Abstract：
BACKGROUND: A series of interesting literature reports acknowledges the notable loss of essential and non-essential amino acids (EAAs and NEAAs) during hemodialysis sessions. These losses may exceed 800 g/year, thus contributing towards accelerating the onset of malnutrition in hemodialysis patients (HD).
OBJECTIVE: A novel tailored amino acid formula for oral administration was developed to replace total amounts of each individual amino acid lost during dialysis diffusive/convective HD strategies, monitoring the effects produced on nutritional and hematological status.
METHODS: A three-month randomized double-blind study was conducted on 30 subjects over the age of 70 years extrapolated from a total population of 86 hemodialysis patients. The 30 patients were randomly assigned to two groups: a treatment group of 15 HD patients (TG) to whom a novel mixture containing 5.4 g of AAs was administered solely on interdialytic days, and a control group of 15 HD patients (CG) who received no amino acid supplementation. The AAs mixture was administered post-dialysis at an extended interval from the end of solute and compartmental rebound to replace AA losses and optimize their role in protein anabolism.
RESULTS: The results obtained highlighted a significant improvement in protein intake g/kg/day (Protein Catabolic Rate, p = 0.014), and increased IgG (p = 0.008) and C3 serum levels (p = 0.003) in the TG group alone. Fat mass losses were initially confirmed by means of bioelectrical impedance analysis (BIA) (p = 0.011) and plicometry (p < 0.001) in the CG group alone, although the main objective was to preserve nutritional status and, particularly, muscle mass. The study was extended to investigate the effects produced on anemia, yielding evidence of continued positive effects three months after the end of the study in the TG group alone based on an increase in Hb levels from 11.2 ± 0.6 to 12.1 ± 0.6 (p = 0.004) associated with a reduced demand for erythropoietin i.v. from 12928 ± 9033 to 9286 ± 5398 U.I/week (p = 0.012) and iron i.v. from 75.9 ± 55 to 71.4 ± 33.4 mg/week (p = 0.045).
CONCLUSIONS: The results obtained following oral administration of this novel tailored AA replacement mixture aimed at reinstating the high AA losses produced during hemodialysis suggest the mixture should be prescribed as a standard procedure to all HD patients.
OBJECTIVE: A novel tailored amino acid formula for oral administration was developed to replace total amounts of each individual amino acid lost during dialysis diffusive/convective HD strategies, monitoring the effects produced on nutritional and hematological status.
METHODS: A three-month randomized double-blind study was conducted on 30 subjects over the age of 70 years extrapolated from a total population of 86 hemodialysis patients. The 30 patients were randomly assigned to two groups: a treatment group of 15 HD patients (TG) to whom a novel mixture containing 5.4 g of AAs was administered solely on interdialytic days, and a control group of 15 HD patients (CG) who received no amino acid supplementation. The AAs mixture was administered post-dialysis at an extended interval from the end of solute and compartmental rebound to replace AA losses and optimize their role in protein anabolism.
RESULTS: The results obtained highlighted a significant improvement in protein intake g/kg/day (Protein Catabolic Rate, p = 0.014), and increased IgG (p = 0.008) and C3 serum levels (p = 0.003) in the TG group alone. Fat mass losses were initially confirmed by means of bioelectrical impedance analysis (BIA) (p = 0.011) and plicometry (p < 0.001) in the CG group alone, although the main objective was to preserve nutritional status and, particularly, muscle mass. The study was extended to investigate the effects produced on anemia, yielding evidence of continued positive effects three months after the end of the study in the TG group alone based on an increase in Hb levels from 11.2 ± 0.6 to 12.1 ± 0.6 (p = 0.004) associated with a reduced demand for erythropoietin i.v. from 12928 ± 9033 to 9286 ± 5398 U.I/week (p = 0.012) and iron i.v. from 75.9 ± 55 to 71.4 ± 33.4 mg/week (p = 0.045).
CONCLUSIONS: The results obtained following oral administration of this novel tailored AA replacement mixture aimed at reinstating the high AA losses produced during hemodialysis suggest the mixture should be prescribed as a standard procedure to all HD patients.
摘要：
背景：一系列有趣的文献报道承认在血液透析期间必需和非必需氨基酸（EAA和NEAA）的显著损失。这些损失可能超过800克/年，因此有助于加速血液透析患者（HD）营养不良的发作。
目的：开发了一种用于口服给药的新型定制氨基酸配方，以替代透析扩散/对流HD策略期间损失的每种氨基酸的总量，监测对营养和血液状态产生的影响。
方法：对30名70岁以上的受试者进行了为期三个月的随机双盲研究，这些受试者是从86名血液透析患者的总人口中推断出来的。将30名患者随机分为两组：一个由15名HD患者（TG）组成的治疗组，仅在透析间日给予含有5.4gAA的新型混合物。和一个由15名没有接受氨基酸补充的HD患者（CG）组成的对照组。从溶质和房室反弹结束开始，透析后间隔较长的时间给药AA混合物，以替代AA损失并优化其在蛋白质合成代谢中的作用。
结果：获得的结果强调了蛋白质摄入量g/kg/天（蛋白质分解代谢率，p=0.014),仅TG组的IgG（p=0.008）和C3血清水平（p=0.003）增加。在单独的CG组中，通过生物电阻抗分析（BIA）（p=0.011）和增重法（p<0.001）初步确认了脂肪质量损失。虽然主要目标是保持营养状况，特别是,肌肉质量。这项研究被扩展到调查对贫血产生的影响，基于Hb水平从11.2±0.6增加到12.1±0.6（p=0.004），与促红细胞生成素i.v.从12928±9033到9286±5398U.I/周（p=0.012）和铁i.v.从75.9±55到71.4±33.4mg/周（p=0.045）的减少相关，仅在研究结束后三个月，TG组继续产生积极作用。
结论：口服这种旨在恢复血液透析过程中产生的高AA损失的新型定制AA替代混合物后获得的结果表明，该混合物应作为所有HD患者的标准程序。
目的：开发了一种用于口服给药的新型定制氨基酸配方，以替代透析扩散/对流HD策略期间损失的每种氨基酸的总量，监测对营养和血液状态产生的影响。
方法：对30名70岁以上的受试者进行了为期三个月的随机双盲研究，这些受试者是从86名血液透析患者的总人口中推断出来的。将30名患者随机分为两组：一个由15名HD患者（TG）组成的治疗组，仅在透析间日给予含有5.4gAA的新型混合物。和一个由15名没有接受氨基酸补充的HD患者（CG）组成的对照组。从溶质和房室反弹结束开始，透析后间隔较长的时间给药AA混合物，以替代AA损失并优化其在蛋白质合成代谢中的作用。
结果：获得的结果强调了蛋白质摄入量g/kg/天（蛋白质分解代谢率，p=0.014),仅TG组的IgG（p=0.008）和C3血清水平（p=0.003）增加。在单独的CG组中，通过生物电阻抗分析（BIA）（p=0.011）和增重法（p<0.001）初步确认了脂肪质量损失。虽然主要目标是保持营养状况，特别是,肌肉质量。这项研究被扩展到调查对贫血产生的影响，基于Hb水平从11.2±0.6增加到12.1±0.6（p=0.004），与促红细胞生成素i.v.从12928±9033到9286±5398U.I/周（p=0.012）和铁i.v.从75.9±55到71.4±33.4mg/周（p=0.045）的减少相关，仅在研究结束后三个月，TG组继续产生积极作用。
结论：口服这种旨在恢复血液透析过程中产生的高AA损失的新型定制AA替代混合物后获得的结果表明，该混合物应作为所有HD患者的标准程序。
