Zhao H L, Xie Y, Li J S
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China; Henan University of Chinese Medicine, Zhengzhou 450046, China.
The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, China.
Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2020 Jan 20;38(1):20-23. doi: 10.3760/cma.j.issn.1001-9391.2020.01.004.
To investigate the registration characteristics and development trend of clinical trials of pneumoconiosis, analyze the clinical research characteristics and current situation of prevention and treatment pneumoconiosis. In December 2018, the databases of primary registries certified by International Clinical Trials Registry Platform (ICTRP) , such as Chinese Clinical Trial Registry (ChiCTR) , Clinical Trials. gov, and Japan Primary Registries Network (JPRN) were retrieved. All clinical trials related to pneumoconiosis were included from the database establishment until December 1, 2018, and the characteristics of registered clinical trials were analyzed. A total of 23 clinical trials related to pneumoconiosis were inclued. The number of registrations in China and Brazil are 9 and 3 respectively, while the registration numbers of Clinical Trials. gov and ChiCTR are 10 and 5 respectively. Fourteen trials have been completed; five trials are ongoing, and four trials are unknown for the research progress. Ten trials were for silicosis patients. Eight trials with a sample size less than 50. Twelve trials were randomized controlled trials. Interventions of five clinical trial are pulmonary rehabilitation. There were six trials with a 12-month course of treatment. At present, the number of registered studies in clinical trials of pneumoconiosis is relatively less; the proportion of published clinical research results is low, and some clinical research status is unknown. It should increase the publicity of the registration of clinical trials for pneumoconiosis, improve the awareness of registration and the intensity of research design to promote the development of high-quality clinical trials.
为探讨尘肺病临床试验的注册特征及发展趋势，分析尘肺病临床研究特点及防治现状。2018年12月，检索国际临床试验注册平台（ICTRP）认证的一级注册库数据库，如中国临床试验注册中心（ChiCTR）、美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）和日本一级注册库网络（JPRN）。纳入自建库至2018年12月1日所有与尘肺病相关的临床试验，并分析注册临床试验的特征。共纳入23项与尘肺病相关的临床试验。中国和巴西的注册数分别为9项和3项，ClinicalTrials.gov和ChiCTR的注册数分别为10项和5项。14项试验已完成；5项试验正在进行，4项试验的研究进展未知。10项试验针对矽肺患者。8项试验样本量小于50。12项试验为随机对照试验。5项临床试验的干预措施为肺康复。6项试验疗程为12个月。目前，尘肺病临床试验注册研究数量相对较少；已发表的临床研究结果比例较低，部分临床研究状况不明。应加大尘肺病临床试验注册宣传力度，提高注册意识和研究设计强度，以促进高质量临床试验的发展。
