背景:接受家庭肠外营养(HPN)的短肠综合征(SBS)患者通常通宵循环营养输注可能导致昼夜节律失调和睡眠中断。
目的:这个准实验的目的,单臂,控制,试点试验是为了检查可行性,安全,无糖尿病成人SBS患者日间输注HPN的疗效。
方法:注册的患者配备了连续血糖监测仪和腕关节肌动仪,并被指示循环输注1周,然后在白天再输注1周(ClinicalTrials.gov:NCT04743960)。24小时平均血糖,超过140mg/dL或低于70mg/dL的时间,得出每周的睡眠碎片,并使用Wilcoxon符号秩检验进行比较。还比较了患者报告的生活质量结果。
结果:20名患者(平均年龄,52岁;75%为女性;平均BMI21.5kg/m2)完成试验。隔夜输液从21:00开始,白天输液从09:00开始。未发现严重不良事件。24小时血糖没有差异(中位数(95%置信区间):白天=3.00(87.7,99.9)mg/dLvs.过夜=91.1(89.6,99.0)mg/dL;P=0.922)。白天(09:00-21:00),平均葡萄糖高13.5(5.7,22.0)mg/dL,与过夜相比,白天HPN低于70mg/dL的时间减少了15.0(-170.0,22.5)分钟。相反,在夜间(21:00-09:00),与过夜相比,日间HPN的平均血糖降低16.6(-23.1,-2.2)mg/dL.从肌动记法得出的睡眠和活动测量没有差异,然而,与夜间HPN相比,白天HPN的睡眠时间更晚,夜间光照更低.患者报告由于排尿引起的睡眠中断较少,并且白天HPN引起的无法控制的腹泻或造口术输出较少。
结论:日间HPN在成人SBS中是可行和安全的,与隔夜HPN相比,改善主观睡眠而不增加24小时血糖水平。
背景:注册ID:NCT04743960(临床试验。Gov);URL:https://classic。
结果:gov/ct2/show/NCT04743960。
Patients with short bowel syndrome (SBS) dependent on home parenteral nutrition (HPN) commonly cycle infusions overnight, likely contributing to circadian misalignment and sleep disruption.
The objective of this quasi-experimental, single-arm, controlled, pilot
trial was to examine the feasibility, safety, and efficacy of daytime infusions of HPN in adults with SBS without diabetes. Enrolled patients were fitted with a continuous glucose monitor and wrist actigraph and were instructed to cycle their infusions overnight for 1 wk, followed by daytime for another week. The 24-h average blood glucose, the time spent >140 mg/dL or <70 mg/dL, and sleep fragmentation were derived for each week and compared using Wilcoxon signed-rank test. Patient-reported quality-of-life outcomes were also compared between the weeks.
Twenty patients (mean age, 51.7 y; 75% female; mean body mass index, 21.5 kg/m2) completed the
trial. Overnight infusions started at 21:00 and daytime infusions at 09:00. No serious adverse events were noted. There were no differences in 24-h glycemia (daytime-median: 93.00 mg/dL; 95% CI: 87.7-99.9 mg/dL, compared with overnight-median: 91.1 mg/dL; 95% CI: 89.6-99.0 mg/dL; P = 0.922). During the day hours (09:00-21:00), the mean glucose concentrations were 13.5 (5.7-22.0) mg/dL higher, and the time spent <70 mg/dL was 15.0 (-170.0, 22.5) min lower with daytime than with overnight HPN. Conversely, during the night hours (21:00-09:00), the glucose concentrations were 16.6 (-23.1, -2.2) mg/dL lower with daytime than with overnight HPN. There were no differences in actigraphy-derived measures of sleep and activity rhythms; however, sleep timing was later, and light at night exposure was lower with daytime than with overnight HPN. Patients reported less sleep disruptions due to urination and fewer episodes of uncontrollable diarrhea or ostomy output with daytime HPN.
Daytime HPN was feasible and safe in adults with SBS and, compared with overnight HPN, improved subjective sleep without increasing 24-h glucose concentrations. This
trial was registered at clinicaltrials.gov as NCT04743960 (https://classic.
gov/ct2/show/NCT04743960).