Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (4): 873-880.DOI: 10.19852/j.cnki.jtcm.2025.04.017
• Original Articles • Previous Articles Next Articles
SUN Weiwei1,2, ZHANG Jiale1,2, YANG Hanwen1,2, YAN Runze1,2, WEI Shuwu1,2, WU Qiaoru1,2, CUI Zhaoli1,2, ZHENG Huijuan3(
), WANG Yaoxian1,2(
)
Received:2024-04-22
Accepted:2024-11-25
Online:2025-08-15
Published:2025-07-25
Contact:
ZHENG Huijuan,WANG Yaoxian
About author:ZHENG Huijuan, Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China. tcmzhenghuijuan@163.com,Telephone: +86-10-84013190Supported by:SUN Weiwei, ZHANG Jiale, YANG Hanwen, YAN Runze, WEI Shuwu, WU Qiaoru, CUI Zhaoli, ZHENG Huijuan, WANG Yaoxian. Traditional Chinese herbal medicine Qingre Xiaozheng formula (清热消癥方) improves renal outcomes in patients with diabetic kidney disease: a retrospective study[J]. Journal of Traditional Chinese Medicine, 2025, 45(4): 873-880.
| Item | All Patients (n = 144) | Treatment group (n = 72) | Control group (n = 72) | P value | |
|---|---|---|---|---|---|
| Sex [n (%)] | Men | 100 (69.4) | 50 (50.0) | 50 (50.0) | 1.000 |
| Women | 44 (30.6) | 22 (50.0) | 22 (50.0) | ||
| Age (years) | 58.7±9.6 | 56.7±9.7 | 55.7±6.7 | 0.790 | |
| BMI (kg/m2) | 26.0±3.6 | 25.6±3.7 | 27.5±4.5 | 0.277 | |
| SBP (mm Hg) | 140.0±17.8 | 142.0±18.1 | 147.0±12.9 | 0.012 | |
| DBP (mm Hg) | 79.0±10.1 | 81.0±13.1 | 80.0±9.5 | 0.166 | |
| Course of diabetes (years) | 16.1±6.6 | 17.7±6.3 | 14.2±6.8 | 0.266 | |
| Course of proteinuria (months) | 44.1±56.2 | 42.7±50.2 | 55.0±65.9 | 0.710 | |
| Smoking [n (%)] | 70 (48.6) | 32 (45.7) | 38 (54.3) | 0.198 | |
| Drinking [n (%)] | 46 (31.9) | 20 (43.5) | 26 (56.5) | 0.284 | |
| Education [n (%)] | ≤6 years | 15 (10.4) | 7 (46.7) | 8 (53.3) | 0.632 |
| 6-12 years | 92 (63.9) | 44 (47.8) | 48 (52.2) | ||
| ≥12 years | 37 (25.7) | 21 (56.8) | 16 (43.2) | ||
| Coexisting diseases [n (%)] | Hypertension | 126 (88.7) | 62 (49.2) | 64 (50.8) | 0.596 |
| Hyperlipidemia | 107 (75.4) | 51 (47.7) | 56 (52.3) | 0.330 | |
| Hyperuricemia | 29 (20.4) | 16 (55.2) | 13 (44.8) | 0.532 | |
| Fatty liver | 44 (31.0) | 22 (50.0) | 22 (50.0) | 1.000 | |
| Coronary heart disease [n (%)] | 38 (29.0) | 15 (39.5) | 23 (60.5) | 0.110 | |
| Cerebrovascular disease [n (%)] | 27 (19.0) | 12 (44.4) | 15 (55.6) | 0.521 | |
| Albumin (g/L) | 36.6±5.5 | 32.6±5.8 | 32.8±4.7 | 0.443 | |
| Alanine aminotransferase (U/L) | 22.3±15.6 | 19.6±14.6 | 21.5±10.7 | 0.947 | |
| Aspartate aminotransferase (U/L) | 20.4±9.1 | 19.5±7.2 | 18.4±5.2 | 0.516 | |
| Glucose (mmol/L) | 8.0±2.2 | 7.7±2.2 | 8.3±2.2 | 0.102 | |
| Glycated hemoglobin (%) | 7.0±1.0 | 6.9±1.0 | 7.1±1.0 | 0.138 | |
| eGFR (mL/min per 1.73 m2) | 71.8±26.3 | 60.0±19.0 | 58.1±23.7 | 0.129 | |
| Serum creatinine (μmol/L) | 101.3±35.8 | 114.8±32.9 | 123.5±41.3 | 0.089 | |
| Blood urea nitrogen (mmol/L) | 8.5±3.5 | 9.0±2.9 | 9.7±3.7 | 0.144 | |
| Serum uric acid (μmol/L) | 376.0±103.1 | 365.2±106.9 | 386.9±98.8 | 0.207 | |
| Cholesterol (mmol/L) | 5.1±1.5 | 5.0±1.4 | 5.3±1.6 | 0.273 | |
| Triglyceride (mmol/L) | 2.9±3.1 | 2.7±1.1 | 3.3±3.5 | 0.703 | |
| LDL-C (mmol/L) | 2.9±1.0 | 3.4±1.2 | 3.5±1.3 | 0.375 | |
| 24 h total urine protein (g/24 h) | 3.3±3.1 | 6.5±2.6 | 7.1±3.3 | 0.704 | |
Table 1 Baseline characteristics between the treatment group and the control group among patients with diabetic kidney disease
| Item | All Patients (n = 144) | Treatment group (n = 72) | Control group (n = 72) | P value | |
|---|---|---|---|---|---|
| Sex [n (%)] | Men | 100 (69.4) | 50 (50.0) | 50 (50.0) | 1.000 |
| Women | 44 (30.6) | 22 (50.0) | 22 (50.0) | ||
| Age (years) | 58.7±9.6 | 56.7±9.7 | 55.7±6.7 | 0.790 | |
| BMI (kg/m2) | 26.0±3.6 | 25.6±3.7 | 27.5±4.5 | 0.277 | |
| SBP (mm Hg) | 140.0±17.8 | 142.0±18.1 | 147.0±12.9 | 0.012 | |
| DBP (mm Hg) | 79.0±10.1 | 81.0±13.1 | 80.0±9.5 | 0.166 | |
| Course of diabetes (years) | 16.1±6.6 | 17.7±6.3 | 14.2±6.8 | 0.266 | |
| Course of proteinuria (months) | 44.1±56.2 | 42.7±50.2 | 55.0±65.9 | 0.710 | |
| Smoking [n (%)] | 70 (48.6) | 32 (45.7) | 38 (54.3) | 0.198 | |
| Drinking [n (%)] | 46 (31.9) | 20 (43.5) | 26 (56.5) | 0.284 | |
| Education [n (%)] | ≤6 years | 15 (10.4) | 7 (46.7) | 8 (53.3) | 0.632 |
| 6-12 years | 92 (63.9) | 44 (47.8) | 48 (52.2) | ||
| ≥12 years | 37 (25.7) | 21 (56.8) | 16 (43.2) | ||
| Coexisting diseases [n (%)] | Hypertension | 126 (88.7) | 62 (49.2) | 64 (50.8) | 0.596 |
| Hyperlipidemia | 107 (75.4) | 51 (47.7) | 56 (52.3) | 0.330 | |
| Hyperuricemia | 29 (20.4) | 16 (55.2) | 13 (44.8) | 0.532 | |
| Fatty liver | 44 (31.0) | 22 (50.0) | 22 (50.0) | 1.000 | |
| Coronary heart disease [n (%)] | 38 (29.0) | 15 (39.5) | 23 (60.5) | 0.110 | |
| Cerebrovascular disease [n (%)] | 27 (19.0) | 12 (44.4) | 15 (55.6) | 0.521 | |
| Albumin (g/L) | 36.6±5.5 | 32.6±5.8 | 32.8±4.7 | 0.443 | |
| Alanine aminotransferase (U/L) | 22.3±15.6 | 19.6±14.6 | 21.5±10.7 | 0.947 | |
| Aspartate aminotransferase (U/L) | 20.4±9.1 | 19.5±7.2 | 18.4±5.2 | 0.516 | |
| Glucose (mmol/L) | 8.0±2.2 | 7.7±2.2 | 8.3±2.2 | 0.102 | |
| Glycated hemoglobin (%) | 7.0±1.0 | 6.9±1.0 | 7.1±1.0 | 0.138 | |
| eGFR (mL/min per 1.73 m2) | 71.8±26.3 | 60.0±19.0 | 58.1±23.7 | 0.129 | |
| Serum creatinine (μmol/L) | 101.3±35.8 | 114.8±32.9 | 123.5±41.3 | 0.089 | |
| Blood urea nitrogen (mmol/L) | 8.5±3.5 | 9.0±2.9 | 9.7±3.7 | 0.144 | |
| Serum uric acid (μmol/L) | 376.0±103.1 | 365.2±106.9 | 386.9±98.8 | 0.207 | |
| Cholesterol (mmol/L) | 5.1±1.5 | 5.0±1.4 | 5.3±1.6 | 0.273 | |
| Triglyceride (mmol/L) | 2.9±3.1 | 2.7±1.1 | 3.3±3.5 | 0.703 | |
| LDL-C (mmol/L) | 2.9±1.0 | 3.4±1.2 | 3.5±1.3 | 0.375 | |
| 24 h total urine protein (g/24 h) | 3.3±3.1 | 6.5±2.6 | 7.1±3.3 | 0.704 | |
Figure 1 Kaplan-Meier estimates of survival during follow-up in diabetic kidney disease between the treatment group and the control group (Log Rank P = 0.023) Treatment group: received conventional Western Medicine plus QRXZF (oral administration, 1 dose/day divided into 2 portions for morning and evening intake, 24-week course); Control group: received conventional Western Medicine only. QRXZF: Qingre Xiaozheng formula.
Figure 2 Forest plots of multivariate analysis of renal endpoint events Sex, age, group, 24h-UTP, coronary heart disease, SBP, albumin, blood urea nitrogen, cholesterol and LDL-C were all adjusted except the variable itself. 24h-UTP: 24 h urinary total protein; SBP: systolic blood pressure; LDL-C: low density lipoprotein cholesterol.
| Item | Treatment group (n = 23) | Control group (n = 25) | P value | |
|---|---|---|---|---|
| Sex, n (%) | Men | 15 (46.9) | 17 (53.1) | 0.838 |
| Women | 8 (50.0) | 8 (50.0) | ||
| Age (years) | 56.7±9.7 | 55.7±6.7 | 0.661 | |
| BMI (kg/m2) | 25.6±3.7 | 27.5±4.5 | 0.077 | |
| SBP (mm Hg) | 142.0±18.1 | 147.0±12.9 | 0.058 | |
| DBP (mm Hg) | 81.0±13.1 | 80.0±9.5 | 0.860 | |
| Course of diabetes (years) | 17.8±6.3 | 14.2±6.8 | 0.069 | |
| Course of proteinuria (months) | 42.7±50.2 | 55.0±65.9 | 0.671 | |
| Smoking [n (%)] | 11 (47.8) | 12 (52.2) | 0.308 | |
| Drinking [n (%)] | 6 (37.5) | 10 (62.5) | 0.307 | |
| Education [n (%)] | ≤6 years | 4 (57.1) | 3 (42.9) | 0.686 |
| 6-12 years | 14 (50.0) | 14 (50.0) | ||
| ≥12 years | 5 (38.5) | 8 (61.5) | ||
| Coexisting diseases [n (%)] | Hypertension | 20 (45.5) | 24 (54.5) | 0.476 |
| Hyperlipidemia | 17 (45.9) | 20 (54.1) | 0.820 | |
| Hyperuricemia | 4 (40.0) | 6 (60.0) | 0.627 | |
| Fatty liver | 3 (27.3) | 8 (72.7) | 0.138 | |
| Coronary heart disease | 7 (41.2) | 10 (58.8) | 0.565 | |
| Cerebrovascular disease | 2 (33.3) | 4 (66.7) | 0.479 | |
| Albumin (g/L) | 32.6±5.8 | 32.8±4.7 | 0.891 | |
| Alanine aminotransferase (U/L) | 19.6±14.6 | 21.5±10.7 | 0.292 | |
| Aspartate aminotransferase (U/L) | 19.5±7.2 | 18.4±5.2 | 0.650 | |
| Glucose (mmol/L) | 7.2±2.2 | 8.0±2.1 | 0.261 | |
| Glycated hemoglobin (%) | 6.6 ±1.0 | 7.0±0.9 | 0.165 | |
| eGFR (mL/min per 1.73 m2) | 60.0±19.0 | 58.1±23.7 | 0.556 | |
| Serum creatinine (μmol/L) | 114.8±32.9 | 123.5±41.3 | 0.427 | |
| Blood urea nitrogen (mmol/L) | 9.0±2.9 | 9.7±3.7 | 0.520 | |
| Serum uric acid (μmol/L) | 350.3±117.5 | 371.7±129.1 | 0.529 | |
| Cholesterol (mmol/L) | 6.0±1.3 | 5.8±1.9 | 0.536 | |
| Triglyceride (mmol/L) | 2.7±1.1 | 3.3±3.5 | 0.726 | |
| LDL-C (mmol/L) | 3.4 ±1.2 | 3.5±1.3 | 0.852 | |
Table 2 Baseline characteristics of diabetic kidney disease according to albuminuria
| Item | Treatment group (n = 23) | Control group (n = 25) | P value | |
|---|---|---|---|---|
| Sex, n (%) | Men | 15 (46.9) | 17 (53.1) | 0.838 |
| Women | 8 (50.0) | 8 (50.0) | ||
| Age (years) | 56.7±9.7 | 55.7±6.7 | 0.661 | |
| BMI (kg/m2) | 25.6±3.7 | 27.5±4.5 | 0.077 | |
| SBP (mm Hg) | 142.0±18.1 | 147.0±12.9 | 0.058 | |
| DBP (mm Hg) | 81.0±13.1 | 80.0±9.5 | 0.860 | |
| Course of diabetes (years) | 17.8±6.3 | 14.2±6.8 | 0.069 | |
| Course of proteinuria (months) | 42.7±50.2 | 55.0±65.9 | 0.671 | |
| Smoking [n (%)] | 11 (47.8) | 12 (52.2) | 0.308 | |
| Drinking [n (%)] | 6 (37.5) | 10 (62.5) | 0.307 | |
| Education [n (%)] | ≤6 years | 4 (57.1) | 3 (42.9) | 0.686 |
| 6-12 years | 14 (50.0) | 14 (50.0) | ||
| ≥12 years | 5 (38.5) | 8 (61.5) | ||
| Coexisting diseases [n (%)] | Hypertension | 20 (45.5) | 24 (54.5) | 0.476 |
| Hyperlipidemia | 17 (45.9) | 20 (54.1) | 0.820 | |
| Hyperuricemia | 4 (40.0) | 6 (60.0) | 0.627 | |
| Fatty liver | 3 (27.3) | 8 (72.7) | 0.138 | |
| Coronary heart disease | 7 (41.2) | 10 (58.8) | 0.565 | |
| Cerebrovascular disease | 2 (33.3) | 4 (66.7) | 0.479 | |
| Albumin (g/L) | 32.6±5.8 | 32.8±4.7 | 0.891 | |
| Alanine aminotransferase (U/L) | 19.6±14.6 | 21.5±10.7 | 0.292 | |
| Aspartate aminotransferase (U/L) | 19.5±7.2 | 18.4±5.2 | 0.650 | |
| Glucose (mmol/L) | 7.2±2.2 | 8.0±2.1 | 0.261 | |
| Glycated hemoglobin (%) | 6.6 ±1.0 | 7.0±0.9 | 0.165 | |
| eGFR (mL/min per 1.73 m2) | 60.0±19.0 | 58.1±23.7 | 0.556 | |
| Serum creatinine (μmol/L) | 114.8±32.9 | 123.5±41.3 | 0.427 | |
| Blood urea nitrogen (mmol/L) | 9.0±2.9 | 9.7±3.7 | 0.520 | |
| Serum uric acid (μmol/L) | 350.3±117.5 | 371.7±129.1 | 0.529 | |
| Cholesterol (mmol/L) | 6.0±1.3 | 5.8±1.9 | 0.536 | |
| Triglyceride (mmol/L) | 2.7±1.1 | 3.3±3.5 | 0.726 | |
| LDL-C (mmol/L) | 3.4 ±1.2 | 3.5±1.3 | 0.852 | |
Figure 3 Kaplan-Meier survival estimates during follow-up in patients with diabetic kidney disease and 24 h-urinary total protein ≥ 3.5 g, between the treatment group and the control group (Log Rank P = 0.023) Treatment group: received conventional Western Medicine plus QRXZF (oral administration, 1 dose/day divided into 2 portions for morning and evening intake, 24-week course); control group: received conventional Western Medicine only. QRXZF: Qingre Xiaozheng formula.
Figure 4 Forest plots of multivariate analysis of renal endpoint events for patients with diabetic kidney disease and 24 h-urinary total protein ≥3.5 g Sex, age, group, smoking, and systolic blood pressure were all adjusted except the variable itself. SBP: systolic blood pressure.
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