Dashtipour Khashayar, Chen Jack J, Walker Heather W, Lee Michael Y
From the School of Medicine, Loma Linda University, Loma Linda, CA (KD, JJC); College of Pharmacy, Marshall B. Ketchum University, Fullerton, CA (JJC); and Department of Physical Medicine and Rehabilitation, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC (HWW, MYL).
Medicine (Baltimore). 2016 Jan;95(2):e2468. doi: 10.1097/MD.0000000000002468.
To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity.A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity.Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower limb spasticity, depending on the muscles injected. All studies in lower limb spasticity showed statistically significant reduction in muscle tone based on Modified Ashworth Scale of ABO versus placebo. 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. Treatment-related adverse events included but not limited to fatigue, local pain at injection site, hypertonia, dry mouth, weakness of the noninjected muscle, abnormal gait, and urinary tract infection.These data from 6 randomized clinical studies provide the beginnings of an evidence base for the use of ABO to reduce lower limb spasticity. Ongoing studies in this area will add to this evidence base.
为阐明阿柏他毒素A（ABO）治疗成年下肢痉挛患者的临床试验疗效、安全性和给药方法。进行了一项系统文献综述，以确定ABO治疗成年下肢痉挛的随机对照试验。在检索到的295篇记录中，6篇主要出版物评估了ABO用于治疗各种病因的下肢痉挛，并进行了评价。根据注射的肌肉不同，下肢痉挛的ABO总剂量在500至2000单位之间。所有下肢痉挛研究均显示，基于改良Ashworth量表，ABO与安慰剂相比，肌张力有统计学意义的降低。尽管对主动运动和疼痛的显著影响不太一致，但仍得到了证实。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。与治疗相关的不良事件包括但不限于疲劳、注射部位局部疼痛、肌张力亢进、口干、未注射肌肉无力、异常步态和尿路感染。这6项随机临床研究的数据为使用ABO减轻下肢痉挛提供了初步的证据基础。该领域正在进行的研究将补充这一证据基础。
