ISSN 1674-3865  CN 21-1569/R
主管：国家卫生健康委员会
主办：中国医师协会
　　　辽宁省基础医学研究所
　　　辽宁中医药大学附属医院
中国中西医结合儿科学

中国中西医结合儿科学 ›› 2020, Vol. 12 ›› Issue (5): 375-379.doi: 10.3969/j.issn.1674-3865.2020.05.003

• 临床论著 • 上一篇    下一篇

小儿荆杏止咳颗粒治疗小儿急性支气管炎风寒化热证的随机、双盲、平行对照、多中心临床研究

韩新民，王雪峰，张葆青，向希雄，魏小维，宋丽君，程燕   

  1. 210029 南京，江苏省中医院儿科（韩新民）；110000 沈阳，辽宁中医药大学附属医院儿科（王雪峰）；250355 济南，山东中医药大学附属医院儿科（张葆青）；420100 武汉，湖北省中医院儿科（向希雄）；300000 天津，天津中医药大学第一附属医院儿科（魏小维）；100081 长春，吉林大学第一医院儿科（宋丽君）；300000 天津，天津中医药大学第二附属医院儿科（程燕）
  • 收稿日期:2020-05-15 出版日期:2020-10-25 上线日期:2020-10-25
  • 通讯作者: 韩新民，E-mail：hxm1nj@163.com
  • 作者简介:韩新民（1957-），男，教授，主任中医师，博士研究生生导师。研究方向：小儿肺系疾病的研究

Randomized, double  blind, parallel controlled, multicenter clinical study of Xiaoer Jingxing Zhike granules in the treatment of children with acute bronchitis with cold induced fever syndrome

HAN Xinmin,WANG Xuefeng,ZHANG Baoqing,XAING Xixiong,WEI Xiaowei,SONG Lijun,CHENG Yan   

  • Received:2020-05-15 Published:2020-10-25 Online:2020-10-25
  • Contact: HAN Xinmin，E-mail：hxm1nj@163.com

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摘要： 目的 进一步评价小儿荆杏止咳颗粒治疗小儿急性支气管炎风寒化热证有效性和安全性。方法 采用随机、平行对照、双盲、多中心临床试验设计入选7家研究中心479例小儿急性支气管炎风寒化热证的患者，分为试验组和对照组。疗程为5 d。以症状体征和综合疗效评价为主要有效性评价指标，以不良事件/不良反应发生率和安全性检测为主要安全性评价指标。结果 疾病疗效总有效率方面，试验组87.71%（307/350），优于对照组27.12%(32/118)；在中医证候疗效总有效率方面，试验组87.71%（307/350），优于对照组28.81%(34/118)。对于疾病疗效和中医证候疗效总有效率的评价，两组比较差异有统计学意义（P<0.05）。安全性方面，试验组有1例发生不良反应（轻度过敏），发生率为0.28%。结论  Ⅲ期临床试验结果进一步证明小儿荆杏止咳颗粒治疗小儿急性支气管炎风寒化热证是安全有效。

关键词: 急性支气管炎, 外感咳嗽, 风寒化热证, 小儿荆杏止咳颗粒, 儿童

Abstract: Objective  To further evaluate the effectiveness and safety of Xiaoer Jingxing Zhike granules in the treatment of pediatric acute bronchitis with cold induced fever syndrome.Methods  A randomized, parallel-controlled, double-blind, multicenter clinical trial design was used. A total of 479 patients with pediatric acute bronchitis with cold induced fever syndrome were selected from 7 research centers. They were divided into experimental group and control group. The duration of treatment was 5 days. Symptoms and signs and comprehensive curative effect evaluation were taken as the main evaluation indicators for effectiveness, and adverse event/adverse reaction incidence and safety detection were taken as the main evaluation indicators for safety.Results In terms of the total effective rate of disease curative effect, the experimental group(87.71%,307/350) was better than the control group(27.12%,32/118).In terms of the total effective rate of TCM symptoms, the experimental group (87.71%,307/350) was superior to the control group (28.81%,34/118).For the evaluation of the efficacy of disease and the total effectiveness of TCM symptoms, the difference between the two groups was statistically significant(P＜0.05). In terms of safety, Adverse reactions(mild allergy) occurred in 1 case in the experimental group, the incidence rate being  0.28%.Conclusion The results of the phase III clinical trial further prove that Xiaoer Jingxing Zhike granules is safe and effective in the treatment of pediatric acute bronchitis with cold induced fever syndrome.

Key words: Acute bronchitis, External cough, Cold-induced fever syndrome, Xiaoer Jingxing Zhike granules, Children