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FDA批准依维莫司治疗结节性硬化症相关性肾肿瘤

2012-05-10 卢秀玲 爱唯医学网

依维莫司肾血管平滑肌脂肪瘤结节性硬化症Afinitor
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       2012年4月26日，诺华公司与美国食品药品管理局(FDA)宣布，已批准Afinitor(依维莫司)用于治疗结节性硬化症(TSC)患者的不必立即手术的肾血管平滑肌脂肪瘤。该药的申请得到了FDA的优先审查，后者适用于带来重要进展的药物或目前无法有效治疗的疾病的新治疗手段。        Afini

       2012年4月26日，诺华公司与美国食品药品管理局(FDA)宣布，已批准Afinitor(依维莫司)用于治疗结节性硬化症(TSC)患者的不必立即手术的肾血管平滑肌脂肪瘤。该药的申请得到了FDA的优先审查，后者适用于带来重要进展的药物或目前无法有效治疗的疾病的新治疗手段。

Afinitor(依维莫司)

       Afinitor通过抑制mTOR——一种参与多种致癌通路的蛋白质——而发挥疗效。据诺华公司介绍，TSC是由TSC1和/或TSC2基因缺陷导致的疾病。当这些基因存在缺陷时，mTOR的活性增强，从而导致不可控的肿瘤细胞生长和增殖、血管生长，以及细胞代谢改变。根据临床前研究，通过抑制这一信号通路中的mTOR活性，依维莫司可降低细胞增殖和血管生长。

       Afinitor的安全性和有效性在一项纳入118例患者的双盲、安慰剂对照临床试验中得到了确证。经过随机分组，2/3的患者使用Afinitor，1/3的患者使用安慰剂。疗程最长可达4年，但安慰剂组患者如果在研究期间出现肾肿瘤明显进展则可以使用Afinitor。受试者均为双侧肾肿瘤，而且大约40%已经接受了手术以控制肿瘤出血。这项试验旨在评估治疗后肿瘤缩小或消失的几率。结果显示，半数患者的治疗时间不足8个月，使用Afinitor的患者42%出现肿瘤实质性缩小并且平均持续超过5个月。而使用安慰剂的患者无1例出现肿瘤缩小。
 
       在接受依维莫司治疗的患者中，最常报告的不良事件为口炎，最常见的3或4级不良反应为口炎、闭经、和惊厥，最常见的实验室异常为高胆固醇血症、高甘油三酯血症和贫血，最常见的3或4级实验室异常为低磷血症。本项研究中观察到的不良事件基本符合依维莫司治疗TSC的已知特点。

 

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    2012-08-20 shenxlcyp

    #相关性#

    0

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    2013-03-01 30397604

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    2013-03-28 crystal0572

    #结节性#

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    2012-10-13 bugit

    #FDA批准#

    0

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    2012-05-12 ms5880526374914242

    #肾肿瘤#

    0

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