新型冠状病毒肺炎相关抗病毒药物临床试验进展  

Research progress of clinical trials of anti-viral drugs for coronavirus disease 2019

作　　者：叶乔峰 王广飞[1] 黄怡蝶[1] 卢金淼[1] 朱琳[1] 徐虹 李智平[1] YE Qiao-feng;WANG Guang-fei;HUANG Yi-die;LU Jin-miao;ZHU Lin;XU Hong;LI Zhi-ping(Department of Clinical Pharmacy,National Children’s Medical Center/Children’s Hospital of Fudan University,SHANGHAI 201102,China;Department of Nephrology,National Children’s Medical Center/Children’s Hospital of Fudan University,SHANGHAI 201102,China)

机构地区：[1]国家儿童医学中心/复旦大学附属儿科医院临床药学部,上海201102 [2]国家儿童医学中心/复旦大学附属儿科医院肾脏科,上海201102

出　　处：《中国新药与临床杂志》2020年第10期577-583,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金：国家自然科学基金(81874325);上海市科学技术委员会科研计划项目(18DZ1910604,19XD1400900,19DZ1910703)。

摘　　要：新型冠状病毒肺炎已成为世界流行性疾病,其相关抗病毒药物临床试验的结果陆续公布,阿比多尔、瑞德西韦和干扰素的疗效不明确;氯喹、羟氯喹单药治疗以及与大环内酯类药物的联合治疗效果存在争议,且高剂量使用氯喹可能会增加心脏毒性的风险;洛匹那韦利托那韦未有显著疗效,其胃肠道不良反应较常见;法匹拉韦相关的临床试验也未报道显著阳性结果。目前的临床试验多为非盲、非随机、观察性研究。药物剂量是否达到有效治疗剂量、患者基线情况是否一致、合并用药的作用、结局指标选择的合理性等问题可能影响研究结果。未来还需要多中心、大样本、随机、双盲、安慰剂对照的临床试验来提供质量更高、更为明确的临床治疗证据。Coronavirus disease 2019(COVID-19)has become a pandemic.The results of several clinical trials of anti-viral drugs for COVID-19 have been published.Arbidol,remdesivir,and interferon had not shown certain efficacy.Efficacy of chloroquine or hydroxychloroquine with or without macrolide was controversial,and high doses of chloroquine might increase the risk of cardiac toxicity.Lopinavir-ritonavir did not show significant efficacy and its gastrointestinal adverse effects were relatively common.Clinical trials on favipiravir also did not show significantly positive results.Currently,most of the published clinical trials were open,non-randomized observational studies.Potential problems,such as dosage adequacy to reach effective target,baseline characteristics of patients,co-administered medications,outcome selection,etc,could possibly affect the results.More multi-center,large-sample,randomized,double-blinded,placebo-controlled clinical trials are needed to provide strong evidence for treatment.

关 键 词：新型冠状病毒肺炎 抗病毒药 临床试验 

分 类 号：R978.7[医药卫生—药品]