[1]曾敏,洪卓民,周茹玉,等.中国临床试验注册中心注册的近视临床试验现状分析[J].眼科新进展,2022,42(11):900-905.[doi:10.13389/j.cnki.rao.2022.0185]
　ZENG Min,HONG Zhuomin,ZHOU Ruyu,et al.Analysis of the current situation of clinical myopia trials registered in Chinese Clinical Trial Registry[J].Recent Advances in Ophthalmology,2022,42(11):900-905.[doi:10.13389/j.cnki.rao.2022.0185]
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中国临床试验注册中心注册的近视临床试验现状分析/HTML
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《眼科新进展》[ISSN:1003-5141/CN:41-1105/R]

卷:
42卷
期数:
2022年11期
页码:
900-905
栏目:
应用研究
出版日期:
2022-11-05

文章信息/Info

Title:
Analysis of the current situation of clinical myopia trials registered in Chinese Clinical Trial Registry
作者:
曾敏; 洪卓民; 周茹玉; 杨芮; 郑菀睿; 庄家圆; 罗向霞
730000　甘肃省兰州市，甘肃中医药大学中医临床学院（曾敏，洪卓民，周茹玉，杨芮，郑菀睿，庄家圆）；730000　甘肃省兰州市，甘肃省中医院眼科（罗向霞）
Author(s):
ZENG Min1; HONG Zhuomin1; ZHOU Ruyu1; YANG Rui1; ZHENG Wanrui1; ZHUANG Jiayuan1; LUO Xiangxia2
1.Clinical College of Traditional Chinese Medicine,Gansu University of Traditional Chinese Medicine,Lanzhou 730000,Gansu Province,China
2.Department of Ophthalmology,Gansu Provincial Hospital of Traditional Chinese Medicine,Lanzhou 730000,Gansu Province,China
关键词:
近视; 临床研究; 临床试验注册; 中国临床试验注册中心; 现状分析
Keywords:
myopia;  clinical research;  clinical trial registration;  Chinese Clinical Trial Registry;  current situation analysis
分类号:
R778.1
DOI:
10.13389/j.cnki.rao.2022.0185
文献标志码:
A
摘要:
目的　分析中国临床试验注册中心（ChiCTR）注册的近视临床试验的研究现状和热点，为我国开展近视相关临床研究提供依据。方法　检索ChiCTR建库至2022年8月18日期间注册的近视相关临床研究，归纳分析纳入临床研究的时间分布、注册地区、注册机构、经费来源、研究类型、研究设计、随机化方法、盲法、研究中心、样本量及干预措施特征。结果　共纳入近视临床研究407项，近4年注册研究项数最多（278项）。注册单位覆盖全国25个省级行政区、113家临床研究机构。经费来源以地方财政（79项）、自筹（66项）、国家财政（54项）为主。研究类型以干预性研究（257项）为主，研究设计以随机平行对照研究（186项）为主；大部分随机对照研究（183项）描述了随机化方法，少部分随机对照研究（34项）注明了盲法。研究中心以单中心研究（336项）为主。预计招募样本总量2 229 063例。干预措施共13类，包括光学矫正（78项）、外科手术（63项）、药物干预（31项）、中医特色诊疗技术干预（26项）、红光干预（20项）、多技术路线干预（17项）等。结论　我国近视临床研究注册数量呈增加趋势，但存在注册地区分布不均、研究设计欠规范、多技术路线联合干预近视研究与中医药治疗近视研究不足等问题。建议促进干预措施多元化发展、优化近视干预方案，做好临床研究顶层设计，将有助于近视综合干预方案的建设。
Abstract:
Objective　To analyze the research status and hotspots of clinical myopia trials registered in the Chinese Clinical Trial Registry (ChiCTR), so as to provide a basis for myopia-related clinical research in China. Methods　The clinical research related to myopia registered in ChiCTR from its establishment to August 18, 2022 was collected. The time distribution, registration area, registration authority, funding source, research type, research design, randomization method, blind method, research center, sample size, and interventions regarding the clinical myopia research were summarized and analyzed. Results　A total of 407 clinical studies (278 registered in the past 4 years) of myopia were included. The registration authority covered 25 provincial-level administrative regions and 113 clinical research institutions. The funds were mainly provided by local finance agencies (79), researchers themselves (66), and national finance agencies (54). The research type was dominated by intervention studies (257), and the research design was dominated by randomized parallel controlled trials (186). Most randomized controlled trials (183) described the randomization method, and only a small number of randomized controlled trials (34) indicated the blind method. The research was mainly single-center trials (336). A total of 2 229 063 samples were collected. There were 13 types of interventions, including optical correction (78), surgery (63), drug intervention (31), TCM intervention (26), red light intervention (20), and multi-technical route intervention (17). Conclusion　The number of registered clinical myopia research in China is increasing, but there are still some problems, such as uneven distribution of registration areas, non-standard research design, and lack of research on myopia intervention by multi-technical routes and myopia treatment with TCM. It is suggested to promote the diversification of intervention measures, optimize the myopia intervention plans, and improve the top-level design of clinical myopia research, which may help develop a comprehensive myopia intervention program.

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备注/Memo

备注/Memo:
甘肃省中医药管理局科研课题（编号：GZKZ-2021-2）
更新日期/Last Update: 2022-11-05