A multicenter, randomized, double-blind study of ulimorelin and metoclopramide in the treatment of critically ill patients with enteral feeding intolerance: PROMOTE trial.
A multicenter, randomized, double-blind study of ulimorelin and metoclopramide in the treatment of critically ill patients with enteral feeding intolerance: PROMOTE trial.
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乌立莫林和甲氧氯普胺治疗肠内喂养不耐受危重患者的多中心、随机、双盲研究：PROMOTE试验
DOI：
10.1007/s00134-019-05593-2
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发表时间：
2019-05
影响因子：
38.9
通讯作者：
Posadas, Juan
中科院分区：
文献类型：
--
作者：
Heyland, Daren K.;van Zanten, Arthur R. H.;Grau-Carmona, Teodoro;Evans, David;Beishuizen, Albertus;Schouten, Jeroen;Hoiting, Oscar;Luisa Bordeje, Maria;Krell, Kenneth;Klein, David J.;Gonzalez, Jesus;Perez, Aitor;Brown, Randy;James, Joyce;Harris, M. Scott;Jolley, Sarah;Raines, Ronald;Servia-Goixart, Lluis;Perez-Quesada, Sonia;Ignacio Herrero-Meseguer, Jose;Calvo-Herranz, Enrique;Lorencio, Carol;Peredes, Amparo;Carlos Yebenes-Reyes, Juan;Angel Garcia-Martinez, Miguel;Cervera, Manuel;Franscisco Fernadez-Ortega, Juan;Fernandez-Gonzalez, Inmaculada;van Zanten, Arthur;Stelfox, Tom;Posadas, Juan
关键词：
肠内喂养不耐受（EFI）是重症监护病房（ICU）的一个常见问题，但目前的促动力学药物的疗效和安全性尚不确定。目前的研究比较了胃促生长素激动剂ulimorelin与甲氧氯普胺治疗EFI的疗效和安全性。120例ICU患者按1:1的比例随机给予乌莫瑞林或甲氧氯普胺治疗5天。经胃残量(GRV)≥500 ml诊断EFI。采用基于量的喂养方案，并标准化肠内配方。主要终点是患者在5天治疗期间每日蛋白质处方的百分比（%DPP）。次要终点包括喂养成功，定义为80% DPP；胃排空，通过对乙酰氨基酚的吸收评估；复发性不耐受发生率（GRV≥500 ml）；呕吐或反流；抽吸，定义为胃蛋白酶气管抽吸阳性；肺部感染。120例患者随机接受研究药物（ulimorelin 62, metoclopramide 58）。APACHEⅱ和SOFA平均评分分别为21.6分和8.6分，63.3%的患者因医疗原因入院。乌莫瑞林和甲氧氯普胺在5天治疗期间的DPPs百分比相当（中位数[Q1， Q3]分别为82.9%[38.4%，100.2%]和82.3% [65.6%,100.2%],p = 0.49）。当排除与喂养无关的终止时，5天喂养成功率分别为67.7%和70.6%，两组之间的任何次要结局或不良事件均无差异。两种促动力剂的喂养成功率相似，两组之间没有观察到安全性差异。
Enteral feeding intolerance (EFI) is a frequent problem in the intensive care unit (ICU), but current prokinetic agents have uncertain efficacy and safety profiles. The current study compared the efficacy and safety of ulimorelin, a ghrelin agonist, with metoclopramide in the treatment of EFI. One hundred twenty ICU patients were randomized 1:1 to ulimorelin or metoclopramide for 5 days. EFI was diagnosed by a gastric residual volume (GRV) ≥ 500 ml. A volume-based feeding protocol was employed, and enteral formulas were standardized. The primary end point was the percentage daily protein prescription (%DPP) received by patients over 5 days of treatment. Secondary end points included feeding success, defined as 80% DPP; gastric emptying, assessed by paracetamol absorption; incidences of recurrent intolerance (GRV ≥ 500 ml); vomiting or regurgitation; aspiration, defined by positive tracheal aspirates for pepsin; and pulmonary infection. One hundred twenty patients were randomized and received the study drug (ulimorelin 62, metoclopramide 58). Mean APACHE II and SOFA scores were 21.6 and 8.6, and 63.3% of patients had medical reasons for ICU admission. Ulimorelin and metoclopramide resulted in comparable %DPPs over 5 days of treatment (median [Q1, Q3]: 82.9% [38.4%, 100.2%] and 82.3% [65.6%, 100.2%], respectively, p = 0.49). Five-day rates of feeding success were 67.7% and 70.6% when terminations unrelated to feeding were excluded, and there were no differences in any secondary outcomes or adverse events between the two groups. Both prokinetic agents achieved similar rates of feeding success, and no safety differences between the two treatment groups were observed.
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影响因子：
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通讯作者：
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影响因子：
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