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甲氧氯普胺治疗失败后延迟胃排空的随机对照可行性和概念验证试验:我们应重新审视鼻肠喂养与双重促动力治疗:在危重症和延迟胃排空情况下实现目标营养:鼻肠喂养与鼻胃喂养加促动力药的试验。

A randomised controlled feasibility and proof-of-concept trial in delayed gastric emptying when metoclopramide fails: We should revisit nasointestinal feeding versus dual prokinetic treatment: Achieving goal nutrition in critical illness and delayed gastric emptying: Trial of nasointestinal feeding versus nasogastric feeding plus prokinetics.

作者信息

Taylor Stephen J, Allan Kaylee, McWilliam Helen, Manara Alex, Brown Jules, Greenwood Rosemary, Toher Deirdre

机构信息

Department of Nutrition and Dietetics, Level 6, Gate 10, Brunel Building, Southmead Hospital, Bristol, BS105 NB, UK.

Department of Anaesthetics, Level 3 Gate 38, Brunel Building, Southmead Hospital, Bristol, BS10 5NB, UK.

出版信息

Clin Nutr ESPEN. 2016 Aug;14:1-8. doi: 10.1016/j.clnesp.2016.04.020. Epub 2016 May 31.

DOI:10.1016/j.clnesp.2016.04.020
PMID:28531392
Abstract

BACKGROUND & AIMS: Delayed gastric emptying (DGE) commonly limits the use of enteral nutrition (EN) and may increase ventilator-associated pneumonia. Nasointestinal feeding has not been tested against dual prokinetic treatment (Metoclopramide and Erythromycin) in DGE refractory to metoclopramide. This trial tests the feasibility of recruiting this 'treatment-failed' population and the proof of concept that nasointestinal (NI) feeding can increase the amount of feed tolerated (% goal) when compared to nasogastric (NG) feeding plus metoclopramide and erythromycin treatment.

METHODS

Eligible patients were those who were mechanically ventilated and over 20 years old, with delayed gastric emptying (DGE), defined as a gastric residual volume ≥250 ml or vomiting, and who failed to respond to first-line prokinetic treatment of 3 doses of 10 mg IV metoclopramide over 24 h. When assent was obtained, patients were randomised to receive immediate nasointestinal tube placement and feeding or nasogastric feeding plus metoclopramide and erythromycin (prokinetic) treatment.

RESULTS

Of 208 patients with DGE, 77 were eligible, 2 refused assent, 25 had contraindications to intervention, almost exclusively prokinetic treatment, and it was feasible to recruit 50. Compared to patients receiving prokinetics (n = 25) those randomised to nasointestinal feeding (n = 25) tolerated more of their feed goal over 5 days (87-95% vs 50-89%) and had a greater area under the curve (median [IQR] 432 [253-464]% vs 350 [213-381]%, p = 0.026) demonstrating proof of concept. However, nasointestinally fed patients also had a larger gastric loss (not feed) associated with the NI route but not with the fluid volume or energy delivered.

CONCLUSIONS

This is first study showing that in DGE refractory to metoclopramide NI feeding can increase the feed goal tolerated when compared to dual prokinetic treatment. Future studies should investigate the effect on clinical outcomes.

EU CLINICAL TRIALS REGISTER

EudraCT number: 2012-001374-29.

摘要

背景与目的

胃排空延迟(DGE)常常限制肠内营养(EN)的使用,并可能增加呼吸机相关性肺炎的发生风险。对于胃复安治疗无效的DGE患者,鼻肠管喂养与双重促动力治疗(胃复安和红霉素)的疗效对比尚未得到验证。本试验旨在验证招募这类“治疗失败”人群的可行性,并验证以下概念:与鼻胃管(NG)喂养加胃复安和红霉素治疗相比,鼻肠管(NI)喂养能够增加患者耐受的喂养量(占目标量的百分比)。

方法

符合条件的患者为机械通气且年龄超过20岁,伴有胃排空延迟(DGE),定义为胃残余量≥250毫升或呕吐,且对24小时内静脉注射3剂10毫克胃复安的一线促动力治疗无反应。获得患者同意后,将患者随机分为两组,一组立即置入鼻肠管并进行喂养,另一组接受鼻胃管喂养加胃复安和红霉素(促动力)治疗。

结果

在208例DGE患者中,77例符合条件,2例拒绝同意,25例存在干预禁忌症,几乎均为促动力治疗相关禁忌症,最终成功招募50例患者。与接受促动力治疗的患者(n = 25)相比,随机接受鼻肠管喂养的患者(n = 25)在5天内耐受的喂养目标量更多(87 - 95% vs 50 - 89%),曲线下面积更大(中位数[四分位间距] 432 [253 - 464]% vs 350 [213 - 381]%,p = 0.026),证明了该概念。然而,鼻肠管喂养的患者与NI途径相关的胃内丢失量(非喂养量)也更大,但与输入的液体量或能量无关。

结论

本研究首次表明,对于胃复安治疗无效的DGE患者,与双重促动力治疗相比,鼻肠管喂养能够增加患者耐受的喂养目标量。未来的研究应调查其对临床结局的影响。

欧盟临床试验注册

EudraCT编号:2012 - 001374 - 29。

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