喘可治注射液治疗儿童支气管哮喘急性发作期的临床研究

Clinical Research on Treatment of Acute Attack of Bronchial Asthma in Children with Chuankezhi Injection

目的 评价喘可治注射液治疗儿童支气管哮喘急性发作期的疗效及安全性。方法 将 2 13例支气管哮喘急性发作期患儿 ,随机分为喘可治治疗组 (15 2例 )和止喘灵对照组 (6 1例 ) ,观测治疗前后主要疗效性指标和安全性指标的变化状况 ,并对部分患儿进行为期 3月的随访。结果 喘可治组中医证候疗效的显效率及有效率分别为 6 1.84 %、 85 .5 3% ,喘息症状的疗效分别为 6 5 .13%、 82 .2 4 % ,哮鸣音的疗效分别为 6 3.16 %、78.95 % ,第一秒用力呼出量 (FEV1)的疗效分别为 4 7.92 %、 84 .38% ,最大呼气流量 (PEF)的疗效分别为5 0 .0 0 %、 83.33% ,分别与对照组比较 ,均无显著性差异 (P均 >0 .0 5 ) ;未发现明显的不良反应。结论 喘可治注射液治疗儿童支气管哮喘急性发作期疗效肯定 ,无毒副作用 ,并具有一定的预防哮喘复发的作用。

Objective:To evaluate the curative effect of Chuankezhi injection on acute attack of bronchial asthma in children and its safety. Methods:Two hundred and thirteen children with acute attack of bronchial asthma were randomly allocated to Chuankezhi treatment group (n=152) and Zhichuanling control group (n=61). Differences of the main therapeutic and safety indexes before and after treatment were observed. A 3-month follow-up was carried out in some of the cases. Results:In Chuankezhi treatment group the remarkably effective rate and the effective rate were 63 16% and 85 53% respectively in relieving TCM syndrome, 65 13% and 82 24% in relieving dyspnea, and 63 16% and 78 95% in relieving wheezing sounds. The remarkably effective rate and the effective rate were 47 92% and 84 38% respectively for forced expiratory volume in the first second (FEV 1) and 50 00% and 83 33% for maximum expiratory flow volume (MXFV). The differences of the above indexes were not significant as compared with the control group (P>0 05). No obviously adverse reaction was found.Conclusion:Chuankezhi injection has a certain effect on acute attack of bronchial asthma in children without toxic or side effect, and can prevent the recurrence of asthma to some extent.