| 中国新型冠状病毒肺炎临床试验注册信息分析 |
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| 引用本文： | 项玉霞,曾 婵,黄志军,王晓敏,张泽宇,阳国平. 中国新型冠状病毒肺炎临床试验注册信息分析[J]. 金属学报, 2020, 25(2): 135-140. DOI: 10.12092/j.issn.1009-2501.2020.02.003 |
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| 作者姓名： | 项玉霞 曾 婵 黄志军 王晓敏 张泽宇 阳国平 |
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| 作者单位： | 1.中南大学湘雅三医院临床试验研究中心，长沙 410013，湖南；;2.中南大学湘雅三医院临床药理中心，长沙 410013，湖南； ;3.药物临床评价技术国家地方联合工程实验室，长沙 410013，湖南 |
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| 基金项目： | 重大新药创制重大专项（2020ZX09201010）；国家自然科学基金（81803639） |
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| 摘 要： | 目的:通过对中国新型冠状病毒肺炎临床试验注册信息进行分析和总结，为突发疫情期间临床试验的开展提供参考。方法:检索在中国临床试验注册中心和clinicaltrials.gov网站上注册的关于新型冠状病毒肺炎的临床研究项目，对研究类型、研究分布、研究设计、干预方案等进行分析。检索时间截至2020年2月17日。结果:共检索到172项临床研究，主要分布在湖北、浙江、广东、北京等地区。在120项干预性研究中：化学药物和生物制品占45%，中药或中西医结合治疗占40%，细胞治疗占7%，血浆治疗占2%；随机、盲法、安慰剂对照13项，占11%，空白对照组（对照组为未设安慰剂的临床常规治疗，试验组以临床常规作基础治疗）占46%；研究频率最高的是抗HIV病毒药物和抗疟药物。结论:中国临床研究意识和能力都得到了很大的提升，但显得有些无序，需要关注临床研究的必要性、科学性、伦理性和质量管理等问题，建议在突发疫情期间由国家统一论证、协调临床试验的发起和实施，集中全国病例信息进行大数据分析。
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| 关 键 词： | 新型冠状病毒肺炎 新型冠状病毒 临床试验 干预方案 |
| 收稿时间： | 2020-02-24 |
| 修稿时间： | 2020-02-26 |
Analysis of clinical trial registration information of COVID-19 in China |
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| XIANG Yuxia,ZENG Chan,HUANG Zhijun,WANG Xiaomin,ZHANG Zeyu,YANG Guoping. Analysis of clinical trial registration information of COVID-19 in China[J]. Acta Metallurgica Sinica, 2020, 25(2): 135-140. DOI: 10.12092/j.issn.1009-2501.2020.02.003 |
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| Authors: | XIANG Yuxia ZENG Chan HUANG Zhijun WANG Xiaomin ZHANG Zeyu YANG Guoping |
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| Affiliation: | 1.Research Center for Clinical Trial of the Third Xiangya Hospital Central South University, Changsha 410013, Hunan, China;2. Center for Clinical Pharmacology, the Third Xiangya Hospital, Changsha 410013, Hunan, China;3.National and Local Joint Engineering Laboratory for Drug Clinical Evaluation Technology , Changsha 410013, Hunan, China |
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| Abstract: | AIM: To provide advice for the clinical trials during the outbreak by analyzing the clinical trial registration information of COVID-19 in China. METHODS: Clinical protocols of COVID-19 registered at the Chinese Clinical Trials Registry and clinicaltrials.gov before February 17, 2020 were collected and the type, distribution, design and interventions of the studies were analyzed.RESULTS:A total of 172 trials were retrieved, mainly distributed in Hubei, Zhejiang, Guangdong and Beijing. Among the 120 interventional studies, chemical drugs and biological products accounted for 45%, traditional Chinese medicine or integrative medicine therapy accounted for 40%, cell therapy accounted for 7%, and plasma therapy accounted for 2%. There were only 13 randomized, blinded and placebo controlled studies, accounting for 11%. Blank control reached 46% (control group with clinical routine treatment without placebo，test group with clinical routine treatment as the basic). HIV and antimalarial drugs were the most frequently used. CONCLUSION: Chinese clinical research capacity and awareness have been greatly improved, but it is somewhat disordered. It is necessary to pay attention to the necessity, scientific nature, ethics and quality management of clinical research. It is recommended to initiate clinical trials coordinated and unified demonstration and to collect the national case information for big data analysis by the state during an emergency outbreak. |
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| Keywords: | COVID-19 SARS-Cov-2 clinical trial intervention protocol |
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