Dongtian Changchun ointment (洞天长春膏) for moderate-to-severe chronic obstructive pulmonary disease: a multicenter, prospective, open-label, randomized controlled trial

doi:10.19852/j.cnki.jtcm.2025.06.017

Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (6): 1395-1404.DOI: 10.19852/j.cnki.jtcm.2025.06.017

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Dongtian Changchun ointment (洞天长春膏) for moderate-to-severe chronic obstructive pulmonary disease: a multicenter, prospective, open-label, randomized controlled trial

ZHANG Yibao¹, CHEN Feng¹, SUN Meng¹, WANG Zhenwei², TANG Binqing³, QIAN Yechang⁴, JIA Wei⁵, BAO Yufang⁶, LI Wenjie⁷, LI Shanqun⁸(), ZHANG Wei⁹()

1 Department of Pulmonary Diseases, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
2 Department of Respiratory Medicine, Yueyang Hospital of Integrated Traditional Chinese and Westem Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200083, China
3 Department of Respiratory Medicine, Shanghai Municipal Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China
4 Department of Respiratory Medicine, Shanghai Baoshan Hospital of Integrated Chinese and Western Medicine, Shanghai 201900, China
5 Department of Respiratory Medicine, Shanghai TCM-integrated hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200082, China
6 Department of Respiratory Medicine, Shanghai Pudong TCM Hospital, Shanghai 201299, China
7 Department of Respiratory Medicine, Shanghai North Station Hospital, Shanghai 200070, China
8 Department of Respiratory Medicine, Zhongshan Hospital Affiliated to Fudan University, Shanghai 200032, China
9 Department of Pulmonary Diseases, Shuguang Hospital, Shanghai Institute of Infectious Diseases and Biosecurity, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; Baoshan Famous Traditional Chinese Medicine Inheritance Studio, Shanghai Baoshan Hospital of Integrated Chinese and Western Medicine, Shanghai 201900, China; Institute of Infectious Diseases, Shanghai Institute of Traditional Chinese Medicine, Shanghai 201203, China

Received:2024-11-22 Accepted:2025-03-26 Online:2025-12-15 Published:2025-11-24
Contact: ZHANG Wei, Department of Pulmonary Diseases, Shuguang Hospital, Shanghai Institute of Infectious Diseases and Biosecurity, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; ZHANG Wei Baoshan famous Traditional Chinese Medicine inheritance studio, Shanghai Baoshan Hospital of Integrated Chinese and Western Medicine, Shanghai 201900, China; Institute of Infectious Diseases, Shanghai Institute of Traditional Chinese Medicine, Shanghai 201203, China. zhangw1190@sina.com. Telephone : +86-21-64041990-693630; +86-21-20256373;
LI Shanqun, Department of Respiratory Medicine, Zhongshan Hospital Affiliated to Fudan University, Shanghai 200032, China. li.shanqun@zs-hospital.sh.cn
About author:ZHANG Yibao and CHEN Feng are co-first authors and contributed equally to this work
Supported by:
Shanghai Municipal Science and Technology Major Project: Clinical Research and Evaluation of TCM Diagnosis and Treatment of Sudden Acute Infectious Diseases(ZD2021CY001);National Key Research and Development Program of China: Research on the Establishment of Rehabilitation Systems and Strategies for Chronic Obstructive Pulmonary Disease and Clinical Applicability(2018YFC1313600);Shanghai Committee of Science and Technology Key Laboratory of Traditional Chinese Medicine Project(20DZ2272200);Shanghai Key Clinical Specialty Construction Project(shslczdzk05101);Cultivation and Construction Project for the Doctoral Program in Medical Technology

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Abstract

Abstract:

OBJECTIVE: To evaluate the clinical efficacy and safety of Dongtian Changchun ointment (洞天长春膏, DTCO) for the treatment of patients with stable moderate-to-severe chronic obstructive pulmonary disease (COPD).

METHODS: This was a multicenter, prospective, open-label, randomized controlled trial. Patients with COPD who met the inclusion and exclusion criteria were randomly divided into a DTCO group and a control group in a 1∶1 ratio. Both groups were treated with Symbicort Turbuhaler (320 μg / 9 μg twice daily) for 48 weeks. The DTCO group was given additional DTCO (15 g twice daily) for the first 12 weeks. Outcome assessments were conducted at five time points: 0, 12, 24, 36, and 48 weeks. Primary outcome measures included frequency and duration of acute exacerbation of COPD (AECOPD). Secondary outcomes included St. George’s Breathing Questionnaire, pulmonary function, 6-min walk test, and modified Medical Research Council (mMRC) scores.

RESULTS: A total of 84 patients were randomly divided into the DTCO group (n = 42) and the control group (n = 42). The results showed that in the DTCO group, 23 patients had AECOPD for a total duration of 166 d compared with 31 patients in the control group for a total duration of 307 d. Compared with the control group, the DTCO group showed a significant reduction in the median (interquartile range) frequency and duration of AECOPD (P < 0.05). The incidence of AECOPD significantly reduced in the DTCO group to 0.539 [95% confidence interval (0.347, 0.836), P = 0.006]. In the DTCO group, a significant improvement in forced vital capacity was observed at 12 and 48 weeks (P < 0.05), and a reduction in mMRC was noted at 36 and 48 weeks (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups.

CONCLUSIONS: DTCO significantly reduced the frequency and duration of AECOPD in patients with moderate-to-severe COPD, and demonstrated satisfactory safety.

Key words: pulmonary disease, chronic obstructive, acute exacerbation, Dongtian Changchun ointment, randomized controlled trial

ZHANG Yibao, CHEN Feng, SUN Meng, WANG Zhenwei, TANG Binqing, QIAN Yechang, JIA Wei, BAO Yufang, LI Wenjie, LI Shanqun, ZHANG Wei. Dongtian Changchun ointment (洞天长春膏) for moderate-to-severe chronic obstructive pulmonary disease: a multicenter, prospective, open-label, randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2025, 45(6): 1395-1404.

Figures/Tables 8

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Baseline characteristics	DTCO group (n = 40)	Control group (n = 42)	P value
Age (years, $\bar{x}$±s)	64.88±6.22	65.50±6.99	0.670
Male [n (%)]	34 (85.00)	37 (88.10)	0.753
Smoker [n (%)]	28 (70.00)	30 (71.43)	1.000
Smoking (pack-years, $\bar{x}$±s)	25.49±29.70	21.3±18.27	0.442
FEV₁ (L, $\bar{x}$±s)	1.36±0.42	1.23±0.34	0.162
FEV₁ % pred (%,$\bar{x}$±s)	57.04±14.34	53.51±13.37	0.252
FVC (L, $\bar{x}$±s)	2.34±0.70	2.17±0.56	0.222
FEV₁/FVC (%, $\bar{x}$±s)	58.37±8.47	57.26±7.78	0.540
Frequency of AECOPD [median (IQR)]	1.50 (1.00, 3.00)	2.00 (1.00, 3.00)	0.719
ALT [U/L median (IQR)]	18.42 (9.24)	15.50 (7.57)	0.152
AST [U/L, median (IQR)]	21.00 (7.00)	21.00 (6.00)	0.298
Scr (μmol/L, $\bar{x}$±s)	64.18±2.00	63.81±1.74	0.372
BUN (μmol/L, $\bar{x}$±s)	5.10±1.83	4.97±0.20	0.346

Baseline characteristics	DTCO group (n = 40)	Control group (n = 42)	P value
Age (years, $\bar{x}$±s)	64.88±6.22	65.50±6.99	0.670
Male [n (%)]	34 (85.00)	37 (88.10)	0.753
Smoker [n (%)]	28 (70.00)	30 (71.43)	1.000
Smoking (pack-years, $\bar{x}$±s)	25.49±29.70	21.3±18.27	0.442
FEV₁ (L, $\bar{x}$±s)	1.36±0.42	1.23±0.34	0.162
FEV₁ % pred (%,$\bar{x}$±s)	57.04±14.34	53.51±13.37	0.252
FVC (L, $\bar{x}$±s)	2.34±0.70	2.17±0.56	0.222
FEV₁/FVC (%, $\bar{x}$±s)	58.37±8.47	57.26±7.78	0.540
Frequency of AECOPD [median (IQR)]	1.50 (1.00, 3.00)	2.00 (1.00, 3.00)	0.719
ALT [U/L median (IQR)]	18.42 (9.24)	15.50 (7.57)	0.152
AST [U/L, median (IQR)]	21.00 (7.00)	21.00 (6.00)	0.298
Scr (μmol/L, $\bar{x}$±s)	64.18±2.00	63.81±1.74	0.372
BUN (μmol/L, $\bar{x}$±s)	5.10±1.83	4.97±0.20	0.346

Group	n	frequency of AECOPD	Duration of AECOPD (d)	frequency of moderate-to-severe AECOPD	duration of moderate-to-sever AECOPD (d)
DTCO	40	1.00 (0.00, 1.00)	2.5 (0.00, 7.75)	0.00 (0.00, 0.00)	0.00 (0.00, 0.00)
Control	42	1.00 (0.00, 2.00)	6.00 (0.00, 11.00)	1.00 (0.00, 2.00)	3.00 (0.00, 9.25)
P value		0.014	0.044	0.000	0.000
Z value		－2.451	－2.019	－3.798	－3.551

Group	n	frequency of AECOPD	Duration of AECOPD (d)	frequency of moderate-to-severe AECOPD	duration of moderate-to-sever AECOPD (d)
DTCO	40	1.00 (0.00, 1.00)	2.5 (0.00, 7.75)	0.00 (0.00, 0.00)	0.00 (0.00, 0.00)
Control	42	1.00 (0.00, 2.00)	6.00 (0.00, 11.00)	1.00 (0.00, 2.00)	3.00 (0.00, 9.25)
P value		0.014	0.044	0.000	0.000
Z value		－2.451	－2.019	－3.798	－3.551

Group	Measure	Week 0	Week 12	Week 24	Week 36	Week 48
Control (n = 42)	FEV₁ %	53.5±13.4	53.1±14.9	54.9±11.4	53.4±14.1	53.6±13.9
	FVC (L)	2.2±0.6	2.2±0.6	2.2±0.6	2.2±0.6	2.2±0.6
	6MWT (m)	386.5±99.4	396.6±102.4	394.2±9.1	390.7±103.4	399.2±102.6^c
	mMRC	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)
	SGRQ	38.4±11.9	37.7±10.6	36.6±11.4	36.3±12.1	35.4±12.8^c
DTCO ( n = 40)	FEV₁%	57.0±14.4	59.6±17.2	59.5±16.1^a	59.6±16.3	59.1±15.2
	FVC (L)	2.3±0.7	2.5±0.7^ab	2.5±0.6^a	2.4±0.7	2.5±0.7^ab
	6MWT (m)	411.6±89.5	417.1±89.5	423.2±86.4^a	427.5±84.3^a	435.8±86.5^a
	mMRC	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)	2.0 (1.0, 2.0)^b	1.5 (1.0, 2.0)^b
	SGRQ	38.5±12.2	37.0±11.8	35.4±11.2^a	33.6±10.7^a	32.5±10.5^a

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Dongtian Changchun ointment (洞天长春膏) for moderate-to-severe chronic obstructive pulmonary disease: a multicenter, prospective, open-label, randomized controlled trial

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Side effects	DTCO group (n = 42)	Control group (n = 42)	P value
Diarrhoea	2 (4.76)	2 (4.76)	1.000
Vomit	2 (4.76)	2 (4.76)	1.000
Insomnia	0 (0.00)	0 (0.00)	-
Dizziness	0 (0.00)	0 (0.00)	-
Palpitation	0 (0.00)	0 (0.00)	-
Serious adverse reactions	0 (0.00)	0 (0.00)	-
ALT	2 (4.76)	1 (2.38)	1.000
AST	1 (2.38)	3 (7.14)	0.616
Scr	0 (0.00)	0 (0.00)	-
BUN	0 (0.00)	0 (0.00)	-

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