小儿黄金止咳颗粒治疗儿童急性支气管炎咳嗽(痰热阻肺证)的有效性和安全性评价
Evaluation of the efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of acute bronchitis-caused cough(syndrome of phlegm-heat obstructing the lung)in children
刘军 1王孟清 2靳秀红 3池永学 4马春英 5刘小会 6滕懿群 7辛美云 8孙飞 9刘明 10路苓 11彭新平 12郭咏霞 13俞蓉 14陈全景 15王斌 16沈彤 17李岚 18刘萍萍 19李雄 20李明 21王桂兰 22徐保平1
作者信息
- 1. 国家儿童医学中心,国家呼吸系统疾病临床医学研究中心,首都医科大学附属北京儿童医院呼吸中心,北京 100045
- 2. 湖南中医药大学第一附属医院儿童医学中心,长沙 410007
- 3. 河南省儿童医院郑州儿童医院呼吸科,郑州 451161
- 4. 延边大学附属医院儿科,延边 133099
- 5. 三门峡市中心医院普通儿科一病区,三门峡 472000
- 6. 国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京 100045
- 7. 嘉兴市第二医院儿科,嘉兴 314000
- 8. 济宁医学院附属医院儿科,济宁 272007
- 9. 嘉兴市第一医院儿科,嘉兴 314000
- 10. 萍乡市人民医院小儿呼吸科,萍乡 337055
- 11. 枣庄市立医院小儿内科,枣庄 277100
- 12. 邵阳学院附属第一医院儿科,邵阳 422000
- 13. 佛山复星禅诚医院小儿呼吸科,佛山 528031
- 14. 无锡市第八医院小儿呼吸科,无锡 214007
- 15. 湖北医药学院附属国药东风总医院儿科,十堰 442008
- 16. 南方医科大学珠江医院儿科,广州 510280
- 17. 厦门大学附属妇女儿童医院儿科,厦门 361003
- 18. 江西省儿童医院呼吸内科,南昌 330200
- 19. 南京市江宁医院儿科,南京 211100
- 20. 桂林医学院附属医院儿科,桂林 541001
- 21. 昆明市儿童医院呼吸内科,昆明 650103
- 22. 中山市博爱医院小儿呼吸内科,中山 528405
- 折叠
摘要
目的 评价小儿黄金止咳颗粒治疗儿童急性支气管炎咳嗽(痰热阻肺证)的有效性和安全性.方法 采用随机、双盲、安慰剂平行对照、多中心临床试验设计.所选病症为急性支气管炎(痰热阻肺证).自2022年1月至2023年9月,从21个参研医院入组359例3～7岁受试患儿,按3∶1比例随机分配至试验组和安慰剂组.分别服用小儿黄金止咳颗粒和小儿黄金止咳颗粒模拟剂.以用药7 d后咳嗽消失/基本消失率作为主要疗效观察指标.结果 1.治疗7 d,试验组咳嗽消失/基本消失率为73.95％,安慰剂组为57.61％,2组间差异有统计学意义(P=0.001).2.治疗7 d咳嗽消失/基本消失中位天数,试验组与安慰剂组分别为5 d、6d,2组间差异有统计学意义(P=0.006).咳嗽症状严重度-时间的曲线下面积,试验组为7.20±3.79,安慰剂组为8.20±4.42,2组间差异有统计学意义(P=0.039).3.治疗7 d,试验组中医证候积分与基线之间的差值为-16.0(-20.0,-15.0)分,安慰剂组为-15.0(-18.0,-12.0)分,2组间差异有统计学意义(P=0.004).中医症候疗效:试验组临床控制49.04％,显效28.35％,有效16.48％,无效6.13％;安慰剂组临床控制38.04％,显效26.09％,有效29.35％,无效6.52％;2组间差异有统计学意义(P=0.014).4.药物临床试验期间不良事件及不良反应发生情况,2组间差异均无统计学意义.偶见呕吐、腹泻不良反应.无与药物相关严重不良事件及不良反应.5.试验药物依从性良好,与安慰剂相比差异无统计学意义.结论 小儿黄金止咳颗粒治疗儿童急性支气管炎咳嗽(痰热阻肺证),有较好的安全性、有效性和依从性.
Abstract
Objective To evaluate the efficacy and safety of Xiao'er Huangjin Zhike Granules in the treatment of cough caused by acute bronchitis in children,which is defined in TCM terms as a syndrome of phlegm-heat obstructing the lung.Methods This was a block-randomized,double-blind,placebo-controlled,multicenter clinical trial.From January 2022 to September 2023,359 children aged 3 to 7 years old diagnosed as acute bronchitis(lung-obstructing phlegm-heat syndrome)were enrolled from 21 participating hospitals and randomly assigned to the experimental group and placebo group in a 3∶1 ratio,and respectively treated with Xiao'er Huangjin Zhike Granules and its matching placebo.Cough resolution/general resolution rate after 7 days of treatment was used as the primary efficacy outcome for both groups.Results(1)On the seventh day of treatment,the rate of cough disappearance/basically disappearance in the experimental group and placebo group were 73.95％and 57.61％retrospectively,which had statistically significance(P=0.001).(2)After 7 days of treatment,the median duration of cough disappearance/basic disappearance were 5 days and 6 days in the two groups,with a statistically significant difference(P=0.006).The area under the curve of cough symptom severity time was 7.20±3.79 in the experimental group and 8.20±4.42 in the placebo group.The difference between the two groups was statistically significant(P=0.039).(3)After 7 days of treatment,the difference between TCM syndrome score and baseline was-16.0(-20.0,-15.0)points in the experimental group and-15.0(-18.0,-12.0)points in the placebo group,with significant difference between the two groups(P=0.004).In the experimental group,the clinical control rate,the markedly effective rate,the effective rate and the ineffective rate were 49.04％,28.35％,16.48％and 6.13％severally;and in the placebo group,the clinical control rate,the markedly effective rate,the effective rate and the ineffective rate were 38.04％,26.09％,29.35％,and 6.52％separately,which had statistically significant(P=0.014).(4)There was no significant difference in the incidence of adverse events or adverse reactions during the trial between both groups.Moreover,while adverse reactions in the form of vomiting and diarrhea were occasionally reported,no serious drug-related adverse event or adverse reaction was reported.(5)The tested drug provided good treatment compliance,showing no statistically significant difference from the placebo in terms of compliance rate.Conclusions Based on the above findings,it can be concluded that Xiao'er Huangjin Zhike Granules provides good safety,efficacy,and treatment compliance in the treatment of cough caused by acute bronchitis,and lung-obstructing phlegm-heat syndrome,in children.
关键词
儿童/小儿黄金止咳颗粒/急性支气管炎/痰热阻肺证/随机双盲Key words
Child/Xiao'er Huangjin Zhike Granules/Acute bronchitis/Syndrome of phlegm-heat obstructing the lung/Block-randomized,double-blind引用本文复制引用
基金项目
北京市研究型病房建设示范单位项目(CRW202101)
出版年
2024
NETL
NSTL
万方数据