| 摘要: |
| 目的:探讨小儿牛黄退热贴膏治疗儿童急性上呼吸道感染的退热作用及安全性。方法:采用前瞻性、双盲、随机、极低剂
量平行对照的方法,纳入64 例急性上呼吸道感染风热证患儿,按3 ∶ 1 比例随机分为试验组和对照组。药物贴敷于大椎穴和神
阙穴,每次贴敷8 h。结果:试验组与对照组中位退热起效时间分别为2. 50 h 和4. 01 h,差异有统计学意义(P<0. 05);1~2 岁段
试验组与对照组分别为2. 53 h 和4. 48 h,差异有统计学意义(P<0. 01);>2~5 岁段试验组与对照组分别为2. 25 h 和3. 76 h,差
异有统计学意义(P<0. 05);绘制Kaplan-Meier 曲线,两组患儿退热起效时间比较差异有统计意义(P<0. 01),且试验组退热起效
时间优于对照组;试验组和对照组4 h 退热率分别为50. 0%和12. 5%,8 h 退热率分别为68. 8%和25. 0%,差异有统计学意义
(P<0. 05)。治疗期间内,用药1 h 后的每个时间点试验组体温均明显低于对照组,且趋势较为明显。两组患儿不良事件发生率比
较差异无统计学意义(P>0. 05)。结论:小儿牛黄退热贴膏治疗儿童急性上呼吸道感染具有较好的退热作用,安全性良好。 |
| 关键词: 小儿牛黄退热贴膏 急性上呼吸道感染 风热证 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.08.008 |
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| 基金项目:基金项目:河南省中医药学科领军人才培养项目,豫卫中医函[2021],8 号;河南省第三批青苗人才项目,豫卫中医药科教[2024],4 号。 |
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| Randomized Controlled Clinical Study on the Treatment of Acute Upper Respiratory Tract Infection inChildren with Niuhuang Antipyretic Plaster for Children |
| Sun Mengmeng1, Chen Shengxin2, Zhao Gang2, Zhang Bingxue1, Lyu Weigang1, Wang Haitao1, Song Guihua |
| (1. The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450046, China; 2. Institute of Pharmaceutical
Research, Jianmin Pharmaceutical Group CO. , LTD, Wuhan 430052, China) |
| Abstract: |
| Objective: To probe into the antipyretic effect and safety of Niuhuang antipyretic plaster for children in the treatment of
acute upper respiratory tract infection in children. Methods: A prospective, double-blind, randomized, ultra-low-dose-controlled
parallel trial was conducted. Sixty-four children with acute upper respiratory tract infection of wind-heat syndrome were enrolled and
randomly divided into the trial group and control group at a 3 ∶ 1 ratio. The plaster was applied to the Dazhui acupoint and Shenque
acupoint for 8 h each time. Results: The median time to onset of antipyretic effect was 2. 50 h in the trial group and 4. 01 h in the
control group, with statistically significant difference (P<0. 05). For the 1 to 2 years old subgroup, the median time of trial group and
control group were respectively 2. 53 h and 4. 48 h, with statistically significant difference (P < 0. 01); for the > 2 to 5 years old
subgroup, the median time of trial group and control group were respectively 2. 25 h and 3. 76 h, with statistically significant difference
(P<0. 05). The Kaplan-Meier curve showed statistically significant difference in the time to onset of antipyretic effect between two groups (P<0. 01), with the trial group demonstrating a superior effect. The fever reduction rates at 4 h were 50. 0% in the trial group
and 12. 5% in the control group; at 8 h, the fever reduction rates were respectively 68. 8% and 25. 0%, with statistically significant
differences (P<0. 05). During the treatment period, the body temperature in trial group was significantly lower than that in control group
at each time point after 1 h of administration, showing a clear trend. There was no statistically significant difference in the incidence of
adverse events between two groups (P>0. 05). Conclusion: Niuhuang antipyretic plaster for children has good antipyretic effect and
favorable safety profile in the treatment of acute upper respiratory tract infection in children. |
| Key words: Niuhuang antipyretic plaster for children acute upper respiratory tract infection wind-heat syndrome |
