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中国注册的 2019-nCoV 疗法的临床试验分析。

Clinical trial analysis of 2019-nCoV therapy registered in China.

机构信息

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.

出版信息

J Med Virol. 2020 Jun;92(6):540-545. doi: 10.1002/jmv.25733. Epub 2020 Mar 5.

Abstract

So far, there is a lack of effective drugs for the new coronavirus pneumonia. With more and more patients diagnosed, China has carried out more than 100 clinical studies of new coronavirus infection, including antiviral drugs, antimalarial drugs, glucocorticoids, plasma therapy, virus vaccine, and other Western drugs, while Chinese medicine research accounted for half of the studies. Most of the trials were initiated by investigators and the study period would last for 1 to 11 months. The primary endpoints included symptom improvement and virus nucleic acid turning negative, but the optimal endpoint has not been determined. Although the final results of studies will take a long time to complete, the interim research data may provide some help for the current urgent demand for drug treatment. Compared with that of during SARS period in 2003, China has the stronger capability to carry out clinical trials of new drugs in emergency period.

摘要

到目前为止,还没有针对新型冠状病毒肺炎的有效药物。随着越来越多的患者被确诊,中国已经开展了 100 多项针对新型冠状病毒感染的临床研究,包括抗病毒药物、抗疟药物、糖皮质激素、血浆疗法、病毒疫苗和其他西药,而中药研究占研究的一半。大多数试验都是由研究人员发起的,研究期为 1 至 11 个月。主要终点包括症状改善和病毒核酸转阴,但最佳终点尚未确定。尽管研究的最终结果需要很长时间才能完成,但中期研究数据可能为目前对药物治疗的迫切需求提供一些帮助。与 2003 年 SARS 期间相比,中国在紧急时期开展新药临床试验的能力更强。

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