仙芪青龙方治疗咳嗽变异性哮喘肺肾两虚、风盛挛急证的随机、阳性对照、非劣效性临床试验  

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

作　　者：陈晓纯 杨建雅 肖晶旻 范斐婷 周明娟[3] 吴蕾[3] 林琳 陈远彬[1,3,4] CHEN Xiaochun;YANG Jianya;XIAO Jingmin;FAN Feiting;ZHOU Mingjuan;WU Lei;LIN Lin;CHEN Yuanbin(The Second Clinical Medical College of Guangzhou University of Chinese Medicine/State Key Laboratory of Dampness Syndrome of Chinese Medicine,Guangzhou,510405;The First Affiliated Hospital of Henan University of Chinese Medicine;Guangdong Province Traditional Chinese Medical Hospital;Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome)

机构地区：[1]广州中医药大学第二临床医学院/省部共建中医湿证国家重点实验室,广东省广州市510405 [2]河南中医药大学第一附属医院 [3]广东省中医院 [4]广东省中医证候临床研究重点实验室

出　　处：《中医杂志》2024年第20期2109-2115,共7页Journal of Traditional Chinese Medicine

基　　金：省部共建中医湿证国家重点实验室项目(SZ2021ZZ42,SZ2023ZZ11);广东省科技计划项目(2023B1212060063);广州市中医药防治慢性咳喘病重点实验室(2023A03J0226);广东省中医院中医药科学技术研究专项(YN2022MS02);广东省名中医传承工作室建设项目(粤中医办函〔2023〕108号);广东省中医院名中医药专家学术经验传承工作室建设项目(中医二院〔2014〕89号)。

摘　　要：目的评价仙芪青龙方治疗咳嗽变异性哮喘肺肾两虚、风盛挛急证患者的临床疗效和安全性。方法采用随机、阳性对照、非劣效临床试验设计,将102例咳嗽变异性哮喘肺肾两虚、风盛挛急证患者随机分为治疗组52例和对照组各50例。治疗组给予仙芪青龙方颗粒口服,每日1剂,每次2袋(9.25 g/袋),每日2次,早晚餐后服用;对照组给予口服仙芪青龙方颗粒安慰剂联合吸入丙酸氟替卡松吸入气雾剂(每次125μg,每日2次)。两组均治疗12周,随访12周,共24周。主要结局指标为两组患者咳嗽症状评分(包括日间评分、夜间评分和总分),于治疗前(入组时)、治疗中(入组第6周后)、治疗结束(入组第12周后)、随访结束(入组第24周后)各评价1次,采用单侧95%可信区间下限(LCL)进行非劣效性判定。次要结局指标包括咳嗽缓解和消失情况、中医证候积分、咳嗽视觉模拟量表(VAS)评分、莱切斯特咳嗽问卷(LCQ)评分和肺功能指标[第1秒用力呼气容积(FEV_(1))、第1秒用力呼气容积占预计值百分比(FEV_(1)%pred)、用力肺活量(FVC)、呼气峰值流量(PEF)]。治疗前后检测血常规和肝肾功能,并详细记录不良事件发生情况。结果101例患者纳入全分析集(FAS)分析,治疗组52例,对照组49例。与本组治疗前比较,两组患者治疗中、治疗结束及随访结束时日间咳嗽症状评分、夜间咳嗽症状评分及咳嗽症状总分均下降(P<0.01)。两组患者在治疗中、治疗结束、随访结束时咳嗽症状总分的单侧95%LCL分别为-0.14、-0.47、-0.27(95%LCL均>-0.6)。两组患者各时间点咳嗽缓解率、咳嗽消失率、咳嗽缓解天数及咳嗽消失天数的组间比较,差异均无统计学意义(P>0.05)。与本组治疗前比较,两组患者治疗中、治疗结束以及随访结束时的中医证候积分、咳嗽VAS评分均下降,LCQ评分均上升(P<0.01),但FEV_(1)、FEV_(1)%、FVC、PEF治疗前后差异无统计学意义(P>0.0Objective 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(125μg 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(FEV_(1)),percentage of predicted forced expiratory volume in 1 second(FEV_(1)%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,

关 键 词：咳嗽变异性哮喘 肺肾两虚 风盛挛急 仙芪青龙方 吸入性糖皮质激素 非劣效性试验 

分 类 号：R256.12[医药卫生—中医内科学]