Lew M F, Adornato B T, Duane D D, Dykstra D D, Factor S A, Massey J M, Brin M F, Jankovic J, Rodnitzky R L, Singer C, Swenson M R, Tarsy D, Murray J J, Koller M, Wallace J D
University of Southern California, Los Angeles 90033-4606, USA.
Neurology. 1997 Sep;49(3):701-7. doi: 10.1212/wnl.49.3.701.
We enrolled and treated 122 patients with idiopathic cervical dystonia in a double-blind, placebo-controlled safety and efficacy study of botulinum toxin type B (BotB). Both A-responsive and A-resistant patients were enrolled. Patients received intramuscular injections of either BotB (2,500 U, 5,000 U, or 10,000 U) or placebo. The primary outcome measure of efficacy was the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score at 4 weeks following study drug administration. Secondary measures of efficacy were TWSTRS-Severity, -Disability, and -Pain subscale scores, and Analog Pain Assessment, Investigator Global Assessment, Patient Global Assessment, and Sickness Impact Profile scores. Duration of effect was estimated with an intent-to-treat analysis of responders. Safety measures included clinical parameters, laboratory tests, and adverse events. The primary and most of the secondary analyses indicated a statistically significant treatment effect and a dose response. BotB is safe, well tolerated, and efficacious in the treatment of cervical dystonia at the doses tested.
在一项关于B型肉毒毒素（BotB）的双盲、安慰剂对照安全性和有效性研究中，我们纳入并治疗了122例特发性颈部肌张力障碍患者。A反应性和A抵抗性患者均被纳入。患者接受了BotB（2500 U、5000 U或10000 U）或安慰剂的肌肉注射。疗效的主要结局指标是研究药物给药后4周时的多伦多西部痉挛性斜颈评定量表（TWSTRS）总分。疗效的次要指标是TWSTRS严重程度、功能障碍和疼痛分量表评分，以及模拟疼痛评估、研究者整体评估、患者整体评估和疾病影响概况评分。通过对有反应者的意向性分析来估计疗效持续时间。安全指标包括临床参数、实验室检查和不良事件。主要分析和大多数次要分析均表明存在统计学上显著的治疗效果和剂量反应。在所测试的剂量下，BotB在治疗颈部肌张力障碍方面是安全、耐受性良好且有效的。
