全球体外膜肺氧合临床试验注册现状分析

卢岩,陈娟,张婷,欧阳昭连

中国医疗设备 ›› 2020, Vol. 35 ›› Issue (6) : 144-149.

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中国医疗设备 ›› 2020, Vol. 35 ›› Issue (6) : 144-149. DOI: 10.3969/j.issn.1674-1633.2020.06.036
专论

全球体外膜肺氧合临床试验注册现状分析

  • 卢岩,陈娟,张婷,欧阳昭连
作者信息 +

Analysis of the Status of Global Extracorporeal Membrane Oxygenation Clinical Trial Registration

  • LU Yan, CHEN Juan, ZHANG Ting, OUYANG Zhaolian
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摘要

通过ClinicalTrials.gov对全球体外膜肺氧合(Extracorporeal Membrane Oxygenation,ECMO)临床试验数据进行采集, 利用文献计量学方法,从注册数量与时间变化趋势、国家分布、申办者及研究类型与方法、分期、适应证等角度对ECMO临 床试验注册现状进行研究。研究结果显示,全球ECMO临床试验共有208项,呈现出逐年增长的趋势,近五年复合增长率达到 43.77%;主要开展于美国(43项)、中国(35项)和法国(33项),其申办者以医疗机构为主(63个,占48.84%)。其中, 实验性研究和观察性研究数量基本相同(93项和115项),实验性研究中处于Ⅳ期的注册数量最多(11项);临床试验的适应 证集中于心源性休克(36项)、心脏骤停(27项)和心力衰竭(16项)等心脏疾病及急性呼吸窘迫综合征(29项)、呼吸 衰竭(26项)等肺部疾病。截至检索时间,中国大陆在该机构注册的ECMO临床试验数量较少(19项),与欧美发达国家 尚存在一定差距。分析全球ECMO临床试验注册现状,可为推动ECMO在我国的广泛应用及相关技术的临床转化提供参考 及依据。

Abstract

This research collected clinical trial data of extracorporeal membrane oxygenation (ECMO) from ClinicalTrials.gov and used bibliometric methods to analyze the status of ECMO clinical trial registration, from the perspectives of quantity and time trends, countries, sponsors, research types, phases and indications. The research results showed that there were 208 ECMO clinical trials, showing a growing trend with a compound annual growth rate of 43.77% in recent five years. These clinical trials were mainly carried out in the United States (43), China (35) and France (33). The sponsors were mainly medical institutions (63, accounting for 48.84%). In all clinical trials, the number of experimental studies was equal to observational studies’ basically (93 vs. 115), and the clinical trials in phase IV were most in experimental studies. The indications for clinical trials focused on cardiac diseases such as cardiogenic shock (36), cardiac arrest (27) and heart failure (16), and pulmonary diseases such as acute respiratory distress syndrome (29) and respiratory failure (26). As of the retrieval time, the number of ECMO clinical trials conducted in mainland China was relatively small (19), and there was still a certain gap between mainland China and European and American developed countries. By analyzing the status of global ECMO clinical trial registration, it was expected to provide some references and basis for promoting the widespread application of ECMO and the clinical transformation of related technologies in China.

关键词

体外膜肺氧合 / ClinicalTrials.gov / 临床试验 / 文献计量

Key words

extracorporeal membrane oxygenation / ClinicalTrials.gov / clinical trials / bibliometrics

引用本文

导出引用
卢岩, 陈娟, 张婷, . 全球体外膜肺氧合临床试验注册现状分析[J]. 中国医疗设备, 2020, 35(6): 144-149 https://doi.org/10.3969/j.issn.1674-1633.2020.06.036
LU Yan, CHEN Juan, ZHANG Ting, et al. Analysis of the Status of Global Extracorporeal Membrane Oxygenation Clinical Trial Registration[J]. China Medical Devices, 2020, 35(6): 144-149 https://doi.org/10.3969/j.issn.1674-1633.2020.06.036
中图分类号: R-1    R459.7   

参考文献

[1] Lee S,Chaturvedi A.Imaging adults on extracorporeal membrane oxygenation (ECMO)[J].I n s i g h t s I n t o Imaging,2014,5(6):731-742.

基金

国家重点研发计划(2016YFC0104805);中国医 学科学院 北京协和医学院 医学信息研究所/图书馆新冠肺炎疫 情专项课题“全球体外膜肺氧合(ECMO)研发态势研究” (2020XG010);中国工程院咨询研究项目“天津市生物医药创新 与产业发展战略研究”。

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