寒喘祖帕颗粒控制哮喘多中心随机双盲安慰剂平行对照研究OA

Objective To evaluate the effect of Hanchuan Zupa granules on asthma control rate in patients with chronic persistent asthma(cold-type asthma).Methods A multicenter,randomized,double-blind,placebo-parallel controlled clinical trial was conducted.A total of 240 patients with chronic persistent asthma(cold-type asthma)collected from 13 hospitals from April 2021 to March 2022 were randomly assigned into the test group(120 cases,oral Hanchuan Zupa granule,6 g each time,twice daily)and the control group(120 cases,oral Hanchuan Zupa granules simulant,6 g each time,twice daily).All patients were treated with salmeterol ticasone powder inhaler 50 μg/100 μg as the control medication,1 inhalation each time,twice daily.After 4 weeks of treatment,the well-control rate of asthma,grading of asthma control level,Chinese medicine(CM)syndrome scores,Mini Asthma Quality of Life Questionnaire(Mini-AQLQ)scores,lung function and adverse drug reactions were observed.Results A total of 238 subjects were enrolled in the full analysis set(FAS).Among them,225 participants completed the trial and were included in the per-protocol set(PPS),consisting of 114 cases in the control group and 111 cases in the test group.Compared with baseline,in both FAS and PPS,the asthma control rate,the proportions of complete and partial asthma control,and Mini-AQLQ scores significantly increased after treatment in both groups(P＜0.01).Furthermore,the proportions of poor control,very poor control,and uncontrolled asthma markedly decreased following treatment(P＜0.01).In the FAS analysis,morning peak expiratory flow(PEF)levels improved after treatment.Moreover,all indicators were better in the test group than in the control group(P＜0.01).Compared with the control group,the total effective response rate of CM symptoms significantly increased in the test group after treatment in FAS(P＜0.05).Conclusion Combining Hanchuan Zupa granules with conventional Western medicine can improve the control level of asthma,with good safety.(Chinese Clinical Trial Registry,No.ChiCTR 2400086925)