Bath Philip M, Woodhouse Lisa J, Suntrup-Krueger Sonja, Likar Rudolf, Koestenberger Markus, Warusevitane Anushka, Herzog Juergen, Schuttler Michael, Ragab Suzanne, Everton Lisa, Ledl Christian, Walther Ernst, Saltuari Leopold, Pucks-Faes Elke, Bocksrucker Christof, Vosko Milan, de Broux Johanna, Haase Claus G, Raginis-Zborowska Alicja, Mistry Satish, Hamdy Shaheen, Dziewas Rainer
Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham NG5 1PB, United Kingdom.
Stroke, Nottingham University Hospital NHS Trust, Nottingham NG5 1PB, United Kingdom.
EClinicalMedicine. 2020 Nov 10;28:100608. doi: 10.1016/j.eclinm.2020.100608. eCollection 2020 Nov.
Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia.
The PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia European Registry (PHADER) was a prospective single-arm observational cohort study. Participants were recruited with neurogenic dysphagia (comprising five groups - stroke not needing ventilation; stroke needing ventilation; ventilation acquired; traumatic brain injury; other neurological causes). PES was administered once daily for three days. The primary outcome was the validated dysphagia severity rating scale (DSRS, score best-worst 0-12) at 3 months.
Of 255 enrolled patients from 14 centres in Austria, Germany and UK, 10 failed screening. At baseline, mean (standard deviation) or median [interquartile range]: age 68 (14) years, male 71%, DSRS 11·4 (1·7), time from onset to treatment 32 [44] days; age, time and DSRS differed between diagnostic groups. Insertion of PES catheters was successfully inserted in 239/245 (98%) participants, and was typically easy taking 11·8 min. 9 participants withdrew before the end of treatment. DSRS improved significantly in all dysphagia groups, difference in means (95% confidence intervals, CI) from 0 to 3 months: stroke ( = 79) -6·7 (-7·8, -5·5), ventilated stroke ( = 98) -6·5 (-7·6, -5·5); ventilation acquired ( = 35) -6·6 (-8·4, -4·8); traumatic brain injury ( = 24) -4·5 (-6·6, -2·4). The results for DSRS were mirrored for instrumentally assessed penetration aspiration scale scores. DSRS improved in both supratentorial and infratentorial stroke, with no difference between them ( = 0·32). In previously ventilated participants with tracheotomy, DSRS improved more in participants who could be decannulated ( = 66) -7·5 (-8·6, -6·5) versus not decannulated ( = 33) -2·1 (-3·2, -1·0) (<0·001). 74 serious adverse events (SAE) occurred in 60 participants with pneumonia (9·2%) the most frequent SAE.
In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration.
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神经源性吞咽困难很常见且尚无确切治疗方法。我们评估了咽部电刺激（PES）是否与吞咽困难减轻相关。
欧洲咽部电刺激治疗神经源性吞咽困难注册研究（PHADER）是一项前瞻性单臂观察性队列研究。招募患有神经源性吞咽困难的参与者（包括五组——无需通气的中风；需要通气的中风；通气相关性；创伤性脑损伤；其他神经原因）。PES每天给药一次，共三天。主要结局是3个月时经过验证的吞咽困难严重程度评定量表（DSRS，评分范围最佳-最差为0-12）。
在来自奥地利、德国和英国14个中心的255名登记患者中，10名未通过筛查。基线时，平均（标准差）或中位数[四分位间距]：年龄68（14）岁，男性占71%，DSRS为11.4（1.7），从发病到治疗的时间为32[44]天；不同诊断组之间的年龄、时间和DSRS有所不同。239/245（98%）的参与者成功插入了PES导管，插入过程通常很容易，耗时11.8分钟。9名参与者在治疗结束前退出。所有吞咽困难组的DSRS均显著改善，从0至3个月的均值差异（95%置信区间，CI）：中风（n=79）-6.7（-7.8，-5.5）；通气性中风（n=98）-6.5（-7.6，-5.5）；通气相关性（n=35）-6.6（-8.4，-4.8）；创伤性脑损伤（n=24）-4.5（-6.6，-2.4）。仪器评估的渗透误吸量表评分的结果与DSRS结果一致。幕上和幕下中风患者的DSRS均有改善，两者之间无差异（P=0.32）。在先前进行气管切开的通气参与者中，能够拔管的参与者（n=66）的DSRS改善更大，为-7.5（-8.6，-6.5），而未拔管者（n=33）为-2.1（-3.2，-1.0）（P<0.001）。60名参与者发生了74起严重不良事件（SAE），其中肺炎最为常见（9.2%）。
在神经源性吞咽困难患者中，PES是安全的，且与吞咽困难及渗透/误吸指标的减轻相关。
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