B型肉毒杆菌毒素(BotB):对A型肉毒杆菌毒素抵抗性颈部肌张力障碍患者安全性和耐受性的评估(初步研究)

BotB (botulinum toxin type B): evaluation of safety and tolerability in botulinum toxin type A-resistant cervical dystonia patients (preliminary study).

作者信息

Truong D D, Cullis P A, O'Brien C F, Koller M, Villegas T P, Wallace J D

机构信息

Parkinson and Movement Disorders Program, Irvine, California, USA.

出版信息

Mov Disord. 1997 Sep;12(5):772-5. doi: 10.1002/mds.870120526.

Abstract

Botulinum toxin (BTX) injection is considered the treatment of choice for patients with cervical dystonia (torticollis). We conducted a pilot, open-label, dose-escalation study with BTX type B in 12 patients who no longer responded clinically to injections with BTX type A. At the doses tested, BTX type B was safe and well tolerated without evidence of dose-limiting toxicity in this patient population. Mild-to-moderate adverse events generally resolved quickly and included asthenia, pain, nausea, dysphagia, hypertonia, and tremor. No serious adverse events or antibodies to type-B treatment were reported. Low-dosing-session (100-899 units) and high-dosing-session (900-1,500 units) groups were defined based on units administered per dosing session. Toronto Western Spasmodic Torticollis Rating Scale-Severity Scale (TWSTRS-Severity), Patient Analogue Pain Scale, and Physician and Patient Global Assessment Scales were measured during this study. The TWSTRS-Severity mean maximum percent improvement from baseline demonstrated a 9.9% versus 28.8% difference between the low-dose and high-dose groups, respectively. EFfectiveness was noted for the high-dose group on the Patient Analogue Pain Scale but not on the Global Assessment Scales.

摘要

肉毒杆菌毒素(BTX)注射被认为是颈部肌张力障碍(斜颈)患者的首选治疗方法。我们对12例对A型肉毒杆菌毒素注射不再有临床反应的患者进行了一项使用B型肉毒杆菌毒素的开放性剂量递增试验研究。在所测试的剂量下,B型肉毒杆菌毒素是安全的,且耐受性良好,在该患者群体中没有剂量限制性毒性的证据。轻度至中度不良事件通常很快得到缓解,包括乏力、疼痛、恶心、吞咽困难、张力亢进和震颤。未报告严重不良事件或针对B型治疗的抗体。低剂量疗程(100 - 899单位)和高剂量疗程(900 - 1500单位)组是根据每次给药疗程所给予的单位来定义的。在本研究期间测量了多伦多西部痉挛性斜颈评定量表 - 严重程度量表(TWSTRS - 严重程度)、患者模拟疼痛量表以及医生和患者整体评估量表。TWSTRS - 严重程度从基线的平均最大改善百分比显示,低剂量组和高剂量组之间分别为9.9%和28.8%的差异。高剂量组在患者模拟疼痛量表上显示出有效性,但在整体评估量表上未显示。

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