Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Basel, Switzerland.
Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.
Lancet. 2019 Jun 8;393(10188):2312-2321. doi: 10.1016/S0140-6736(18)32776-4. Epub 2019 Apr 25.
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.
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.
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).
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.
The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau, Switzerland.
指南建议对有营养不良风险的住院医疗患者（非危重症且未接受手术的患者）在住院期间使用营养支持。然而，这一推荐的支持证据不足，并且人们越来越担心急性疾病期间营养治疗可能对恢复和临床结果产生负面影响。因此，我们的目的是检验这样一个假设，即根据个体化营养支持方案达到蛋白质和热量目标可降低有营养不良风险的住院内科患者不良临床结局的风险。
早期营养支持对虚弱、功能结局和营养不良的住院内科患者康复的影响试验（EFFORT）是一项实用性、研究者发起的、开放性标签、多中心研究。我们从瑞士 8 家医院招募了有营养不良风险（营养风险筛查 2002 评分[NRS 2002]≥3 分）和预计住院时间超过 4 天的内科患者。这些患者以 1:1 的比例随机分配到接受个体化营养支持方案以达到蛋白质和热量目标（干预组）或接受标准医院饮食（对照组）。采用交互式网络应答系统，按照研究地点和营养不良严重程度进行分组，以可变大小的区组进行随机分组。在干预组中，由营养师个体化确定营养支持目标，在入院后不迟于 48 小时开始营养支持。对照组患者不接受饮食咨询。主要复合终点是任何不良临床结局，定义为全因死亡率、入住重症监护病房、非计划再次住院、主要并发症和 30 天时功能状态下降，所有完成试验的随机患者均进行了测量。该试验在 ClinicalTrials.gov 上注册，编号为 NCT02517476。
对 5015 名患者进行了筛查，在 2014 年 4 月 1 日至 2018 年 2 月 28 日期间招募并监测了 2088 名患者。1050 名患者被分配到干预组，1038 名患者被分配到对照组。在试验过程中有 60 名患者撤回了同意（干预组 35 名，对照组 25 名）。在住院期间，800 名（79%）干预组患者达到了热量目标，770 名（76%）患者达到了蛋白质目标。在 30 天时，干预组 232 名（23%）患者发生了不良临床结局，而对照组 1013 名患者中有 272 名（27%）（调整后的优势比[OR]0·79[95%CI 0·64-0·97]，p=0·023）。在干预组中有 73 名（7%）患者在第 30 天死亡，而对照组中有 100 名（10%）（调整后的 OR 0·65[0·47-0·91]，p=0·011）。干预组和对照组之间接受营养支持的患者发生副作用的比例没有差异（162 名[16%]比 145 名[14%]，调整后的 OR 1·16[0·90-1·51]，p=0·26）。
在有营养不良风险的住院内科患者中，与标准医院饮食相比，在住院期间使用个体化营养支持可改善重要的临床结局，包括存活率。这些发现强烈支持系统地对入院的内科住院患者进行营养风险筛查的概念，无论其医疗状况如何，随后对有风险的患者进行营养评估和个体化营养支持。
瑞士国家科学基金会和瑞士阿劳州立医院研究委员会。
