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一个随机,双盲,主动控制,多中心,第3期研究,评估Liztox®与Botox®在中风后上肢性的有效性和安全性

Dong Hyun Ye¹, Min Ho Chun¹, Yoon Ghil Park²

¹Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Republic of Korea.

|December 22, 2023

概括

利兹托克斯 (Liztox®) 注射是一种安全有效的治疗中风后上肢性,在第三阶段临床试验中证明对毒素A (Botox®) 的不劣.

科学领域:

神经学神经学
康复医学康复医学康复医学
临床药理学临床药理学

背景情况:

上肢是中风后的一个常见并发症.
毒素A型 (BTX-A) 注射是中风后的标准治疗方法.
评估新的BTX-A配方对于扩大治疗选择至关重要.

研究的目的:

评估Liztox®的安全性和有效性,而不是在治疗中风后上肢性方面使用的上abotulinum毒素A (Botox®).
为了确定Liztox®与已确定的Botox®治疗的非劣势.

主要方法:

一个随机的,活性药物控制的,双盲的,多中心的,第三阶段临床试验.
参与的患者有中风后的上肢性.
主要终点:第4周手腕 flexor 肌肉度的变化 (修改的阿什沃思尺度 - MAS).

主要成果:

在第4周,Liztox®在减少手腕曲器动性方面表现为与Botox®无劣 (MAS变化:-1.14对-1.22).
在所有时间点中,在二次结果 (MAS,DAS,SGA,IGA,CBS) 中没有观察到群体之间的显著差异.
在研究期间,没有报告Liztox®的安全问题.

结论:

利兹托克斯 (Liztox®) 是一种安全有效的治疗方案,用于治疗中风幸存者的上肢性.
利兹托克斯 (Liztox®) 的疗效与甲基毒素A的疗效相当,提供了可行的替代治疗方法.
这项研究支持Liztox®在临床实践中用于中风后性管理的使用.

关键词:

肉毒毒素是一种毒素.性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性等.一次性中风中风中风中风中风在上肢的上端.

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