Efficacy and mechanism of traditional Chinese medicine in relieving antibiotic-resistant bacterial diarrhea in children: study protocol for a randomized controlled trial.
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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DOI：
10.1186/s13063-021-05381-8
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发表时间：
2021-06-29
期刊：
影响因子：
2.5
通讯作者：
Liu YJ
中科院分区：
文献类型：
--
作者：
Bi CR;Jing W;Xie XF;Liu YJ
细菌感染是儿童腹泻的重要原因，可能导致营养不良，生长发育障碍，甚至死亡。抗生素滥用和耐药性是世界范围内普遍存在的问题，特别是在中国。因此，本研究旨在探讨中药在缓解小儿细菌性腹泻耐药性、提高病原菌对抗生素敏感性方面的临床疗效及作用机制。这项随机、双盲、安慰剂对照的临床试验已完成ChiCTR注册。本试验将符合入选标准的120例患儿随机分为三组：实验1组（基础治疗+葛根芩连汤颗粒+二白饮安慰剂）、实验2组（基础治疗+二白饮颗粒+葛根芩连汤安慰剂）、对照组（基础治疗+葛根芩连汤安慰剂+二白饮安慰剂）。主要疗效指标为抗生素使用率和临床治愈率，次要疗效指标为5天后确定的抗生素干预时间、有效率和疗程。将测量以下理化指标：血常规、降钙素原、C反应蛋白、心电图、肝肾功能、电解质、尿常规、大便常规、大便培养（包括药物敏感性）。本研究结果可为中医药治疗儿童耐药细菌性腹泻提供客观的临床依据，制定相关指南，并为减少抗生素的使用提供中医药的示范。中国临床试验注册中心ChiCTR 1900027915。最后更新于2019年12月4日。
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.
中国发达地区的儿童感染性腹泻的病因：与发达地区的发展中心和成人腹泻相比。
影响因子：
3.7
作者：
Wang X;Wang J;Sun H;Xia S;Duan R;Liang J;Xiao Y;Qiu H;Shan G;Jing H
通讯作者：
Jing H
DOI：
10.13381/j.cnki.cjm.202002001
发表时间：
2020-01-01
期刊：
Zhongguo Weishengtaxixue Zazhi / Chinese Journal of Microecology
影响因子：
--
作者：
He, Yun-shan;Tang, Yuan;Hui, H. Y.
通讯作者：
Hui, H. Y.