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标题: PLoS Med:埃博拉治疗的以“毒”攻“毒”策略并无明显效果 [打印本页]

作者: rentianyixu    时间: 2016-3-8 00:57
标题: PLoS Med:埃博拉治疗的以“毒”攻“毒”策略并无明显效果

图片来自:www.networkedblogs.com

埃博拉病毒病导致的综合征,目前为止,还没有非常有效的针对性治疗方法。在2014年9月埃博拉疫情正处于高峰期的时候,世界卫生组织发布几种治疗埃博拉带来综合征的药物。法匹拉韦Favipiravir,本是为治疗流感而开发抗病毒剂,也在这次世卫组织给出的抗埃博拉的药物清单中。最近的一项研究认为,法匹拉韦治疗法并不能直接降低埃博拉疫情带来的死亡率。

在2014年年底,一项针对治疗埃博拉的随机试验项目并没有完成。原因有二,其中之一是,鉴于大量的病人同时感染病毒,死亡率极高,来自同一家庭或村庄内的病人接受或不接受一种实验性药物可能存在道德和伦理上的困难,针对随机分类重病患者不可能实现。另一个原因是,在埃博拉病毒治疗中心,谣言和疫情一起扩张,采用随机设计在一开始就可能导致甚至更多的患者拒绝就医。

因此,研究人员们采取了多中心、非随机的试验,所有的病人都同时接受法匹拉韦治疗和标准化护理。该试验的目的是,测试博拉病毒大爆发的情况下,使用法匹拉韦治疗的可行性和治疗难度,并且收集法匹拉韦治疗对患者的死亡率、安全性的数据。该试验的目的不是直接开发有效的治疗方法,而是在于收集法匹拉韦治疗方法的初步数据,来优化未来的抗埃博拉药物的研究设计。

研究者们招募了126位参与者。这其中,111位计入了最后的分析数据中。55位体内的埃博拉病毒载量较低,而44位的病毒携带量很高。在低载量组的死亡率为20%,高病毒载量组的死亡率为91%。然而,结果显示,法匹拉韦配合标准治疗,并没有比只有标准治疗法的死亡率更低。但是,患者们对法匹拉韦治疗都有耐受性,而且没有明显的呕吐之类的副作用。因此,在未来如果有埃博拉疫情大爆发,法匹拉韦治疗可以在紧急情况下利用感染者进行临床测试。

该研究的意义在于,法匹拉韦治疗法对患者没有明显副作用,可以作为埃博拉疫情的一种治疗方法,积累前期数据,也可以为今后的长期测试奠定基础。截止该研究在《Plos Medicine》发表时,该研究组正在进行使用法匹拉韦作为埃博拉病的治疗方法的长期的研究项目。目前还没有发现,法匹拉韦相对于标准治疗法,对于埃博拉疫情导致的死亡率的降低效果。(生物谷Bioon.com)

DOI: 10.1371/journal.pmed.1001967

PMC:

PMID:

Experimental Treatment with Favipiravir for Ebola Virus Disease (the JIKI Trial): A Historically Controlled, Single-Arm Proof-of-Concept Trial in Guinea

Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care.

Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.


来源:生物谷



作者: tinglei711    时间: 2016-11-10 13:39
不是有抗体治疗吗?天广实生物的抗体药物。




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