XU Yinji, TANG Xuechun, LIN Lin, et al. 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[J]. Journal of Traditional Chinese Medicine2017, 58(6): 489-492.
XU Yinji, TANG Xuechun, LIN Lin, et al. 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[J]. Journal of Traditional Chinese Medicine2017, 58(6): 489-492.DOI: 10.13288/j.11-2166/r.2017.06.010.
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
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( FEF50) 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.
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