Journal of Traditional Chinese Medicine ›› 2022, Vol. 42 ›› Issue (2): 234-241.DOI: 10.19852/j.cnki.jtcm.20210220.001
• Research Articles • Previous Articles Next Articles
XIA Wenguang1, ZHENG Chanjuan1, ZHANG Jixian2, HUANG Min1,3, LI Qinglin1, DUAN Can1, LI Zhengliang1, FAN Cunyu2, ZOU Yilong2, XU Bo2, YANG Fengwen4, LIU Qingquan5()
Received:
2021-01-06
Accepted:
2021-02-19
Online:
2022-04-01
Published:
2022-04-01
Contact:
LIU Qingquan
About author:
LIU Qingquan, Emergency Department, Beijing Hospital of tra ditional Chinese Medicine, Beijing 100010, China. hxyykfzx@163.com, Telephone: +86-13910055687Supported by:
XIA Wenguang, ZHENG Chanjuan, ZHANG Jixian, HUANG Min, LI Qinglin, DUAN Can, LI Zhengliang, FAN Cunyu, ZOU Yilong, XU Bo, YANG Fengwen, LIU Qingquan. Randomized controlled study of a diagnosis and treatment plan for moderate coronavirus disease 2019 that integrates Traditional Chinese and Western Medicine[J]. Journal of Traditional Chinese Medicine, 2022, 42(2): 234-241.
Characteristics | Total | Experimental group (n = 80) | Control group (n = 40) | P valuea | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Age (years, $\bar{x}± s$) | 55.5±13.1 | 55.1±13.7 | 56.3±11.9 | 0.649 | |||||||
18-40 | 20 (16.7) | 15 (18.8) | 5 (12.5) | 0.386 | |||||||
41-60 | 48 (40.0) | 31 (38.8) | 17 (42.5) | 0.693 | |||||||
61-80 | 52 (43.3) | 34 (42.5) | 18 (45.0) | 0.794 | |||||||
Sex, n (%) | Female | 69 (57.5) | 45 (56.3) | 24 (60.0) | 0.695 | ||||||
Male | 51 (42.5) | 35 (43.8) | 16 (40.0) | ||||||||
Smokers (active/ex-) | 38 (31.7) | 26 (32.5) | 12 (30.0) | 0.781 | |||||||
Alcohol drinkers | 34 (28.3) | 24 (30.0) | 10 (25.0) | 0.567 | |||||||
Comorbidities [n (%)] | Pulmonary tuberculosis | 2 (1.7) | 1 (1.3) | 1 (2.5) | 1 | ||||||
COPD | 2 (1.7) | 1 (1.3) | 1 (2.5) | 1 | |||||||
Hypertension | 59 (49.2) | 40 (50.0) | 19 (47.5) | 0.796 | |||||||
Diabetes | 28 (23.3) | 20 (25.0) | 8 (20.0) | 0.542 | |||||||
CKD | 3 (2.5) | 2 (2.5) | 1 (2.5) | 1 | |||||||
Chronic liver disease | 3 (2.5) | 2 (2.5) | 1 (2.5) | 1 | |||||||
Stroke | 4 (3.3) | 3 (3.8) | 1 (2.5) | 1 | |||||||
Time from illness onset to hospitalization (days, $\bar{x}± s$) Signs and symptoms [n (%)] | 8.6±3.8 | 8.4±4.0 | 9.0±3.2 | 0.394 | |||||||
Fever | 105 (87.5) | 71 (88.8) | 34 (85.0) | 0.558 | |||||||
Cough | 59 (49.2) | 37 (46.3) | 22 (55.0) | 0.366 | |||||||
Fatigue | 16 (13.3) | 10 (12.5) | 6 (15.0) | 0.704 | |||||||
Diarrhea | 8 (6.7) | 5 (6.3) | 3 (7.5) | 1 | |||||||
Other | 32 (26.7) | 23 (28.7) | 9 (22.5) | 0.465 | |||||||
TCM syndrome [n (%)] | 0.901 | ||||||||||
Dampness and stagnation lung | 55 (45.8) | 37 (46.3) | 18 (45.0) | 0.892 | |||||||
Dampness and heat-accumulation lung | 33 (27.5) | 21 (26.3) | 12 (30.0) | 0.665 | |||||||
Cold dampness lung | 32 (26.7) | 22 (27.5) | 10 (25.0) | 0.770 | |||||||
Temperature (℃, $\bar{x}± s$) | 38.1±0.7 | 38.1±0.7 | 38.2±0.7 | 0.380 | |||||||
Heart rate (bpm, $\bar{x}± s$) | 81.2±12.3 | 80.8±12.6 | 82.1±11.8 | 0.570 | |||||||
Respiratory rate (bpm, $\bar{x}± s$) | 20.5±1.7 | 20.4±1.8 | 20.6±1.7 | 0.604 | |||||||
Systolic pressure (mm Hg, $\bar{x}± s$) | 122.7±15.2 | 122.8±15.2 | 122.5±15.4 | 0.923 | |||||||
Finger blood oxygen saturation (%) | 96.5±2.8 | 96.3±2.6 | 97.0±3.2 | 0.232 |
Table 1 Baseline characteristics of the patients with moderate COVID-19
Characteristics | Total | Experimental group (n = 80) | Control group (n = 40) | P valuea | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Age (years, $\bar{x}± s$) | 55.5±13.1 | 55.1±13.7 | 56.3±11.9 | 0.649 | |||||||
18-40 | 20 (16.7) | 15 (18.8) | 5 (12.5) | 0.386 | |||||||
41-60 | 48 (40.0) | 31 (38.8) | 17 (42.5) | 0.693 | |||||||
61-80 | 52 (43.3) | 34 (42.5) | 18 (45.0) | 0.794 | |||||||
Sex, n (%) | Female | 69 (57.5) | 45 (56.3) | 24 (60.0) | 0.695 | ||||||
Male | 51 (42.5) | 35 (43.8) | 16 (40.0) | ||||||||
Smokers (active/ex-) | 38 (31.7) | 26 (32.5) | 12 (30.0) | 0.781 | |||||||
Alcohol drinkers | 34 (28.3) | 24 (30.0) | 10 (25.0) | 0.567 | |||||||
Comorbidities [n (%)] | Pulmonary tuberculosis | 2 (1.7) | 1 (1.3) | 1 (2.5) | 1 | ||||||
COPD | 2 (1.7) | 1 (1.3) | 1 (2.5) | 1 | |||||||
Hypertension | 59 (49.2) | 40 (50.0) | 19 (47.5) | 0.796 | |||||||
Diabetes | 28 (23.3) | 20 (25.0) | 8 (20.0) | 0.542 | |||||||
CKD | 3 (2.5) | 2 (2.5) | 1 (2.5) | 1 | |||||||
Chronic liver disease | 3 (2.5) | 2 (2.5) | 1 (2.5) | 1 | |||||||
Stroke | 4 (3.3) | 3 (3.8) | 1 (2.5) | 1 | |||||||
Time from illness onset to hospitalization (days, $\bar{x}± s$) Signs and symptoms [n (%)] | 8.6±3.8 | 8.4±4.0 | 9.0±3.2 | 0.394 | |||||||
Fever | 105 (87.5) | 71 (88.8) | 34 (85.0) | 0.558 | |||||||
Cough | 59 (49.2) | 37 (46.3) | 22 (55.0) | 0.366 | |||||||
Fatigue | 16 (13.3) | 10 (12.5) | 6 (15.0) | 0.704 | |||||||
Diarrhea | 8 (6.7) | 5 (6.3) | 3 (7.5) | 1 | |||||||
Other | 32 (26.7) | 23 (28.7) | 9 (22.5) | 0.465 | |||||||
TCM syndrome [n (%)] | 0.901 | ||||||||||
Dampness and stagnation lung | 55 (45.8) | 37 (46.3) | 18 (45.0) | 0.892 | |||||||
Dampness and heat-accumulation lung | 33 (27.5) | 21 (26.3) | 12 (30.0) | 0.665 | |||||||
Cold dampness lung | 32 (26.7) | 22 (27.5) | 10 (25.0) | 0.770 | |||||||
Temperature (℃, $\bar{x}± s$) | 38.1±0.7 | 38.1±0.7 | 38.2±0.7 | 0.380 | |||||||
Heart rate (bpm, $\bar{x}± s$) | 81.2±12.3 | 80.8±12.6 | 82.1±11.8 | 0.570 | |||||||
Respiratory rate (bpm, $\bar{x}± s$) | 20.5±1.7 | 20.4±1.8 | 20.6±1.7 | 0.604 | |||||||
Systolic pressure (mm Hg, $\bar{x}± s$) | 122.7±15.2 | 122.8±15.2 | 122.5±15.4 | 0.923 | |||||||
Finger blood oxygen saturation (%) | 96.5±2.8 | 96.3±2.6 | 97.0±3.2 | 0.232 |
Item | Normal range | Total (n = 108) | Experimental group (n = 73) | Control group (n = 35) | P value |
---|---|---|---|---|---|
WBC count (×109/L) | 4-10 | 6.00±2.59 | 6.17±2.80 | 5.68±2.11 | 0.290 |
NEUT (%) | 50-70 | 62.98±11.62 | 62.40±11.31 | 64.15±12.30 | 0.439 |
LYMPH (%) | 20-40 | 14.91±6.96 | 14.29±6.51 | 16.16±7.71 | 0.164 |
SAA (mg/L) | < 10 | 151.01±109.22 | 150.98±105.51 | 151.07±117.70 | 0.997 |
CRP (mg/L) | < 10 | 31.15±24.43 | 32.70±23.52 | 28.06±26.19 | 0.329 |
ESR (mm/H) | < 20 | 30.55±17.98 | 29.92±19.56 | 31.82±14.43 | 0.549 |
PCT (µg/L) | < 0.046 | 0.03±0.04 | 0.03±0.04 | 0.03±0.05 | 0.899 |
CK-MB (U/L) | 0-24 | 25.83±9.94 | 25.23±7.17 | 27.05±13.98 | 0.441 |
LDH (U/L) | 114-240 | 284.00±128.13 | 277.96±108.43 | 296.08±161.39 | 0.524 |
ALT (U/L) | 7-40 | 45.37±35.71 | 45.90±36.08 | 44.30±35.39 | 0.818 |
AST (U/L) | 13-35 | 42.07±22.94 | 41.03±20.66 | 44.18±27.11 | 0.481 |
BUN (mmol/L) | 2.3-8.2 | 7.57±3.54 | 7.42±3.74 | 7.87±3.12 | 0.509 |
D-dimer (mg/L) | < 0.5 | 2.50±6.97 | 2.52±7.22 | 2.46±6.54 | 0.960 |
Table 2 Comparison of laboratory findings on admission between the experimental and control groups of patients with moderate COVID-19
Item | Normal range | Total (n = 108) | Experimental group (n = 73) | Control group (n = 35) | P value |
---|---|---|---|---|---|
WBC count (×109/L) | 4-10 | 6.00±2.59 | 6.17±2.80 | 5.68±2.11 | 0.290 |
NEUT (%) | 50-70 | 62.98±11.62 | 62.40±11.31 | 64.15±12.30 | 0.439 |
LYMPH (%) | 20-40 | 14.91±6.96 | 14.29±6.51 | 16.16±7.71 | 0.164 |
SAA (mg/L) | < 10 | 151.01±109.22 | 150.98±105.51 | 151.07±117.70 | 0.997 |
CRP (mg/L) | < 10 | 31.15±24.43 | 32.70±23.52 | 28.06±26.19 | 0.329 |
ESR (mm/H) | < 20 | 30.55±17.98 | 29.92±19.56 | 31.82±14.43 | 0.549 |
PCT (µg/L) | < 0.046 | 0.03±0.04 | 0.03±0.04 | 0.03±0.05 | 0.899 |
CK-MB (U/L) | 0-24 | 25.83±9.94 | 25.23±7.17 | 27.05±13.98 | 0.441 |
LDH (U/L) | 114-240 | 284.00±128.13 | 277.96±108.43 | 296.08±161.39 | 0.524 |
ALT (U/L) | 7-40 | 45.37±35.71 | 45.90±36.08 | 44.30±35.39 | 0.818 |
AST (U/L) | 13-35 | 42.07±22.94 | 41.03±20.66 | 44.18±27.11 | 0.481 |
BUN (mmol/L) | 2.3-8.2 | 7.57±3.54 | 7.42±3.74 | 7.87±3.12 | 0.509 |
D-dimer (mg/L) | < 0.5 | 2.50±6.97 | 2.52±7.22 | 2.46±6.54 | 0.960 |
Figure 2 Comparison of efficacy endpoints for coronavirus disease 2019 patients who received combination treatment versus control treatment Experimental group: patients received Western Medicine treatment plus Traditional Chinese Medicine; control group: patients received only Western Medicine treatment. Significant differences compared with control group were designated as aP < 0.01.
Figure 3 Comparison of efficacy endpoints for coronavirus disease 2019 patients who received combination treatment versus control treatment Experimental group: patients received Western Medicine treatment plus Traditional Chinese Medicine; control group: patients received only Western Medicine treatment. Significant differences compared with control group were designated as aP < 0.05 and bP < 0.01.
Figure 4 Hospital discharge rates in the experimental and control groups over 2 weeks following coronavirus disease 2019 diagnosis Experimental group: patients received Western Medicine treatment plus Traditional Chinese Medicine; control group: patients received only Western Medicine treatment. Significant differences compared with control group were designated as aP < 0.05.
Group | n | Before treatment | After treatmenta | Z value | P value | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 | |||||
Control | 35 | 2 | 4 | 13 | 16 | 0 | 7 | 10 | 10 | 6 | 2 | –3.810 | < 0.001 | |
Experimental | 73 | 4 | 11 | 25 | 33 | 0 | 20 | 38 | 8 | 6 | 1 | –6.789 | < 0.001 |
Table 3 Comparison of mMRC scale scores between the experimental and control groups of patients with moderate coronavirus disease 2019
Group | n | Before treatment | After treatmenta | Z value | P value | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 | |||||
Control | 35 | 2 | 4 | 13 | 16 | 0 | 7 | 10 | 10 | 6 | 2 | –3.810 | < 0.001 | |
Experimental | 73 | 4 | 11 | 25 | 33 | 0 | 20 | 38 | 8 | 6 | 1 | –6.789 | < 0.001 |
Item | Experimental group (n = 73) | Control Group (n = 35) | P value |
---|---|---|---|
WBC count (×109/L) | 69 (94.5) | 26 (74.3) | 0.007 |
NEUT (%) | 68 (93.2) | 31 (88.6) | 0.664 |
LYMPH (%) | 67 (91.8) | 23 (65.7) | 0.001 |
SAA (mg/L) | 64 (87.7) | 25 (71.4) | 0.038 |
CRP (mg/L) | 66 (90.4) | 23 (65.7) | 0.002 |
ESR (mm/H) | 70 (95.9) | 27 (77.1) | 0.007 |
PCT (µg/L) | 69 (94.5) | 32 (91.4) | 0.847 |
CK-MB (U/L) | 69 (94.5) | 28 (80.0) | 0.046 |
LDH (U/L) | 70 (95.9) | 28 (80.0) | 0.021 |
ALT (U/L) | 68 (93.2) | 26 (74.3) | 0.015 |
AST (U/L) | 70 (95.9) | 28 (80.0) | 0.021 |
BUN (mmol/L) | 67 (91.8) | 29 (82.9) | 0.292 |
D-dimer (mg/L) | 70 (95.9) | 31 (88.6) | 0.304 |
Table 4 Comparison of the percentages of patients with normal values after treatment between the experimental and control groups of patients with moderate COVID-19 [n (%)]
Item | Experimental group (n = 73) | Control Group (n = 35) | P value |
---|---|---|---|
WBC count (×109/L) | 69 (94.5) | 26 (74.3) | 0.007 |
NEUT (%) | 68 (93.2) | 31 (88.6) | 0.664 |
LYMPH (%) | 67 (91.8) | 23 (65.7) | 0.001 |
SAA (mg/L) | 64 (87.7) | 25 (71.4) | 0.038 |
CRP (mg/L) | 66 (90.4) | 23 (65.7) | 0.002 |
ESR (mm/H) | 70 (95.9) | 27 (77.1) | 0.007 |
PCT (µg/L) | 69 (94.5) | 32 (91.4) | 0.847 |
CK-MB (U/L) | 69 (94.5) | 28 (80.0) | 0.046 |
LDH (U/L) | 70 (95.9) | 28 (80.0) | 0.021 |
ALT (U/L) | 68 (93.2) | 26 (74.3) | 0.015 |
AST (U/L) | 70 (95.9) | 28 (80.0) | 0.021 |
BUN (mmol/L) | 67 (91.8) | 29 (82.9) | 0.292 |
D-dimer (mg/L) | 70 (95.9) | 31 (88.6) | 0.304 |
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