2020年 第6卷 第10期
《工程（英文）》 >> 2020年 第6卷 第10期 doi: 10.1016/j.eng.2020.06.011
特力阿扎维林治疗新冠病毒肺炎的疗效和安全性——试验方案
a Department of Pharmacology & State-Province Key Laboratories of Biomedicine-Pharmaceutics of China & Key Laboratory of Cardiovascular Medicine Research, Ministry of Education, College of Pharmacology, Harbin Medical University, Harbin 150001, China
b First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China
c The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China
d The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China
e The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China
f Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China
# These authors contributed equally to this work.
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摘要
根据2019年12月的报道，新冠病毒肺炎（coronavirus disease 2019, COVID-19）是由一种新型冠状病毒引起的肺炎。到目前为止，还没有发现能够治疗这种病毒的有效药物。本研究是一项在黑龙江省10个研究中心正在进行的多中心双盲随机对照试验（randomized controlled trial, RCT），其目的是研究与安慰剂相比，特力阿扎维林（triazavirin, TZV）治疗COVID-19患者的疗效和安全性。共计划招募240名COVID-19患者参加这项试验。咽拭子病毒核酸检测为阳性的受试者被随机（1∶1）分为两组：使用标准治疗加TZV或标准治疗加安慰剂，进行为期7 d的治疗和为期21 d的随访。主要结局是受试者临床改善的时间。次要结局包括临床改善率、退热时间、肺内炎症明显吸收的平均时间和人数比例、病毒核酸转阴率、病死率以及重症和危重症患者的转化率。整个试验过程将对不良事件，严重不良事件，肝功能、肾功能以及合并用药进行监测和记录。本试验的结果可为临床医生治疗COVID-19提供循证医学的证据和建议。
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