药物涂层球囊治疗冠状动脉支架内再狭窄临床试验方案中入选、排除标准的探讨  

Inclusion and exclusion criteria in clinical trial of drug-coated balloon therapy for coronary stent restenosis

作　　者：陶苑茹 张晓燕 TAO Yuan-ru;ZHANG Xiao-yan(Department of Biomedical Engineering,Inner Mongolian Medical University,Hohhot 010110,China;Department of Biomedical Engineering,Inner Mongolia People's Hospital,Hohhot 010017,China)

机构地区：[1]内蒙古医科大学生物医学工程专业,呼和浩特010110 [2]内蒙古自治区人民医院医学工程处,呼和浩特010017

出　　处：《医疗卫生装备》2020年第6期85-89,共5页Chinese Medical Equipment Journal

摘　　要：通过文献分析法、案例调查法及实地调研法,分析了药物涂层球囊治疗冠状动脉支架内再狭窄(in-stent restenosis,ISR)临床试验方案(以下简称“临床试验方案”)的入选、排除标准,指出了临床试验方案的入选、排除标准中存在的问题。提出了临床试验方案的入选、排除标准中应包括的内容,为其他相关临床试验项目方案的设计提供了参考。The inclusion and exclusion criteria of clinical trial protocols of drug-coated balloon therapy for coronary in-stent restenosis(ISR)were explored with literature analysis,case study and field investigation,and the problems existed in the criteria were pointed out.The contents were pointed out that should be included in the inclusion and exclusion criteria of the clinical trial protocols,so as to provide references for the design of other relevant clinical trial protocols.

关 键 词：药物涂层球囊 临床试验方案 入选标准 排除标准 

分 类 号：R318.6[医药卫生—生物医学工程]