传染病爆发流行期间的临床研究方法与卫生经济学考量  

Conducting clinical studies during the epidemics of communicable diseases: perspectives of methodology and health economics

作　　者：弓孟春 刘莉[2] 吴琛 杨越 沈杨 李杰 林凯程[2] 郭怡[2] 魏红云[2] 徐泽宇 朱宏[1,2] GONG Mengchun;LIU Li;WUChen;YANG Yue;SHEN Yang;LI Jie;LIN Kaicheng;GUO Yi;WEI Hongyun;XU Zeyu;ZHU Hong(Institute of Health Management,Southern Medical University,Guangzhou 510515,China;Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;Digital China Health Technologies Co.Ltd,Beijing 100085,China)

机构地区：[1]南方医科大学卫生与健康管理研究院,广东广州510515 [2]南方医科大学南方医院,广东广州510515 [3]神州数码医疗科技股份有限公司,北京100085

出　　处：《南方医科大学学报》2020年第3期353-357,共5页Journal of Southern Medical University

摘　　要：爆发性传染性疾病流行期间,尽早开展流行病学和临床诊疗数据的汇集、分析及相关研究至关重要。新型冠状病毒肺炎(COVID-19)在中国及其他国家的流行从方法学角度为研究传染病提供了重要的契机。本文提出疫情期间进行病例报告、临床随机对照试验、基于真实世界数据的研究和卫生经济学研究方法的考量。病例报告在传染病爆发期间扮演重要角色,疫情期间病例报告的发表应该重视写作规范和同行评议程序。疫情期间治疗有效性的金标准仍是开展临床随机对照试验,本文总结了在疫情爆发期间开展临床随机对照试验会面临的诸多挑战。在疫情爆发流行期间,各定点收治医院对患者实际诊疗所形成的真实世界数据,在验证疫情相关医学干预措施的安全性和有效性方面显示出一定优势。卫生经济学研究对优化传染病防控策略提供数据支撑有重要意义,本文对传染病爆发期间的卫生经济学研究方法、研究设计、技术要点进行总结。本文建议提前将临床研究和卫生经济学研究纳入到爆发性传染性疾病的防治规划中,兼顾标准与可行性,以提高对传染病爆发的应对能力。In the setting of epidemics of communicable diseases, early initiation of epidemiological and clinical data collection and analysis and conducting relevant researches are essential to the success of epidemic containment. The coronavirus disease2019(COVID-19), starting initially as an epidemic in China in late 2019 and now becoming a pandemic globally, poses grave challenges to the global health care systems while also provides an opportunity for studying infectious diseases in the perspective of methodology. The authors propose the evaluation methods for case reports, randomized controlled trials(RCTs), real-world evidence studies and health economics researches during an epidemic. Case reports, which are of important value for health care workers during outbreaks of infectious diseases, should be written in standard format and style and published following a strict peer review process. RCTs provides the gold standard for evaluating the effectiveness of a given treatment for the patients from the outbreaks. We review the potential challenges faced in conducting RCTs during the outbreaks. The real-world data collected from the cases in designated hospitals allow the verification of the safety and effectiveness of the intervention measures. The data from health economics research also provide important support for optimizing communicable disease prevention and control strategies. Herein we summarize the health economics research methods, study design, and technical points during the outbreaks. We recommend that clinical research and health economics research be incorporated into the prevention and control plan and measures be taken to ensure both the standards and feasibility of these studies to improve the response capacity against outbreaks of communicable diseases.

关 键 词：爆发流行 COVID-19 随机临床对照试验 基于真实世界数据的研究 卫生经济学研究 

分 类 号：R1[医药卫生—公共卫生与预防医学] R181.3