间歇性口食管喂养加速神经源性吞咽困难患者气管造口拔管：一项多中心随机对照试验
Accelerating tracheostomy decannulation with intermittent oro-esophageal feeding in neurogenic dysphagia: a multicenter randomized controlled trial.
文献信息
| PMID | 42968156 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Qing Li |
| 作者单位 | Pulmonary Rehabilitation Center, Beijing Rehabilitation Hospital, Capital Medical University, Xixiazhuang, Badachu, Shijingshan, Beijing, 100144, China. |
| 期刊 | Critical care (London, England) |
| SCI 分区 | Q1 |
| IF | 11 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
背景： 神经源性吞咽困难常是气管造口患者拔管的主要障碍。传统鼻胃管（NGT）喂养可能促进吞咽肌群废用性萎缩并持续存在误吸风险。间歇性口食管管（IOE）喂养是一种模拟自然吞咽的生理导向方式，可能加速拔管，但缺乏高质量证据。
方法： 在这项于中国三家三级学术中心开展的多中心随机对照试验中，伴有神经源性吞咽困难的气管造口成人按1:1随机分配至IOE或NGT。所有参与者均接受标准化药物治疗、肺康复和结构化吞咽训练，并进入采用预设就绪标准的机构拔管方案。主要结局为从进入方案至实际拔管的时间。次要结局包括30天成功拔管率、营养指标、吞咽功能及吞咽相关生活质量。结局评估者和统计人员对分组设盲。分析遵循意向性治疗原则。
结果： 共140例患者随机分配至IOE组（n=70）或NGT组（n=70）。IOE组拔管时间更短（22.16±1.86天 vs. 26.33±1.30天；组间差异4.17天；95%置信区间[CI] 1.90-6.44；p<0.001；log-rank p=0.005）。IOE组30天成功拔管率更高（65.71% vs. 47.14%；绝对差异18.57个百分点；95% CI 2.43-34.71；p=0.028）。1个月时，IOE组在体重指数、血清白蛋白、血清前白蛋白、吞咽功能及吞咽相关生活质量方面改善更明显（均p<0.001）。IOE组咽部不适发生率更低（14.06% vs. 34.21%；p=0.006）；未发生Ⅲ级或以上不良事件。
结论： 在伴有神经源性吞咽困难的气管造口患者中，与鼻胃管喂养相比，间歇性口食管管喂养缩短了拔管时间，并改善了营养、吞咽和生活质量结局。
试验注册： ClinicalTrials.gov，NCT06791590，注册日期2025年1月19日。
英文摘要
BACKGROUND: Neurogenic dysphagia frequently constitutes a major barrier to decannulation for tracheostomized patients. Conventional nasogastric tube (NGT) feeding may promote disuse atrophy of swallowing musculature and persistent aspiration risk. Intermittent oro-esophageal tube (IOE) feeding, a physiologically oriented modality mimicking natural swallowing, may accelerate decannulation, yet high-quality evidence is lacking.
METHODS: In this multicenter randomized controlled trial conducted at three tertiary academic centers in China, tracheostomized adults with neurogenic dysphagia were randomly assigned 1:1 to IOE or NGT. All participants received standardized pharmacological treatment, pulmonary rehabilitation, and structured swallowing training, and entered an institutional decannulation protocol with predefined readiness criteria. The primary outcome was time from protocol entry to actual decannulation. Secondary outcomes included the 30-day successful decannulation rate, nutritional indices, swallowing function, and swallowing-related quality of life. Outcome assessors and statisticians were blinded to allocation. Analyses followed the intention-to-treat principle.
RESULTS: A total of 140 patients were randomized to IOE (n = 70) or NGT (n = 70). Time to decannulation was shorter with IOE (22.16 ± 1.86 vs. 26.33 ± 1.30 days; between-group difference, 4.17 days; 95% confidence interval [CI], 1.90-6.44; p < 0.001; log-rank p = 0.005). The 30-day successful decannulation rate was higher with IOE (65.71% vs. 47.14%; absolute difference, 18.57% points; 95% CI, 2.43-34.71; p = 0.028). At 1 month, the IOE group demonstrated greater improvements in body mass index, serum albumin, serum prealbumin, swallowing function, and swallowing-related quality of life (all p < 0.001). Pharyngeal discomfort was less frequent with IOE (14.06% vs. 34.21%; p = 0.006); no Grade Ⅲ or higher adverse events occurred.
CONCLUSIONS: Intermittent oro-esophageal tube feeding shortens time to decannulation and improves nutritional, swallowing, and quality-of-life outcomes compared with nasogastric tube feeding in tracheostomized patients with neurogenic dysphagia.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT06791590, registration date January 19, 2025.