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埃博拉病毒试验性新药究竟有没有效? - 站长搜索
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埃博拉病毒试验性新药究竟有没有效?

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2014-08-08 12:15:51 转载来源: 网络整理/侵权必删

AS网站目录(www.adminso.com):埃博拉病毒试验性新药究竟有没有效? 对于埃博拉试验性新药,用或不用成了一个问题。一边是严峻的疫情,另一边是个别冒险的患者用药后病情有好转迹象

AS网站目录(www.adminso.com):埃博拉病毒试验性新药竟有有效

对于埃博拉试验性新药,用或不用成了一个问题。一边是严峻的疫情,另一边是个别冒险的患者用药后病情有好转迹象。

处于舆论漩涡中心的这种药名叫ZMapp,由美国一家公司生产。两名在利比里亚感染埃博拉病毒的美国医疗援助人员,原本家人都开始考虑他们的葬礼,但在使用这种药物治疗后病情开始好转,重燃活下去的希望。现阶段,至少尼日利亚政府向美国政府打听过这一药物的情况。

围绕ZMapp,人们主要提出三大疑问。首先,它是否适合给更多患者使用?这也是在6日的美非领导人峰会闭幕记者会上,美国总统奥巴马被问的第一个问题。他的回答是,对于试验性新药是否会起作用,“我认为我们还没有掌握所有信息”,“应该让科学指导我们”。总之,给西非国家提供这种试验性药物的时机仍“不成熟”。

此前,美国疾病控制和预防中心也认为,ZMapp尚处于试验阶段,没有进行过人体安全或有效性测试,现在就说这种新药能有效治疗埃博拉出血热“为时尚早”。

哈佛大学病毒学家马丁・赫希教授在接受新华社记者采访时说:“报道所说的健康状况好转是否与用了ZMapp有关,我们现在无法判断。对于ZMapp疗法的利与弊,唯有严格控制的临床试验才能评估。”

现阶段看,谨慎使用的意见似乎占了上风。毕竟,在此次疫情中,虽然已有近千人死亡,但总体上仍有约40%的患者幸存。而ZMapp未进行临床试验,是否安全、可能的副作用、是否会带来更大伤害,均不得而知。世卫组织6日发表声明说:“任何新药的使用指导原则是‘不会造成伤害’。安全总是主要关切。”

其次,假如ZMapp有效,或被紧急批准可以使用,是否能马上大量生产?从目前获得的信息看,答案是否定的。生产ZMapp的美国肯塔基生物处理公司发言人戴维・霍华德6日告诉新华社记者,他们和政府机构以及相关方面“正紧密合作以提高ZMapp的产量,但这个过程可能需要几个月”。而研制ZMapp的美国马普生物制药公司也表示,此药尚未进行人体安全试验,因此目前这种药的储备“极少”。

美国国家过敏症和传染病研究所所长安东尼・福奇则指出,生产ZMapp的技术比较复杂,需要利用烟草生产相关抗体,然后进行纯化,整个过程极为缓慢。据他所知,即使少量生产也需要2到3个月时间。

新药在美国被食品和药物管理局监管,该机构确实有相关规则,允许在别无选择的情况下,在非临床试验中使用试验性药物,上述两名美国人就是在签署知情同意书后获得ZMapp进行治疗。美国食品和药物管理局6日也根据这一规则,批准一种试验性埃博拉病毒血液检测技术给患者紧急使用。这一技术由美国国防部研发,所以也只限于美国国防部指定实验室使用。

第三,在资源紧张的情况下,谁应优先使用?这是世卫组织6日声明所提出的一个问题。正如世卫组织助理总干事玛丽―波勒・基尼所言:“我们需要向医学伦理学家请教,请他们指导我们去做负责任的事。”

西非埃博拉疫情严峻。即便试验性新药有效,它在短期内也不会成为遏制疫情的灵丹妙药,不能因此干扰、偏移抗击埃博拉的主题:帮助西非加强公共卫生基础设施建设。

标签: 埃博拉 博拉 病毒 试验性 新药 竟有 有效


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