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Multicenter and random clinical study of Huaiqihuang granule combined with inhaled corticosteroids in the treatment of bronchial asthma in children

  

  1. *Department of Respiration,Children’s Hospital Affiliated to Nanjing Medical University,Nanjing 210008,China
  • Online:2020-05-06 Published:2020-05-18

槐杞黄颗粒联合吸入糖皮质激素治疗儿童支气管哮喘有效性的随机对照多中心临床研究

  

  1. 1.南京医科大学附属儿童医院呼吸科, 江苏 南京210008; 2.南京医科大学第二附属医院儿童呼吸科, 江苏 南京210011; 3.无锡市儿童医院呼吸科,江苏 无锡 214023; 4.扬州大学附属医院儿科, 江苏 扬州 225012

Abstract: Objective To observe the effect of Huaiqihuang granule combined with ICS(inhaled corticosteriods) in the treatment of pediatric bronchial asthma. Methods A total of 180 children with mild persistent asthma treated in 4 hospitals between September 2016 and February 2017 in China were selected. According to admission time sequence based on random Numbers DAS 3.0 software produced by various centers, all children were randomly divided into 3 groups:group A of 60 cases(ICS+ Huaiqihuang), group B of 60 cases(ICS) and group C of 60 cases(on-demand ICS+ Huaiqihuang). Before and 3 months after the treatment,forced expiratory volume as a percentage of predicted value in the first second(FEV1%pred), peak expiratory flow rate as a percentage of predicted value(PEF%pred) and exhaled nitric oxide(FeNO) were detected and compared. Results Among 180 cases, 21cases dropped out on their own. A total of 159 cases were included in the study, including 60 cases in group A, 58 cases in group B and 41cases in group C. The FEV1%pred, PEF%pred and FeNO were improved after treatment in groups A and B(P<0.05). The FEV1%pred, PEF%pred and FeNO had no significant difference between before and after treatment in group C(P>0.05). After 3 months of treatment, the increase in FEV1%pred and PEF%pred and the decrease in FeNO were more significant in group A, and the difference was statistically significant compared with groups B and C(P<0.05). Compared with group C, the increase in FEV1%pred and PEF%pred and the decrease in FeNO were more significant in group B(P<0.05). Conclusion Children with mild persistent asthma need long-term standardized ICS treatment, and Huaiqihuang granules combined with ICS can improve lung function and clinical symptoms of children with asthma to a greater extent.

Key words: Huaiqihuang granule, ICS, asthma, child, multicenter study

摘要: 目的 观察槐杞黄颗粒联合吸入性糖皮质激素(ICS)对儿童支气管哮喘的疗效。方法 收集2016年9月至2017年2月国内四家医院哮喘门诊就诊的轻度持续哮喘儿童180例。按照就诊时间顺序依据DAS 3.0软件产生的各中心随机编号分为3组, A组60例(ICS+槐杞黄)、 B组60例(ICS)、 C组60例(按需ICS)。治疗前及治疗3个月后分别进行测定第1秒用力呼气容积占预测值百分比(FEV1%pred)、 呼气峰流速占预测值百分比(PEF%pred)、 呼出气一氧化氮(FeNO)调查, 并分析比较。结果 180例患儿退出21例, 实际收集有效病例159例,其中A组60例, B组58例, C组41例。A组、 B组治疗后FEV1%pred、 PEF%pred、 FeNO均较治疗前有改善(P<0.05), C组治疗后FEV1%pred、 PEF%pred、 FeNO与治疗前比较差异无统计学意义(P>0.05)。治疗3个月后,A 组FEV1%pred、 PEF%pred上升及FeNO值降低更明显, 与B、 C 组比较差异有统计学意义(P<0.05)。B组FEV1%pred、 PEF%pred 上升及FeNO值降低与C组比较差异有统计学意义(P<0.05)。结论 轻度持续哮喘患儿需要长期规范化ICS治疗, 槐杞黄颗粒联合ICS可以更大程度改善哮喘儿童肺功能及临床症状。

关键词: 槐杞黄, ICS, 哮喘, 儿童, 多中心研究