口腔医学研究

口腔医学研究 ›› 2023, Vol. 39 ›› Issue (12): 1080-1084.DOI: 10.13701/j.cnki.kqyxyj.2023.12.010

• 口腔肿瘤学研究 • 上一篇    下一篇

基于Clinicaltrials.gov平台的口腔鳞状细胞癌临床研究注册特点分析

王韧1,2, 周诗洁1,2, 郭锦材1,2,3*   

  1. 1.长沙市口腔医院药剂科 湖南 长沙 410006;
    2.湖南中医药大学口腔医学院 湖南 长沙 410006;
    3.湖南中医药大学药学院 湖南 长沙 410208
  • 收稿日期:2023-06-26 出版日期:2023-12-28 发布日期:2023-12-25
  • 通讯作者: * 郭锦材,E-mail:540009728@qq.com
  • 作者简介:王韧(1994~ ),男,湖南湘潭人,硕士,主管药师,主要从事口腔临床药物学研究。
  • 基金资助:
    湖南省自然科学基金项目(2021JJ70062)湖南省卫生健康委科研计划项目(D202313048136)湖南省中医药科研课题(B2023048)湖南中医药大学院校联合基金项目(2022XYLH134)

Analysis of Registration Status of Oral Squamous Cell Carcinoma Clinical Trials Based on ClinicalTrials.gov Database

WANG Ren1,2, ZHOU Shijie1,2, GUO Jincai1,2,3*   

  1. 1. Department of Pharmacy, Changsha Stomatological Hospital, Changsha 410006, China;
    2. School of Stomatology, Hunan University of Chinese Medicine, Changsha 410006, China;
    3. School of Pharmacy, Hunan University of Chinese Medicine, Changsha 410208, China
  • Received:2023-06-26 Online:2023-12-28 Published:2023-12-25

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摘要： 目的:基于Clinicaltrials.gov平台分析全球口腔鳞状细胞癌(oral squamous cell carcinoma,OSCC)的临床研究注册特点,了解研究现状和发展趋势,为OSCC临床研究和诊疗提供新思路。方法:通过挖掘Clinicaltrials.gov平台建库至2023年3月24日已注册的OSCC临床试验数据,从年度趋势、地域分布、临床分期、研究类型、受试者人数、经费来源、机构数量等多方面进行统计分析,归纳其临床研究特征。结果:共纳入OSCC临床注册研究332项,注册数量最多的3个国家是美国(188项,56.63%),中国(37项,11.14%)和法国(18项,5.42%)。332项研究中干预性研究和观察性研究分别占83.43%和16.57%,277项干预性试验中药物干预204项(73.65%),其中单克隆抗体药物研究79项(28.52%),顺铂60项(21.66%)。119项平行试验中105项(88.24%)采用随机方法,44项(36.97%)为盲法。332项研究中约1/3(111项,33.43%)归属于Ⅱ期临床试验,受试者人数在50以下的占比超过一半(177项,53.31%)。结论:OSCC的临床研究存在地区不均衡性,多中心大样本随机三盲对照的高质量临床研究不足,应加强临床试验注册的培训和审查,以促进OSCC临床试验高质量的开展,推动其治疗方案的优化。

关键词: 口腔鳞状细胞癌, 药物临床试验, 数据挖掘

Abstract: Objective: To investigate the current status and trends of clinical research in oral squamous cell carcinoma (OSCC) worldwide based on Clinicaltrials.gov, and to provide new ideas for clinical research and treatment of OSCC. Methods: The data of clinical trials for OSCC registered on Clinicaltrials.gov were searched from inception to March, 2023. Statistical analysis was performed on the annual trend, regional distribution, clinical stage, type of study and number of subjects, sources of funds, and number of institutions. Results: A total of 332 clinical registries of OSCC were included, with the top three countries with the highest number of registrations being the United States (188,56.63%),China (37,11.14%),and France (18,5.42%). 83.43% were intervention studies and 16.57% were observational studies. Within 277 intervention trials, 204 were drug intervention clinical trials (73.65%), of which 79 were monoclonal antibody drug studies (28.52%) and 60 items were cisplatin (21.66%). Within 119 parallel trials, 105 (88.24%) were randomized and 44 (36.97%) were blinded. About one-third (111,33.43%) of the 332 studies were assigned to phase II trials, with more than half (177,53.31%) having fewer than 50 participants. Conclusion: Regional imbalance exists in clinical studies of OSCC, and high quality clinical studies with multi-center, large sample, and triple blind control are insufficient. Therefore, training and review of clinical trial registration should be strengthened to promote the high quality clinical trials of OSCC. It might be helpful for promoting the optimization of treatment programs.

Key words: oral squamous cell carcinoma, drug clinical trials, data mining