Dashtipour Khashayar, Chen Jack J, Walker Heather W, Lee Michael Y
From the Department of Neurology, Loma Linda University School of Medicine, Loma Linda, California (KD, JJC); Loma Linda University, Schools of Pharmacy, Loma Linda, California (KD, JJC); and the Department of Physical Medicine and Rehabilitation, School of Medicine, the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina (HWW, MYL).
Am J Phys Med Rehabil. 2015 Mar;94(3):229-38. doi: 10.1097/PHM.0000000000000208.
The aim of this study was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with upper limb spasticity (ULS).
A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of adult ULS published in English between January 1991 and January 2013. Medical literature databases (PubMed, Cochrane Library, and EMBASE) were searched, and a total of 295 records were identified. Of these, 12 primary publications that evaluated ABO for the management of ULS were included in the final data report.
Total ABO doses ranged between 500 and 1500 U for ULS. Most of the studies in ULS showed statistically significant benefits (reduction in muscle tone based on Ashworth score) of ABO vs. placebo. Statistical significance was reached for most evaluations of spasticity using the Modified Ashworth Scale. Statistically significant effects on active movement and pain were demonstrated, albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Adverse events considered associated with ABO treatment included fatigue, tiredness, arm pain, skin rashes, flu-like symptoms, worsening of spasm, and weakness.
On the basis of data extracted from 12 randomized clinical studies, a strong evidence base (9/12 studies) exists for the use of ABO to reduce ULS caused by stroke.
本研究旨在阐明阿柏他肉毒毒素A（ABO）治疗成年上肢痉挛（ULS）患者的临床试验疗效、安全性及给药方法。
进行一项系统性文献综述，以识别1991年1月至2013年1月期间以英文发表的关于ABO治疗成年ULS的随机对照试验及其他比较性临床研究。检索医学文献数据库（PubMed、Cochrane图书馆和EMBASE），共识别出295条记录。其中，12篇评估ABO治疗ULS的主要出版物纳入最终数据报告。
治疗ULS时，ABO的总剂量在500至1500单位之间。大多数关于ULS的研究显示，与安慰剂相比，ABO在统计学上具有显著疗效（基于Ashworth评分的肌张力降低）。使用改良Ashworth量表对痉挛进行的大多数评估均达到统计学显著性。对主动运动和疼痛有统计学显著影响，尽管不太一致。在各个研究中，ABO总体耐受性良好；报告的大多数不良事件被认为与治疗无关。被认为与ABO治疗相关的不良事件包括疲劳、疲倦、手臂疼痛、皮疹、流感样症状、痉挛加重和虚弱。
基于从12项随机临床研究中提取的数据，有充分的证据基础（9/12项研究）支持使用ABO减轻中风引起的ULS。
