Journal of Shanghai Jiao Tong University (Medical Science) ›› 2024, Vol. 44 ›› Issue (8): 1023-1029.doi: 10.3969/j.issn.1674-8115.2024.08.011
• Clinical research • Previous Articles
WU Wangshu(), WANG Minzhou, SONG Ahui, ZHAO Bingru, LU Jiayue, HONG Wenkai, GU Leyi, XIE Kewei, LU Renhua()
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:
CLC Number:
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.
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URL: https://xuebao.shsmu.edu.cn/EN/10.3969/j.issn.1674-8115.2024.08.011
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%) | 0.835① | 0.361 |
Dialysis duration/month | 29.1 (64.4) | 34.9 (58.1) | 181.000② | 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(%) | 10.608① | 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) |
Tab 1 Comparison of general characteristics between the two groups
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%) | 0.835① | 0.361 |
Dialysis duration/month | 29.1 (64.4) | 34.9 (58.1) | 181.000② | 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(%) | 10.608① | 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 | 102.000① | 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) | 127.000① | 0.050 |
Serum phosphorus/(mmol·L-1) | 2.09±0.35 | 1.87±0.38 | 125.500① | 0.045 |
Serum calcium/(mmol·L-1) | 1.77±0.51 | 2.21±0.25 | 68.500① | 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) | 155.000① | 0.338 |
hsCRP/(mg·L-1) | 2.55 (8.81) | 1.53 (2.19) | 106.000① | 0.018 |
Tab 2 Comparison of baseline parameters between the two groups
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 | 102.000① | 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) | 127.000① | 0.050 |
Serum phosphorus/(mmol·L-1) | 2.09±0.35 | 1.87±0.38 | 125.500① | 0.045 |
Serum calcium/(mmol·L-1) | 1.77±0.51 | 2.21±0.25 | 68.500① | 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) | 155.000① | 0.338 |
hsCRP/(mg·L-1) | 2.55 (8.81) | 1.53 (2.19) | 106.000① | 0.018 |
Time | Treatment group (n=21) | Control group (n=19) | ||||
---|---|---|---|---|---|---|
Serum albumin/(g·L-1) | t value① | P value① | Serum albumin/(g·L-1) | t value① | P value① | |
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 |
Tab 3 Comparison of serum albumin between the two groups
Time | Treatment group (n=21) | Control group (n=19) | ||||
---|---|---|---|---|---|---|
Serum albumin/(g·L-1) | t value① | P value① | Serum albumin/(g·L-1) | t value① | P value① | |
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 |
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 |
Tab 4 Comparison of serum albumin increase between the two groups
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 value① | P value① | Hemoglobin/ (g·L-1) | t value① | P value① | Serum ferritin/(μg·L-1) | t/Z value① | P value① |
---|---|---|---|---|---|---|---|---|---|
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 | -2.485② | 0.013 | 106.76±16.32 | 1.199 | 0.245 | 502.20 (450.15) | -1.894② | 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) | -0.080② | 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 |
Tab 5 Comparison of serum prealbumin, hemoglobin and ferritin between the two groups
Group | Serum prealbumin/(mg·L-1) | t/Z value① | P value① | Hemoglobin/ (g·L-1) | t value① | P value① | Serum ferritin/(μg·L-1) | t/Z value① | P value① |
---|---|---|---|---|---|---|---|---|---|
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 | -2.485② | 0.013 | 106.76±16.32 | 1.199 | 0.245 | 502.20 (450.15) | -1.894② | 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) | -0.080② | 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 |
Group | Serum phosphorus/(mmol·L-1) | t/Z value① | P value① | Serum calcium/(mmol·L-1) | t/Z value① | P value① | 1,25-(OH)2-D3/(ng·mL-1) | t/Z value① | P value① | iPTH/ (pg·mL-1) | t/Z value① | P value① |
---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | -1.568② | 0.117 | 2.32±0.19 | 4.922 | 0.000 | 18.31±8.74 | -2.374② | 0.018 | 218.00 (379.25) | 1.045 | 0.308 |
9-month | 1.81±0.38 | -2.103② | 0.035 | 2.42±0.25 | 5.008 | 0.000 | 15.50±8.07 | -0.282② | 0.778 | 211.20 (307.15) | -0.330② | 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 | -1.132② | 0.257 | 2.39±0.30 | -2.571② | 0.010 | 16.14±9.48 | -1.087② | 0.277 | 176.50 (270.35) | 0.000② | >0.999 |
6-month | 1.84±0.46 | -0.202 | 0.842 | 2.32±0.19 | 2.06 | 0.054 | 15.90±11.08 | -0.563② | 0.573 | 148.60 (189.88) | -0.675 | 0.509 |
9-month | 2.23±0.57 | -2.178② | 0.029 | 2.34±0.22 | -2.202② | 0.028 | 12.99±8.14 | -0.679 | 0.506 | 178.50 (209.18) | -0.081 | 0.936 |
Tab 6 Comparison of serum phosphorus, serum calcium, 1,25-(OH)2-D3 and iPTH between the two groups
Group | Serum phosphorus/(mmol·L-1) | t/Z value① | P value① | Serum calcium/(mmol·L-1) | t/Z value① | P value① | 1,25-(OH)2-D3/(ng·mL-1) | t/Z value① | P value① | iPTH/ (pg·mL-1) | t/Z value① | P value① |
---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | -1.568② | 0.117 | 2.32±0.19 | 4.922 | 0.000 | 18.31±8.74 | -2.374② | 0.018 | 218.00 (379.25) | 1.045 | 0.308 |
9-month | 1.81±0.38 | -2.103② | 0.035 | 2.42±0.25 | 5.008 | 0.000 | 15.50±8.07 | -0.282② | 0.778 | 211.20 (307.15) | -0.330② | 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 | -1.132② | 0.257 | 2.39±0.30 | -2.571② | 0.010 | 16.14±9.48 | -1.087② | 0.277 | 176.50 (270.35) | 0.000② | >0.999 |
6-month | 1.84±0.46 | -0.202 | 0.842 | 2.32±0.19 | 2.06 | 0.054 | 15.90±11.08 | -0.563② | 0.573 | 148.60 (189.88) | -0.675 | 0.509 |
9-month | 2.23±0.57 | -2.178② | 0.029 | 2.34±0.22 | -2.202② | 0.028 | 12.99±8.14 | -0.679 | 0.506 | 178.50 (209.18) | -0.081 | 0.936 |
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 |
Tab 7 Comparison of adverse event incidence between the two groups
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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