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急性肺损伤患者的初始营养支持与全肠内营养支持比较:EDEN 随机试验。

Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial.

出版信息

JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.

DOI:10.1001/jama.2012.137
PMID:22307571
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3743415/
Abstract

CONTEXT

The amount of enteral nutrition patients with acute lung injury need is unknown.

OBJECTIVE

To determine if initial lower-volume trophic enteral feeding would increase ventilator-free days and decrease gastrointestinal intolerances compared with initial full enteral feeding.

DESIGN, SETTING, AND PARTICIPANTS: The EDEN study, a randomized, open-label, multicenter trial conducted from January 2, 2008, through April 12, 2011. Participants were 1000 adults within 48 hours of developing acute lung injury requiring mechanical ventilation whose physicians intended to start enteral nutrition at 44 hospitals in the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network.

INTERVENTIONS

Participants were randomized to receive either trophic or full enteral feeding for the first 6 days. After day 6, the care of all patients who were still receiving mechanical ventilation was managed according to the full feeding protocol.

MAIN OUTCOME MEASURES

Ventilator-free days to study day 28.

RESULTS

Baseline characteristics were similar between the trophic-feeding (n = 508) and full-feeding (n = 492) groups. The full-feeding group received more enteral calories for the first 6 days, about 1300 kcal/d compared with 400 kcal/d (P < .001). Initial trophic feeding did not increase the number of ventilator-free days (14.9 [95% CI, 13.9 to 15.8] vs 15.0 [95% CI, 14.1 to 15.9]; difference, -0.1 [95% CI, -1.4 to 1.2]; P = .89) or reduce 60-day mortality (23.2% [95% CI, 19.6% to 26.9%] vs 22.2% [95% CI, 18.5% to 25.8%]; difference, 1.0% [95% CI, -4.1% to 6.3%]; P = .77) compared with full feeding. There were no differences in infectious complications between the groups. Despite receiving more prokinetic agents, the full-feeding group experienced more vomiting (2.2% vs 1.7% of patient feeding days; P = .05), elevated gastric residual volumes (4.9% vs 2.2% of feeding days; P < .001), and constipation (3.1% vs 2.1% of feeding days; P = .003). Mean plasma glucose values and average hourly insulin administration were both higher in the full-feeding group over the first 6 days.

CONCLUSION

In patients with acute lung injury, compared with full enteral feeding, a strategy of initial trophic enteral feeding for up to 6 days did not improve ventilator-free days, 60-day mortality, or infectious complications but was associated with less gastrointestinal intolerance.

TRIAL REGISTRATION

clinicaltrials.gov Identifiers: NCT00609180 and NCT00883948.

摘要

背景

急性肺损伤患者需要的肠内营养量尚不清楚。

目的

确定初始低容量营养性肠内喂养与初始全肠内喂养相比,是否会增加无呼吸机天数并减少胃肠道不耐受。

设计、地点和参与者:EDEN 研究是一项随机、开放标签、多中心试验,于 2008 年 1 月 2 日至 2011 年 4 月 12 日进行。参与者为急性肺损伤发病后 48 小时内需要机械通气的 1000 名成年人,其医生计划在国家心肺血液研究所 ARDS 临床试验网络的 44 家医院开始肠内营养。

干预

参与者被随机分配接受营养或全肠内喂养 6 天。第 6 天后,所有仍接受机械通气的患者的护理均按照全喂养方案进行管理。

主要观察终点

无呼吸机天数至研究第 28 天。

结果

营养组(n=508)和全喂养组(n=492)的基线特征相似。全喂养组在前 6 天接受的肠内热量更多,约 1300 kcal/d 与 400 kcal/d(P <.001)。初始营养性喂养并未增加无呼吸机天数(14.9[95%CI,13.9 至 15.8]与 15.0[95%CI,14.1 至 15.9];差异,-0.1[95%CI,-1.4 至 1.2];P =.89)或降低 60 天死亡率(23.2%[95%CI,19.6%至 26.9%]与 22.2%[95%CI,18.5%至 25.8%];差异,1.0%[95%CI,-4.1%至 6.3%];P =.77)与全喂养相比。两组之间的感染并发症无差异。尽管全喂养组使用了更多的促动力药物,但该组发生更多的呕吐(2.2%与 1.7%的患者喂养天数;P =.05)、胃残留量升高(4.9%与 2.2%的喂养天数;P <.001)和便秘(3.1%与 2.1%的喂养天数;P =.003)。在最初的 6 天中,全喂养组的平均血浆葡萄糖值和平均每小时胰岛素给药量均较高。

结论

在急性肺损伤患者中,与全肠内喂养相比,最初 6 天内采用营养性肠内喂养的策略并未改善无呼吸机天数、60 天死亡率或感染并发症,但与胃肠道不耐受的发生率降低有关。

试验注册

clinicaltrials.gov 标识符:NCT00609180 和 NCT00883948。

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