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

doi:10.3969/j.issn.1674-8115.2024.08.011

上海交通大学学报（医学版） ›› 2024, Vol. 44 ›› Issue (8): 1023-1029.doi: 10.3969/j.issn.1674-8115.2024.08.011

• 论著 · 临床研究 • 上一篇

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

吴望舒(), 王旻洲, 宋阿会, 赵冰茹, 鲁嘉越, 洪文凯, 顾乐怡, 谢可炜, 陆任华()

上海交通大学医学院附属仁济医院肾脏科，上海 200127

收稿日期:2024-04-10 接受日期:2024-05-13 出版日期:2024-08-28 发布日期:2024-08-27
通讯作者: 陆任华 E-mail:wangshu0825@qq.com;lurenhua1977@hotmail.com
作者简介:吴望舒（1999—），女，博士生；电子信箱：wangshu0825@qq.com。
基金资助:
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)

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

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

Received:2024-04-10 Accepted:2024-05-13 Online:2024-08-28 Published:2024-08-27
Contact: LU Renhua E-mail:wangshu0825@qq.com;lurenhua1977@hotmail.com
Supported by:
Clinical Three-year Action Plan of Shanghai Hospital Development Center(SHDC2020CR4004);Scientific Research Seed Fund Training Program of Renji Hospital(RJZZ19-04);Clinical Medical Research Special Project of Chinese Medical Association(18020030782);National Natural Science Foundation of China(82000634);Shanghai Sailing Program(20YF1425000)

摘要/Abstract

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-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。

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

Abstract:

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.

Key words: renal dialysis, malnutrition, calcium metabolism disorder, phosphorus metabolism disorder, compound amino acid capsules

中图分类号:

R692.5

吴望舒, 王旻洲, 宋阿会, 赵冰茹, 鲁嘉越, 洪文凯, 顾乐怡, 谢可炜, 陆任华. 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[J]. 上海交通大学学报（医学版）, 2024, 44(8): 1023-1029.

WU Wangshu, WANG Minzhou, SONG Ahui, ZHAO Bingru, LU Jiayue, HONG Wenkai, GU Leyi, XIE Kewei, LU Renhua. Efficacy and safety of compound amino acid capsules in the treatment of malnutrition and calcium and phosphorus metabolism disorders in maintenance hemodialysis patients[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2024, 44(8): 1023-1029.

图/表 9

参考文献 24

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Item	Treatment group (n=21)	Control group (n=19)	t/χ²/U value	P value
Age/year	64.67±10.75	59.37±12.78	1.424	0.163
Male/n(%)	14 (66.7)	16 (84.2%)	0.835^①	0.361
Dialysis duration/month	29.1 (64.4)	34.9 (58.1)	181.000^②	0.616
Baseline body mass index/(kg·m^-2)	20.34±2.59	22.91±4.40	-1.251	0.219
Baseline Kt /V	1.60±0.40	1.57±0.26	0.211	0.834
Baseline ultrafiltration volume/mL	2 400.00±989.95	2 742.11±697.07	-1.273	0.211
Primary renal disease/n(%)			10.608^①	0.035
Chronic glomerulonephritis	6 (28.6)	6 (31.6)
Hypertensive nephrosclerosis	4 (20.0)	4 (21.1)
Diabetic nephropathy	0 (0)	1 (5.3)
Polycystic kidney	3 (7.5)	0 (0)
Other	5 (12.5)	0 (0)
Unknown causes	3 (27.5)	8 (42.1)

Item	Treatment group (n=21)	Control group (n=19)	t/χ²/U value	P value
Age/year	64.67±10.75	59.37±12.78	1.424	0.163
Male/n(%)	14 (66.7)	16 (84.2%)	0.835^①	0.361
Dialysis duration/month	29.1 (64.4)	34.9 (58.1)	181.000^②	0.616
Baseline body mass index/(kg·m^-2)	20.34±2.59	22.91±4.40	-1.251	0.219
Baseline Kt /V	1.60±0.40	1.57±0.26	0.211	0.834
Baseline ultrafiltration volume/mL	2 400.00±989.95	2 742.11±697.07	-1.273	0.211
Primary renal disease/n(%)			10.608^①	0.035
Chronic glomerulonephritis	6 (28.6)	6 (31.6)
Hypertensive nephrosclerosis	4 (20.0)	4 (21.1)
Diabetic nephropathy	0 (0)	1 (5.3)
Polycystic kidney	3 (7.5)	0 (0)
Other	5 (12.5)	0 (0)
Unknown causes	3 (27.5)	8 (42.1)

Item	Treatment group (n=21)	Control group (n=19)	t/U value	P value
Albumin/(g·L^-1)	35.20±3.05	37.47±2.19	102.000^①	0.008
Prealbumin/(mg·L^-1)	284.51±77.54	312.38±61.80	1.248	0.220
Hemoglobin/(g·L^-1)	102.14±14.64	112.05±15.52	2.078	0.045
Ferritin/(μg·L^-1)	454.50 (390.90)	247.70 (362.00)	127.000^①	0.050
Serum phosphorus/(mmol·L^-1)	2.09±0.35	1.87±0.38	125.500^①	0.045
Serum calcium/(mmol·L^-1)	1.77±0.51	2.21±0.25	68.500^①	0.000
1,25-(OH)₂-D₃/(ng·mL^-1)	14.59±5.03	13.87±6.45	0.382	0.705
iPTH/(pg·mL^-1)	221.00 (248.45)	147.05 (194.33)	155.000^①	0.338
hsCRP/(mg·L^-1)	2.55 (8.81)	1.53 (2.19)	106.000^①	0.018

Item	Treatment group (n=21)	Control group (n=19)	t/U value	P value
Albumin/(g·L^-1)	35.20±3.05	37.47±2.19	102.000^①	0.008
Prealbumin/(mg·L^-1)	284.51±77.54	312.38±61.80	1.248	0.220
Hemoglobin/(g·L^-1)	102.14±14.64	112.05±15.52	2.078	0.045
Ferritin/(μg·L^-1)	454.50 (390.90)	247.70 (362.00)	127.000^①	0.050
Serum phosphorus/(mmol·L^-1)	2.09±0.35	1.87±0.38	125.500^①	0.045
Serum calcium/(mmol·L^-1)	1.77±0.51	2.21±0.25	68.500^①	0.000
1,25-(OH)₂-D₃/(ng·mL^-1)	14.59±5.03	13.87±6.45	0.382	0.705
iPTH/(pg·mL^-1)	221.00 (248.45)	147.05 (194.33)	155.000^①	0.338
hsCRP/(mg·L^-1)	2.55 (8.81)	1.53 (2.19)	106.000^①	0.018

Time	Treatment group (n=21)			Control group (n=19)
Time	Serum albumin/(g·L^-1)	t value^①	P value^①	Serum albumin/(g·L^-1)	t value^①	P value^①
Baseline	35.20±3.05	‒	‒	37.47±2.19	‒	‒
3-month	36.41±3.74	1.700	0.105	38.57±2.92	2.057	0.054
6-month	37.53±2.75	3.574	0.002	38.01±3.22	1.173	0.256
9-month	39.42±2.73	5.599	0.000	38.92±1.73	3.670	0.002

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

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参考文献 24

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Metrics

Comparison	Serum albumin increase of treatment group/[g·L^-1 (95% CI)]	Serum albumin increase of control group/[g·L^-1 (95% CI)]	t value	P value
3-month vs baseline	1.21 (-0.27‒2.69)	1.10 (-0.02‒2.22)	0.121	0.904
6-month vs baseline	2.33 (0.97‒3.70)	0.53 (-0.42‒1.48)	2.222	0.032
9-month vs baseline	4.22 (2.65‒5.80)	1.08 (0.46‒1.71)	3.877	0.001

Group	Serum prealbumin/(mg·L^-1)	t/Z value^①	P value^①	Hemoglobin/ (g·L^-1)	t value^①	P value^①	Serum ferritin/(μg·L^-1)	t/Z value^①	P value^①
Treatment group
Baseline	284.51±77.54	‒	‒	102.14±14.64	‒	‒	454.50 (390.90)	‒	‒
3-month	267.21±78.38	-1.382	0.183	108.24±15.57	2.192	0.040	580.40 (639.70)	2.994	0.007
6-month	316.58±80.11	-2.485^②	0.013	106.76±16.32	1.199	0.245	502.20 (450.15)	-1.894^②	0.058
9-month	320.77±57.98	2.921	0.008	115.29±13.63	3.739	0.001	488.50 (451.25)	1.889	0.074
Control group
Baseline	312.38±61.80	‒	‒	112.05±15.52	‒	‒	247.70 (362.00)	‒	‒
3-month	296.45±55.78	-1.961	0.066	113.89±20.37	0.377	0.711	350.50 (345.90)	1.632	0.120
6-month	313.83±62.77	0.155	0.879	111.63±13.10	-0.184	0.856	214.30 (373.10)	-0.080^②	0.936
9-month	337.47±61.95	1.775	0.094	119.94±15.93	1.704	0.107	250.25 (384.95)	0.113	0.911

Scope	Treatment group (n=21)	Control group (n=19)	χ² value	P value
Total adverse event/n(%)	1 (4.76)	4 (21.05)	1.160	0.281
Cardio-cerebrovascular accidents/n(%)	1 (4.76)	3 (15.79)	0.401	0.527
Vascular access failure/n(%)	0 (0)	1 (4.76)	‒	0.475

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Group	Serum phosphorus/(mmol·L^-1)	t/Z value^①	P value^①	Serum calcium/(mmol·L^-1)	t/Z value^①	P value^①	1,25-(OH)₂-D₃/(ng·mL^-1)	t/Z value^①	P value^①	iPTH/ (pg·mL^-1)	t/Z value^①	P value^①
Treatment group
Baseline	2.09±0.35	‒	‒	1.77±0.51	‒	‒	14.59±5.03	‒	‒	221.00 (248.45)	‒	‒
3-month	1.67±0.45	-2.743	0.013	2.35±0.21	4.581	0.000	18.03±5.02	4.504	0.000	156.60 (276.15)	-0.362	0.722
6-month	1.87±0.63	-1.568^②	0.117	2.32±0.19	4.922	0.000	18.31±8.74	-2.374^②	0.018	218.00 (379.25)	1.045	0.308
9-month	1.81±0.38	-2.103^②	0.035	2.42±0.25	5.008	0.000	15.50±8.07	-0.282^②	0.778	211.20 (307.15)	-0.330^②	0.741
Control group
Baseline	1.87±0.38	‒	‒	2.21±0.25	‒	‒	13.87±6.45	‒	‒	147.05 (194.33)	‒	‒
3-month	1.79±0.53	-1.132^②	0.257	2.39±0.30	-2.571^②	0.010	16.14±9.48	-1.087^②	0.277	176.50 (270.35)	0.000^②	>0.999
6-month	1.84±0.46	-0.202	0.842	2.32±0.19	2.06	0.054	15.90±11.08	-0.563^②	0.573	148.60 (189.88)	-0.675	0.509
9-month	2.23±0.57	-2.178^②	0.029	2.34±0.22	-2.202^②	0.028	12.99±8.14	-0.679	0.506	178.50 (209.18)	-0.081	0.936

Group	Serum phosphorus/(mmol·L^-1)	t/Z value^①	P value^①	Serum calcium/(mmol·L^-1)	t/Z value^①	P value^①	1,25-(OH)₂-D₃/(ng·mL^-1)	t/Z value^①	P value^①	iPTH/ (pg·mL^-1)	t/Z value^①	P value^①
Treatment group
Baseline	2.09±0.35	‒	‒	1.77±0.51	‒	‒	14.59±5.03	‒	‒	221.00 (248.45)	‒	‒
3-month	1.67±0.45	-2.743	0.013	2.35±0.21	4.581	0.000	18.03±5.02	4.504	0.000	156.60 (276.15)	-0.362	0.722
6-month	1.87±0.63	-1.568^②	0.117	2.32±0.19	4.922	0.000	18.31±8.74	-2.374^②	0.018	218.00 (379.25)	1.045	0.308
9-month	1.81±0.38	-2.103^②	0.035	2.42±0.25	5.008	0.000	15.50±8.07	-0.282^②	0.778	211.20 (307.15)	-0.330^②	0.741
Control group
Baseline	1.87±0.38	‒	‒	2.21±0.25	‒	‒	13.87±6.45	‒	‒	147.05 (194.33)	‒	‒
3-month	1.79±0.53	-1.132^②	0.257	2.39±0.30	-2.571^②	0.010	16.14±9.48	-1.087^②	0.277	176.50 (270.35)	0.000^②	>0.999
6-month	1.84±0.46	-0.202	0.842	2.32±0.19	2.06	0.054	15.90±11.08	-0.563^②	0.573	148.60 (189.88)	-0.675	0.509
9-month	2.23±0.57	-2.178^②	0.029	2.34±0.22	-2.202^②	0.028	12.99±8.14	-0.679	0.506	178.50 (209.18)	-0.081	0.936