中医药治疗支气管扩张症多中心随机对照研究OA北大核心CSTPCD

Objective To evaluate the efficacy and safety of Chinese medicine(CM)in the treatment of patients with bronchiectasis.Methods The multicenter randomized controlled trial was conducted in 216 patients with bronchiectasis who were randomly assigned to the experimental group and the control group,with 108 cases in each group.As for the experimental group,the patients with Fei-Pi qi deficiency and phlegm-dampness obstructing Fei pattern received Bufei Huatan Formula,and those with qi-yin deficiency and phlegm heat obstructing Fei pattern received Yifei Qinghua Formula based on CM pattern differentiation,while the patients in the control group received placebo.Both groups were treated for 24 weeks and followed up for 24 weeks.The primary outcome was the frequency of acute exacerbation,and the secondary outcomes included the time to the first acute exacerbation,lung function[forced expiratory volume in one second(FEV1),FEV1％pred,forced vital capacity(FVC),and FEV1/FVC],and quality of life[St George's Respiratory Questionnaire(SGRQ),Leicester Cough Questionnaire(LCQ),and Quality of Life-Bronchiectasis(QoL-B)].Results Totally 96 cases in the experimental group and 90 cases in the control group completed the trial and were included for statistical analysis.Compared with during the past year,the frequency of acute exacerbation in the experimental group decreased during the study period(P＜0.01).Compared with before treatment in the experimental group,the FEV1％pred increased at 24 of treatment and 24 weeks of follow-up,the SGRQ scores decreased to varying degrees at 12 and 24 weeks of treatment,and 24 weeks of follow-up,and both LCQ and QoL-B scores increased to varying degrees at 12 and 24 weeks of treatment,and 24 weeks of follow-up(P＜0.05,P＜0.01).As for the control group,the FEV1,FEV1％pred,and FVC increased at 24 weeks of treatment,the FVC increased at 24 weeks of follow-up,the SGRQ scores decreased to varying degrees at 12 and 24 weeks of treatment,and 24 weeks of follow-up,and both LCQ and QoL-B scores increased to varying degrees at 12 and 24 weeks of treatment,and 24 weeks of follow-up(P＜0.05,P＜0.01).Compared with the control group,the time to the first acute exacerbation in the experimental group prolonged(P＜0.05).Compared with the control group at the same period,the symptom domain scores of SGRQ decreased,the physiological domain scores of LCQ and the respiratory symptoms domain scores of QoL-B increased in the experimental group at 12 weeks of treatment(P＜0.05);the frequency of acute exacerbation,SGRQ total scores and its domain scores decreased,LCQ total scores and its domain scores,and domain scores of QoL-B increased at 24 weeks of treatment(P＜0.05,P＜0.01);the frequency of acute exacerbation,SGRQ total scores and its domain scores decreased,LCQ total scores and its domain scores,and physical function,sense of health,vitality,emotional function,role function,social function,and respiratory symptoms domains scores of QoL-B increased at 24 weeks of follow-up(P＜0.05,P＜0.01).Conclusion CM treatment based on pattern differentiation is effective and safe for patients with bronchiectasis,and can reduce acute exacerbation,relieve symptoms,and improve quality of life.(ClinicalTrials.gov,No.NCT03443531).