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标题：Efficacy and mechanism of traditional Chinese medicine in relieving antibiotic-resistant bacterial diarrhea in children: study protocol for a randomized controlled trial
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作者：Chao-ran Bi ; Wei Jing ; Xiao-fei Xie 等
期刊名称：Trials
印刷版ISSN：1745-6215
电子版ISSN：1745-6215
出版年度：2021
卷号：22
期号：1
页码：1-8
DOI：10.1186/s13063-021-05381-8
出版社：BioMed Central
摘要：Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems worldwide, especially in China. We therefore designed a study to evaluate the clinical efficacy and mechanism of traditional Chinese medicine in alleviating the effects of antibiotic resistance in childhood bacterial diarrhea and enhancing the sensitivity of pathogenic bacteria to antibiotics. This randomized, double-blind, placebo-controlled clinical trial has completed ChiCTR registration. The trial will randomly divide 120 children who meet the inclusion criteria into three groups: experimental group 1 (basic treatment Gegen Qinlian decoction granules Erbai drink placebo), experimental group 2 (basic treatment Erbai drink granules Gegen Qinlian decoction placebo), and control group (basic treatment Gegen Qinlian decoction placebo Erbai drink placebo). The main efficacy indicators will be antibiotic use rate and clinical cure rate, and the secondary efficacy indicators will be time to antibiotic intervention, effective rate, and course of treatment determined after 5 days. The following physical and chemical indicators will be measured: routine blood parameters, procalcitonin, C-reactive protein, electrocardiogram, liver and kidney function, electrolytes, routine urinalysis, routine stool analysis, and stool culture (including drug sensitivity). The results of this study may provide an objective clinical basis for the use of traditional Chinese medicine in managing antibiotic-resistant bacterial diarrhea in children, formulating relevant guidelines, and demonstrating the use of traditional Chinese medicine for reducing the use of antibiotics. Chinese Clinical Trial Registry ChiCTR1900027915 . Last refreshed on December 4, 2019.
关键词：Bacterial diarrhea ; Traditional Chinese medicine ; Antibiotic resistance ; Clinical efficacy evaluation ; Mechanism study