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  

作　　者：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 

机构地区：[1]Department of Respiratory Medicine,the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230031,Anhui Province,China [2]Graduate School,Anhui University of Traditional Chinese Medicine,Hefei 230012,Anhui Province,China [3]Department of Respiratory Medicine,Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi Province,China [4]Department of Respiratory Diseases,the First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,Henan Province,China [5]Department of Pulmonary Diseases,Taihe Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Traditional Chinese Medicine,Fuyang 236600,Anhui Province,China [6]Department of Respiratory and Critical Care Medicine,Jiangxi Province Hospital of Integrated Chinese and Western Medicine,Nanchang 330002,Jiangxi Province,China [7]Department of Respiratory Medicine,the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China [8]Collaborative Innovation Center for Respiratory Disease Diagnosis and Treatment and Chinese Medicine Development of Henan Province,Zhengzhou 450046,Henan Province,China

出　　处：《Journal of Integrative Medicine》2024年第5期561-569,共9页结合医学学报（英文版）

基　　金：supported by Research on the Modernisation of Traditional Chinese Medicine in National Key R&D Programmes(No.2018YFC1704804 and 2018YFC1704800);the Sixth Special Support Program for Innovative Leading Talents in Anhui(No.T000614).

摘　　要：Background Chronic obstructive pulmonary disease(COPD),a common respiratory disease,can be effectively 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,dyspnoea 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

关 键 词：Acute exacerbation of chronic obstructive pulmonary disease Clinical trial Syndrome of phlegm-heat congesting lung Qingfei Huatan formula Traditional Chinese medicine 

分 类 号：R259[医药卫生—中西医结合]