参蛤青龙丸治疗支气管哮喘寒哮证的非劣效性随机对照试验

Non-inferiority Randomized Controlled Trials of Modified Shenge Qinglong Wan( 参蛤青龙丸) in Treating Bronchial Asthma with Wheezing Due to Cold Syndrome

目的观察参蛤青龙丸治疗支气管哮喘寒哮证的临床疗效。方法采用随机对照、第三方评价的临床试验设计,纳入1~3级支气管哮喘急性发作期及慢性持续期寒哮证患者129例,随机分为中药组65例,西药组64例。中药组采用参蛤青龙丸治疗,西药组吸入沙美特罗替卡松气雾剂50μg,每日2次,两组疗程均为12周。分别于治疗前和治疗后4、8、12周进行哮喘控制(ACT)评分评测,分别于治疗前后评测肺功能,结果均采用意向性分析(ITT)和符合方案集分析(PP),ACT评分采用可信区间法进行非劣效性判定。结果 ITT分析与PP分析均显示,治疗4、8、12周时两组ACT评分的95%可信区间下限均>-1.5,提示中药组均不劣效于西药组。治疗后中药组的50%呼气峰流速(FEF_(50))和西药组的第一秒用力呼气容积(FEV1)、FEF50与本组治疗前比较差异具有统计学意义(P<0.05),治疗后两组间肺功能各项指标比较,差异均无统计学意义(P>0.05)。结论参蛤青龙丸治疗1~3级支气管哮喘寒哮证患者的ACT评分不劣效于沙美特罗替卡松气雾剂,两者亦可不同程度地改善肺功能。

Objective To observe the clinical effect of modified Shenge Qinglong Wan （参蛤青龙丸） in treating bronchial asthma with wheezing due to cold syndrome. Methods With randomly control and the third party evaluation design, the study included 129 patients with acute and chronic bronchial asthma with wheezing due to cold syndrome （class I-class III）, which were randomly allocated into Chinese medicine group （65 cases） and western medicine group （64 cases）. In the Chinese medicine group, the patients were treated with modified Shenge Qinglong Wan （参蛤青龙丸）, while in the western medicine group, the patients were treated with the salmeterol/flutieasone aerosol （50 μg, twice per day）. The course of treatment lasted for 12 weeks. , The asthma control test （ACT） scores were measured at baseline, and 4 weeks, 8 weeks and 12 weeks after treatment, and the lung function was evaluated before and after treatment. The results were analyzed by intention-to-treatment and per-protocol analyses. Confidence interval was used to determine whether ACT scores were non-inferior or not. Results Both ITT and PP analyses showed that, at 4 weeks, 8 weeks and 12 weeks after treatment, the 95% CI lower limits of ACT scores were greater than - 1.5, suggesting Chinese medicine group being non-inferior to western medicine group. In Chinese medicine group, there was significant difference in 50% forced expiratory flow （FEFS0） between before and after treatment （P 〈 0. 05 ）. In western medicine group, there were significant difference in forced vital capacity （ FEV1 ） and FEF50 between before and after treatment （P 〈 0. 05 ）. After treatment, there were no significant differences in the lung function measures between the groups （P 〉 0. 05）. Conclusion In patients with bronchial asthma with wheezing due to cold syndrome （class I -class III ） , ACT scores in the modified Shenge Qinglong Wan group are non-inferior to those in the salmeterol/flutieasone aerosol group. Both therapies could improve lung function with varying degrees.