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住院糖尿病患者和营养不良风险患者的营养支持:一项瑞士研究者发起的、随机对照多中心试验的二次分析。

Nutritional support in hospitalised patients with diabetes and risk for malnutrition: a secondary analysis of an investigator-initiated, Swiss, randomised controlled multicentre trial.

机构信息

Kantonsspital Aarau AG, Aarau, Switzerland.

Faculty of Medicine, University of Bern, Bern, Bern, Switzerland.

出版信息

BMJ Open. 2024 Aug 17;14(8):e084754. doi: 10.1136/bmjopen-2024-084754.

Abstract

OBJECTIVES

The main objective of this study was to investigate the effects of nutritional support on mortality in hospitalised patients with diabetes and nutritional risk participating in the (EFFORT) trial.

DESIGN

Secondary analysis of a Swiss-wide multicentre, randomised controlled trial.

PARTICIPANTS

Patients with diabetes and risk for malnutrition.

INTERVENTIONS

Individualised nutritional support versus usual care.

PRIMARY OUTCOME MEASURE

30-day all-cause mortality.

RESULTS

Of the 2028 patients included in the original trial, 445 patients were diagnosed with diabetes and included in this analysis. In terms of efficacy of nutritional therapy, there was a 25% lower risk for mortality in patients with diabetes receiving nutritional support compared with controls (7% vs 10%, adjusted HR 0.75 (95% CI 0.39 to 1.43)), a finding that was not statistically significant but similar to the overall trial effects with no evidence of interaction (p=0.92). Regarding safety of nutritional therapy, there was no increase in diabetes-specific complications associated with nutritional support, particularly there was no increase in risk for hyperglycaemia (adjusted OR 0.97, 95% CI 0.56 to 1.67 p=0.90).

CONCLUSION

Patients with diabetes and malnutrition in the hospital setting have a particularly high risk for adverse outcomes and mortality. Individualised nutritional support reduced mortality in this secondary analysis of a randomized trial, but this effect was not significant calling for further large-scale trials in this vhighly ulnerable patient population.

TRIAL REGISTRATION NUMBER

NCT02517476.

摘要

目的

本研究的主要目的是调查营养支持对参与 EFFORT 试验的住院糖尿病和营养风险患者的死亡率的影响。

设计

瑞士多中心、随机对照试验的二次分析。

参与者

患有糖尿病和营养不良风险的患者。

干预措施

个体化营养支持与常规护理。

主要结局测量

30 天全因死亡率。

结果

在原试验纳入的 2028 例患者中,有 445 例患者被诊断为糖尿病,并纳入本分析。在营养治疗的疗效方面,接受营养支持的糖尿病患者的死亡率降低了 25%(7%比 10%,调整后的 HR 0.75(95%CI 0.39 至 1.43)),这一发现虽然没有统计学意义,但与总体试验效果相似,没有交互作用的证据(p=0.92)。关于营养治疗的安全性,与营养支持相关的糖尿病特定并发症没有增加,特别是没有增加高血糖的风险(调整后的 OR 0.97,95%CI 0.56 至 1.67,p=0.90)。

结论

住院的糖尿病和营养不良患者发生不良结局和死亡的风险特别高。个体化营养支持降低了二次分析中随机试验的死亡率,但这一效果不显著,需要在这一高脆弱患者群体中进行更大规模的试验。

试验注册号

NCT02517476。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2bb4/11535698/51c8535ad122/bmjopen-14-8-g001.jpg

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