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[LANCET在线发表]:早期等热卡肠内营养不能改善接受机械通气的休克患者预后
2017年11月19日 时讯速递, 进展交流 暂无评论

Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2)

Jean Reignier, Julie Boisramé-Helms, Laurent Brisard, et al

Lancet Published: 08 November 2017

DOI: http://dx.doi.org/10.1016/S0140-6736(17)32146-3

Summary

Background 背景

Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition.

早期喂养途径是否影响危重病患者预后尚存在争议。我们假设与早期进行一线肠外营养相比,早期进行一线肠内营养患者预后更佳。

Methods 方法

In this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial) done at 44 French intensive-care units (ICUs), adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20–25 kcal/kg per day), within 24 h after intubation. Randomisation was stratified by centre using permutation blocks of variable sizes. Given that route of nutrition cannot be masked, blinding of the physicians and nurses was not feasible. Patients receiving parenteral nutrition could be switched to enteral nutrition after at least 72 h in the event of shock resolution (no vasopressor support for 24 consecutive hours and arterial lactate <2 mmol/L). The primary endpoint was mortality on day 28 after randomisation in the intention-to-treat-population. This study is registered with ClinicalTrials.gov, number NCT01802099.

这项随机、对照、多中心、开放、平行对照试验(NUTRIREA-2 试验)在44个法国ICU进行,将接受机械通气及升压药物治疗休克的成年患者随机分为 (1:1) 肠外营养或肠内营养组。两组均以气管插管24小时内达到正常热卡 (20–25 kcal/kg/d)为目标。采用大小不同的排列区组根据中心进行随机。营养支持途径无法对医生和护士设盲。接受肠外营养的患者在休克缓解(连续24小时无升压药物,动脉乳酸< 2 mmol/L)至少72小时后可转换为肠内营养。主要预后终点为随机分组后28天病死率的意向治疗分析。研究在ClinicalTrials.gov注册,注册号 NCT01802099

Findings 结果

After the second interim analysis, the independent Data Safety and Monitoring Board deemed that completing patient enrolment was unlikely to significantly change the results of the trial and recommended stopping patient recruitment. Between March 22, 2013, and June 30, 2015, 2410 patients were enrolled and randomly assigned; 1202 to the enteral group and 1208 to the parenteral group. By day 28, 443 (37%) of 1202 patients in the enteral group and 422 (35%) of 1208 patients in the parenteral group had died (absolute difference estimate 2·0%; [95% CI −1·9 to 5·8]; p=0·33). Cumulative incidence of patients with ICU-acquired infections did not differ between the enteral group (173 [14%]) and the parenteral group (194 [16%]; hazard ratio [HR] 0·89 [95% CI 0·72–1·09]; p=0·25). Compared with the parenteral group, the enteral group had higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1·89 [1·62–2·20]; p<0·0001), diarrhoea (432 [36%] vs 393 [33%]; 1·20 [1·05–1·37]; p=0·009), bowel ischaemia (19 [2%] vs five [<1%]; 3·84 [1·43–10·3]; p=0·007), and acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3·7 [1·03–13·2; p=0·04).

在第二次中期分析后,独立的数据安全及监督委员会认为,继续完成患者入选不能显著改变研究结果,因而建议终止患者入选。在2013年3月22日至2015年6月30日间,2410名患者入选并接受随机分组;1202名患者进入肠内营养组,1208名患者进入肠外营养组。至第28天时,肠内组1202名患者中443名 (37%) 以及肠外组1208名患者中422名 (35%)死亡(绝对差异 2·0%; [95% CI −1·9 to 5·8]; p=0·33)。肠内组(173 [14%])与肠外组(194 [16%]) ICU获得性感染的累积发生率没有显著差异 (风险比 [HR] 0·89 [95% CI 0·72–1·09]; p=0·25)。与肠外营养组相比,肠内营养组患者呕吐 (406 [34%] vs 246 [20%]; HR 1·89 [1·62–2·20]; p<0·0001)、腹泻(432 [36%] vs 393 [33%]; 1·20 [1·05–1·37]; p=0·009)、肠道缺血(19 [2%] vs five [<1%]; 3·84 [1·43–10·3]; p=0·007)以及急性结肠假性梗阻(11 [1%] vs 3 [<1%]; 3·7 [1·03–13·2; p=0·04)的发生率更高。

Interpretation 结论

In critically ill adults with shock, early isocaloric enteral nutrition did not reduce mortality or the risk of secondary infections but was associated with a greater risk of digestive complications compared with early isocaloric parenteral nutrition.

在罹患休克的成年危重病患者,与早期等热卡肠外营养相比,早期等热卡肠内营养不能降低病死率或继发感染风险,但伴随消化系统并发症风险增加。

Funding

La Roche-sur-Yon Departmental Hospital and French Ministry of Health.

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