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Gastroenterology: 布地奈德有望成为治疗嗜酸细胞性食管炎新药物

2012-07-12 吴莹莹 爱唯医学网

       北卡罗来纳大学教堂山分校的Evan S.Dellon博士及其同事报告称,一种可吞服的黏性局部类固醇药物在减少嗜酸细胞性食管炎(EoE)患者嗜酸细胞计数的效果方面 优于喷雾溶液,但嗜酸细胞减少与吞咽困难改善并不相关。文章于5月7日在线发表于《Gastroenterology》。        这项首次比较


       北卡罗来纳大学教堂山分校的Evan S.Dellon博士及其同事报告称,一种可吞服的黏性局部类固醇药物在减少嗜酸细胞性食管炎(EoE)患者嗜酸细胞计数的效果方面 优于喷雾溶液,但嗜酸细胞减少与吞咽困难改善并不相关。文章于5月7日在线发表于《Gastroenterology》。

       
这项首次比较局部类固醇激素两种给药方法治疗EoE以及首次考察口服黏性布地奈德用于成人EoE治疗的研究,入组22例吞咽困难患者,随机给予1 mg布地奈德治疗,2次/d,治疗8周,其中11例采用喷雾后吞服给药方式(NEB),另外11例口服黏性混悬溶液(OVB)。患者平均年龄35 岁,60%为男性。

       基线时,NEB组最大嗜酸细胞计数为101个/高倍视野,而OVB组为83个/高倍视野(P=0.62);治疗后,NEB组最大计数为89个/高倍 视野,而OVB组为11个/高倍视野(P=0.02)。研究者应用核素显像方法评价黏膜药物接触时间,中位食管排空曲线下面积(AUC)较高即表示接触时 间较长。结果发现,OVB组AUC的确高于NEB组,但黏膜药物接触时间与嗜酸细胞计数下降相关,与药物制剂类型无关(P=0.001)。

       “梅奥吞咽困难问卷-30d”(尚未经EoE患者验证)对吞咽困难改善情况的评价结果显示,与嗜酸细胞计数不同,两组吞咽困难症状评分均有所改善,即使排除基线接受试管扩张治疗的患者后,吞咽困难改善仍然存在。吞咽困难改善与内镜或组织学检查结果改善均无关联。

       在副作用方面,有3例患者治疗后内镜检查为无症状性念珠菌性食管炎,NEB组1例患者因鼻出血放弃治疗,但未见其他副作用或不良事件。此外,肾上腺皮质素刺激试验未见患者肾上腺皮质功能不全,8周后患者血清中未检出布地奈德,表明仅发挥局部作用而非全身作用。

       研究者承认该研究存在样本量较小以及未设安慰剂对照组等局限性。但他们认为,该研究的主要结果具有足够效能,且证明估算检验效能的效应量是准确的。 此外,核素显像机制分析进一步证实了主要结果,并为该领域引入一种新的定量方法,对未来药物开发具有指导意义。虽然吞咽剂型比吸入剂使用更方便,但前者还 未上市,目前凝胶、散剂和口溶片等尚处于开发阶段。
 

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  4. 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  5. 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    2013-06-05 许安
  6. 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  7. 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style='color:#2F92EE;'>#Gastroenterology#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7854, encryptionId=7730e85412, topicName=Gastroenterology)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=21015, createdName=heli0118, createdTime=Sat Jul 14 06:12:00 CST 2012, time=2012-07-14, status=1, ipAttribution=)]
    2012-07-14 zhouqu_8
  8. 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  9. 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