九味竺黄散治疗儿童上呼吸道感染咳嗽的多中心随机对照试验

Hui LUO; Gui-Hua SONG; Xiao-jian MA; Meng-meng SUN; Man ZHANG; Jian-rong XIE; Shao PENG

doi:10.1007/s11655-021-3462-x

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九味竺黄散治疗儿童上呼吸道感染咳嗽的多中心随机对照试验

Original Article | Updated：2022-06-27

- 九味竺黄散治疗儿童上呼吸道感染咳嗽的多中心随机对照试验
- Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections:A Multicenter Randomized Controlled Trial
- Chinese Journal of Integrative Medicine 2022年28卷第5期页码：387-393
- Affiliations：
  
  1.Institute for Tibetan Medicine, China Tibetology Research Center, Beijing (100101), China
  2.Department of Pediatrics, the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou (450000), China
  3.Department of Pediatrics,Huaihe Hospital of Henan University, Zhengzhou (450000),China
  4.Department of Pediatrics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou (475000), China
  5.School of Statistics, Renmin University of China, Beijing (100872), China
- Author bio：
  
  Prof. PENG Shao, E-mail: Pengshaodh630@126.com
- Funds：
  
  the National Natural Science Foundation of China(81704197)
- DOI：10.1007/s11655-021-3462-x
  中图分类号：
- 纸质出版日期：2022-05-01，
  
  网络出版日期：2021-12-15，
  
  录用日期：2021-11-09
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Hui LUO, Gui-Hua SONG, Xiao-jian MA, 等. 九味竺黄散治疗儿童上呼吸道感染咳嗽的多中心随机对照试验[J]. Chinese Journal of Integrative Medicine, 2022,28(5):387-393.

Hui LUO, Gui-Hua SONG, Xiao-jian MA, et al. Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections:A Multicenter Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(5):387-393.
Hui LUO, Gui-Hua SONG, Xiao-jian MA, 等. 九味竺黄散治疗儿童上呼吸道感染咳嗽的多中心随机对照试验[J]. Chinese Journal of Integrative Medicine, 2022,28(5):387-393. DOI： 10.1007/s11655-021-3462-x.

Hui LUO, Gui-Hua SONG, Xiao-jian MA, et al. Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections:A Multicenter Randomized Controlled Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(5):387-393. DOI： 10.1007/s11655-021-3462-x.

摘要

目的:

评价藏药九味竺黄散治疗儿童上呼吸道感染咳嗽的疗效.

方法:

本研究为多中心开放性随机对照试验. 共纳入142名2~14岁的上呼吸道感染咳嗽的儿童

发病时间在48小时内. 通过计算机生成的随机序列

将受试者按1∶1的比例随机分为两组. 治疗组用九味竺黄散 (1~1.5克

每日2~3次) 治疗

对照组用常规治疗 (小儿氨酚黄那敏颗粒

0.25~1克

每日3次) . 两组疗程均为5天. 主要结局指标为咳嗽痊愈时间和4天咳嗽痊愈率. 次要结局指标为研究期间的每日症状评分改善情况和咳嗽缓解率.

结果:

138名患儿被纳入意向性分析

其中治疗组71例

对照组67例. 与常规治疗相比

服用九味竺黄散的儿童咳嗽痊愈时间更短[风险比 (HR) : 2.10; 95%可信区间 (CI) : 1.29–3.40;

=0.003]

其咳嗽痊愈的中位时间为2天

短于对照组的3天 (

0.001) . 治疗第4天时

九味竺黄散治疗组的咳嗽痊愈率为94.4%

高于对照组的74.6% (率差: 19.8%

95% CI: 8.1%-31.5%; 相对危险度: 1.265

95% CI: 1.088-1.470;

=0.001) . 两组的上呼吸道感染其他症状 (发热、鼻塞、流涕、喷嚏) 评分改善无统计学差异. 在治疗组和对照组的受试者中

分别有5.6% (4/71) 和4.5% (3/67) 报告了不良事件 (

0.05)

这些不良事件均较轻

未经治疗即缓解.

结论:

九味竺黄散治疗儿童上呼吸道感染咳嗽安全有效. (试验注册号ChiCTR2000039421)

Abstract

Objective:

To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH)

a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children.

Methods:

The study was a multicenter

randomized

open-label

controlled trial. A total of 142 children aged 2 to 14 years old

with URTIassociated cough within 48 h of onset

were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g

twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol

Artificial Cow-bezoar and Chlorphenamine Maleate Granules

0.25 to 1 g

thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.

Results:

A total of 138 children were included in the intention-to-treat analysis

with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment

the children receiving JWZH had a shorter time to cough resolution [hazard ratio

2.10; 95% confidence interval (CI)

1.29–3.40;

=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days;

0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%

95% CI: 8.1%–31.5%; relative risk: 1.265

95% CI: 1.088–1.470;

=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (

0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (

0.05)

respectively

which were all mild and resolved without treatment.

Conclusion:

JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421)

关键词

Keywords

child coughupper respiratory tract infectionJiuwei Zhuhuang Powderrandomized controlled trialTibetan medicine

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