Baricich Alessio, Grana Elisa, Carda Stefano, Santamato Andrea, Molinari Claudio, Cisari Carlo, Invernizzi Marco
Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont "A. Avogadro", Novara, Italy; Department of Physical Medicine and Rehabilitation, University Hospital «Maggiore della Carità», V.le Piazza d'Armi 1, 28100, Novara, Italy.
Neuropsychology and Neurorehabilitation Service, Department of Clinical Neuroscience, Lausanne University Hospital (CHUV), Av. Pierre-Decker 5, 1011, Lausanne, Switzerland.
Toxicon. 2017 Nov;138:145-150. doi: 10.1016/j.toxicon.2017.08.027. Epub 2017 Sep 4.
Botulinum toxin type A is a valid and safe treatment for focal spasticity, with documented effects on both sympathetic and parasympathetic systems. Heart rate variability can provide detailed information about the control of the autonomic nervous system on cardiovascular activities. Previous studies in literature showed no significant changes in Heart Rate Variability with doses >600 U of incobotulinumtoxinA in chronic post stroke spastic patients; however, at present time, these results have not been confirmed with doses >600 U of onabotulinumtoxinA.
To evaluate changes in Heart Rate Variability induced by high doses (>600 U) of incobotulinumtoxinA or onabotulinumtoxinA in spastic stroke patients over a 1-year period.
single blind randomized controlled crossover study design.
Rehabilitation Unit of the University Hospital in Novara.
10 stroke survivors with spastic hemiplegia (Modified Ashworth Scale ≥ 2) were recruited and randomly divided in two groups (A and B).
In the first part of the study, patients in Group A were injected with incobotulinumtoxinA while patients in Group B with onabotulinumtoxinA; after 6 months, a crossover intervention was performed. All patients were blinded to Botulinum toxin type A type, and performed an ECG registration in the 24 h before injection (t0) and 10 days after treatment (t1), both in the first and in the second part of the study. Functional status was evaluated with Barthel Index, Motricity Index and Functional Ambulation Category scores.
Heart Rate Variability analysis showed no significant changes after each Botulinum toxin type A injection in both groups at any evaluation time. Moreover, no statistically significant differences were found regarding each variable between the two groups.
Our data show that high doses (>600 U) of incobotulinumtoxinA and onabotulinumtoxinA do not influence the cardiovascular activity of the autonomic nervous system in chronic hemiplegic spastic stroke survivors.
A型肉毒毒素是治疗局灶性痉挛的一种有效且安全的方法，已证明其对交感神经系统和副交感神经系统均有作用。心率变异性能够提供有关自主神经系统对心血管活动控制的详细信息。既往文献研究表明，在慢性卒中后痉挛患者中，使用剂量大于600 U的因卡波糖毒素A时心率变异性无显著变化；然而，目前尚未用剂量大于600 U的昂丹司琼毒素A证实这些结果。
评估高剂量（>600 U）的因卡波糖毒素A或昂丹司琼毒素A在1年时间内对痉挛性卒中患者心率变异性的影响。
单盲随机对照交叉研究设计。
诺瓦拉大学医院康复科。
招募10例痉挛性偏瘫（改良Ashworth量表≥2级）的卒中幸存者，并随机分为两组（A组和B组）。
在研究的第一部分，A组患者注射因卡波糖毒素A，B组患者注射昂丹司琼毒素A；6个月后进行交叉干预。所有患者对A型肉毒毒素类型不知情，并在研究的第一部分和第二部分中，于注射前24小时（t0）和治疗后10天（t1）进行心电图记录。用Barthel指数、运动指数和功能步行分类评分评估功能状态。
心率变异性分析显示，在任何评估时间，两组每次注射A型肉毒毒素后均无显著变化。此外，两组之间在各变量上未发现统计学显著差异。
我们的数据表明，高剂量（>600 U）的因卡波糖毒素A和昂丹司琼毒素A不会影响慢性偏瘫痉挛性卒中幸存者自主神经系统的心血管活动。
