Journal of Traditional Chinese Medicine ›› 2026, Vol. 46 ›› Issue (3): 652-665.DOI: 10.19852/j.cnki.jtcm.20260206.001
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DING Huanzhang1,2, WANG Hui3,4, YANG Qinjun3,4, MA Xiao3,4, WU Di1,4, LI Qiao5, ZHENG Caixia6, LU Jiasheng7, WU Chengming8, HUANG Pingfu9, CHEN Zhixiang10, WANG Shihan11, FENG Jihong12, LIU Jian12, SUN Dengdi13, ZHU Jie3,4, TONG Jiabing1,4, GAO Yating1,4, LI Zegeng1,4(
)
Received:2025-04-14
Accepted:2025-08-11
Online:2026-06-15
Published:2026-02-06
Contact:
Prof. LI Zegeng, Department of Respiratory Medicine, the First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230000, China; Anhui Provincial Key Laboratory for the Application and Transformation of Traditional Chinese Medicine in the Prevention and Treatment of Major Respiratory Diseases, Hefei 230000, China. ahzyfb@sina.com, Telephone: +86-13805516609
About author:First author contact:DING Huanzhang and WANG Hui are co-first authors and contributed equally to this work
Supported by:DING Huanzhang, WANG Hui, YANG Qinjun, MA Xiao, WU Di, LI Qiao, ZHENG Caixia, LU Jiasheng, WU Chengming, HUANG Pingfu, CHEN Zhixiang, WANG Shihan, FENG Jihong, LIU Jian, SUN Dengdi, ZHU Jie, TONG Jiabing, GAO Yating, LI Zegeng. A multicenter randomized controlled trial and metabolomics exploration of Traditional Chinese Medicine pattern-based therapy for stable chronic obstructive pulmonary disease[J]. Journal of Traditional Chinese Medicine, 2026, 46(3): 652-665.
Figure 1 Study participant flow diagram Trial group: received TBPI 18 μg once daily plus TCM compound granules tailored to TCM patterns (SQWF 16 g/pack for LQD, SQBZ 18 g/pack for LSQD, SQTS 19 g/pack for LKQD; 1 pack twice daily, 24-week course); Control group: received TBPI 18 μg once daily for 24 weeks. TCM: Traditional Chinese Medicine; TBPI: tiotropium bromide powder for inhalation; SQWF: Shenqi Wenfei formula; SQBZ: Shenqi Buzhong formula; SQTS: Shenqi Tiaoshen formula; LQD: lung Qi deficiency; LSQD: lung-spleen Qi deficiency; LKQD: lung-kidney Qi deficiency.
| Characteristic | Intent-to-treat analysis set | Per-protocol analysis set | |||||
|---|---|---|---|---|---|---|---|
| Trial group (n = 180) | Control group (n = 90) | P value | Trial group (n = 174) | Control group (n = 82) | P value | ||
| Age (years, | 68.0±6.1 | 67.1±6.8 | 0.361 | 68.0±6.1 | 66.7±6.8 | 0.185 | |
| Male [n (%)] | 143 (79.4) | 78 (86.7) | 0.147 | 138 (79.3) | 72 (87.8) | 0.099 | |
| BMI ( | 23.0±3.9 | 23.7±3.4 | 0.132 | 22.9±3.9 | 23.6±3.5 | 0.163 | |
| Smoking history [n (%)] | 0.839 | 0.999 | |||||
| Never smoking | 51 (28.3) | 26 (28.9) | 40 (23.0) | 19 (23.2) | |||
| Current smoking | 41 (22.8) | 23 (25.6) | 85 (48.9) | 40 (48.8) | |||
| Former smoking | 88 (48.9) | 41 (45.6) | 49 (28.2) | 23 (28.0) | |||
| Gold stage [n (%)] | 0.209 | 0.178 | |||||
| GOLD 1 | 15 (8.3) | 3 (3.3) | 15 (8.6) | 3 (3.7) | |||
| GOLD 2 | 63 (35.0) | 36 (40.0) | 60 (34.5) | 33 (40.2) | |||
| GOLD 3 | 75 (41.7) | 32 (35.6) | 73 (42.0) | 28 (34.1) | |||
| GOLD 4 | 27 (15.0) | 19 (21.1) | 26 (14.9) | 18 (22.0) | |||
| Medication use [n (%)] | 0.907 | 0.911 | |||||
| None | 68 (37.8) | 34 (37.8) | 64 (36.8) | 34 (41.5) | |||
| ICS/LABA | 42 (23.3) | 24 (26.7) | 42 (24.1) | 19 (23.2) | |||
| LAMA | 42 (23.3) | 17 (18.9) | 40 (23.0) | 15 (18.3) | |||
| LABA+LAMA | 13 (7.2) | 6 (6.7) | 13 (7.5) | 6 (7.3) | |||
| ICS/LABA+LAMA | 15 (8.3) | 9 (10.0) | 15 (8.6) | 8 (9.8) | |||
| Exacerbations, previous 52 weeks [median (IQR)] | 1 (0.25, 2) | 1 (0, 2) | 0.310 | 1 (0, 2) | 1 (0, 2) | 0.323 | |
| Exacerbations, previous 52 weeks [n (%)] | 0.647 | 0.624 | |||||
| 0 acute exacerbation | 45 (25.0) | 28 (31.1) | 45 (25.9) | 27 (32.9) | |||
| 1 acute exacerbation | 67 (37.2) | 32 (35.6) | 64 (36.8) | 28 (34.1) | |||
| 2 acute exacerbation | 44 (24.4) | 19 (21.1) | 42 (24.1) | 16 (19.5) | |||
| 3 acute exacerbation | 15 (8.3) | 9 (10.0) | 15 (8.6) | 9 (11.0) | |||
| >3 acute exacerbation | 9 (5.0) | 2 (2.2) | 8 (4.6) | 2 (2.4) | |||
| 6MWT in metres ( | 397.0±95.2 | 399.1±100.1 | 0.866 | 398.2±92.2 | 399.8±101.5 | 0.900 | |
| CAT scores ( | 20.0±7.0 | 19.9±7.1 | 0.978 | 19.8±7.1 | 19.9±7.2 | 0.945 | |
| mMRC scores [median (IQR)] | 2 (1, 3) | 2 (1, 3) | 0.520 | 2 (1, 3) | 2 (1, 3) | 0.581 | |
| Lung function | |||||||
| FEV1 (L, | 1.2±0.5 | 1.3±0.5 | 0.583 | 1.2±0.5 | 1.3±0.5 | 0.515 | |
| FEV1%pred ( | 48.5±19.2 | 46.0±18.3 | 0.353 | 48.7±19.4 | 46.1±18.4 | 0.359 | |
| FVC (L, | 2.2±0.8 | 2.3±0.7 | 0.355 | 2.3±0.8 | 2.3±0.7 | 0.360 | |
| FEV1/FVC% (%, | 53.6±9.5 | 53.2±9.8 | 0.746 | 53.5±9.5 | 53.4±10.1 | 0.941 | |
Table 1 Characteristics and clinical indicators of the patients
| Characteristic | Intent-to-treat analysis set | Per-protocol analysis set | |||||
|---|---|---|---|---|---|---|---|
| Trial group (n = 180) | Control group (n = 90) | P value | Trial group (n = 174) | Control group (n = 82) | P value | ||
| Age (years, | 68.0±6.1 | 67.1±6.8 | 0.361 | 68.0±6.1 | 66.7±6.8 | 0.185 | |
| Male [n (%)] | 143 (79.4) | 78 (86.7) | 0.147 | 138 (79.3) | 72 (87.8) | 0.099 | |
| BMI ( | 23.0±3.9 | 23.7±3.4 | 0.132 | 22.9±3.9 | 23.6±3.5 | 0.163 | |
| Smoking history [n (%)] | 0.839 | 0.999 | |||||
| Never smoking | 51 (28.3) | 26 (28.9) | 40 (23.0) | 19 (23.2) | |||
| Current smoking | 41 (22.8) | 23 (25.6) | 85 (48.9) | 40 (48.8) | |||
| Former smoking | 88 (48.9) | 41 (45.6) | 49 (28.2) | 23 (28.0) | |||
| Gold stage [n (%)] | 0.209 | 0.178 | |||||
| GOLD 1 | 15 (8.3) | 3 (3.3) | 15 (8.6) | 3 (3.7) | |||
| GOLD 2 | 63 (35.0) | 36 (40.0) | 60 (34.5) | 33 (40.2) | |||
| GOLD 3 | 75 (41.7) | 32 (35.6) | 73 (42.0) | 28 (34.1) | |||
| GOLD 4 | 27 (15.0) | 19 (21.1) | 26 (14.9) | 18 (22.0) | |||
| Medication use [n (%)] | 0.907 | 0.911 | |||||
| None | 68 (37.8) | 34 (37.8) | 64 (36.8) | 34 (41.5) | |||
| ICS/LABA | 42 (23.3) | 24 (26.7) | 42 (24.1) | 19 (23.2) | |||
| LAMA | 42 (23.3) | 17 (18.9) | 40 (23.0) | 15 (18.3) | |||
| LABA+LAMA | 13 (7.2) | 6 (6.7) | 13 (7.5) | 6 (7.3) | |||
| ICS/LABA+LAMA | 15 (8.3) | 9 (10.0) | 15 (8.6) | 8 (9.8) | |||
| Exacerbations, previous 52 weeks [median (IQR)] | 1 (0.25, 2) | 1 (0, 2) | 0.310 | 1 (0, 2) | 1 (0, 2) | 0.323 | |
| Exacerbations, previous 52 weeks [n (%)] | 0.647 | 0.624 | |||||
| 0 acute exacerbation | 45 (25.0) | 28 (31.1) | 45 (25.9) | 27 (32.9) | |||
| 1 acute exacerbation | 67 (37.2) | 32 (35.6) | 64 (36.8) | 28 (34.1) | |||
| 2 acute exacerbation | 44 (24.4) | 19 (21.1) | 42 (24.1) | 16 (19.5) | |||
| 3 acute exacerbation | 15 (8.3) | 9 (10.0) | 15 (8.6) | 9 (11.0) | |||
| >3 acute exacerbation | 9 (5.0) | 2 (2.2) | 8 (4.6) | 2 (2.4) | |||
| 6MWT in metres ( | 397.0±95.2 | 399.1±100.1 | 0.866 | 398.2±92.2 | 399.8±101.5 | 0.900 | |
| CAT scores ( | 20.0±7.0 | 19.9±7.1 | 0.978 | 19.8±7.1 | 19.9±7.2 | 0.945 | |
| mMRC scores [median (IQR)] | 2 (1, 3) | 2 (1, 3) | 0.520 | 2 (1, 3) | 2 (1, 3) | 0.581 | |
| Lung function | |||||||
| FEV1 (L, | 1.2±0.5 | 1.3±0.5 | 0.583 | 1.2±0.5 | 1.3±0.5 | 0.515 | |
| FEV1%pred ( | 48.5±19.2 | 46.0±18.3 | 0.353 | 48.7±19.4 | 46.1±18.4 | 0.359 | |
| FVC (L, | 2.2±0.8 | 2.3±0.7 | 0.355 | 2.3±0.8 | 2.3±0.7 | 0.360 | |
| FEV1/FVC% (%, | 53.6±9.5 | 53.2±9.8 | 0.746 | 53.5±9.5 | 53.4±10.1 | 0.941 | |
| Item | Intent-to-treat analysis set | Per-protocol analysis set | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Trial group (n = 180) | Control group (n = 90) | χ 2/Z value | P value | Trial group (n = 174) | Control group (n = 82) | χ 2/Z value | P value | ||
| Number of exacerbation events [n (%)] | 11.518 | 0.021 | 13.898 | 0.008 | |||||
| 0 acute exacerbation | 97 (53.9) | 37 (41.1) | 97 (55.7) | 36 (43.9) | |||||
| 1 acute exacerbation | 37 (20.6) | 26 (28.9) | 34 (19.5) | 22 (26.8) | |||||
| 2 acute exacerbation | 33 (18.3) | 11 (12.2) | 31 (17.8) | 8 (9.8) | |||||
| 3 acute exacerbation | 9 (5) | 10 (11.1) | 9 (5.2) | 10 (12.2) | |||||
| >3 acute exacerbation | 4 (2.2) | 6 (6.7) | 3 (1.7) | 6 (7.3) | |||||
| Number of exacerbation events [median (IQR)] | 0 (0, 2) | 1 (0, 2) | -2.036 | 0.042 | 0 (0, 1.25) | 1 (0, 2) | -1.961 | 0.049 | |
Table 2 Comparison of COPD exacerbation frequency
| Item | Intent-to-treat analysis set | Per-protocol analysis set | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Trial group (n = 180) | Control group (n = 90) | χ 2/Z value | P value | Trial group (n = 174) | Control group (n = 82) | χ 2/Z value | P value | ||
| Number of exacerbation events [n (%)] | 11.518 | 0.021 | 13.898 | 0.008 | |||||
| 0 acute exacerbation | 97 (53.9) | 37 (41.1) | 97 (55.7) | 36 (43.9) | |||||
| 1 acute exacerbation | 37 (20.6) | 26 (28.9) | 34 (19.5) | 22 (26.8) | |||||
| 2 acute exacerbation | 33 (18.3) | 11 (12.2) | 31 (17.8) | 8 (9.8) | |||||
| 3 acute exacerbation | 9 (5) | 10 (11.1) | 9 (5.2) | 10 (12.2) | |||||
| >3 acute exacerbation | 4 (2.2) | 6 (6.7) | 3 (1.7) | 6 (7.3) | |||||
| Number of exacerbation events [median (IQR)] | 0 (0, 2) | 1 (0, 2) | -2.036 | 0.042 | 0 (0, 1.25) | 1 (0, 2) | -1.961 | 0.049 | |
| Item | Intent-to-treat analysis set | Per-protocol analysis set | ||||||
|---|---|---|---|---|---|---|---|---|
| 0 Week | 24 Week | 52 Week | 0 Week | 24 Week | 52 Week | |||
| CAT ( | Trial group | 20±7 | 16±6 | 17±7 | 20±7 | 16±6 | 17±7 | |
| Control group | 20±7 | 18±7 | 18±7 | 20±7 | 18±7 | 18±7 | ||
| Estimate (95% CI) | 0.000 (-2.000, 2.000) | -1.799 (-3.120, -0.479) | -1.366 (-2.748, 0.016) | 0.000 (-2.000, 2.000) | -1.622 (-3.023, -0.221) | -1.200 (-2.663, 0.263) | ||
| χ 2/Z value | -0.027 | 7.130 | 3.753 | -0.069 | 5.147 | 2.586 | ||
| P value | 0.978 | 0.008 | 0.053 | 0.945 | 0.023 | 0.108 | ||
| mMRC [median (IQR)] | Trial group | 2 (1, 3) | 2 (1, 2) | 2 (1, 2) | 2 (1, 3) | 2 (1, 2) | 2 (1, 2) | |
| Control group | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | ||
| Estimate (95% CI) | 0.000 (0.000, 0.000) | -0.581 (-1.059, -0.102) | -0.712 (-1.258, -0.166) | 0.000 (0.000, 0.000) | -0.584 (-1.097, -0.070) | -0.745 (-1.319, -0.171) | ||
| χ 2/Z value | -0.644 | 5.657 | 6.541 | -0.551 | 4.967 | 6.478 | ||
| P value | 0.520 | 0.017 | 0.011 | 0.581 | 0.026 | 0.011 | ||
| 6MWT ( | Trial group | 397±95 | 417±90 | 407±95 | 398±92 | 419±88 | 408±93 | |
| Control group | 399±100 | 392±100 | 383±105 | 400±102 | 392±102 | 383±107 | ||
| Estimate (95% CI) | -2.111 (-26.733, 22.511) | 27.105 (16.924, 37.285) | 25.598 (14.891, 36.305) | -1.599 (-26.724, 23.525) | 27.483 (16.630, 38.335) | 26.323 (14.946, 37.701) | ||
| χ 2/Z value | -0.169 | 27.230 | 21.958 | -0.125 | 24.636 | 20.563 | ||
| P value | 0.866 | 0.000 | 0.000 | 0.900 | 0.000 | 0.000 | ||
Table 3 Secondary outcomes: CAT, mMRC and 6MWT
| Item | Intent-to-treat analysis set | Per-protocol analysis set | ||||||
|---|---|---|---|---|---|---|---|---|
| 0 Week | 24 Week | 52 Week | 0 Week | 24 Week | 52 Week | |||
| CAT ( | Trial group | 20±7 | 16±6 | 17±7 | 20±7 | 16±6 | 17±7 | |
| Control group | 20±7 | 18±7 | 18±7 | 20±7 | 18±7 | 18±7 | ||
| Estimate (95% CI) | 0.000 (-2.000, 2.000) | -1.799 (-3.120, -0.479) | -1.366 (-2.748, 0.016) | 0.000 (-2.000, 2.000) | -1.622 (-3.023, -0.221) | -1.200 (-2.663, 0.263) | ||
| χ 2/Z value | -0.027 | 7.130 | 3.753 | -0.069 | 5.147 | 2.586 | ||
| P value | 0.978 | 0.008 | 0.053 | 0.945 | 0.023 | 0.108 | ||
| mMRC [median (IQR)] | Trial group | 2 (1, 3) | 2 (1, 2) | 2 (1, 2) | 2 (1, 3) | 2 (1, 2) | 2 (1, 2) | |
| Control group | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | 2 (1, 3) | ||
| Estimate (95% CI) | 0.000 (0.000, 0.000) | -0.581 (-1.059, -0.102) | -0.712 (-1.258, -0.166) | 0.000 (0.000, 0.000) | -0.584 (-1.097, -0.070) | -0.745 (-1.319, -0.171) | ||
| χ 2/Z value | -0.644 | 5.657 | 6.541 | -0.551 | 4.967 | 6.478 | ||
| P value | 0.520 | 0.017 | 0.011 | 0.581 | 0.026 | 0.011 | ||
| 6MWT ( | Trial group | 397±95 | 417±90 | 407±95 | 398±92 | 419±88 | 408±93 | |
| Control group | 399±100 | 392±100 | 383±105 | 400±102 | 392±102 | 383±107 | ||
| Estimate (95% CI) | -2.111 (-26.733, 22.511) | 27.105 (16.924, 37.285) | 25.598 (14.891, 36.305) | -1.599 (-26.724, 23.525) | 27.483 (16.630, 38.335) | 26.323 (14.946, 37.701) | ||
| χ 2/Z value | -0.169 | 27.230 | 21.958 | -0.125 | 24.636 | 20.563 | ||
| P value | 0.866 | 0.000 | 0.000 | 0.900 | 0.000 | 0.000 | ||
| Item | Intent-to-treat analysis set | Per-protocol analysis set | ||||||
|---|---|---|---|---|---|---|---|---|
| 0 Week | 24 Week | 52 Week | 0 Week | 24 Week | 52 Week | |||
| FEV1 (L, | Trial group | 1.2±0.5 | 1.2±0.6 | 1.2±0.5 | 1.2±0.5 | 1.2±0.6 | 1.2±0.5 | |
| Control group | 1.3±0.5 | 1.3±0.5 | 1.2±0.5 | 1.3±0.5 | 1.3±0.5 | 1.2±0.5 | ||
| Estimate (95% CI) | -0.031 (-0.167, 0.090) | 0.006 (-0.056, 0.067) | 0.008 (-0.054, 0.070) | -0.040 (-0.184, 0.092) | -0.006 (-0.067, 0.055) | -0.000 (-0.063, 0.063) | ||
| χ 2/Z value | -0.549 | 0.032 | 0.067 | -0.650 | 0.037 | 0.000 | ||
| P value | 0.583 | 0.858 | 0.795 | 0.515 | 0.848 | 0.995 | ||
| FEV1%pred (%, | Trial group | 48.5±19.3 | 48.5±20.3 | 47.3±19.7 | 48.7±19.4 | 48.8±20.4 | 47.6±19.8 | |
| Control group | 46.0±18.3 | 46.0±16.4 | 44.438±17.5 | 46.1±18.4 | 46.6±16.6 | 44.8±17.8 | ||
| Estimate (95% CI) | 2.021 (-2.501, 7.010) | 0.473 (-2.040, 2.986) | 0.932 (-1.400, 3.264) | 2.681 (-2.810, 7.730) | 0.152 (-2.443, 2.747) | 0.727 (-1.666, 3.120) | ||
| χ 2/Z value | -0.928 | 0.136 | 0.613 | -0.916 | 0.013 | 0.355 | ||
| P value | 0.353 | 0.712 | 0.434 | 0.359 | 0.909 | 0.551 | ||
| FVC (L, | Trial group | 2.2±0.8 | 2.2±0.8 | 2.2±0.7 | 2.3±0.8 | 2.3±0.8 | 2.3±0.7 | |
| Control group | 2.3±0.7 | 2.3±0.7 | 2.3±0.7 | 2.3±0.7 | 2.4±0.7 | 2.3±0.7 | ||
| Estimate (95% CI) | -0.090 (-0.291, 0.105) | -0.033 (-0.126, 0.059) | -0.004 (-0.085, 0.077) | -0.091 (-0.301, 0.118) | -0.047 (-0.144, 0.049) | -0.016 (-0.099, 0.068) | ||
| χ 2/Z value | -0.924 | 0.5 | 0.01 | -0.914 | 0.939 | 0.137 | ||
| P value | 0.355 | 0.479 | 0.920 | 0.360 | 0.332 | 0.712 | ||
| FEV1/FVC (%, | Trial group | 53.6±9.5 | 54.2±10.0 | 51.8±11.1 | 53.5±9.5 | 54.0±10.0 | 51.5±11.2 | |
| Control group | 53.2±9.8 | 53.2±9.9 | 51.4±10.6 | 53.4±10.1 | 53.4±10.0 | 51.5±10.8 | ||
| Estimate (95% CI) | 0.402 (-2.036, 2.839) | 0.867 (-0.735, 2.469) | 0.205 (-1.413, 1.823) | 0.096 (-2.457, 2.649) | 0.775 (-0.913, 2.463) | 0.201 (-1.501, 1.904) | ||
| χ 2/Z value | 0.324 | 1.124 | 0.062 | 0.074 | 0.809 | 0.054 | ||
| P value | 0.746 | 0.289 | 0.804 | 0.941 | 0.368 | 0.817 | ||
Table 4 Secondary outcomes: FEV1, FEV1%pred, FVC and FEV1/FVC
| Item | Intent-to-treat analysis set | Per-protocol analysis set | ||||||
|---|---|---|---|---|---|---|---|---|
| 0 Week | 24 Week | 52 Week | 0 Week | 24 Week | 52 Week | |||
| FEV1 (L, | Trial group | 1.2±0.5 | 1.2±0.6 | 1.2±0.5 | 1.2±0.5 | 1.2±0.6 | 1.2±0.5 | |
| Control group | 1.3±0.5 | 1.3±0.5 | 1.2±0.5 | 1.3±0.5 | 1.3±0.5 | 1.2±0.5 | ||
| Estimate (95% CI) | -0.031 (-0.167, 0.090) | 0.006 (-0.056, 0.067) | 0.008 (-0.054, 0.070) | -0.040 (-0.184, 0.092) | -0.006 (-0.067, 0.055) | -0.000 (-0.063, 0.063) | ||
| χ 2/Z value | -0.549 | 0.032 | 0.067 | -0.650 | 0.037 | 0.000 | ||
| P value | 0.583 | 0.858 | 0.795 | 0.515 | 0.848 | 0.995 | ||
| FEV1%pred (%, | Trial group | 48.5±19.3 | 48.5±20.3 | 47.3±19.7 | 48.7±19.4 | 48.8±20.4 | 47.6±19.8 | |
| Control group | 46.0±18.3 | 46.0±16.4 | 44.438±17.5 | 46.1±18.4 | 46.6±16.6 | 44.8±17.8 | ||
| Estimate (95% CI) | 2.021 (-2.501, 7.010) | 0.473 (-2.040, 2.986) | 0.932 (-1.400, 3.264) | 2.681 (-2.810, 7.730) | 0.152 (-2.443, 2.747) | 0.727 (-1.666, 3.120) | ||
| χ 2/Z value | -0.928 | 0.136 | 0.613 | -0.916 | 0.013 | 0.355 | ||
| P value | 0.353 | 0.712 | 0.434 | 0.359 | 0.909 | 0.551 | ||
| FVC (L, | Trial group | 2.2±0.8 | 2.2±0.8 | 2.2±0.7 | 2.3±0.8 | 2.3±0.8 | 2.3±0.7 | |
| Control group | 2.3±0.7 | 2.3±0.7 | 2.3±0.7 | 2.3±0.7 | 2.4±0.7 | 2.3±0.7 | ||
| Estimate (95% CI) | -0.090 (-0.291, 0.105) | -0.033 (-0.126, 0.059) | -0.004 (-0.085, 0.077) | -0.091 (-0.301, 0.118) | -0.047 (-0.144, 0.049) | -0.016 (-0.099, 0.068) | ||
| χ 2/Z value | -0.924 | 0.5 | 0.01 | -0.914 | 0.939 | 0.137 | ||
| P value | 0.355 | 0.479 | 0.920 | 0.360 | 0.332 | 0.712 | ||
| FEV1/FVC (%, | Trial group | 53.6±9.5 | 54.2±10.0 | 51.8±11.1 | 53.5±9.5 | 54.0±10.0 | 51.5±11.2 | |
| Control group | 53.2±9.8 | 53.2±9.9 | 51.4±10.6 | 53.4±10.1 | 53.4±10.0 | 51.5±10.8 | ||
| Estimate (95% CI) | 0.402 (-2.036, 2.839) | 0.867 (-0.735, 2.469) | 0.205 (-1.413, 1.823) | 0.096 (-2.457, 2.649) | 0.775 (-0.913, 2.463) | 0.201 (-1.501, 1.904) | ||
| χ 2/Z value | 0.324 | 1.124 | 0.062 | 0.074 | 0.809 | 0.054 | ||
| P value | 0.746 | 0.289 | 0.804 | 0.941 | 0.368 | 0.817 | ||
| Type of adverse event | Trial group | Control group |
|---|---|---|
| Nausea | 1 | 0 |
| Bloating | 7 | 2 |
| Diarrhea | 3 | 1 |
| Urticaria | 1 | 0 |
| Joint pain | 3 | 2 |
| Palpitation | 0 | 1 |
| Acute myocardial infarction | 0 | 1 |
| Deep venous thrombosis | 1 | 0 |
| Periodontitis | 2 | 1 |
| Cervical spondylopathy | 1 | 1 |
| Urinary tract infection | 2 | 2 |
| Gallstone | 0 | 1 |
| Lung cancer | 1 | 0 |
| Solitary pulmonary nodule | 2 | 2 |
| Mouth ulcers | 0 | 1 |
| Constipation | 1 | 2 |
| Hypertension | 2 | 1 |
| Fracture | 0 | 1 |
Table 5 Comparison of adverse events (SS set, n)
| Type of adverse event | Trial group | Control group |
|---|---|---|
| Nausea | 1 | 0 |
| Bloating | 7 | 2 |
| Diarrhea | 3 | 1 |
| Urticaria | 1 | 0 |
| Joint pain | 3 | 2 |
| Palpitation | 0 | 1 |
| Acute myocardial infarction | 0 | 1 |
| Deep venous thrombosis | 1 | 0 |
| Periodontitis | 2 | 1 |
| Cervical spondylopathy | 1 | 1 |
| Urinary tract infection | 2 | 2 |
| Gallstone | 0 | 1 |
| Lung cancer | 1 | 0 |
| Solitary pulmonary nodule | 2 | 2 |
| Mouth ulcers | 0 | 1 |
| Constipation | 1 | 2 |
| Hypertension | 2 | 1 |
| Fracture | 0 | 1 |
Figure 2 Metabolomics analysis of serum samples A: PLS-DA plot showing the metabolic profile distribution of Group A (blue), Group B (orange), and Group C (green); B: PLS-DA-3D plot visualizing the 3D clustering of metabolic features among the three groups; C: heatmap of differential metabolites, with hierarchical clustering reflecting the relative abundance of metabolites in each group; D: KEGG pathway comparison between Group A and Group C, reflecting serum metabolic changes in patients; E: KEGG pathway comparison between Group B and Group A, showing metabolic changes after drug intervention. For panels D and E: blue bars indicate downregulated pathways, red bars indicate upregulated pathways. The x-axis represents the ratio of differential (foreground) to total (background) metabolites in each pathway; the y-axis lists pathway names. Group A: patients with stable COPD before TCM pattern-based comprehensive therapy; Group B: patients with stable COPD after TCM pattern-based comprehensive therapy (TBPI 18 μg once daily + TCM granules tailored to TCM patterns: SQWF 16 g/pack for LQD, SQBZ 18 g/pack for LSQD, SQTS 19 g/pack for LKQD; 1 pack twice daily, 24-week course); Group C: healthy controls without intervention. PLS-DA: partial least squares discriminant analysis; OPLS-DA: orthogonal partial least squares discriminant analysis; KEGG: kyoto encyclopedia of genes and genomes; COPD: chronic obstructive pulmonary disease; TCM: traditional chinese medicine; TBPI: tiotropium bromide powder for inhalation; SQWF: Shenqi Wenfei formula; SQBZ: Shenqi Buzhong formula; SQTS: Shenqi Tiaoshen formula; LQD: lung Qi deficiency; LSQD: lung-spleen Qi deficiency; LKQD: lung-kidney Qi deficiency; VIP: variable importance in projection; ANOVA: analysis of variance. PLS-DA and OPLS-DA models distinguished group metabolic profiles. Differential metabolites were identified by two-tailed Student's t-test (P < 0.05) and VIP > 1. Multi-group comparisons used one-way ANOVA, with hierarchical clustering for heatmap visualization.
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