Xianqi Qinglong Formula(仙芪青龙方)for the Treatment of Cough Variant Asthma with Lung and Kidney Deficiency and Exuberant Wind-induced Spasm and Tension Syndrome:A Randomized,Positive-controlled,Non-inferiority Clinical Trial
Objective To evaluate the clinical efficacy and safety of Xianqi Qinglong Formula(仙芪青龙方,XQF)in the treatment of cough variant asthma(CVS)patients with lung and kidney deficiency and exuberant wind-induced spasm and tension syndrome.Methods A randomized,positive-controlled,non-inferiority clinical trial was designed.Totally,102 CVS patients with lung and kidney deficiency and exuberant wind-induced spasm and tension syndrome were randomly divided into a treatment group(52 cases)and a control group(50 cases).The treatment group was given XQF granules orally,1 dose per day,2 bags each time(9.25 g/bag),twice a day,after breakfast and dinner;the control group was given XQF granules placebo orally combined with inhaled fluticasone propionate inhalation aerosol(125 μg each time,twice a day).Both groups were treated for 12 weeks and followed up for 12 weeks,with a total of 24 weeks.The primary outcome was the cough symptom score(including daytime,nighttime and total score),evaluated before treatment(at enrollment),during treatment(after the 6th week of enrollment),at the end of treat-ment(after the 12th week of enrollment),and at the end of follow-up(after the 24th week of enrollment).The non-inferiority was determined by the lower limit(LCL)of the unilateral 95％confidence interval.The secondary out-comes included cough relief and disappearance,total score of TCM syndrome,cough visual analogue(VAS)score,Leicester Cough Questionnaire(LCQ)score,and lung function indicators including forced expiratory volume in 1 second(FEV1),percentage of predicted forced expiratory volume in 1 second(FEVl％pred),forced vital capacity(FVC),and peak expiratory flow(PEF).Blood routine and liver and kidney function were tested before and after treatment,and the adverse events were recorded.Results A total of 101 patients were included in the full analysis set(FAS),including 52 cases in the treatment group and 49 cases in the control group.After treatment,the daytime,nighttime and total cough symptom scores during treatment,at the end of treatment and at the end of follow-up all decreased in both two groups(P＜0.01).The unilateral 95％LCL of the total cough symptom scores during treatment,at the end of treatment and at the end of follow-up of the two groups were-0.14,-0.47 and-0.27(95％LCL all＞-0.6).There were no significant differences in the cough relief rate,cough disappearance rate,cough relief days and cough disappearance days between the two groups at each time point(P＞0.05).Compared to those before treatment,the TCM syndrome scores and cough VAS scores during treatment,at the end of treatment and at the end of follow-up decreased in both groups,while the LCQ scores increased(P＜0.01),but there were no significant differences in FEV1,FEV1％,FVC and PEF before and after treatment(P＞0.05).There were no significant differences in TCM syndrome scores,cough VAS scores,LCQ scores,FEV1,FEV1％,FVC,and PEF between the two groups at each time point(P＞0.05).No clinically significant abnormal liver and kidney function were found in the two groups before and after treatment.Conclusion XQF is not inferior to fluticasone propionate inhalation aerosol in relieving cough symptoms,reducing cough scores,decreasing the number of cough attack days,and improving the quality of life when treating CVS patients with lung and kidney deficiency and exuberant wind-induced spasms and tension syndrome,and relatively safe.
cough variant asthmalung and kidney deficiencyspasms and tension due to exuberant windXianqi Qinglong Formula(仙芪青龙方)inhaled glucocorticoidsnon-inferiority trial
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