<italic style="font-style: italic">Sufei Pingchuan Formula</italic> （肃肺平喘方） for the Treatment of Bronchiectasis Patients Combined with Airflow Limitation of Phlegm-Heat Obstructing the Lung and Lung-Spleen <italic style="font-style: italic">Qi</italic> Deficiency Syndrome： A Randomised Controlled Trial

YUAN Shasha; ZHANG Haiyan; SHI Xia; WANG Bing; CONG Xiaodong; MIAO Qing

doi:10.13288/j.11-2166/r.2025.06.007

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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

更新时间：2025-03-12

- 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
- Journal of Traditional Chinese Medicine Vol. 66, Issue 6, Pages: 581-587(2025)
- 作者机构：
  
  1.中国中医科学院西苑医院，北京市海淀区西苑操场1号，100091
  2.北京中医药大学深圳医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.06.007
  CLC：
- Received：16 September 2024，
  
  Revised：2024-12-30，
  
  Published：17 March 2025
- 稿件说明：
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袁沙沙,张海艳,石霞等.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[J].中医杂志,2025,66(06):581-587.

YUAN Shasha,ZHANG Haiyan,SHI Xia,et al.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[J].Journal of Traditional Chinese Medicine,2025,66(06):581-587.
袁沙沙,张海艳,石霞等.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[J].中医杂志,2025,66(06):581-587. DOI： 10.13288/j.11-2166/r.2025.06.007.

YUAN Shasha,ZHANG Haiyan,SHI Xia,et al.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[J].Journal of Traditional Chinese Medicine,2025,66(06):581-587. DOI： 10.13288/j.11-2166/r.2025.06.007.

摘要

目的

评价肃肺平喘方治疗支气管扩张症（简称支扩）合并气流受限痰热蕴肺兼肺脾气虚证患者的有效性及安全性。

方法

采用随机、双盲、安慰剂对照试验方案，将72例稳定期支扩合并气流受限的痰热蕴肺兼肺脾气虚证患者随机分为治疗组和对照组各36例。两组患者在规律使用噻托溴铵吸入喷雾剂的基础上，治疗组给予肃肺平喘方颗粒剂，对照组给予肃肺平喘方颗粒剂模拟剂，两组疗程均为12周。分别观察两组患者治疗前后肺功能第一秒用力呼气容积（FEV1）；分别于治疗前及治疗4、8、12周后观察两组患者改良版英国医学研究委员会呼吸困难量表（mMRC）、24小时痰量、慢性阻塞性肺病评估测试（CAT）、中医证候积分；于治疗4、8、12周后统计两组患者急性加重情况；记录两组患者治疗前后血常规、尿常规、肝肾功能等变化及不良事件的发生情况。

结果

治疗后治疗组脱落4例，对照组脱落6例。治疗12周后两组FEV1均较治疗前升高（

＜0.05），但治疗后组间比较差异无统计学意义（

＞0.05）。与治疗前比较，治疗组在治疗12周后mMRC评分降低（

＜0.05），在治疗4、8、12周后24小时痰量、CAT评分、中医证候积分均降低（

＜0.05）；对照组在治疗12周后24小时痰量降低（

＜0.05），在治疗8、12周后中医证候积分均降低（

＜0.05）。与对照组比较，治疗组在治疗12周后mMRC降低（

＜0.05），在治疗4、8、12周后24小时痰量、中医证候积分均降低（

＜0.05），在治疗8、12周后CAT评分降低（

＜0.05）。治疗组的急性加重例次及急性加重次数在治

疗12周后均低于对照组（

＜0.05）。两组患者均未发生严重不良事件。

结论

肃肺平喘方可以改善支扩合并气流受限患者的肺功能FEV1、呼吸困难严重程度，减少24小时痰量和频繁急性加重，并改善生活质量，且安全性较好。

Abstract

Objective

To 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

deficiency syndrome.

Methods

A 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

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.

Results

After 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 （

＜0.05）， but the difference betw

een groups was not statistically significant （

＞0.05）. Compared to before treatment， the treatment group showed a reduction in mMRC scores after 12 weeks （

＜0.05） and a decrease in 24-hour sputum volume， CAT scores， and TCM syndrome scores at weeks 4， 8， and 12 （

＜0.05）. In the control group， 24-hour sputum volume decreased after 12 weeks （

＜0.05）， and TCM syndrome scores decreased at weeks 8 and 12 （

＜0.05）. Compared to the control group， the treatment group showed a greater reduction in mMRC scores at week 12 （

＜0.05）， a decrease in 24-hour sputum volume and TCM syndrome scores at weeks 4， 8， and 12 （

＜0.05）， and lower CAT scores at weeks 8 and 12 （

＜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 （

＜0.05）. No severe adverse events occurred in either group.

Conclusion

Sufei 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.

关键词

Keywords

references

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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

DOI：10.13288/j.11-2166/r.2025.06.007

摘要

Abstract

关键词

Keywords

references