龙香平喘胶囊治疗支气管哮喘临床疗效观察  

Clinical Observation on AsthmaTreated with Longxiangpingchuan Capsules

作　　者：杨璐[1] 朱玉梅[1] 陈信义[1] Yang Lu;Zhu Yumei;Chen Xinyi(Dongzhimen Hospital Affiliation to Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院,100700

出　　处：《医学研究杂志》2021年第6期66-69,共4页Journal of Medical Research

基　　金：国家科技部“十五”重大科技计划项目(2001BA701A-21);国家科技部创新基金资助项目(03C26226110309)。

摘　　要：目的观察龙香平喘胶囊治疗支气管哮喘临床安全性与有效性。方法采用随机单盲、阳性药平行对照、多中心临床研究方法,以肺功能、中医证候与症状、体征等为观察指标,并观察其不良反应。结果共计入组432例。进入ITT、PP分析病例数为425例。其中,治疗组(龙香平喘胶囊)318例,对照组(蠲哮片)107例。两组病例治疗前后肺功能疗效组内比较,差异有统计学意义(P<0.05),表明两组病例治疗后肺功能检测指标均有改善。两组病例证候总疗效比较,差异无统计学意义(P>0.05)。两组病例喘息症状有效率组间比较,差异有统计学意义(P=0.012),治疗组优于对照组;喘息症状消失率组间比较,差异有统计学意义(P=0.035),治疗组优于对照组。两组病例均有不良反应分别为8.41%(对照组)和3.77%(治疗组),主要不良反应为轻度恶心、胃脘部不适等。结论龙香平喘胶囊治疗支气管哮喘(痰瘀互阻、肺失宣降证)安全有效,并无明显不良反应,值得推广应用。Objective To observe the clinical safety and effectiveness of Longxiang Pingchuan Capsule in the treatment of Asthma.Methods A randomized,single-blind,parallel control of positive drugs,multi-center clinical research methodology was used.Pulmonary function,TCM syndromes and symptoms,and signs as observation indicators,and its adverse reactions were also observed.Results A total of 432 patients were enrolled.The analysis of ITT and PP was 425 cases,of which 318 cases were in the treatment group(Longxiang Pingchuan Capsule)and 107 cases were in the control group(taking Xiaotong tablets).The results of the study showed that:The comparison of lung function detection index changes before and after treatment in the group was statistically significant(P<0.05).It showed that the pulmonary function indexes of the two groups were improved after treatment.The pulmonary function curative effect was similar between the two groups.The total curative effect of the two groups of cases was not statistically significant(P>0.05).The comparison of the wheezing symptoms between the two groups is statistically significant(P=0.012).The treatment group was better than the control group.Z test was statistically significant(P=0.035),and the treatment group was better than the control group.The adverse reactions in the two groups were 8.41%(control group)and 3.77%(treatment group).The main adverse reactions were mild nausea and gastric discomfort.Conclusion Longxiang Pingchuan Capsule is safe and effective in the treatment of asthma(syndrome of stasis of sputum and blood,inaction and sluggishness of lung-energy),without obvious adverse reactions,and is worthy of popularization and application.

关 键 词：龙香平喘胶囊 支气管哮喘 痰瘀互阻、肺失宣降证 

分 类 号：R259[医药卫生—中西医结合]