Efficacy and safety of Yi Huo Hua Tan granule in the treatment of stable chronic obstructive pulmonary disease (syndrome of Qi deficiency with phlegm and blood stagnation)_West China Medical Journal

Authors：

LI Ting , FENG Ruizhi , PENG Liqiao , JIANG Hongli ,  LIU Wei ,  MAO Bing

Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

LIU Wei, Email: liuwei0929@wchscu.cn; MAO Bing, Email: maobing@medmail.com.cn

Keywords：

Stable chronic obstructive pulmonary disease; syndrome of Qi deficiency with phlegm and blood stagnation; Yi Huo Hua Tan granule

DOI：

10.7507/1002-0179.202302084

Video：

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Objective To study the efficacy and safety of Yi Huo Hua Tan granule in the treatment of stable chronic obstructive pulmonary disease (COPD) patients with a traditional Chinese medicine (TCM) syndrome of Qi deficiency with phlegm and blood stagnation. Methods The stable COPD patients with a TCM syndrome of Qi deficiency with phlegm and blood stagnation who visited the outpatient in the Department of Integrated Traditional and Western Medicine, West China Hospital of Sichuan University between August 2016 and March 2017 were selected. The patients were randomly divided into an experimental group and a control group using a random number table method. Patients in both groups received conventional western medicine, with Yi Huo Hua Tan granule being additionally prescribed in patients in the experimental group. The treatment during was 60 days. The TCM effective rate, TCM syndrome score, COPD Assessment Test (CAT) score, modified Medical Research Council Dyspnea Scale, six minutes walking distance, long-term prognostic indicators, lung function indicators, inflammatory cytokines in serum and induced sputum supernatant were compared between groups. The safety of Yi Huo Hua Tan granule was also observed. Results A total of 69 patients were included, including 34 patients in the experimental group and 35 patients in the control group. After treatment of Yi Huo Hua Tan granule for 2 months , the total effective rate of TCM syndrome was 44.1% and 8.6% in the experimental group and the control group, respectively (P=0.001). There were statistically significant differences at 2 months and 4 months of follow-up visits between groups (P<0.05). After 2 months treatment, TCM syndrome score, CAT score, modified Medical Research Council score, number of acute exacerbations per year, hospitalization per year, and total length of hospital stay per year in the experimental group were lower than those in the control group (P<0.05). The six minutes walking distance, forced vital capacity, forced expiratory volume in one second, forced expiratory volume in one second /predicted value, serum, and the concentrations of interleukin (IL)-6, IL-1β, and IL-10 in induced sputum supernatant between the two groups showed no statistically significant difference (P>0.05). There was no significant change in blood routine, liver and kidney function, electrocardiogram, or urine and urine routine of the patients in the two groups. Conclusion Yi Huo Hua Tan granule improves the clinical symptoms and quality of life in patients with stable COPD, with a good safety.

Citation： LI Ting, FENG Ruizhi, PENG Liqiao, JIANG Hongli, LIU Wei, MAO Bing. Efficacy and safety of Yi Huo Hua Tan granule in the treatment of stable chronic obstructive pulmonary disease (syndrome of Qi deficiency with phlegm and blood stagnation). West China Medical Journal, 2024, 39(4): 526-534. doi: 10.7507/1002-0179.202302084 Copy

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1. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (2023 report). (2023-12-02).
2. Wang C, Xu J, Yang L, et al. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China pulmonary health [CPH] study): a national cross-sectional study. Lancet, 2018, 391(10131): 1706-1717.
3. Zhou M, Wang H, Zeng X, et al. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet, 2019, 394(10204): 1145-1158.
4. GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the global burden of disease study 2017. Lancet Respir Med, 2020, 8(6): 585-596.
5. 李若曈, 饶蓁蓁, 傅晏红, 等. 2030 年中国慢性阻塞性肺疾病的疾病负担预测与危险因素控制效果模拟. 中华流行病学杂志, 2022, 43(2): 201-206.
6. 张海龙, 王明航, 赵栋梁, 等. 中医药辨证治疗慢性阻塞性肺疾病稳定期随机对照试验的疗效评价指标系统评价. 世界科学技术-中医药现代化, 2013, 15(6): 1416-1424.
7. 王至婉, 李建生, 余学庆, 等. 基于文献的 COPD 稳定期证候要素分布规律的研究. 辽宁中医杂志, 2008(4): 513-514.
8. 刘建, 刘忠义, 赵文鹏, 等. 中药治疗慢性阻塞性肺疾病稳定期浅析. 河北中医, 2011, 33(2): 224.
9. 李建生, 王至婉, 王明航, 等. 慢性阻塞性肺疾病稳定期肺功能与证素及基础证分布规律的相关性研究. 中华中医药杂志, 2011, 26(7): 1500-1503.
10. 李建生, 李素云, 余学庆. 慢性阻塞性肺疾病中医诊疗指南(2011 版). 中医杂志, 2012, 53(1): 80-84.
11. 闵婕, 毛兵, 蒋红丽, 等. “益气活血”法治疗慢性阻塞性肺疾病稳定期(气虚血瘀证)的临床研究. 四川大学学报(医学版), 2014, 45(4): 601-605.
12. van der Molen T, Miravitlles M, Kocks JW. COPD management: role of symptom assessment in routine clinical practice. Int J Chron Obstruct Pulmon Dis, 2013, 8: 461-471.
13. Salzman SH. The 6-min walk test: clinical and research role, technique, coding, and reimbursement. Chest, 2009, 135(5): 1345-1352.
14. Leelarungrayub J, Puntumetakul R, Sriboonreung T, et al. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis, 2018, 13: 3909-3921.
15. de Jong JW, van der Belt-Gritter B, Koëter GH, et al. Peripheral blood lymphocyte cell subsets in subjects with chronic obstructive pulmonary disease: association with smoking, IgE and lung function. Respir Med, 1997, 91(2): 67-76.
16. Wang G, Liu B, Cao Y, et al. Effects of two Chinese herbal formulae for the treatment of moderate to severe stable chronic obstructive pulmonary disease: a multicenter, double-blind, randomized controlled trial. PLoS One, 2014, 9(8): e103168.
17. Wang ZW, Yang PL, Shen L, et al. Clinical efficacy and mechanism of BaibuYangfei decoction for chronic obstructive pulmonary disease. Jilin J Trad Chin Med, 2014, 34: 899-902.
18. Li JS, Xie Y, Li SY, et al. Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial. Trials, 2014, 15: 153.
19. Hong M, Hong C, Chen H, et al. Effects of the Chinese herb formula Yufeining on stable chronic obstructive pulmonary disease: a randomized, double-blind, placebo-controlled trial. Medicine (Baltimore), 2018, 97(39): e12461.
20. Bardsley S, Criner GJ, Halpin DMG, et al. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis. Respir Med, 2022, 205: 107040.
21. Park SY, Kim S, Kim JH, et al. A randomized, noninferiority trial comparing ICS + LABA with ICS + LABA + LAMA in asthma-COPD overlap (ACO) treatment: the ACO treatment with optimal medications (ATOMIC) study. J Allergy Clin Immunol Pract, 2021, 9(3): 1304-1311.

West China Medical Journal

Efficacy and safety of Yi Huo Hua Tan granule in the treatment of stable chronic obstructive pulmonary disease (syndrome of Qi deficiency with phlegm and blood stagnation)

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