目的·探索复方氨基酸胶囊治疗维持性血液透析患者营养不良及钙磷代谢障碍的有效性和安全性。方法·采用前瞻性、随机、对照、单中心的研究设计，40例上海交通大学医学院附属仁济医院的维持性血液透析患者随机分入治疗组（n=21）和对照组（n=19），治疗组在维持性血液透析常规治疗的基础上予口服复方氨基酸胶囊，对照组无特殊营养干预，每3月检测1次2组患者的血清白蛋白、前白蛋白、血红蛋白、铁蛋白，血钙、血磷、1, 25-二羟维生素D3［1, 25-(OH)₂-D₃］和全段甲状旁腺激素水平，并记录死亡、心脑血管意外、血管通路失功等不良事件的发生情况，共随访9个月。结果·治疗组血清白蛋白和前白蛋白水平在第6月和第9月时较基线升高（白蛋白t=3.574、5.599，均P<0.05；前白蛋白t/Z=-2.485、2.921，均P<0.05），对照组白蛋白在第9月开始升高，但增幅显著小于治疗组（t=3.877，P=0.001），前白蛋白水平则无明显变化。治疗组血红蛋白和铁蛋白水平在第3月即出现升高（血红蛋白t=2.192，铁蛋白t=2.994，均P<0.05）。治疗组血磷在第3月和第9月时较基线明显降低（t/Z=-2.743、-2.103，均P<0.05），而对照组血磷在第3月和第6月时无明显变化，第9月时较基线升高（Z=-2.178，P=0.029）。治疗组血钙和1, 25-（OH）₂-D₃水平在第3月和第6月均较基线升高（血钙t=4.581、4.922，均P=0.000；1, 25-（OH）₂-D₃t/Z=4.504、-2.374，均P<0.05），对照组血钙增幅显著小于同时期治疗组，1, 25-（OH）₂-D₃水平则无明显变化。2组患者的血全段甲状旁腺素水平、不良事件发生率及其他实验室指标在随访期内无统计学差异。结论·复方氨基酸胶囊在改善维持性血液透析患者营养状况、调节钙磷代谢方面有一定的疗效，且安全性高。

Objective ·To explore the efficacy and safety of compound amino acid capsules in the treatment of malnutrition and calcium and phosphorus metabolism disorders in maintenance hemodialysis patients. Methods ·In this prospective, randomized, controlled, single-center study, forty maintenance hemodialysis patients from Renji Hospital, Shanghai Jiao Tong University School of Medicine were randomly divided into two groups, the treatment group (n=21) and the control group (n=19). The treatment group was given oral compound amino acid capsules on the basis of regular hemodialysis treatment, while the control group received no special nutritional intervention. Serum albumin, prealbumin, hemoglobin, ferritin, calcium, phosphorus, 1,25-(OH)₂-D₃ and intact parathyroid hormone levels were analyzed every 3 months, and the incidence of adverse events including death, cardio-cerebrovascular accidents and vascular access failure was recorded. The total follow-up period was 9 months. Results ·Serum albumin and prealbumin in the treatment group at 6-month and 9-month were significantly higher than the baseline parameters (albumin, t=3.574, 5.599, both P<0.05; prealbumin, t/Z=-2.485, 2.921, both P<0.05). Albumin in the control group increased at 9-month with a lower amplification compared to the treatment group (t=3.877, P=0.001), while the difference of prealbumin showed no statistical significance during follow-up. Hemoglobin and serum ferritin in the treatment group started to increase at 3-month (hemoglobin, t=2.192; ferritin, t=2.994; both P<0.05). Phosphorus in treatment group decreased at 3-month and 9-month (t/Z=-2.743, -2.103, both P<0.05), while phosphorus in the control group remained relatively stable during the first 6 months and increased at 9-month (Z=-2.178, P=0.029). Calcium and 1,25-(OH)₂-D₃ in the treatment group at 3-month and 6-month were significantly higher than the baseline parameters (calcium, t=4.581, 4.922, both P=0.000; 1,25-(OH)₂-D₃t/Z=4.504, -2.374, both P<0.05), while the increase in blood calcium in the control group was significantly smaller than that in the treatment group during the same period. 1,25-(OH)₂-D₃ in the control group showed no significant improvement. There was no significant difference in intact parathyroid hormone level, incidence of adverse events and other laboratory examination results between the two groups. Conclusion ·Compound amino acid capsules can ameliorate the nutrition status and regulate calcium and phosphorus metabolism effectively and safely in maintenance hemodialysis patients.