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作 者:张艳[1] 尹珊[1] 顾闻怡 李海[1] ZHANG Yan;YIN Shan;GU Wenyi;LI Hai(Department of Gastroenterology,Henji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 201112,China)
机构地区:[1]上海交通大学医学院附属仁济医院消化科,上海201112
出 处:《胃肠病学和肝病学杂志》2018年第9期969-971,共3页Chinese Journal of Gastroenterology and Hepatology
基 金:重大传染病专项基金(2018ZX10723203;2018ZX100302);上海市申康重大疾病临床技能提升项目(16CR1024B)
摘 要:良好的设计、严格的质量控制是构建和管理全球最大的乙肝高流行区慢加急性肝衰竭(acute-on-chronic liver failure,ACLF)高危患者队列的关键,是获得高质量循证医学证据的前提。从切实的临床问题出发,基于现有的国内外研究经验,制定科学、可行的研究方案,是该ACLF高危患者队列得以成功建立的根本。落实人员培训、定期质量核查、可追溯的原始资料获取、严格的标本管理制度等措施,保证研究数据的真实性、可靠性,保障研究的质量,是获得高质量循证医学证据的必备条件。在循证医学理念的指导下,中国慢(加急)性肝衰竭联盟(Chinese CLIF Consortium)成功完成了第1项Chinese CANONIC研究,完成了中国最大型的ACLF患者队列及世界上最大型的HBV相关ACLF患者队列建设。Good design and strict quality control are the keys to the construction and management of the cohort of patients at high risk of acute-on-chronic liver failure (ACLF) in the world' s largest HBV epidemic area, and the prerequisite ior obtaining evidence of high quality. Based on practical clinical problems and existing relevant research, making a scientific and feasible research plan is essential to successfully establish the cohort of patients at high risk of ACLF. Training, periodic quality verification, traceable original data acquisition and strict specimen management to ensure the authenticity and reliability of the research data and guarantee the quality of the research are indispensable for obtaining evidence of high quality. Hence, under the guidance of evidence-based medicine, Chinese CLIF Consortium successfully completed the first Chinese CANONIC study, constructing the largest cohort of ACLF patients in China and also the largest cohort of HBV-related ACLF patients in the world.
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