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基于ClinicalTrials.gov数据库的子宫内膜异位症临床研究多维度分析OA北大核心CSTPCD

Multidimensional analysis of endometriosis clinical trials based on the ClinicalTrials.gov database

中文摘要英文摘要

目的:基于ClinicalTrials.gov数据库对子宫内膜异位症的临床研究特点进行多维度分析,为研究者、临床医师和临床药师提供全面和客观的信息参考.方法:全面检索建库以来至2023年10月20日在ClinicalTrials.gov平台注册的子宫内膜异位症临床试验研究,提取相关试验数据,采用文献计量学及对比研究的方法进行统计分析.结果:全球子宫内膜异位症临床研究注册数量共667项,呈逐年增长趋势;美国(127项)、法国(70项)和意大利(57项)的临床试验注册数量最多;试验类型以干预性研究为主(416项,62.4%),其次是观察性研究(251项,37.6%).在干预性研究中药物治疗有223项(53.6%),为主要干预方式.尽管子宫内膜异位症为女性疾病,但男性受试者亦被纳入考虑范围,其中受试者要求为男性的临床试验有6项,不限性别的临床试验有37项.公司/企业是主要的经费来源,而公共和政府机构的资助相对较少.结论:子宫内膜异位症临床试验研究的发展呈上升阶段,治疗方式以药物治疗为主,但仍存在公共资金和政府机构的投入和关注相对不足的问题.

AIM:To perform a multidimensional analysis of the clinical study characteristics of endo-metriosis based on the ClinicalTrials.gov,providing comprehensive and objective information for re-searchers,clinicians,and clinical pharmacists.METHODS:A thorough investigation was conduct-ed on clinical trials related to endometriosis,regis-tered on the ClinicalTrials.gov from its inception to October 20,2023.Relevant trial data were extract-ed and statistically analyzed using bibliometrics and comparative research methods.RESULTS:A to-tal of 667 endometriosis clinical studies were regis-tered globally,showing an annual increase.The United States(127 trials),France(70 trials),and Ita-ly(57 trials)had the highest number of registered trials.Interventional studies were predominant(416 trials,62.4%),followed by observational stud-ies(251 trials,37.6%).Within interventional stud-ies,drug therapy was the primary intervention(223 trials,53.6%).Despite endometriosis being a female condition,male subjects were also consid-ered,with 6 trials specifically requiring male partici-pants and 37 trials not restricting gender.Compa-nies/corporations were the main funding sources,while public and governmental organizations pro-vided relatively less funding.CONCLUSION:Clinical trial research on endometriosis is in a phase of growth,with drug therapy being the main treat-ment approach.However,there is a relative lack of investment and attention from public funds and governmental organizations.

张保寅;杨文辉;刘青蓝;王琛;武婧;刘倩;孙楠

郑州大学第三附属医院药学部,郑州 450052,河南

临床医学

子宫内膜异位症临床研究注册Clini-calTrials.gov多维度分析

endometriosisclinical study registra-tionClinicalTrials.govmultidimensional analysis

《中国临床药理学与治疗学》 2024 (005)

520-526 / 7

河南省医学科技攻关联合共建项目(LHGJ20190402);博士科研基金项目(2021038)

10.12092/j.issn.1009-2501.2024.05.006

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