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Journal of Traditional Chinese Medicine >

2026 , Vol. 46 >Issue 3: 666 - 673

DOI: https://doi.org/10.19852/j.cnki.jtcm.20250930.001

Original Articles

Efficacy and safety of the Chinese herbal medicine Xiao’er Niuhuang antipyretic plaster (小儿牛黄退热贴膏) for treating fever in children with acute upper respiratory tract infection with wind-heat syndrome: a multicenter, randomized, double-blind, controlled clinical trial

  • LIU Na ,
  • CHEN Zhimin ,
  • ZHAO Gang ,
  • YUAN Bin ,
  • HUANG Zhijun ,
  • ZHANG Xuerong ,
  • SONG Guihua ,
  • CHEN Huafang
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  • 1 Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
    2 Department of Rehabilitation, Ningbo Hospital of Traditional Chinese Medicine, Ningbo 315016, China
    3 Institute of Pharmaceutical Research, Jianmin Pharmaceutical Group Co., Ltd., Wuhan 430050, China
    4 Department of pediatrics, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing 210004, China
    5 Department of pediatrics, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430060, China
    6 Department of pediatrics, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450099, China
    7 Drug Clinical Trials Office, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China
First author contact:

LIU Na and CHEN Zhimin are co-first authors and contributed equally to this work

Prof. CHEN Huafang, Drug Clinical Trials Office, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China. chenhuafang2011@126.com, Telephone: +86-13857727395; +86-577-55579590

Received date: 2025-05-05

  Accepted date: 2025-09-26

  Online published: 2025-09-30

Supported by

Major Project of the National Science and Technology Program of China: the Research and Development of Children’s Medications and Key Technologies(2018ZX09721003)

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Abstract

OBJECTIVE: To evaluate the efficacy and safety of Xiao’er Niuhuang antipyretic plaster (小儿牛黄退热贴膏) in treating fever associated with acute upper respiratory tract infection (AURI) accompanied by wind-heat syndrome in children.

METHODS: A total of 464 pediatric patients diagnosed with AURI and wind-heat syndrome were enrolled. Participants were stratified into two age subgroups (1-2 years and 3-5 years) and then randomly assigned in a 3:1 ratio to receive either the Xiao’er Niuhuang antipyretic plaster or an extremely low-dose control plaster. The primary outcome was the time to onset of fever reduction. Safety assessments included monitoring of vital signs, laboratory tests (complete blood count, urinalysis, stool routine, and liver and kidney function), electrocardiogram, and local skin reactions.

RESULTS: The median time to onset of antipyretic effect was significantly shorter in the Xiao’er Niuhuang antipyretic plaster group than in the control group (2.53 h vs 3.98 h). The complete antipyretic rates at the 4-h time point were 31.76% for the Xiao’er Niuhuang antipyretic plaster group and 17.70% for the control group; at the 8-h time point, the rates were 49.55% and 33.04%, respectively. No significant difference was observed in the incidence of adverse events between the two groups (P >0.05). No serious adverse events were reported.

CONCLUSION: Xiao’er Niuhuang antipyretic plaster is an effective and safe treatment for fever in children with AURI and wind-heat syndrome.

Key words： fever; respiratory tract infections; children; wind-heat; double-blindmethod; randomized controlled trial; Xiao’er Niuhuang antipyretic plaster

Cite this article

LIU Na , CHEN Zhimin , ZHAO Gang , YUAN Bin , HUANG Zhijun , ZHANG Xuerong , SONG Guihua , CHEN Huafang . Efficacy and safety of the Chinese herbal medicine Xiao’er Niuhuang antipyretic plaster (小儿牛黄退热贴膏) for treating fever in children with acute upper respiratory tract infection with wind-heat syndrome: a multicenter, randomized, double-blind, controlled clinical trial[J]. Journal of Traditional Chinese Medicine, 2026 , 46(3) : 666 -673 . DOI: 10.19852/j.cnki.jtcm.20250930.001

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