首页|Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease:A multi-centre,randomised,double-blind,placebo-controlled trial

Efficacy and safety of Qingfei Huatan formula in the treatment of acute exacerbation of chronic obstructive pulmonary disease:A multi-centre,randomised,double-blind,placebo-controlled trial

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Background:Chronic obstructive pulmonary disease(COPD),a common respiratory disease,can be effec-tively treated by traditional Chinese medicine(TCM).Qingfei Huatan,a TCM formula,has been reported to effectively alleviate the clinical symptoms of COPD patients.However,there is a lack of multi-centre,randomised,double-blind,controlled clinical trials documenting the clinical efficacy and safety of this formula in the treatment of acute exacerbation of COPD(AECOPD).Objective:This study evaluated the efficacy and safety of Qingfei Huatan formula in the treatment of AECOPD,thereby providing high-quality clinical evidence.Design,setting,participants and interventions:A total of 276 patients with AECOPD were included in this multi-centre,randomised,double-blind,placebo-controlled trial and were randomised into treatment and control groups at a ratio of 1:1.Patients in the treatment and control groups took Qingfei Huatan granules or simulated Qingfei Huatan granules twice a day,for 14 days,in addition to Western medicine treatment.All patients were followed up for 3 months.Main outcome measures:The primary outcome was time taken to symptom stabilisation.The secondary outcomes included duration of antibiotic use,clinical symptom and sign score,TCM syndrome score,dys-pnoea score,and quality of life(QOL)score.Meanwhile,the safety of the formula was assessed through routine urine and stool tests,electrocardiograms,liver and kidney function tests,and the observation of adverse events throughout the trial.Results:The time taken for effective stabilisation(P＜0.05)and obvious stabilisation(P＜0.01),and the duration of antibiotic use(P＜0.05)were significantly shorter in the treatment group than in the control group.On days 6,9,12 and 14 of treatment,clinical symptom and sign score decreased in both groups,particularly in the treatment group(P＜0.01).On days 9,12 and 14 of treatment,the TCM syndrome scores of both groups were reduced(P＜0.01),with more significant reductions in the treatment group.At 3 months after the end of treatment,the treatment group continued to have lower clinical symptom and sign score and TCM syndrome score than the control group(P＜0.01).On days 6,9,12 and 14 of treat-ment,dyspnoea and QOL scores were markedly reduced in the two groups(P＜0.05 and P＜0.01,respec-tively),especially in the treatment group.At 3 months after the end of treatment,dyspnoea and QOL scores were lower in the treatment group than those in the control group(P＜0.01).No serious adverse events were observed in either group.Conclusion:The Qingfei Huatan formula can effectively shorten the duration of AECOPD and antibiotic use,significantly relieve clinical symptoms,and increase QOL for AECOPD patients,with a favourable safety profile.These results suggest that this formula can be used as a complementary treatment for AECOPD patients.

Acute exacerbation of chronic obstructive pulmonary diseaseClinical trialSyndrome of phlegm-heat congesting lungQingfei Huatan formulaTraditional Chinese medicine

Hui-zhi Zhu、Cheng-yi Li、Liang-ji Liu、Jia-bing Tong、Zhi-hui Lan、Shu-guang Tian、Qiao Li、Xiang-li Tong、Ji-feng Wu、Zhen-gang Zhu、Su-yun Li、Jian-sheng Li

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Department of Respiratory Medicine,the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230031,Anhui Province,China

Graduate School,Anhui University of Traditional Chinese Medicine,Hefei 230012,Anhui Province,China

Department of Respiratory Medicine,Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi Province,China

Department of Respiratory Diseases,the First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,Henan Province,China

Department of Pulmonary Diseases,Taihe Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Traditional Chinese Medicine,Fuyang 236600,Anhui Province,China

Department of Respiratory and Critical Care Medicine,Jiangxi Province Hospital of Integrated Chinese and Western Medicine,Nanchang 330002,Jiangxi Province,China

Department of Respiratory Medicine,the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China

Collaborative Innovation Center for Respiratory Disease Diagnosis and Treatment and Chinese Medicine Development of Henan Province,Zhengzhou 450046,Henan Province,China

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2024

10.1016/j.joim.2024.07.003

结合医学学报(英文版)
上海市中西医结合学会,上海长海医院

结合医学学报(英文版)

CSTPCD
影响因子：0.711
ISSN：2095-4964
年,卷(期)：2024.22(5)