作　　者： (李征途）; (莫红缨）; ; (叶枫）;

机构地区： 广州医科大学

出　　处： 《中国继续医学教育》 2021年第16期68-72,共5页

摘　　要： 抗菌药物的广泛使用,造成了大范围的细菌耐药问题,然而抗菌药物的研发与细菌耐药的发展速度不相匹配,导致细菌耐药性问题愈趋严重,因此新型抗菌药物的研发显的尤为重要。而新型抗菌药物在成功研发上市环节中,临床试验是检验其有效性与安全性最重要的环节之一。如何规范化地开展抗菌药物临床试验,从而提供安全、有效的抗菌药物,规避高耐药率问题,是所有研究者的责任。笔者总结广州医科大学附属第一医院在社区获得性细菌性肺炎抗菌新药临床试验协作网的构建、培训、教学交流平台的构建的相关资料,积极探索抗感染药物临床试验的培训模式,为规范化开展抗菌药物临床试验提供科学的参考依据。 With the wide application of antibacterial drugs,it has caused a lot of bacterial resistance problems.However,antibacterial drugs’development does not match the development rate of bacterial resistance,leading to the increasingly serious problem of bacterial resistance.Therefore,the development of new antibacterial drugs is significant.In developing antibacterial drugs,clinical trials are one of the most important aspects of testing their efficiency and safety.Thus,it is the responsibility of all investigators to standardize how to conduct clinical trials of antibacterial drugs,to provide safe and effective antibacterial drugs and deal with the high drug resistance rates.The author summarizes the information and experience related to the construction,training,and teaching exchange platform of the collaborative network of new antimicrobial drug clinical trials for community-acquired bacterial pneumonia at The First Affiliated Hospital of Guangzhou Medical University,and actively explores the training model of clinical trials of anti-infective drugs.It will provide a scientific reference for standardizing the clinical trials of antibacterial drugs.

关 键 词： 细菌性肺炎 耐药 抗菌药物 临床试验 规范化培训 教学

领　　域： [医药卫生—呼吸系统] [医药卫生—内科学] [医药卫生—临床医学]