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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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Journal of Integrative Medicine 2024年第5期22卷 561-569页

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 Department of Respiratory Medicine the First Affiliated Hospital of Anhui University of Traditional Chinese MedicineHefei 230031Anhui ProvinceChina Graduate School Anhui University of Traditional Chinese MedicineHefei 230012Anhui ProvinceChina Department of Respiratory Medicine Affiliated Hospital of Jiangxi University of Traditional Chinese MedicineNanchang 330006Jiangxi ProvinceChina Department of Respiratory Diseases the First Affiliated Hospital of Henan University of Traditional Chinese MedicineZhengzhou 450000Henan ProvinceChina Department of Pulmonary Diseases Taihe Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Traditional Chinese MedicineFuyang 236600Anhui ProvinceChina Department of Respiratory and Critical Care Medicine Jiangxi Province Hospital of Integrated Chinese and Western MedicineNanchang 330002Jiangxi ProvinceChina Department of Respiratory Medicine the First Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300381China Collaborative Innovation Center for Respiratory Disease Diagnosis and Treatment and Chinese Medicine Development of Henan Province Zhengzhou 450046Henan ProvinceChina

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 ***,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 ***,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:*** 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 *** patients were followed up for 3 *** outcome measures The primary outcome was time taken to symptom *** secondary outcomes included duration of antibiotic use,clinical symptom and sign score,TCM syndrome score,dyspnoea score,and quality of life(QOL)***,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 *** 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 *** 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 treatm

关键词： Acute exacerbation of chronic obstructive pulmonary disease Clinical trial Syndrome of phlegm-heat congesting lung qingfei huatan formula Traditional Chinese medicine

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