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早产儿坏死性小肠结肠炎：IBT和FDA就III期研究的设计达成一致

2019-05-21 不详 网络

坏死性小肠结肠炎早产儿FDA
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IBT已经与美国食品和药品监督管理局（FDA）就如何设计IBP-9414的III期研究进行了长时间的磋商。目前，FDA现以书面形式通知IBT，对IBT的试验设计表示满意

IBT已经与美国食品和药品监督管理局（FDA）就如何设计IBP-9414的III期研究进行了长时间的磋商。目前，FDA现以书面形式通知IBT，对IBT的试验设计表示满意。IBT计划在即将进行的III期研究中评估IBP-9414对早产儿消化系统疾病（如坏死性小肠结肠炎）的影响，因为早产儿的一个严重的医疗问题是他们不能正常摄取营养。

85%的坏死性小肠结肠炎发生于早产儿。病因不清，患儿肠道的血供减少可能导致肠壁的损伤，使正常存在于肠道的细菌侵袭受损的肠壁，然后进入婴儿的血液，引起感染（败血症）。如果损伤了肠壁全层，肠壁穿孔，肠道内容物漏进腹腔就会引起腹膜炎。这种疾病往往是致命的。


原始出处：

http://www.firstwordpharma.com/node/1641984#axzz5oW6BiU1G

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    2020-03-23 juliusluan78

    #III#

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    #坏死性小肠结肠炎#

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    2019-05-23 智智灵药

    #III期#

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