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  

Efficacy and safety of compound amino acid capsules in the treatment of malnutrition and calcium and phosphorus metabolism disorders in maintenance hemodialysis patients

作　　者：吴望舒 王旻洲 宋阿会 赵冰茹 鲁嘉越[1] 洪文凯 顾乐怡[1] 谢可炜[1] 陆任华[1] WU Wangshu;WANG Minzhou;SONG Ahui;ZHAO Bingru;LU Jiayue;HONG Wenkai;GU Leyi;XIE Kewei;LU Renhua(Department of Nephrology,Renji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200127,China)

机构地区：[1]上海交通大学医学院附属仁济医院肾脏科,上海200127

出　　处：《上海交通大学学报（医学版）》2024年第8期1023-1029,共7页Journal of Shanghai Jiao tong University:Medical Science

基　　金：上海申康医院发展中心临床三年行动计划(SHDC2020CR4004);2019年度上海交通大学医学院附属仁济医院科研种子基金培养计划(RJZZ19-04);2019中华医学会临床医学科研专项(18020030782);国家自然科学基金(82000634);上海市青年科技英才扬帆计划(20YF1425000)。

摘　　要：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)-D_(3)]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)-D_(3)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)-D_(3)t/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)-D_(3)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)-D_(3) and intact parathyroid hormone levels were analyzed every 3 months,and the incidence of adverse events including death,cardiocerebrovascular 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)-D_(3) 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)-D_(3) t/Z=4.504,−2.374,both P<0.05),while the increase in blood calcium in the control group was signific

关 键 词：肾透析 营养障碍 钙代谢障碍 磷代谢障碍 复方氨基酸胶囊 

分 类 号：R692.5[医药卫生—泌尿科学]