Bath Philip M, Scutt Polly, Love Jo, Clavé Pere, Cohen David, Dziewas Rainer, Iversen Helle K, Ledl Christian, Ragab Suzanne, Soda Hassan, Warusevitane Anushka, Woisard Virginie, Hamdy Shaheen
From the Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, United Kingdom (P.M.B., P.S.); Phagenesis, Ltd, Manchester Science Park, United Kingdom (J.L.); Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (Ciberehd), Hospital de Mataró, Universitat Autònoma de Mataró, Spain (P.C.); Stroke Service, Northwick Park Hospital, London, United Kingdom (D.C.); Department of Neurology, University Hospital Münster, Germany (R.D.); Department of Neurology, Glostrup Hospital and University of Copenhagen, Denmark (H.K.I.); Schoen Klinik Bad Aibling, Bad Aibling, Germany (C.L.); Stroke Service, Poole Hospital, Poole, United Kingdom (S.R.); Neurology Clinic, Bad Neustadt, Germany (H.S.); Acute Stroke Unit, University Hospitals of North Midlands, Stoke-on-Trent, United Kingdom (A.W.); Unité de la voix et de la deglutition, Service ORL CHU de Toulouse, Octogone Lordat Université Toulouse Mirail, France (V.W.); and Centre for Gastrointestinal Sciences, University of Manchester, United Kingdom (S.H.).
Stroke. 2016 Jun;47(6):1562-70. doi: 10.1161/STROKEAHA.115.012455. Epub 2016 May 10.
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.
吞咽困难在卒中后很常见，与死亡率和依赖程度增加相关，且治疗选择有限。咽部电刺激（PES）是一种针对卒中后吞咽困难的新型治疗方法，已在3项试验性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且存在吞咽困难（定义为电视透视吞咽功能检查的渗透误吸评分（PAS）≥3）的患者，随机分为接受连续3天的PES治疗组或假治疗组。主要结局是在2周时使用PAS评估的吞咽安全性。次要结局包括6周和12周时的吞咽困难严重程度、功能、生活质量以及严重不良事件。
随机分组的患者中，平均年龄为74岁，男性占58%，缺血性卒中占89%，PAS为4.8。平均治疗电流为14.8（7.9）mA，每次治疗持续时间为9.9（1.2）分钟。根据既往数据，随机分配至PES组的45例患者（58.4%）似乎接受了次优刺激。经基线校正后，2周时随机分组的两组间PAS无差异：PES组为3.7（2.0），假治疗组为3.6（1.9），P = 0.60。同样，次要结局也无差异，包括临床吞咽和功能结局。未发生严重的与器械相关的不良事件。
在亚急性卒中和吞咽困难患者中，PES是安全的，但并未改善吞咽困难。接受PES治疗的患者治疗不足可能导致了这一中性结果。
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