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尼麦角林治疗神经肌肉性口咽吞咽困难:一项双盲、安慰剂对照随机试验

Nicergoline for Neuromuscular Oropharyngeal Dysphagia: A Double-Blind, Placebo-Controlled Randomized Trial.

临床研究咽喉科IF 3.1Q1

文献信息

中文摘要

神经肌肉性口咽吞咽困难损害吞咽的神经和肌肉协调机制,使患者易发生吸入性肺炎、营养不良和生活质量下降。P物质参与吞咽反射;尼麦角林是一种麦角衍生物,可增加P物质浓度,但其对吞咽困难的治疗效果仍不确定。我们开展了一项双盲、随机、安慰剂对照试验,以确定尼麦角林是否改善吞咽功能,并通过视觉模拟量表和柔性内镜吞咽评估进行量化。44例神经肌肉性口咽吞咽困难患者被随机分配接受尼麦角林30 mg/日(n=21)或匹配安慰剂(n=23),为期4周。比较基线和第4周时视觉模拟量表评分、柔性内镜吞咽评估评分和渗透-误吸量表评级,进行组内和组间比较。38名参与者完成了研究(尼麦角林n=19;安慰剂n=19)。视觉模拟量表和柔性内镜吞咽评估评分的变化在组间无显著差异。然而,尼麦角林使渗透-误吸量表评分出现统计学显著降低,表明吞咽时气道保护增强。这些数据提示,尼麦角林可增强神经肌肉性口咽吞咽困难的吞咽安全性,并可能为其管理提供一种治疗选择。

英文摘要

Neuromuscular oropharyngeal dysphagia impairs the coordinated neurologic and muscular mechanisms of deglutition, predisposing patients to aspiration pneumonia, malnutrition, and diminished quality of life. Substance P participates in the swallow reflex; nicergoline, an ergot derivative, increases substance P concentrations, yet its therapeutic effect on dysphagia remains uncertain. We conducted a double-blind, randomized, placebo-controlled trial to determine whether nicergoline improves swallow function, quantified by the visual analog scale and flexible endoscopic evaluation of swallowing. Forty-four patients with neuromuscular oropharyngeal dysphagia were randomized to receive nicergoline 30 mg daily (n = 21) or matched placebo (n = 23) for 4 weeks. Baseline and week-4 visual analog scale scores, flexible endoscopic evaluation of swallowing scores, and penetration-aspiration scale ratings were compared within and between groups. Thirty-eight participants completed the study (nicergoline n = 19; placebo n = 19). Changes in visual analog scale and flexible endoscopic evaluation scores did not differ significantly between groups. However, nicergoline produced a statistically significant reduction in penetration-aspiration scale score, indicating enhanced airway protection during swallowing. These data suggest that nicergoline augments swallow safety in neuromuscular oropharyngeal dysphagia and may offer a therapeutic option for its management.