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[Lancet在线发表]:具有营养风险的内科住院患者个体化营养支持治疗:一项随机临床试验
2019年06月13日 时讯速递, 进展交流 暂无评论

Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial

Philipp Schuetz, Rebecca Fehr, Valerie Baechli, et al

Lancet 2019 Published:April 25, 2019

DOI:https://doi.org/10.1016/S0140-6736(18)32776-4

Summary

Background 背景

Guidelines recommend the use of nutritional support during hospital stays for medical patients (patients not critically ill and not undergoing surgical procedures) at risk of malnutrition. However, the supporting evidence for this recommendation is insufficient, and there is growing concern about the possible negative effects of nutritional therapy during acute illness on recovery and clinical outcomes. Our aim was thus to test the hypothesis that protocol-guided individualised nutritional support to reach protein and caloric goals reduces the risk of adverse clinical outcomes in medical inpatients at nutritional risk.

指南推荐具有营养不良风险的内科患者(病情不危重且不接受外科手术)住院期间应接受营养支持治疗。然而,支持这一推荐意见的证据并不充分,而且对于急性病期间营养治疗对于疾病康复及临床预后的负面影响的顾虑越来越多。我们的目的在于验证假设,即对具有营养不良风险的内科住院患者根据方案指导进行个体化营养支持以达到蛋白质及热卡目标,能够降低不良临床预后的风险。

Methods 方法

The Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) is a pragmatic, investigator-initiated, open-label, multicentre study. We recruited medical patients at nutritional risk (nutritional risk screening 2002 [NRS 2002] score ≥3 points) and with an expected length of hospital stay of more than 4 days from eight Swiss hospitals. These participants were randomly assigned (1:1) to receive either protocol-guided individualised nutritional support to reach protein and caloric goals (intervention group) or standard hospital food (control group). Randomisation was done with variable block sizes and stratification according to study site and severity of malnutrition using an interactive web-response system. In the intervention group, individualised nutritional support goals were defined by specialist dietitians and nutritional support was initiated no later than 48 h after admission. Patients in the control group received no dietary consultation. The composite primary endpoint was any adverse clinical outcome defined as all-cause mortality, admission to intensive care, non-elective hospital readmission, major complications, and decline in functional status at 30 days, and it was measured in all randomised patients who completed the trial. This trial is registered with ClinicalTrials.gov, number NCT02517476.

EFFORT试验是一项实效性、研究者发起的、开放多中心研究。我们从瑞士8家医院入选具有营养风险(营养风险筛查2002评分[NRS 2002] ≥ 3分)且预期住院日超过4天的内科患者。这些患者按照1:1的比例随机分为方案指导个体化营养支持治疗以达到蛋白质和热卡目标(干预组)或标准医院饮食(对照组)。随机分组时采用互动式网络反应系统,区组大小可变,且根据研究中心及营养不良严重程度分层。在干预组,个体化营养支持目标由专业营养师定义,住院后不超过48小时即开始营养支持治疗。对照组患者不接受营养会诊。复合主要终点为任何不良临床预后,包括30天全因病死率,收入ICU,非择期再次住院,严重并发症及功能状态下降,对所有完成试验的随机分组患者均进行评估。试验在ClinicalTrials.gov网站注册,注册号NCT02517476

Findings 结果

5015 patients were screened, and 2088 were recruited and monitored between April 1, 2014, and Feb 28, 2018. 1050 patients were assigned to the intervention group and 1038 to the control group. 60 patients withdrew consent during the course of the trial (35 in the intervention group and 25 in the control group). During the hospital stay, caloric goals were reached in 800 (79%) and protein goals in 770 (76%) of 1015 patients in the intervention group. By 30 days, 232 (23%) patients in the intervention group experienced an adverse clinical outcome, compared with 272 (27%) of 1013 patients in the control group (adjusted odds ratio [OR] 0·79 [95% CI 0·64–0·97], p=0·023). By day 30, 73 [7%] patients had died in the intervention group compared with 100 [10%] patients in the control group (adjusted OR 0·65 [0·47–0·91], p=0·011). There was no difference in the proportion of patients who experienced side-effects from nutritional support between the intervention and the control group (162 [16%] vs 145 [14%], adjusted OR 1·16 [0·90–1·51], p=0·26).

2014年4月1日至2018年2月28日期间,我们筛查了5015名患者,2088名患者纳入研究。1050名患者分至干预组,1038名患者分至对照组。60名患者在试验过程中撤除知情同意(干预组35名,对照组25名)。在住院期间,干预组1015名患者中分别有800名 (79%) 和 770名 (76%) 患者达到热卡和蛋白质目标。至30天时,干预组232名 (23%) 患者经历不良临床预后,对照组1013名患者中272名 (27%) 发生不良预后(校正比数比 [OR] 0·79 [95% CI 0·64–0·97], p=0·023)。至30天时,干预组73名 [7%] 患者及对照组100名 [10%] 患者死亡(校正OR 0·65 [0·47–0·91], p=0·011)。干预组和对照组间出现营养支持治疗副作用的患者比例并无差异(162 [16%] vs 145 [14%], 校正OR 1·16 [0·90–1·51], p=0·26)。

Interpretation 结论

In medical inpatients at nutritional risk, the use of individualised nutritional support during the hospital stay improved important clinical outcomes, including survival, compared with standard hospital food. These findings strongly support the concept of systematically screening medical inpatients on hospital admission regarding nutritional risk, independent of their medical condition, followed by a nutritional assessment and introduction of individualised nutritional support in patients at risk.

对于具有营养风险的内科住院患者,与标准医院饮食相比,住院期间采用个体化营养支持治疗能够改善包括生存率在内的重要临床预后。这些结果强烈支持在入院时系统筛查内科住院患者的营养风险,对于具有风险的患者进行营养评估并开始个体化营养支持治疗。

Funding 资助

The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau, Switzerland.

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