Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial.
Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial.
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DOI：
10.1161/strokeaha.115.012455
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发表时间：
2016-06
期刊：
影响因子：
8.3
通讯作者：
Swallowing Treatment Using Pharyngeal Electrical Stimulation (STEPS) Trial Investigators
中科院分区：
文献类型：
--
作者：
Bath PM;Scutt P;Love J;Clavé P;Cohen D;Dziewas R;Iversen HK;Ledl C;Ragab S;Soda H;Warusevitane A;Woisard V;Hamdy S;Swallowing Treatment Using Pharyngeal Electrical Stimulation (STEPS) Trial Investigators
补充数字内容可在文本中找到。卒中后吞咽困难很常见，与死亡和依赖性增加相关，治疗选择有限。咽部电刺激（PES）是一种治疗卒中后吞咽困难的新方法，已在3项初步随机对照试验中显示出前景。我们将162例近期发生缺血性或出血性卒中和吞咽困难的患者（定义为视频荧光透视下穿刺抽吸评分（PAS）≥3分）随机分配至PES组或假治疗组，连续3天给药。主要结果是吞咽安全性，使用PAS评估，在2周。次要结局包括吞咽困难的严重程度、功能、生活质量和6周和12周时的严重不良事件。在随机化患者中，平均年龄为74岁，男性58%，缺血性卒中89%，PAS 4.8。每次治疗的平均治疗电流为14.8（7.9）mA，持续时间为9.9（1.2）分钟。根据既往数据，45例（58.4%）随机接受PES的患者似乎接受了次优刺激。经基线校正的2周PAS在随机化组之间无差异：PES组3.7（2.0）与假手术组3.6（1.9），P=0.60。同样，次要结局也没有差异，包括临床吞咽和功能结局。未发生器械相关严重不良事件。在亚急性卒中和吞咽困难患者中，PES是安全的，但不能改善吞咽困难。接受PES的患者治疗不足可能导致中性结果。网址：http://www.controlled-trials.com。唯一标识符：ISRCTN25681641。
Supplemental Digital Content is available in the text. Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641.