Abstract
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.
维普
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