标评估其可比性。选择多伦多西部痉挛性斜颈评定量表（TWSTRS）作为疗效评估的结果指标。使用贝叶斯分层模型进行混合治疗比较（MTC），以间接比较干预措施。由于现有临床数据的局限性，本研究仅调查了毒素治疗的主要效果，未明确考虑潜在的混杂因素，如性别和制剂差异。在无约束数据点数量、残差偏差和两两比较结果之间存在合理的一致性。本研究表明，除衡力外，所有A型和B型肉毒杆菌毒素治疗在治疗CD方面均比安慰剂有效。基于该MTC分析，注射后第4周时，Dysport、Botox、Xeomin和Myobloc之间无显著疗效差异。在所测量的不良事件中，治疗组或安慰剂组的吞咽困难和注射部位疼痛均无显著增加。
