Author:
Bi Chao-ran,Jing Wei,Xie Xiao-fei,Liu Yan-jing
Abstract
Abstract
Background
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.
Methods
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).
Discussion
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.
Trial registration
Chinese Clinical Trial Registry ChiCTR1900027915. Last refreshed on December 4, 2019.
Funder
the National Key Research and Development Project
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference16 articles.
1. Wang X, Wang J, Sun H, Xia SL, Duan R, Lian JR, et al. Etiology of childhood infectious diarrhea in a developed region of China:compared to childhood diarrhea in a developing region and adult diarrhea in a developed region. PLoS One. 2015;10(11):e0142136. https://doi.org/10.1371/journal.pone.0142136.
2. Wang P, Kang Q, Zhang HM, Yu DS. Monitoring and analysis on pathogens and drug resistance of bacterial diarrhea in Lanzhou in 2013. Chinese J Health Lab Technol. 2017;27:570–1.
3. Wang CJ, Lei C, Liu JF, Wei XG, Liu N, He HL. Bacterial diarrhoea pathogens among children, Xi’an,2004-2016. Modern Prev Med. 2017;44:2877–80.
4. Yuan HY, Zhang MX, Ma RW. Analysis of distribution and resistance to antibiotics of pathogenic bacteria in chil- dren ′s diarrhea in Taiyuan area from 2002 to 2007. Chinese J Microecol. 2008;20:589–90 593.
5. Cui EB, Chen SM, Zhang CL, Wang Y, Jia TY, Bao CM, et al. Distribution of the community-acquired bacterial diarrheal pathogens and drug resistance in 16 provinces or cities in China during 2009-2013. Infect Dis Inform. 2014;27:143–7.
Cited by
6 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献