University of Arizona College of Pharmacy, Tucson, Arizona 85721-0202, USA.
Clin Ther. 2010 Dec;32(14):2282-303. doi: 10.1016/j.clinthera.2011.01.005.
Muscle spasticity after stroke may be painful and severe and may restrict the patient's ability to perform routine daily tasks, particularly when the affected muscles are in the upper limbs. Treatments targeted at reducing this spasticity have evolved over time.
This was a systematic review of recent studies focusing on contemporary pharmacologic therapies for upper limb spasticity after stroke.
MEDLINE, EMBASE, and the Cochrane Controlled Trials Register were searched for clinical trials published in English from January 1995 to July 2010 using search terms that included spasticity, stroke, hemiplegia, phenol, baclofen, tizanidine, dantrolene, benzodiazepine, and botulinum toxin. The level of evidence of the identified publications was assessed using the Oxford Centre for Evidence-Based Medicine criteria.
A total of 113 potentially relevant articles were identified by the search; of these, 54 studies were included in the review (23 randomized controlled trials [RCTs] and 31 open-label, nonrandomized, or observational studies). Of these, 51 involved treatment with botulinum toxin (BTX). All studies assessed spasticity; some also assessed additional outcomes, such as pain, disability, and functional status. Thirty-eight clinical trials reported a significant reduction in spasticity with BTX, either compared with baseline or with placebo (P < 0.05). A head-to-head comparison found a significant reduction in spasticity with BTX injections compared with oral tizanidine (TZD) (P < 0.001). Two studies of intrathecal baclofen (ITB) reported significant reductions in upper limb spasticity after 12 months of treatment, and 1 study of tizanidine reported significant reductions in upper limb spasticity after 16 weeks of treatment (all, P < 0.001). General or local weakness, injection-site pain, and fatigue were the most frequently reported adverse events with BTX type A, and dry mouth was the most frequently reported adverse event with BTX type B. No serious or life-threatening adverse events were reported in any trial of BTX.
The 54 studies included in this systematic review of treatments for upper limb spasticity after stroke measured multiple outcomes using a variety of instruments. Fifty-one studies focused on treatment with a BTX formulation. BTX appeared to be an effective and well-tolerated focal treatment for reducing tonicity in patients with upper limb spasticity after stroke, supporting current guideline recommendations.
中风后肌肉痉挛可能会引起疼痛且较为严重，并可能限制患者进行日常活动的能力，尤其是当受影响的肌肉在上肢时。随着时间的推移，针对这种痉挛的治疗方法也在不断发展。
这是一项对近期研究的系统性回顾，重点关注中风后上肢痉挛的当代药物治疗方法。
使用包括痉挛、中风、偏瘫、苯酚、巴氯芬、替扎尼定、丹曲林、苯二氮䓬类药物和肉毒毒素在内的检索词，检索了 1995 年 1 月至 2010 年 7 月间在英文期刊上发表的临床试验，检索数据库包括 MEDLINE、EMBASE 和 Cochrane 对照试验注册库。根据牛津循证医学中心的标准评估所确定出版物的证据水平。
通过检索共确定了 113 篇可能相关的文章，其中 54 项研究纳入了综述（23 项随机对照试验[RCT]和 31 项开放标签、非随机或观察性研究）。其中 51 项研究涉及肉毒毒素（BTX）的治疗。所有研究均评估了痉挛，部分研究还评估了疼痛、残疾和功能状态等其他结局。38 项临床试验报告 BTX 治疗可显著降低痉挛，无论是与基线相比还是与安慰剂相比（P < 0.05）。一项头对头比较发现，BTX 注射治疗与口服替扎尼定（TZD）相比，痉挛显著减轻（P < 0.001）。2 项鞘内巴氯芬（ITB）治疗的研究报告上肢痉挛在 12 个月的治疗后显著减轻，1 项替扎尼定的研究报告上肢痉挛在 16 周的治疗后显著减轻（均 P < 0.001）。A型 BTX 最常报告的不良反应是全身性或局部无力、注射部位疼痛和疲劳，B 型 BTX 最常报告的不良反应是口干。任何 BTX 试验均未报告严重或危及生命的不良事件。
这项对中风后上肢痉挛治疗方法的系统性综述纳入了 54 项研究，这些研究使用了多种工具测量了多种结局。51 项研究侧重于 BTX 制剂的治疗。BTX 似乎是一种有效且耐受性良好的局灶性治疗方法，可降低中风后上肢痉挛患者的紧张度，这与当前的指南建议一致。
