Department of Rehabilitation Medicine, Weill Cornell Medicine, Baker Pavilion, Box #142, 525 East 68th Street, New York, NY 10065.
Wake Forest Baptist Medical Center, Department of Neurology, Winston-Salem, NC.
PM R. 2018 Jan;10(1):1-10. doi: 10.1016/j.pmrj.2017.06.008. Epub 2017 Jun 19.
AbobotulinumtoxinA has beneficial effects on spasticity and active movements in hemiparetic adults with upper limb spasticity (ULS). However, evidence-based information on optimal dosing for clinical use is limited.
To describe joint-specific dose effects of abobotulinumtoxinA in adults with ULS.
Secondary analysis of a phase 3 study (NCT01313299).
Multicenter, international, double-blind, placebo-controlled clinical trial.
A total of 243 adults with ULS >6 months after stroke or traumatic brain injury, aged 52.8 (13.5) years and 64.3% male, randomized 1:1:1 to receive a single-injection cycle of placebo or abobotulinumtoxinA 500 U or 1000 U (total dose).
The overall effects of injected doses were assessed in the primary analysis, which showed improvement of angles of catch in finger, wrist, and elbow flexors and of active range of motion against these muscle groups. This secondary analysis was performed at each of the possible doses received by finger, wrist, and elbow flexors to establish possible dose effects.
Angle of arrest (X) and angle of catch (X) were assessed with the Tardieu Scale, and active range of motion (X).
At each muscle group level (finger, wrist, and elbow flexors) improvements in all outcome measures assessed (X, X, X) were observed. In each muscle group, increases in abobotulinumtoxinA dose were associated with greater improvements in X and X, suggesting a dose-dependent effect.
Previous clinical trials have established the clinical efficacy of abobotulinumtoxinA by total dose only. The wide range of abobotulinumtoxinA doses per muscle groups used in this study allowed observation of dose-dependent improvements in spasticity and active movement. This information provides a basis for future abobotulinumtoxinA dosing recommendations for health care professionals based on treatment objectives and quantitative assessment of spasticity and active range of motion at individual joints.
I.
阿巴毒素 A 对上肢痉挛的偏瘫成人的痉挛和主动运动具有有益的影响（ULS）。然而，临床应用的最佳剂量的循证信息有限。
描述 ULS 成人阿巴毒素 A 的关节特异性剂量效应。
一项 3 期研究（NCT01313299）的二次分析。
多中心、国际、双盲、安慰剂对照临床试验。
共有 243 名 ULS >6 个月的中风或外伤性脑损伤成人，年龄 52.8（13.5）岁，64.3%为男性，随机分为 1:1:1 接受单剂量注射周期的安慰剂或阿巴毒素 A 500 U 或 1000 U（总剂量）。
在主要分析中评估了注射剂量的总体效果，该分析显示了手指、手腕和肘部屈肌的角度捕获以及这些肌肉群的主动运动范围的改善。这是在每个可能的剂量下进行的二次分析手指、手腕和肘部屈肌，以确定可能的剂量效应。
用 Tardieu 量表评估角度（X）和角度（X），并评估主动运动范围（X）。
在每个肌肉群水平（手指、手腕和肘部屈肌），所有评估的结果测量（X，X，X）均观察到改善。在每个肌肉群中，阿巴毒素 A 剂量的增加与 X 和 X 的改善相关，提示存在剂量依赖性效应。
先前的临床试验仅通过总剂量确立了阿巴毒素 A 的临床疗效。本研究中每个肌肉群使用的阿巴毒素 A 剂量范围广泛，观察到痉挛和主动运动的剂量依赖性改善。这些信息为未来的阿巴毒素 A 剂量推荐提供了依据，为医务人员提供了基于治疗目标和个体关节痉挛和主动运动范围的定量评估的剂量推荐。
一。
