槐杞黄颗粒辅助治疗幼儿及学龄前儿童支气管哮喘的临床研究

Clinical trial of Huaiqihuang granules in adjuvant treatment of bronchial asthma in young children and preschool children

目的观察槐杞黄颗粒辅助治疗幼儿及学龄前儿童支气管哮喘的疗效。方法入选明确诊断支气管哮喘且处于临床缓解期的2~5岁患儿,随机分成对照组和试验组。对照组患儿使用常规哮喘长期控制药物(吸入糖皮质激素和/或口服白三烯受体拮抗药)进行治疗;试验组在对照组基础上口服槐杞黄颗粒5 g,bid。收集所有患儿的基线临床资料,于治疗后第4、8、12、20、28、36周及入组第4年(2020年)进行门诊或电话随访。随访内容包括哮喘发作情况、鼻炎症状、呼吸道感染情况等,并对随访观察指标的变化进行统计学分析,评价2组患儿的临床疗效。结果对照组和试验组分别入组99例患儿。治疗后,试验组与对照组的哮喘总有效率分别为97.56%和80.00%;试验组和对照组哮喘发作天数分别为0.52和0.95 d;试验组和对照组鼻炎症状的天数分别为0.38和0.97 d;试验组和对照组呼吸道感染发生率分别为6.06%和17.17%;呼吸道感染天数分别为2.03和4.20 d,对照组的以上指标与试验组比较,差异均有统计学意义(均P<0.05);试验组和对照组分别有82例和85例患儿完成入组后第4年的随访调查,试验组和对照组近3年哮喘发作率分别为15.85%和35.29%,总发作次数分别为3.24次和4.41次,差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有腹泻和皮疹,对照组的药物不良反应有皮疹,试验组和对照组的总药物不良反应发生率分别为2.02%和1.01%,差异无统计学意义(P>0.05)。结论槐杞黄颗粒联合哮喘长期控制药物辅助治疗幼儿及学龄前儿童哮喘可提高哮喘控制水平,减轻鼻炎症状,减少呼吸道感染,可提高总有效率。

Objective To investigate the therapeutic effect of Huaiqihuang granule on bronchial asthma in young children and preschool children.Methods Children aged 2~5 years who were diagnosed with bronchial asthma and in clinical remission were randomly divided into control group and treatment group.The control group was treated with conventional long-term asthma control drugs(inhaled corticosteroids and/or oral leukotriene receptor antagonists);on the basis of the control group,the treatment group was treated with Huaiqihuang granules 5 g,bid.The personal and baseline clinical data of all children were collected,and outpatient or telephone follow-up was performed at 4,8,12,20,28,36 weeks after treatment and 4 years after enrollment(2020).The follow-up contents included asthma attack,rhinitis symptoms and respiratory tract infection.The changes of follow-up observation indexes were statistically analyzed to evaluate the clinical efficacy of the two groups.Results The control group and the treatment group were enrolled in 99 children.After treatment,the total control rates of asthma in the treatment group and the control group were 97.56%and 80.00%,respectively;the days of asthma attack were 0.52 and 0.95 days,respectively;the days of rhinitis symptoms were 0.38 and 0.97 days,respectively;the incidence of respiratory tract infection were 6.06%and 17.17%,respectively;the days of respiratory tract infection were 2.03 and 4.20 days,respectively.There were significant differences in the above indexes between the control group and the treatment group(all P<0.05).A total of 82 children in the treatment group and 85 children in the control group completed the follow-up survey in the fourth year after enrollment.The asthma attack rates in the treatment group and the control group in the past three years were 15.85%and 35.29%,respectively.The total number of episodes was 3.24 and 4.41,respectively,and the differences were statistically significant(all P<0.05).The adverse drug reactions in the treatment group were mainly diarrhea and rash,and the adverse drug reactions in the control group were rash.The total incidence of adverse drug reactions in the treatment group and the control group were 2.02%and 1.01%,respectively,and the difference was not statistically significant(P>0.05).Conclusion Huaiqihuang granules combined with long-term asthma control drugs treatment,can improve the level of asthma control in young children and preschool children,reduce the symptoms of rhinitis,reduce the number of respiratory tract infections,and improve the total effective rate.