摘要
背景:腹水是一种处理起来费时费力的肝硬化并发症。尽管低盐饮食是临床上治疗腹水的核心,但其疗效受限于患者的低依从性。我们旨在评估一种低盐的医学定制配餐(MTM)用于腹水治疗的可行性及疗效。方法:前瞻性纳入40例肝硬化腹水患者进行一个为期12周的1:1随机对照预试验,接受标准治疗(SOC)的患者遵照低盐饮食教育手册自由饮食;MTM组患者的配餐中,盐<2000 mg,热量>2100 kcal,蛋白质≥80 g。我们测算了入组患者的比例及其对MTM的依从性。本研究的主要结局指标是12周内穿刺抽水的次数,同时,我们还记录了腹水特异性生活质量(ASI-7)评分。结果:入组病例的中位年龄为54(IQR:47-63)岁,46%是女性,中位MELD-Na评分为18(IQR:11-23),中位白蛋白水平2.7(IQR:2.5-3.3)g/dL。作为基线资料,研究开始前4周内,患者接受穿刺抽水的中位次数为2(IQR:1-3)。入组病例住院期间对于配餐计划的依从性良好。12周后,MTM组患者每周所需的穿刺抽水次数显著低于SOC组[中位数(IQR):0.34(0.14-0.54)vs 0.45(0.25-0.64)]。研究期间,4例(20%)SOC组患者死亡,MTM组中2例死亡,1例行肝移植术。腹水特异性生活质量改善程度MTM组优于SOC组,分别为25%(IQR:-11%-61%)和13%(IQR:-28%-54%)。结论:对于腹水患者开展MTM临床试验是可行的,也是潜在有效的。两组患者都有获益,需要强调的是,该研究挑战性高,需加强宣教和密切监测。
Background:Ascites is a costly,morbid complication of cirrhosis.Although a low-sodium diet is central to the clinical management of ascites,its efficacy is limited by poor adherence.We aimed to determine the feasibility and impact of lowsodium medically tailored meals(MTM)intervention.Methods:We enrolled 40 persons with cirrhosis and ascites at the time of a paracentesis in a 12-week,1:1 randomized trial of standard of care(SOC)(low-sodiumdiet educational handout)or MTM with<2,000mg of sodium,>2,100 kcal,and>80 g of protein including a nocturnal protein supplement.We determined the proportion of eligible candidates recruited and adherence to MTM.The primary outcome was the number of paracenteses performed during weeks 0-12.We also collected ascites-specific quality-of-life(ASI-7)scores.Results:The median age of the enrolled subjects was 54(IQR,47-63)years,46%were female,with median MELD-Na 18(IQR,11-23)and albumin 2.7(IQR,2.5-3.3)g/dL.At baseline,subjects reported a median of two(IQR,1-3)paracenteses in the prior 4 weeks.Adherence to the meal schedule was excellent save for when hospitalizations occurred.After 12 weeks,patients in the MTM arm required fewer paracenteses per week than those in the SOC group[median(IQR):0.34(0.14-0.54)vs 0.45(0.25-0.64)].During the trial,four(20%)SOC patients died,whereas two(10%)died and one(5%)was transplanted in the MTM arm.Ascites-specific quality of life improved to a greater degree in the MTM arm compared to the SOC arm,by 25%(IQR,-11%to 61%)vs 13%(IQR,-28%to 54%).Conclusion:A trial of MTM for persons with ascites is feasible and potentially effective.Both arms experienced benefits,highlighting the role for improved education and closer monitoring in this challenging condition.
基金
the National Institutes of Health through the Michigan Institute for Clinical and Health Research[KL2TR002241]and NIDDK[1K23DK117055-01A1].
