背景:肠内喂养不耐受(EFI)是重症监护病房(ICU)中常见的问题,并且与不良的临床结局相关,导致死亡率和ICU停留时间方面的预后较差。如今,促动力药物是EFI治疗的主要手段.然而,可用的前动力学具有不确定的疗效和安全性。Itopride,是一种促动力剂,由于其双重作用模式以及其耐受性和安全性,与可用的促动力剂不同且独特。本研究比较了伊托必利与甲氧氯普胺治疗危重患者EFI的疗效和安全性。此外,它测试了超声检查在该人群中测量胃残留量(GRV)的实用性和适用性。
方法:这是随机的,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.主要结果是通过超声检查测量GRV。次要结果包括肠内喂养量的百分比,患者在治疗7天内接受的能量和蛋白质,ICU住院时间,安全参数和感染并发症或呕吐的发生。
结果:每组35名患者完成研究。在第7天,与甲氧氯普胺组相比,伊托必利显着降低了GRV(p=0.001)。此外,接受肠内营养饲料量的比率显着增加,卡路里,伊托必利组治疗一周后的蛋白质含量高于甲氧氯普胺组(p=0.001),(p=0.002),(p=0.01),两组间的次要结局或不良事件均无差异.
结论:在EFI危重患者中,伊托必利耐受性良好,疗效优于甲氧氯普胺.此外,我们证明了超声检查是一个简单的,非侵入性,便宜,和要求不高的GRV测量方法,可以在胃排空方式中提供可靠的评估。
背景:该试验已在ClinicalTrials.gov(NCT03698292)中注册。日期:2018年10月5日。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: The
trial was registered in ClinicalTrials.gov (NCT03698292). Date: October 5, 2018.