槐杞黄颗粒辅助治疗儿童哮喘的随机对照多中心临床研究

目的：比较全球哮喘防治创议(The Global Initiative for Asthma,GINA)方案与 GINA 方案联合口服槐杞黄颗粒治疗哮喘患儿的临床疗效和安全性。方法采用随机、多中心平行对照临床试验方法。共收集1128例哮喘患儿,随机分为两组。观察组患儿采用 GINA 方案联合口服槐杞黄颗粒治疗,GINA 方案治疗组患儿按 GINA 方案治疗。分别于用药后的第1个月、3个月、6个月进行临床评价及 C-ACT 评分。临床评价指标为上呼吸道感染次数、支气管炎和肺炎发生次数、喘息发作次数、应用急救药次数、因喘息住院次数。比较两组的药物不良反应发生情况。结果用药后的第1个月、3个月、6个月,观察组较 GINA方案治疗组上呼吸道感染发生次数、支气管炎和肺炎发生次数及喘息发作次数均明显减少(P ＜0.05),C-ACT 评分均明显升高(P ＜0.05)。与药物相关的不良反应16例(轻度腹泻),其中观察组7例(1.15％), GINA 方案治疗组9例(1.73％),组间差异无统计学意义(P ＞0.05)。结论 GINA 方案联合口服槐杞黄颗粒治疗哮喘患儿,能明显减少其呼吸道感染及喘息发作的次数,可显著改善临床疗效,更好地达到哮喘控制的目标,且安全性好。

Huaiqihuang granule in adjuvant treatment of childhood asthma:a randomized controlled,multicenter study

Objective To observe the clinical efficacy and safety of GINA regimen and GINA regimen combined with oral Huaiqihuang granule in the treatment of children with bronchial asthma.Methods A ran-domized,single blind,multicenter,parallel controlled clinical trial wascarried out.A total of 1 128 patients with bronchial asthma in children were randomized into two groups.The observation group were treated with GINA regimen combined with oral Huaiqihuang granule.The GINA regimen treatment group was treated by GINA reg-imen.Clinical assessment and C-ACT scores was observed in first month,third month,sixth month after treat-ment.Clinical assessment included the times of upper respiratory tract infection occurrence,bronchitis and pneu-monia,asthmatic attacks,application of emergency medicine,hospitalizations due to asthmatic.Drug adverse effect in the two groups was compared.Results The times of upper respiratory tract infection,bronchitis and pneumonia,asthmatic was significantly decreased(P <0.05 ),and C-ACTscores were significantly higher(P <0.05)in the first month,the third month,and the sixth month after treatment.There were 16 cases of drug relat-ed adverse reactions.Seven cases were in observation group(n ﹦7)(1.15%)and 9 cases in the GINA regimen treatment group(n ﹦9)(1.73%).There was no significant difference of adverse effect between the two groups (P >0.05).Conclusion The treatment of bronchial asthma in children with GINA regimen combined with oral Huaiqihuang granule can significantly reduce the incidence of respiratory infections and the number of asthmatic attacks dramatically and safely improve clinical curative effect,asthma control.