小儿喘宝辅助控制儿童支气管哮喘外寒内热证临床研究

Clinical Research of Xiaoer Chuanbao on Bronchial Asthma in Children

目的研究小儿喘宝辅助控制儿童支气管哮喘外寒内热证的有效性和安全性。方法将66例儿童支气管哮喘患儿,按随机对照单盲的研究方法分为实验组对照组,对照组予吸入布地奈德混悬液1 mg,每日1次,口服孟鲁司特钠5 mg,每日1次,实验组同时予小儿喘宝6~12 g/d。两组疗程均为12周。观察哮喘控制及中医证候疗效。结果实验组哮喘控制率76.67%,高于对照组的56.67%（P〈0.05）;中医证候疗效实验组有效率90.00%,与对照组70.00%比较,差异有统计学意义（P〈0.05）;中医证候积分实验组治疗后积分与本组治疗前比较,与对照组治疗后比较,差异均有统计学意义（P〈0.05）;治疗结束随访12周,实验组哮喘复发率14.29%,对照组复发率50.00%。实验期间两组均未发现不良反应。结论小儿喘宝辅助控制儿童支气管哮喘,临床疗效确切,复发率低,使用安全。

Objective： To explore the clinical effect and safety of Xiaoer Chuanbao on bronchial asthma in children with the syndrome of external cold andinterior heat. Methods： 66 cases of bronchial asthma in children were randomly divided into the treatment group and the control group,using parallel control and single-blind clinical trial methods. The control group were treated with Budesonide 1mg per day and Montelukast 5mg per day. At the same time,the treatment group were treated with Xiaoer Chuanbao 6 ~12 g per day. The clinical effect was observed in 12 weeks for a course of treatment. Results： After treatment,the control rate of asthma in the treatment group（76.67%） was higher than that of the control group（56.67%）,which had a significant difference（P 0.05）.TCM syndrome efficacy rate of the treatment group（90.00%） was higher than that of the control group（70.00%）,which had a significant difference（P 0.05）. TCM syndrome score of the treatment group was significantly different from that of the control group（P 0.05）. And In the follow-up of 12 weeks after treatment,the recurrence rate of the treatment was 14.29%,the control group 50.00%. No adverse reactions were found in the two groups during the experiment. Conclusion： The clinical effect of Xiaoer Chuanbao in curing bronchial asthma in children is significant with a low recurrence rate and safety.