Elmokadem Eman Mohamed, El Borolossy Radwa Maher, Bassiouny Ahmed M, Hanna Maha Gamil, Darweesh Ebtissam Abdel Ghaffar, Sabri Nagwa A
Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University in Egypt, Cairo, Egypt.
Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
BMC Gastroenterol. 2021 Mar 19;21(1):126. doi: 10.1186/s12876-021-01712-w.
Enteral feeding intolerance (EFI) is a frequent problem in the Intensive care unit (ICU) and is associated with poor clinical outcomes leading to worse prognosis in terms of mortality and ICU stay. Nowadays, prokinetic drugs are the mainstay of therapy in EFI. However, available prokinetics have uncertain efficacy and safety profiles. Itopride, is a prokinetic agent which is different and unique from the available prokinetics because of its dual mode of action as well as its tolerability and safety. The current study compared the efficacy and safety of Itopride against metoclopramide for EFI in critically ill patients. Moreover, it tested the utility and applicability of ultrasonography to measure gastric residual volume (GRV) in this population.
This randomized, double-blind study included 76 EFI patients who were randomly assigned to either Itopride or metoclopramide group. The primary outcome was to measure GRV by ultrasonography. Secondary outcomes included the percentage ratio of enteral feed volume, energy and protein received by patients over 7 days of treatment, ICU length of stay, safety parameters and occurrence of infectious complications or vomiting.
Thirty-five patients of each group completed the study. At day 7, itopride significantly decreased GRV compared with metoclopramide group (p = 0.001). Moreover, there was a significant increase in the ratios of received enteral nutrition feed volume, calories, and protein after the one-week therapy in the itopride group more than the metoclopramide group (p = 0.001), (p = 0.002), (p = 0.01), respectively and there were no differences in any secondary outcomes or adverse events between the two groups.
In critically ill patients with EFI, itopride was well tolerated with superior efficacy to metoclopramide. In addition, we demonstrated that ultrasonography is a simple, non-invasive, inexpensive, and undemanding method for GRV measurements and can offer reliable assessments in the gastric emptying modality.
The trial was registered in ClinicalTrials.gov (NCT03698292). Date: October 5, 2018.
肠内喂养不耐受（EFI）是重症监护病房（ICU）中常见的问题，与不良临床结局相关，导致死亡率和ICU住院时间方面的预后更差。如今，促动力药物是EFI治疗的主要手段。然而，现有的促动力药疗效和安全性尚不明确。伊托必利是一种促动力剂，因其双重作用模式以及耐受性和安全性，与现有的促动力药不同且独特。本研究比较了伊托必利与甲氧氯普胺治疗重症患者EFI的疗效和安全性。此外，还测试了超声检查在测量该人群胃残余容积（GRV）方面的实用性和适用性。
这项随机、双盲研究纳入了76例EFI患者，他们被随机分配到伊托必利组或甲氧氯普胺组。主要结局是通过超声检查测量GRV。次要结局包括患者在7天治疗期间接受的肠内喂养量、能量和蛋白质的百分比、ICU住院时间、安全参数以及感染并发症或呕吐的发生情况。
每组35例患者完成了研究。在第7天，与甲氧氯普胺组相比，伊托必利显著降低了GRV（p = 0.001）。此外，伊托必利组在一周治疗后接受的肠内营养喂养量、热量和蛋白质的比例显著高于甲氧氯普胺组（分别为p = 0.001、p = 0.002、p = 0.01），两组在任何次要结局或不良事件方面均无差异。
在患有EFI的重症患者中，伊托必利耐受性良好，疗效优于甲氧氯普胺。此外，我们证明超声检查是一种简单、无创、廉价且要求不高的GRV测量方法，并且可以在胃排空方式中提供可靠的评估。
该试验已在ClinicalTrials.gov（NCT03698292）注册。日期：2018年10月5日。
