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在治疗眼睑痉挛中,用 Xeomin 的临床疗效和耐受性。

Clinical efficacy and tolerability of Xeomin in the treatment of blepharospasm.

机构信息

Department of Neurology, Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine, Houston, TX 77030, USA.

出版信息

Eur J Neurol. 2009 Dec;16 Suppl 2:14-8. doi: 10.1111/j.1468-1331.2009.02880.x.

DOI:10.1111/j.1468-1331.2009.02880.x
PMID:20002742
Abstract

BACKGROUND AND PURPOSE

Blepharospasm is classified as a focal dystonia, and botulinum toxin type A (BoNT/A) has been shown to be a highly effective and well-tolerated symptomatic treatment. Xeomin, the latest addition to BoNT/A preparations, is a purified, freeze-dried BoNT/A that is free from complexing proteins.

METHODS AND RESULTS

In a double-blind, parallel-group, multicentre study, 300 patients with blepharospasm received either Xeomin or Botox 15-80 U (J Neural Transm 2006; 113: 303). Both treatments produced statistically significant improvements from baseline in the Jankovic Rating Scale at week 3 (primary efficacy variable; Xeomin: -2.90; Botox: -2.67; P < 0.0001 from baseline for both), with the difference between treatments (-0.23) indicating that Xeomin was clinically non-inferior to Botox. No significant differences were found between Xeomin and Botox for all secondary variables. There were no clinically relevant differences between Xeomin and Botox in safety parameters, with 40 of 148 patients (27.0%) treated with Xeomin reporting adverse events versus 45 of 155 patients (29.0%) treated with Botox. The most common adverse event was ptosis (6.1% Xeomin and 4.5% Botox).

CONCLUSION

Clinical evidence to date suggests that Xeomin is an effective treatment for blepharospasm that does not differ from Botox in terms of its potency, duration of effect or adverse reaction profile.

摘要

背景与目的

眼睑痉挛被归类为局灶性肌张力障碍,肉毒毒素 A 型(BoNT/A)已被证明是一种高度有效且耐受良好的对症治疗方法。Xeomin 是 BoNT/A 制剂的最新成员,是一种不含复合同种型蛋白的纯化、冻干型 BoNT/A。

方法与结果

在一项双盲、平行分组、多中心研究中,300 例眼睑痉挛患者接受了 Xeomin 或 Botox 15-80U 治疗(J Neural Transm 2006;113:303)。两种治疗均在第 3 周(主要疗效变量;Xeomin:-2.90;Botox:-2.67;P<0.0001)从基线开始产生了统计学上显著的改善,治疗之间的差异(-0.23)表明 Xeomin 在临床上与 Botox 等效。在所有次要变量中,Xeomin 与 Botox 之间没有发现显著差异。Xeomin 和 Botox 在安全性参数方面没有临床相关差异,148 例接受 Xeomin 治疗的患者中有 40 例(27.0%)报告了不良事件,而 155 例接受 Botox 治疗的患者中有 45 例(29.0%)报告了不良事件。最常见的不良事件是上睑下垂(6.1%Xeomin 和 4.5%Botox)。

结论

迄今为止的临床证据表明,Xeomin 是一种有效的眼睑痉挛治疗方法,其疗效、作用持续时间或不良反应谱与 Botox 无差异。

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