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FDA批准阿维莫泮用于术后加速恢复胃肠道功能的新适应症

2013-10-24 fyc5078 dxy

阿维莫泮胃肠道功能
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FDA批准了阿维莫泮(Entereg)一种新的适应症，该药物可加速腹腔骨盆手术后的肠胃功能恢复。阿维莫泮现在可用于所有手术后上下消化道的加速恢复，包括一期吻合术的局部肠切除。 这款药物最初于2008年获得批准用于加速一期吻合术切除局部大肠或小肠后上下消化道的恢复。这次增加的适应症基于一项IV期、随机、安慰剂对照、双盲临床研究，受试者为正在进行根治性膀胱切除术的患者，其中也包括接受肠切除术的患者。

FDA批准了阿维莫泮(Entereg)一种新的适应症，该药物可加速腹腔骨盆手术后的肠胃功能恢复。阿维莫泮现在可用于所有手术后上下消化道的加速恢复，包括一期吻合术的局部肠切除。

这款药物最初于2008年获得批准用于加速一期吻合术切除局部大肠或小肠后上下消化道的恢复。这次增加的适应症基于一项IV期、随机、安慰剂对照、双盲临床研究，受试者为正在进行根治性膀胱切除术的患者，其中也包括接受肠切除术的患者。

阿维莫泮是一种作用于外围的mu-阿片受体拮剂。这款药物的标签中带有一项黑框警告，提示患者只能短期（15个剂量）使用这款药物，因为阿维莫泮长期使用时与心肌梗死风险有关。此外，只有已经注册和满足阿维莫泮获取支持和教育(E.A.S.E.)计划所有要求的医院才可以使用这款药物。

开始使用阿维莫泮之前已连续使用治疗性阿片类药物超过7天的患者禁用这款药物。卫生保健专业人员在将这款药物用于手术前一周内已使用过三个剂量阿片类药物的患者时应该提高警惕。患有严重肝损伤、终末期肾病、完全肠道阻塞，或实施胰腺或胃吻合术的患者，或接受过完全肠道阻塞修正手术的患者不能使用这款药物。这款药物常见不良事件为消化不良。阿维莫泮由列克星敦市的Cubist制药公司上市销售。

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    2014-04-02 bugit

    #FDA批准#

    0

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    2013-10-26 644982816_68283321

    #适应症#

    0

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    2013-10-26 liao1619

    #胃肠道#

    0

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    2013-10-26 sunyl08

    #新适应症#

    0