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金振口服液与盐酸氨溴索和盐酸克仑特罗口服溶液治疗小儿急性支气管炎的比较:一项多中心、非劣效性、前瞻性、随机对照试验。

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.

作者信息

Fan Qinhua, Wu Chongming, Du Yawei, Wang Boyang, Xie Yanming, Zhang Zeling, Su Wenquan, Wang Zizhuo, Xu Changchang, Li Xueke, Ding Ying, An Xinjiang, Chen Jing, Xiao Yunying, Yu Rong, Li Nan, Wang Juan, Teng Yiqun, Lv Hongfen, Yang Nian, Wen Yuling, Huang Xiaoli, Pan Wei, Liu Yufeng, Xi Xueqin, Zhao Qianye, Liu Changshan, Xu Jian, Zhang Haitao, Zhuo Lie, Rong Qiangquan, Xia Yu, Shen Qin, Li Shao, Wang Junhong, Wu Shengxian

机构信息

Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.

School of Chinese Materia Medica, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China.

出版信息

Acta Pharm Sin B. 2024 Dec;14(12):5186-5200. doi: 10.1016/j.apsb.2024.09.001. Epub 2024 Sep 3.

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-1/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.

摘要

中药金振口服液(JZOL)与西药治疗小儿急性支气管炎(AB)的比较显示出令人鼓舞的结果。本试验评估了JZOL改善AB患儿咳嗽和咳痰的疗效及安全性。480名儿童被随机分配服用JZOL或盐酸氨溴索和盐酸克仑特罗口服溶液,为期7天。主要结局为咳嗽缓解时间。两组咳嗽缓解的中位时间均为5.0天,止咳起效中位时间仅为1天。这项随机对照试验表明,JZOL在治疗咳嗽和痰液方面不劣于止咳化痰西药,且能综合治疗呼吸道和全身不适症状。结合临床试验,通过网络靶点分析揭示了JZOL抗AB的作用机制,发现IL-1/IL1R/TRPV1/TRPA1、NGF/TrkA/TRPV1/TRPA1和PGE2/EP/PKA/TRPV1/TRPA1等TRP通道相关通路可能发挥重要作用。动物实验进一步证实,JZOL治疗AB时的炎症和免疫调节作用至关重要,TRP通道是其关键作用机制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c145/11725170/930995779cc9/ga1.jpg

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