中国中西医结合杂志2026，Vol.46Issue(8)：924-931,8.DOI:10.7661/j.cjim.20260605.287
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
Effect of Hanchuan Zupa Granules on Asthma Control:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Parallel Study
王文雅 1查日田 2赵琦 3孙绪武 4张小飞 5甄会 6丁俊平 7方云 8李永生 9林江涛 1苗青 10纳建荣 11赵丽敏 12李贵芳 13张晓谊 14黄友明 15陆光兵 16李博17
作者信息
- 1. 中日友好医院呼吸与危重症医学科(北京 100029)
- 2. 芜湖市第一人民医院呼吸内科(安徽 241060)
- 3. 黑龙江省森工总医院呼吸内科(哈尔滨 150040)
- 4. 牡丹江市中医医院呼吸与危重症医学科(黑龙江 157001)
- 5. 山西省汾阳医院呼吸与危重症医学科(山西 032299)
- 6. 中国中药协会呼吸病药物研究专业委员会(北京 100102)
- 7. 哈尔滨康赛思医药科技开发有限公司(哈尔滨 150001)
- 8. 北京药海宁康医药科技有限公司(北京 100101)
- 9. 新奇康药业股份有限公司(乌鲁木齐 830010)
- 10. 中国中医科学院西苑医院肺病科(北京 100091)
- 11. 宁夏医科大学总医院呼吸内科(银川 750003)
- 12. 河南省人民医院呼吸与危重症医学科(郑州 462000)
- 13. 华北医疗健康集团峰峰总医院呼吸内科(河北 056299)
- 14. 乌鲁木齐市中医医院呼吸与危重症医学科(乌鲁木齐 830099)
- 15. 皖南医学院第二附属医院呼吸与危重症医学科(安徽 241100)
- 16. 眉山市中医医院呼吸与危重症医学科(四川 620010)
- 17. 北大荒集团建三江医院呼吸内科(黑龙江 156399)
- 折叠
摘要
Abstract
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)关键词
寒喘祖帕颗粒/冷哮/哮喘慢性持续期/哮喘控制率Key words
Hanchuan Zupa granules/cold-type asthma/chronic persistent asthma/asthma control rate引用本文复制引用
王文雅,查日田,赵琦,孙绪武,张小飞,甄会,丁俊平,方云,李永生,林江涛,苗青,纳建荣,赵丽敏,李贵芳,张晓谊,黄友明,陆光兵,李博..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[J].中国中西医结合杂志,2026,46(8):924-931,8.
