Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, San Francisco.
Department of Preventive and Restorative Dental Sciences, University of California, San Francisco.
JAMA Pediatr. 2021 Jan 1;175(1):19-27. doi: 10.1001/jamapediatrics.2020.3359.
The standard of care for refeeding inpatients with anorexia nervosa, starting with low calories and advancing cautiously, is associated with slow weight gain and protracted hospital stay. Limited data suggest that higher-calorie refeeding improves these outcomes with no increased risk of refeeding syndrome.
To compare the short-term efficacy, safety, and cost of lower-calorie vs higher-calorie refeeding for malnourished adolescents and young adults with anorexia nervosa.
DESIGN, SETTING, AND PARTICIPANTS: In this multicenter randomized clinical trial with prospective follow-up conducted at 2 inpatient eating disorder programs at large tertiary care hospitals, 120 adolescents and young adults aged 12 to 24 years hospitalized with anorexia nervosa or atypical anorexia nervosa and 60% or more of median body mass index were enrolled from February 8, 2016, to March 7, 2019. The primary analysis was a modified intent-to-treat approach.
Higher-calorie refeeding, beginning at 2000 kcal/d and increasing by 200 kcal/d vs lower-calorie refeeding, beginning at 1400 k/cal and increasing by 200 kcal every other day.
Main outcomes were end-of-treatment outcomes; the primary end point of this trial will be clinical remission over 12 months. Short-term efficacy was defined a priori as time to restore medical stability in the hospital, measured by the following 6 indices: 24-hour heart rate of 45 beats/min or more, systolic blood pressure of 90 mm Hg or more, temperature of 35.6 °C or more, orthostatic increase in heart rate of 35 beats/min or less, orthostatic decrease in systolic blood pressure of 20 mm Hg or less, and 75% or more of median body mass index for age and sex. The prespecified safety outcome was incidence of electrolyte abnormalities; cost efficacy was defined as savings associated with length of stay.
Because 9 participants withdrew prior to treatment, the modified intention-to-treat analyses included 111 participants (93%; 101 females [91%]; mean [SD] age, 16.4 [2.5] years). Higher-calorie refeeding restored medical stability significantly earlier than lower-calorie refeeding (hazard ratio, 1.67 [95% CI, 1.10-2.53]; P = .01). Electrolyte abnormalities and other adverse events did not differ by group. Hospital stay was 4.0 days shorter (95% CI, -6.1 to -1.9 days) among the group receiving higher-calorie refeeding, which was associated with a savings of $19 056 (95% CI, -$28 819 to -$9293) in hospital charges per participant.
In the first randomized clinical trial in the US to compare refeeding approaches in patients with anorexia nervosa and atypical anorexia nervosa, higher-calorie refeeding demonstrated short-term efficacy with no increase in safety events during hospitalization.
ClinicalTrials.gov Identifier: NCT02488109.
对于患有神经性厌食症的住院患者，采用标准的喂养方式，从低热量开始，谨慎推进，与体重增加缓慢和住院时间延长有关。有限的数据表明，高卡路里喂养可以改善这些结果，且不会增加喂养综合征的风险。
比较低卡路里和高卡路里喂养对营养不良的青少年和年轻成年人神经性厌食症的短期疗效、安全性和成本。
设计、设置和参与者：这是一项多中心随机临床试验，前瞻性随访，在两家大型三级保健医院的 2 个住院饮食失调项目中进行，共纳入了 120 名年龄在 12 至 24 岁之间的青少年和年轻成年人，这些患者患有神经性厌食症或非典型神经性厌食症，体重指数中位数的 60%或更多。研究于 2016 年 2 月 8 日至 2019 年 3 月 7 日进行，主要分析采用改良意向治疗方法。
高卡路里喂养，起始剂量为 2000 千卡/天，每 200 千卡/天增加一次；低卡路里喂养，起始剂量为 1400 千卡/天，每隔一天增加 200 千卡/天。
主要结局为治疗结束时的结果；该试验的主要终点将是 12 个月的临床缓解。短期疗效预先定义为在医院内恢复医疗稳定的时间，通过以下 6 项指标来衡量：24 小时心率为 45 次/分钟或更高、收缩压为 90 毫米汞柱或更高、体温为 35.6°C 或更高、直立时心率增加 35 次/分钟或更低、直立时收缩压下降 20 毫米汞柱或更低、以及年龄和性别中位数体重指数的 75%或更高。预定的安全性结局为电解质异常的发生率；成本效益定义为与住院时间相关的节省。
由于 9 名参与者在治疗前退出，改良意向治疗分析纳入了 111 名参与者（93%；101 名女性[91%]；平均[SD]年龄 16.4[2.5]岁）。高卡路里喂养使医疗稳定的恢复时间明显早于低卡路里喂养（风险比，1.67[95%CI，1.10-2.53]；P=0.01）。电解质异常和其他不良事件在两组间无差异。接受高卡路里喂养的患者住院时间缩短了 4.0 天（95%CI，-6.1 至-1.9 天），每位患者的住院费用节省了 19056 美元（95%CI，-28819 至-9293 美元）。
这是美国首例比较神经性厌食症和非典型神经性厌食症患者喂养方法的随机临床试验，高卡路里喂养在住院期间显示出短期疗效，且安全性事件无增加。
ClinicalTrials.gov 标识符：NCT02488109。
