Lancet Child Adol Health:羟丁酸钠治疗小儿嗜睡症疗效显著

2018-05-23 zhangfan MedSci原创

研究认为羟丁酸钠治疗小儿嗜睡症和昏睡症的临床疗效显著,安全性与成人研究结果一致

嗜睡症是一种终生性神经系统疾病,通常发生在儿童或青少年时期。目前尚无针对小儿嗜睡症患者昏厥和过度白天嗜睡的药物。羟丁酸钠被批准用于过度白天嗜睡症或昏睡症的成人患者。近日研究人员考察了口服羟丁酸钠对儿童及青少年嗜睡昏厥的治疗效果。

研究在美国、芬兰、法国、意大利以及荷兰开展,7-16岁的嗜睡昏厥患者参与研究。参与者首先接受2周的羟丁酸钠或安慰剂治疗,随后全部接受为期1年的公开治疗。主要终点为嗜睡昏厥发生率。

106名患者参与研究,104人接受药物治疗。在2周的对照研究中,31人接受羟丁酸钠,32人接受安慰剂。预先设定结果的中期分析表明羟丁酸钠治疗效果显著,所有安慰剂组患儿停止安慰剂治疗。统计发现,安慰剂组以及治疗组退出患儿每周昏厥发生率显著高于持续治疗人群(12.7 vs 0.3)。发生率超过5%的不良事件为遗尿、恶心、头痛、体重降低、食欲降低、鼻咽炎和头晕。发生2起严重不良事件(急性精神病以及中度自杀意念)均与药物治疗相关,治疗过程中未发生患者死亡。

研究认为羟丁酸钠治疗小儿嗜睡症和昏睡症的临床疗效显著,安全性与成人研究结果一致。

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    2018-09-15 1e145228m78(暂无匿称)

    学习了,谢谢作者分享!

    0

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    2018-05-24 shizhenshan
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    2018-09-13 howi
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    2018-07-15 docwu2019
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    2018-05-23 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2018-05-23 1ddf0692m34(暂无匿称)

    学习了.长知识

    0

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