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 ›› 2025, Vol. 17 ›› Issue (3): 213-220.doi: 10.20274/j.cnki.issn.1674-3865.2025.03.005

• 临床论著 • 上一篇    下一篇

蒡勃乳蛾消颗粒治疗小儿急性扁桃体炎外感风热证的临床研究

沈红岩1, 王雪峰1(), 韩新民2, 袁斌2, 胡思源3, 李新民3, 熊磊4, 何平4, 周盈5, 张雪荣6, 穆婧雯7   

  1. 110032 沈阳，辽宁中医药大学附属医院儿科（沈红岩，王雪峰）
    210029 南京，南京中医药大学附属医院儿科（韩新民，袁斌）
    300193 天津，天津中医药大学第一附属医院儿科（胡思源，李新民）
    650032 昆明，云南中医药大学第一附属医院儿科（熊磊，何平）
    830099 乌鲁木齐，新疆维吾尔自治区中医医院儿科（周盈）
    430061 武汉，湖北省中医院儿科（张雪荣）
    110847 沈阳，辽宁中医药大学2022级中医儿科学专业研究生（穆婧雯）
  • 收稿日期:2025-03-15 修回日期:2025-05-02 出版日期:2025-06-25 上线日期:2025-06-25
  • 通讯作者: 王雪峰 E-mail:lnzywxf@163.com;lnzywxfa@163.com
  • 作者简介:沈红岩（1982?），女，医学硕士,副主任医师。研究方向：中西医结合治疗儿科疾病

Clinical study on the treatment for children with acute tonsillitis (external wind⁃heat syndrome) with Bangbo Ruexiao granule

Hongyan SHEN1, Xuefeng WANG1(), Xinmin HAN2, Bin YUAN2, Siyuan HU3, Xinmin LI3, Lei XIONG4, Ping HE4, Ying ZHOU5, Xuerong ZHANG6, Jingwen MU7   

  1. 1.Liaoning University of Traditional Chinese Medicine Affiliated Hospital，Shenyang 110032，China
    2.Affiliated Hospital of Nanjing University of Traditional Chinese Medicine，Nanjing 210029，China
    3.First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine，Tianjin 300193，China
    4.First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine，Kunming 650032，China
    5.Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital，Urumqi 830099，China
    6.Hubei Provincial Hospital of Traditional Chinese Medicine，Wuhan 430061，China
    7.Liaoning University of Traditional Chinese Medicine，Shenyang 110847，China
  • Received:2025-03-15 Revised:2025-05-02 Published:2025-06-25 Online:2025-06-25
  • Contact: Xuefeng WANG E-mail:lnzywxf@163.com;lnzywxfa@163.com

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摘要：

目的 验证小儿急性扁桃体炎（外感风热证）使用蒡勃乳蛾消颗粒治疗的有效性及安全性。 方法 本研究采用多中心、随机、双盲双模拟、阳性药物平行对照设计。选择2010年1月至2012年3月在辽宁中医药大学附属医院、天津中医药大学第一附属医院、江苏省中医院、新疆维吾尔自治区中医医院、云南省中医医院、湖北省中医院就诊的急性扁桃体炎（外感风热证）患儿520例，按3∶1随机分为观察组和对照组。观察组使用的药物为蒡勃乳蛾消颗粒，对照组使用的药物为小儿清咽颗粒，疗程为5 d。观察临床疗效、中医病证疗效、单项症状和体征（咽部痛或吞咽痛、扁桃体肿大充血、咽黏膜充血、发热、咳嗽、恶风、头痛）消失率、咽痛起效时间及咽痛消失时间、C反应蛋白转阴率及安全性指标。 结果 （1）进入意向治疗集（ITTS）509例，符合方案集（PPS）491例，安全性数据集（SS）515例。（2）有效性评价：两组临床疗效比较，观察组总显效率为85.9%（329/383），显著优于对照组58.7%（74/126），差异有统计学意义（P<0.001）。两组中医病证疗效比较，总显效率为89.8%（344/383），显著优于对照组64.3%（81/126），差异有统计学意义（P<0.001）。观察组咽喉痛或吞咽痛消失率、扁桃体肿大充血消失率、咽黏膜充血消失率显著高于对照组，差异有统计学意义（P<0.05)；其他的症状和体征消失率（发热、咳嗽、恶风、头痛）两组比较差异无统计学意义（P>0.05）。观察组咽痛起效中位时间及咽痛消失中位时间低于对照组，差异有统计学意义（P<0.001）。两组C反应蛋白转阴率比较差异无统计学意义（P>0.05）。（3）安全性评价：两组不良事件发生率、合并用药发生率及用药依从性比较差异均无统计学意义（P>0.05）。 结论 小儿急性扁桃体炎（外感风热证）使用蒡勃乳蛾消颗粒治疗具有较好的临床疗效，改善中医证候疗效，缩短咽痛时间，且安全性良好，可以为急性扁桃体炎（外感风热证）患儿提供一种新的替代治疗药物。

关键词: 急性扁桃体炎, 外感风热证, 蒡勃乳蛾消颗粒, 儿童

Abstract:

Objective To verify the efficacy and safety of Bangbo Ruexiao granule in the treatment of children with acute tonsillitis (external wind?heat syndrome). Methods This study was a multicenter, randomized, double?blind, double?dummy, positive drug parallel control design. A total of 520 children with acute tonsillitis (external wind?heat syndrome) treated in Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine, Yunnan Province Hospital of Traditional Chinese Medicine and Hubei Province Hospital of Traditional Chinese Medicine from January 2010 to March 2012 were selected and randomly divided into observation group and control group by 3∶1. The observation group was treated with Bangbo Ruexiao granule, and the control group was treated with Xiaoer Qingyan granule. The course of treatment was 5 days. The following items were observed: clinical efficacy, TCM disease and syndrome efficacy, the disappearance rate of single symptoms and signs (pharyngalgia or odynophagia, tonsil swelling and congestion, pharyngeal mucosa congestion, fever, cough, aversion to wind and headache), the onset time of the effect on pharyngalgia, the disappearance time of pharyngalgia, the negative conversion rate of C-reactive protein and safety indicators. Results (1) There were 509 patients in the intention?to?treat set(ITTS), 491 patients in the per?protocol set(PPS), and 515 patients in the safety set(SS). (2) Effectiveness evaluation: the total effective rate of the observation group was 85.9%(329/383), which was significantly better than that of the control group (58.7%, 74/126), and the difference was statistically significant(P<0.001). The total rate of significant effect of TCM disease and syndrome was 89.8%(344/383) in the observation group, which was significantly better than 64.3% (81/126) in the control group, and the difference was statistically significant (P<0.001). The disappearance rate of sore throat or odynophagia, the disappearance rate of tonsil swelling and congestion, and the disappearance rate of pharyngeal mucosa congestion in the observation group were significantly higher than those in the control group, and the differences were statistically significant(P<0.05). There was no significant difference in the disappearance rate of other symptoms and signs(fever, cough, aversion to wind, headache) between the two groups(P>0.05). The median onset time of the effect on pharyngalgia and the median time of pharyngalgia disappearance in the observation group were lower than those in the control group, and the differences were statistically significant(P<0.001). There was no significant difference in the negative conversion rate of C-reactive protein between the two groups(P>0.05). (3) Safety evaluation: there were no significant differences in the incidence of adverse events, the incidence of combined medication or medication compliance between the two groups(P>0.05). Conclusions Bangbo Ruexiao granule has a good clinical effect in the treatment of children with acute tonsillitis(external wind?heat syndrome), which can improve the efficacy of TCM syndromes, shorten the duration of sore throat, and has good safety. It can provide a new alternative treatment for children with acute tonsillitis(external wind?heat syndrome).

Key words: Acute tonsillitis, External wind?heat syndrome, Bangbo Ruexiao granule, Child

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