\n\n
2018 年,瑞德西韦曾作为抗击埃博拉病毒的新药上阵试验,体外试验及动物试验都表现不俗,但最终在临床对照试验环节,惜败给另外两款药物(mAb-114 和 REGN-EB3),提前退出抗击埃博拉的战役。
\n\n治愈美国首例新冠患者,火速出征抗疫战场
\n\n虽然早早退出抗埃博拉的战场,但科学家关于瑞德西韦的研究却并未停止。
\n\n2018 年,吉利德发表了瑞德西韦用于抗冠状病毒感染的早期研究结果,显示其可以在体外抑制 SARS(非典型性肺炎)和 MERS(中东呼吸综合征)病毒。这两种病毒也是冠状病毒,在结构上与新冠病毒类似。
\n\n此次抗击新冠病毒初期,瑞德西韦因为此前对各种冠状病毒的不俗表现,进入不少权威机构“有潜力抗击新型冠状肺炎”药物候选名单。
\n\n一份来自世界卫生组织研发蓝图临床实验专家组的报告拟稿中,科学家将瑞德西韦作为治疗本次新冠肺炎的最有希望的候选药物。在实验中,瑞德西韦成功地抑制了猴子肾脏的感染。实验中得出的 EC50(半最大效应浓度,指在一半个体中有效的药物浓度)是 0.77 um[1],而在人体中,瑞德西韦在最低 0.21 um 的浓度下就已经开始显现作用。
\n\n1 月 31 日,权威医学期刊《新英格兰医学杂志》(NEJM)在线发表了美国首例确诊病例的诊疗过程以及临床表现,瑞德西韦“次日起效”的突出表现,像是给处于黑暗中的人们打了一束光[2]。
\n\n在多方努力下,2 月 5 日,瑞德西韦,这个在全球都没有上市的新药,在中国火速完成临床试验的注册审批工作,正式获批进入三期临床试验。
\n\n是否众望所归,期待好消息
\n\n瑞德西韦的英文名字 Remdesivir,也被民间谐音译为“人民的希望”,可以看出,它被大家寄予了巨大的期望。
\n\n中国工程院副院长、呼吸与危重症医学专家王辰院士,2 月 5 日晚接受《新闻 1+1》主持人白岩松采访时表示,“根据前期的结果,我们对瑞德西韦抱有比较大的希望,我们需要进一步的临床观察来确定其疗效。特别提醒大家的是,个例的药品有效与否不是科学结论,一定要进行临床实验。”
\n\n吉利德 2 月 17 日晚间发布信息称,“他们在中国政府机构的大力支持下,快速确立了两项用于评估瑞德西韦的随机、对照试验,其中一项针对重症患者,另一项针对中症患者。这两项试验正在湖北省多家医院展开,患者入组均在进行中。临床试验由中日友好医院负责协调。患者将接受为期 10 天的瑞德西韦静脉注射,预计在四月份获得试验结果。”
\n\n2 月 25 日,在国务院联防联控机制举行的新闻发布会上,国家知识产权局副局长何志敏表示,瑞德西韦的临床试验目前正在进行中,4 月 27 日才能公布临床试验的结果。根据目前公开的情况来看,围绕瑞德西韦,吉利德科学公司的确在中国申请了 8 件专利,目前已经有 3 件专利得到授权,还有 5 件正在审查的过程中。这 8 件专利申请的保护范围涵盖了化合物的核心结构和类似结构以及晶型,以及相关的制造方法、用途等。
\n\n另外,据 CNBC 2 月 25 日报道,美国政府临床试验数据库发布消息显示,美国正计划对吉利德的在研药物瑞德西韦进行临床试验。该试验由内布拉斯加大学医学中心和美国国家过敏与传染病研究所联合进行,将在全球多达 50 个地点进行,并将根据协议,对这种名为瑞德西韦的药物与安慰剂进行对比测试。
\n\n针对“为什么说瑞德西韦是目前认为唯一有效的药物,是否有相关临床试验数据或研究支持?”,腾讯医典第一时间发邮件给 WHO 媒体中心求证,很快就收到了世卫组织中国联络团(WCCT)的邮件回复, 内容翻译如下:
\n\n\n\t- 为了讨论在目前新冠病毒流行病中可进一步评估的潜在治疗候选方案,世界卫生组织专门召集了一个独立专家小组。随着可获取数据的增多,这类审查评估将定期进行。
\n\t- 就 1 月 27 日提供的有关不同治疗方案的证据而言,基于广谱性抗病毒、冠状病毒的体外和体内实验数据、以及广泛的临床安全数据库,评估认为瑞德西韦(Remdesivir)是最有希望的候选药物。
\n\t- 在其他候选药物中,抗逆转录病毒药物(HIV 蛋白酶抑制剂)洛匹那韦(lopinavir)/ 利托那韦(ritonavir),无论单独用药还是与 IFN-β1b 联合用药,都被认为是快速实施临床试验的第二选择。现有临床前数据和在中东呼吸综合征(MERS)背景下有限的临床经验表明,它具有一定程度的临床效益,在重症病例中尤其值得研究[3]。
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