Sufei Pingchuan Formula （肃肺平喘方） for the Treatment of Bronchiectasis Patients Combined with Airflow Limitation of Phlegm-Heat Obstructing the Lung and Lung-Spleen Qi Deficiency Syndrome： A Randomised Controlled Trial
10.13288/j.11-2166/r.2025.06.007
- VernacularTitle:肃肺平喘方治疗支气管扩张症合并气流受限痰热蕴肺兼肺脾气虚证患者的随机对照试验
- Author:
Shasha YUAN
1
;
Haiyan ZHANG
2
;
Xia SHI
1
;
Bing WANG
1
;
Xiaodong CONG
1
;
Qing MIAO
1
Author Information
1. Xiyuan Hospital，China Academy of Chinese Medical Sciences，Beijing，100091
2. Shenzhen Hospital of Beijing University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
bronchiectasis;
airflow limitation;
Sufei Pingchuan Formula （肃肺平喘方）;
pulmonary function;
mucus hypersecretion
- From:
Journal of Traditional Chinese Medicine
2025;66(6):581-587
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the effectiveness and safety of Sufei Pingchuan Formula （肃肺平喘方） in the treatment of bronchiectasis with airflow limitation， phlegm-heat obstructing the lung， and lung-spleen qi deficiency syndrome. MethodsA randomized， double-blind， placebo-controlled trial was conducted. A total of 72 patients with stable bronchiectasis with airflow limitation of phlegm-heat obstructing the lung and lung-spleen qi deficiency syndrome were randomly divided into treatment group and control group， with 36 cases in each group. On the basis of regular inhalation of tiotropium bromide inhalation spray， the treatment group was given Sufei Pingchuan Formula granules， and the control group was given Sufei Pingchuan Formula granule simulant. The course of treatment in both groups was 12 weeks. The pulmonary function of both groups before and after treatment was observed， specifically focusing on forced expiratory volume in one second （FEV1）； the modified British Medical Research Council （mMRC） dyspnea scale， 24-hour sputum volume， COPD assessment test （CAT）， and traditional Chinese medicine （TCM） syndrome scores were assessed before treatment and after 4， 8， and 12 weeks of treatment； acute exacerbations were recorded at weeks 4， 8， and 12； additionally， changes in routine blood tests， urinalysis， liver and kidney function， and adverse events were monitored before and after treatment. ResultsAfter treatment， 4 patients in the treatment group and 6 in the control group dropped out. After 12 weeks of treatment， FEV1 increased in both groups compared to pre-treatment levels （P＜0.05）， but the difference between groups was not statistically significant （P＞0.05）. Compared to before treatment， the treatment group showed a reduction in mMRC scores after 12 weeks （P＜0.05） and a decrease in 24-hour sputum volume， CAT scores， and TCM syndrome scores at weeks 4， 8， and 12 （P＜0.05）. In the control group， 24-hour sputum volume decreased after 12 weeks （P＜0.05）， and TCM syndrome scores decreased at weeks 8 and 12 （P＜0.05）. Compared to the control group， the treatment group showed a greater reduction in mMRC scores at week 12 （P＜0.05）， a decrease in 24-hour sputum volume and TCM syndrome scores at weeks 4， 8， and 12 （P＜0.05）， and lower CAT scores at weeks 8 and 12 （P＜0.05）. The frequency and number of acute exacerbations in the treatment group were significantly lower than those in the control group at week 12 （P＜0.05）. No severe adverse events occurred in either group. ConclusionSufei Pingchuan Formula can improve the pulmonary function FEV1， the severity of dyspnea， reduce 24-hour sputum volume and frequent acute exacerbations， and improve the quality of life in patients with bronchiectasis and airflow limitation， with good safety.
