槐杞黄颗粒辅助治疗儿童支气管哮喘疗效的真实世界研究

Efficacy of Huaiqihuang granules as adjuvant therapy for bronchial asthma in children:a real-world study

目的观察槐杞黄颗粒辅助治疗儿童支气管哮喘的疗效。方法采取多中心、前瞻性、登记注册的真实世界研究方法,于全国21家医院门诊依序纳入已明确诊断支气管哮喘、年龄2~5岁、采用以下两种治疗方案之一的患儿:使用哮喘长期控制药物,即吸入激素和/或白三烯受体拮抗剂,但未使用槐杞黄颗粒(控制治疗组,n=390);使用哮喘长期控制药物,同时加用槐杞黄颗粒(联合治疗组,n=1014)。收集所有患儿的个人及临床资料,于治疗后第4、8、12、20、28、36周进行门诊或电话随访。随访内容包括哮喘发作情况、鼻炎症状等,并对随访观察指标的变化进行统计学分析。结果入组前两组患儿哮喘发作次数、天数及鼻炎发作天数比较差异均无统计学意义(P>0.05)。经治疗后,联合治疗组患儿每月哮喘发作天数、重度哮喘发作次数及鼻炎发作天数均显著少于控制治疗组(P<0.05)。两组患儿不良反应发生率比较差异无统计学意义(P=0.667)。结论在使用哮喘长期控制药物治疗基础上加用槐杞黄颗粒能够改善支气管哮喘患儿的临床症状及伴发的鼻炎症状,提高哮喘控制水平,且在治疗过程中使用安全,无明显不良反应。

Objective To study the efficacy of Huaiqihuang granules as adjuvant therapy for bronchial asthma in children.Methods A multicenter,prospective,and registered real-world study was performed for the children,aged 2-5 years,who had a confirmed diagnosis of bronchial asthma in the outpatient service of 21 hospitals in China.Among these children,the children treated with medications for long-term asthma control(inhaled corticosteroid and/or leukotriene receptor antagonist)without Huaiqihuang granules were enrolled as the control treatment group,and those treated with medications for long-term asthma control combined with Huaiqihuang granules were enrolled as the combined treatment group.The medical data of all children were collected.Outpatient or telephone follow-up was performed at weeks 4,8,12,20,28,and 36 after treatment,including asthma attacks and rhinitis symptoms.A statistical analysis was performed for the changes in these indices.Results There was no significant difference in the frequency of asthma attacks or rhinitis attacks between the two groups before treatment(P>0.05).After treatment,the combined treatment group had significantly lower frequencies of asthma attacks,severe asthma attacks,and rhinitis attacks compared with the control treatment group(P<0.05).There was no signification difference in the incidence rate of adverse reactions between the two groups(P=0.667).Conclusions Huaiqihuang granules in addition to medications for long-term asthma control can alleviate the symptoms of bronchial asthma and rhinitis and improve the level of asthma control in children with bronchial asthma,with good safety and little adverse effect.