使用特殊口服营养补充剂治疗的营养不良老年住院成人的再入院率和死亡率：一项随机临床试验。

Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: A randomized clinical trial.

作者信息

Deutz Nicolaas E, Matheson Eric M, Matarese Laura E, Luo Menghua, Baggs Geraldine E, Nelson Jeffrey L, Hegazi Refaat A, Tappenden Kelly A, Ziegler Thomas R

机构信息

Center for Translational Research in Aging & Longevity, Department of Health & Kinesiology, Texas A&M University, 1700 Research Parkway, College Station, TX 77845, USA.

Department of Family Medicine, Medical University of South Carolina, 5 Charleston Center Dr, Charleston, SC, USA.

出版信息

Clin Nutr. 2016 Feb;35(1):18-26. doi: 10.1016/j.clnu.2015.12.010. Epub 2016 Jan 18.

DOI:10.1016/j.clnu.2015.12.010

PMID:26797412

Abstract

BACKGROUND

Hospitalized, malnourished older adults have a high risk of readmission and mortality.

OBJECTIVE

Evaluation of a high-protein oral nutritional supplement (HP-HMB) containing beta-hydroxy-beta-methylbutyrate on postdischarge outcomes of nonelective readmission and mortality in malnourished, hospitalized older adults.

DESIGN

Multicenter, randomized, placebo-controlled, double-blind trial.

SETTING

Inpatient and posthospital discharge.

PATIENTS

Older (≥65 years), malnourished (Subjective Global Assessment [SGA] class B or C) adults hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.

INTERVENTIONS

Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day.

MEASUREMENTS

Primary composite endpoint was 90-day postdischarge incidence of death or nonelective readmission. Other endpoints included 30- and 60-day postdischarge incidence of death or readmission, length of stay (LOS), SGA class, body weight, and activities of daily living (ADL).

RESULTS

The primary composite endpoint was similar between HP-HMB (26.8%) and placebo (31.1%). No between-group differences were observed for 90-day readmission rate, but 90-day mortality was significantly lower with HP-HMB relative to placebo (4.8% vs. 9.7%; relative risk 0.49, 95% confidence interval [CI], 0.27 to 0.90; p = 0.018). The number-needed-to-treat to prevent 1 death was 20.3 (95% CI: 10.9, 121.4). Compared with placebo, HP-HMB resulted in improved odds of better nutritional status (SGA class, OR, 2.04, 95% CI: 1.28, 3.25, p = 0.009) at day 90, and an increase in body weight at day 30 (p = 0.035). LOS and ADL were similar between treatments.

LIMITATIONS

Limited generalizability; patients represent a selected hospitalized population.

CONCLUSIONS

Although no effects were observed for the primary composite endpoint, compared with placebo HP-HMB decreased mortality and improved indices of nutritional status during the 90-day observation period.

CLINICAL TRIAL REGISTRATION

www.ClinicalTrials.govNCT01626742.

摘要

背景

住院的营养不良老年人再入院和死亡风险很高。

目的

评估一种含β-羟基-β-甲基丁酸的高蛋白口服营养补充剂（HP-HMB）对营养不良的住院老年人出院后非选择性再入院和死亡结局的影响。

设计

多中心、随机、安慰剂对照、双盲试验。

地点

住院期间及出院后。

患者

年龄≥65岁、营养不良（主观全面评定法[SGA]为B级或C级）、因充血性心力衰竭、急性心肌梗死、肺炎或慢性阻塞性肺疾病住院的成年人。

干预措施

标准治疗加HP-HMB（n = 328）或安慰剂补充剂（n = 324），每日2份。

测量指标

主要复合终点为出院后90天内死亡或非选择性再入院的发生率。其他终点包括出院后30天和60天内死亡或再入院的发生率、住院时间（LOS）、SGA分级、体重和日常生活活动能力（ADL）。

结果

HP-HMB组（26.8%）和安慰剂组（31.1%）的主要复合终点相似。90天再入院率在组间未观察到差异，但HP-HMB组90天死亡率相对于安慰剂组显著降低（4.8%对9.7%；相对风险0.49，95%置信区间[CI]，0.27至0.90；p = 0.018）。预防1例死亡所需治疗人数为20.3（95%CI：10.9，121.4）。与安慰剂相比，HP-HMB在第90天时改善营养状况更好的几率（SGA分级，优势比[OR]，2.04，95%CI：1.28，3.25，p = 0.009），并在第30天时使体重增加（p = 0.035）。治疗组间LOS和ADL相似。