Division of Physical Medicine and Rehabilitation, Deparment of Surgery, University of Ioannina Medical School, 45110, Ioannina, Greece.
Medical Statistics, Epirus Science and Technology Park Campus of the University of Ioannina, Ioannina, 45110, Greece.
Toxicon. 2021 Nov;203:74-84. doi: 10.1016/j.toxicon.2021.09.020. Epub 2021 Oct 7.
The aim of the study is to evaluate the evidence supporting the efficacy of botulinum toxin type A (BTA) injections in lower limb of hemiplegic patients, after stroke or cerebrovascular accident, and their gait analysis. This study included: randomized controlled trials (RCTs), non-randomized or controlled clinical trials (CCTs) or cluster trials, clinical trials of various phases (I-III), interrupted time series (ITS) studies with at least three data points before and after the intervention, controlled before and after (CBA) studies, prospective and retrospective comparative cohort studies, case-control and multicentred studies. The patients included in these studies had similar characteristics: age over 18 years, history of stroke and following hemiplegia, minimum modified Ashworth scale (MAS) score of 2 and duration since stroke over 6 months. The number of studies included in this review was 21. A meta-analysis was performed on a fraction of them depending on the reported index and the methodology as reported in detail in the results section. MAS score, following BTA injections, was significantly improved (Hedges' g: -1.17; 95% CI: -1.66, 0.67; p < 0.001). The same applied for the 10 Meter Walk Test (MWT) (-0.35; 95% CI: -0.68, -0.02; p = 0.016). The gait velocity showed improvement, yet without statistical significance (0.27; 95% CI: -0.09, 0.63; p = 0.285). We concluded that botulinum toxin injections showed effectiveness on lower limb hypertonia reduction of hemiplegic patients after stroke. Apart from significantly reducing the MAS scores, 10 MWT was also improved. However, more research is required in order to determine the advancement in specific gait and posture parameters.
本研究旨在评估肉毒杆菌毒素 A（BTA）注射治疗中风或脑血管意外后偏瘫患者下肢的疗效及其步态分析的证据。本研究包括：随机对照试验（RCT）、非随机或对照临床试验（CCT）或聚类试验、各阶段（I-III）临床试验、干预前后至少有三个数据点的中断时间序列（ITS）研究、干预前后对照（CBA）研究、前瞻性和回顾性比较队列研究、病例对照和多中心研究。这些研究纳入的患者具有相似的特征：年龄大于 18 岁，有中风病史和偏瘫，改良 Ashworth 量表（MAS）评分至少为 2 分，中风后时间超过 6 个月。本综述纳入了 21 项研究。根据报告的指标和方法学，对其中一部分进行了荟萃分析，详见结果部分。BTA 注射后 MAS 评分显著改善（Hedges' g：-1.17；95%CI：-1.66，0.67；p<0.001）。10 米步行测试（MWT）也同样如此（-0.35；95%CI：-0.68，-0.02；p=0.016）。步态速度有所改善，但无统计学意义（0.27；95%CI：-0.09，0.63；p=0.285）。我们得出结论，肉毒杆菌毒素注射可有效降低中风后偏瘫患者下肢的肌张力。除了显著降低 MAS 评分外，10 MWT 也得到了改善。然而，需要进一步的研究来确定在特定步态和姿势参数方面的进展。
