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

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

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 endometriosis based on the ClinicalTrials.gov,providing comprehensive and objective information for re-searchers,clinicians,and clinical pharmacists.METHODS:A thorough investigation was conducted on clinical trials related to endometriosis,registered on the ClinicalTrials.gov from its inception to October 20,2023.Relevant trial data were extracted and statistically analyzed using bibliometrics and comparative research methods.RESULTS:A total of 667 endometriosis clinical studies were registered globally,showing an annual increase.The United States(127 trials),France(70 trials),and Italy(57 trials)had the highest number of registered trials.Interventional studies were predominant(416 trials,62.4%),followed by observational studies(251 trials,37.6%).Within interventional studies,drug therapy was the primary intervention(223 trials,53.6%).Despite endometriosis being a female condition,male subjects were also considered,with 6 trials specifically requiring male participants and 37 trials not restricting gender.Companies/corporations were the main funding sources,while public and governmental organizations provided relatively less funding.CONCLUSION:Clinical trial research on endometriosis is in a phase of growth,with drug therapy being the main treatment approach.However,there is a relative lack of investment and attention from public funds and governmental organizations.