Effects of oral branched-chain amino acid granules on event-free survival in patients with liver cirrhosis
Effects of oral branched-chain amino acid granules on event-free survival in patients with liver cirrhosis
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DOI：
10.1016/s1542-3565(05)00017-0
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发表时间：
2005-07-01
影响因子：
12.6
通讯作者：
Kumada, H
中科院分区：
文献类型：
--
作者：
Muto, Y;Sato, S;Kumada, H
背景和目标：据报道，支链氨基酸（BCAA）营养干预可增加失代偿期肝硬化患者的血清白蛋白浓度。但它是否能提高患者的生存率尚未得出确切的结论。本研究的目的是测试通过使用适合长期口服的BCAA制剂来改善失代偿期肝硬化患者生存的可能性。研究方法：在646例失代偿期肝硬化患者中进行了一项多中心、随机和营养素摄入对照试验，比较了口服12 g/天BCAA 2年与限定每日食物摄入量（1.0-1.4 g蛋白质/kg（-1）/天，包括BCAA制剂和25-35 kcal/kg（-1）/天）的饮食治疗的效果。主要终点是任何原因导致的死亡、肝癌发展、食管静脉曲张破裂或肝功能衰竭进展（无事件生存）的复合终点。次要终点为血清白蛋白浓度和健康相关生活质量（QOL），采用简表-36问卷进行测量。结果如下：与饮食组相比，BCAA组的主要终点事件发生率显著降低（风险比，0.67; 95%置信区间，0.49-0.93; P = 0.015;中位观察期，445天）。与饮食组相比，BCAA组的血清白蛋白浓度显著增加（P = 0.018）。简表-36项措施中的“一般健康感知”领域也有所改善（P =.003）。患者对处方的依从性良好。结论：长期口服补充BCAA制剂可改善失代偿期肝硬化患者的无事件生存率、血清白蛋白浓度和生活质量，且每日食物摄入充足。
Background & Aims: Nutritional intervention with branched-chain amino acid (BCAA) is reported to increase serum albumin concentration in patients with decompensated cirrhosis. However, a definite conclusion on whether it can improve patients' survival has not yet been reached. The present study aimed to test possibilities of improving survival of patients with decompensated cirrhosis by using a BCAA preparation that is suitable for long-term oral administration. Methods: A multicenter, randomized, and nutrient intake-controlled trial on the comparative effects of BCAA orally administered at 12 g/day for 2 years versus diet therapy with defined daily food intake (1.0-1.4 g protein kg(-1) day(-1) including BCAA preparation and 25-35 kcal kg(-1) day(-1)) was conducted in 646 patients with decompensated cirrhosis. The primary end point was a composite of death by any cause, development of liver cancer, rupture of esophageal varices, or progress of hepatic failure (event-free survival). The secondary end points were serum albumin concentration and health-related quality of life (QOL) measured by Short Form-36 questionnaire. Results: The incidence of events comprising the primary end point significantly decreased in the BCAA group as compared with the diet group (hazard ratio, 0.67; 95% confidence interval, 0.49-0.93; P =.015; median observation period, 445 days). Serum albumin concentration increased significantly in the BCAA group as compared with the diet group (P =.018). The "general health perception" domain in Short Form-36 measures was also improved (P =.003). Patients' adherence to the prescription was favorable. Conclusions: Oral supplementation with a BCAA preparation that can be administered for a long period improves event-free survival, serum albumin concentration, and QOL in patients with decompensated cirrhosis with an adequate daily food intake.