宣肺止嗽合剂治疗急性支气管炎(风邪犯肺证)随机双盲多中心研究
Randomized Double-Blind Multicenter Study on Xuanfei Zhisou Mixture(宣肺止嗽合剂)in Treatment of Acute Bronchitis(Wind Evil Invading Lung Type)
张洪春 1杨道文 1崔红生 2高峰 3封继宏 4杨佩兰 5罗光伟 6朱佳 7李明 8郭栋伟 9梁爱武 10何咏 11耿立梅 12林志成 13黄燕 14刘杰军 15赵建清 16邝敏 17苏海华 18李兴芳 19吕红霞 20康永红21
作者信息
- 1. 中日友好医院,北京 100029
- 2. 北京中医药大学第三附属医院,北京 100029
- 3. 中国中医科学院望京医院,北京 100102
- 4. 天津中医药大学第二附属医院,天津 300150
- 5. 上海中医药大学附属岳阳中西医结合医院,上海 200437
- 6. 武汉市中西医结合医院,湖北武汉 430030
- 7. 江苏省中医院,江苏南京 210004
- 8. 通化市中心医院,吉林通化 134099
- 9. 柳州市中医医院,广西柳州 545026
- 10. 广西中医药大学附属瑞康医院,广西南宁 530011
- 11. 郑州市中医院,河南郑州 450006
- 12. 河北省中医院,河北石家庄 050013
- 13. 白山市中医院,吉林白山 134399
- 14. 内蒙古自治区中医医院,内蒙古呼和浩特 010020
- 15. 德州市人民医院,山东德州 253052
- 16. 河北北方学院附属第一医院,河北张家口 050051
- 17. 南宁市第二人民医院,广西南宁 530031
- 18. 新疆生产建设兵团医院,新疆乌鲁木齐 830002
- 19. 甘肃省中医院,甘肃兰州 730050
- 20. 北京康义堂中医研究院,北京 100070;北京康众时代医药科技集团有限公司,北京 100070
- 21. 甘肃普安制药股份有限公司,甘肃武威 733006
- 折叠
摘要
目的 观察宣肺止嗽合剂对急性支气管炎(风邪犯肺证)患者中医证候及生活质量的影响.方法 采用随机、双盲、安慰剂对照研究,在19个平行中心进行观察,将240例急性支气管炎(风邪犯肺证)患者分为试验组和对照组,每组120例.试验组口服宣肺止嗽合剂,对照组口服宣肺止嗽合剂模拟剂,疗程均为7 d.比较两组中医证候(日间咳嗽、夜间咳嗽、咳痰、咽痒)积分和莱塞斯特咳嗽生命质量问卷(the Leicester cough questionnaire,LCQ)评分.结果 最终完成试验者232例,其中试验组118例,对照组114例.治疗后,两组中医证候积分降低,LCQ中生理性得分、心理性得分、社会性得分和总分均升高,试验组改变更为明显(P＜0.01).两组上述指标在治疗后、治疗后较基线的差值均有统计学意义(P＜0.01).全分析集(full analysis set,FAS)及符合方案集(per protocol set,PPS)结果一致.结论 宣肺止嗽合剂可以明显改善急性支气管炎(风邪犯肺证)患者中医证候,提高其生活质量.
Abstract
Objective To observe the impacts of Xuanfei Zhisou Mixture(宣肺止嗽合剂)on TCM syndromes and quality of life of patients with acute bronchitis of wind evil invading lung type.Methods Randomized,controlled and placebo-controlled parallel trial design was adopted.The observation was conducted in 19 parallel centers,and 240 cases were randomly divided in-to trial group and control group,with 120 cases in each group.The trial group was administered with Xuanfei Zhisou Mixture,while the control group was given Xuanfei Zhisou Mixture simulation agent.The treatment course was 7 days.The scores of TCM syndromes(daytime cough,night cough,expectoration,itchy throat)and Leicester cough quality of life questionnaire(LCQ)were compared.Results There were 232 cases completed this trial,including 118 cases in the trial group and 114 cases in the control group.After treatment,the TCM syndromes scores decreased,and physiological score,psychological score,social score and total score of LCQ increased in both groups,and the trial group showed more significant changes(P＜0.01).The difference between the two groups of the above indicators after treatment and baseline was statistically significant(P＜0.01).The results of the full analysis set(FAS)and per protocol set(PPS)were consistent.Conclusion Xuanfei Zhisou Mixture could significantly im-prove the TCM syndromes of patients with acute bronchitis(wind evil invading lung type)and increase the quality of life of the patients.
关键词
宣肺止嗽合剂/急性支气管炎/风邪犯肺/中医证候/生活质量Key words
Xuanfei Zhisou Mixture(宣肺止嗽合剂)/acute bronchitis/wind evil invading lung/TCM syndromes/quality of life引用本文复制引用
基金项目
甘肃省科技计划项目(22ZD6FA021-2)
武威市科技计划项目(WW2201ZDS001)
出版年
2024
NETL
NSTL
万方数据