Comparison of Jinzhen oral liquid and ambroxol hydrochloride and clenbuterol hydrochloride oral solution in the treatment of acute bronchitis in children: A multicenter, non-inferiority, prospective, randomized controlled trial.

Qinhua FAN; Chongming WU; Yawei DU; Boyang WANG; Yanming XIE; Zeling ZHANG; Wenquan SU; Zizhuo WANG; Changchang XU; Xueke LI; Ying DING; Xinjiang AN; Jing CHEN; Yunying XIAO; Rong YU; Nan LI; Juan WANG; Yiqun TENG; Hongfen LV; Nian YANG; Yuling WEN; Xiaoli HUANG; Wei PAN; Yufeng LIU; Xueqin XI; Qianye ZHAO; Changshan LIU; Jian XU; Haitao ZHANG; Lie ZHUO; Qiangquan RONG; Yu XIA; Qin SHEN; Shao LI; Junhong WANG; Shengxian WU

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Comparison of Jinzhen oral liquid and ambroxol hydrochloride and clenbuterol hydrochloride oral solution in the treatment of acute bronchitis in children: A multicenter, non-inferiority, prospective, randomized controlled trial.

Author: Qinhua FAN ¹ ; Chongming WU ² ; Yawei DU ¹ ; Boyang WANG ³ ; Yanming XIE ⁴ ; Zeling ZHANG ¹ ; Wenquan SU ¹ ; Zizhuo WANG ¹ ; Changchang XU ¹ ; Xueke LI ¹ ; Ying DING ⁵ ; Xinjiang AN ⁶ ; Jing CHEN ⁷ ; Yunying XIAO ⁸ ; Rong YU ⁹ ; Nan LI ¹⁰ ; Juan WANG ¹¹ ; Yiqun TENG ¹² ; Hongfen LV ¹³ ; Nian YANG ¹⁴ ; Yuling WEN ¹⁵ ; Xiaoli HUANG ¹⁶ ; Wei PAN ¹⁷ ; Yufeng LIU ¹⁸ ; Xueqin XI ¹⁹ ; Qianye ZHAO ²⁰ ; Changshan LIU ²¹ ; Jian XU ²² ; Haitao ZHANG ²³ ; Lie ZHUO ²⁴ ; Qiangquan RONG ²⁵ ; Yu XIA ²⁶ ; Qin SHEN ²⁷ ; Shao LI ³ ; Junhong WANG ¹ ; Shengxian WU ¹
Author Information

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
2. School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China.
3. Institute for TCM-X, MOE Key Laboratory of Bioinformatics, Bioinformatics Division, BNRist, Department of Automation, Tsinghua University, Beijing 100084, China.
4. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
5. The First Affiliated Hospital of Henan University of CM, Zhengzhou 450099, China.
6. Xuzhou Children's Hospital, Xuzhou 221002, China.
7. Women and Children's Health Care Hospital of Linyi, Linyi 276016, China.
8. Taian Maternity and Child Health Hospital, Taian 271001, China.
9. Wuxi No.8 People's Hospital Group, Wuxi 214011, China.
10. Shi Jia Zhuang Maternity & Child Healthcare Hospital, Shijiazhuang 050006, China.
11. The First People's Hospital of Lianyungang, Lianyungang 222002, China.
12. Jiaxing Second Hospital, Jiaxing 314001, China.
13. Jiangyan Hospital of Traditional Chinese Medicine, Taizhou 225599, China.
14. Linshu County People's Hospital, Linyi 276799, China.
15. Qiqihar Hospital of Traditional Chinese Medicine, Qiqihar 161005, China.
16. Liuzhou Maternal and Child Health Care Hospital, Liuzhou 545001, China.
17. Wuxi Hospital of Traditional Chinese Medicine, Wuxi 214071, China.
18. The Fourth Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110103, China.
19. Shandong Maternal and Child Health Hospital, Jinan 250014, China.
20. Lianyungang Maternal and Child Health Hospital, Lianyungang 222062, China.
21. The Second Hospital of Tianjin Medical University, Tianjin 300211, China.
22. Qidong Maternal and Child Health Hospital, Qidong 226299, China.
23. Suzhou Integrated Traditional and Western Medicine Hospital, Suzhou 215101, China.
24. Nanjing Drum Tower Hospital Group Suqian Hospital, Nanjing 210008, China.
25. Nanjing Gaochun People's Hospital, Nanjing 211302, China.
26. Nanjing Lishui People's Hospital, Nanjing 211299, China.
27. The Affiliated Suqian First People's Hospital of Nanjing Medical University, Suqian 223812, China.
Publication Type:Journal Article
Keywords: Acute bronchitis; Clinical trial; Complementary and alternative medicine; Jinzhen oral liquid; Network target analysis
From: Acta Pharmaceutica Sinica B 2024;14(12):5186-5200
CountryChina
Language:English
Abstract: The comparison between traditional Chinese medicine Jinzhen oral liquid (JZOL) and Western medicine in treating children with acute bronchitis (AB) showed encouraging outcomes. This trial evaluated the efficacy and safety of the JZOL for improving cough and expectoration in children with AB. 480 children were randomly assigned to take JZOL or ambroxol hydrochloride and clenbuterol hydrochloride oral solution for 7 days. The primary outcome was time-to-cough resolution. The median time-to-cough resolution in both groups was 5.0 days and the antitussive onset median time was only 1 day. This randomized controlled trial showed that JZOL was not inferior to cough suppressant and phlegm resolving western medicine in treating cough and sputum and could comprehensively treat respiratory and systemic discomfort symptoms. Combined with clinical trials, the mechanism of JZOL against AB was uncovered by network target analysis, it was found that the pathways in TRP channels like IL-1β/IL1R/TRPV1/TRPA1, NGF/TrkA/TRPV1/TRPA1, and PGE2/EP/PKA/TRPV1/TRPA1 might play important roles. Animal experiments further confirmed that inflammation and the immune regulatory effect of JZOL in the treatment of AB were of vital importance and TRP channels were the key mechanism of action.