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J Am Acad Dermatol：crisaborole治疗特应性皮炎是安全和有效的

2016-07-24 Mechront 译 MedSci原创

crisaborole特应性皮炎瘙痒
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背景：对于特应性皮炎(AD)需要额外的局部治疗，在提供治疗的同时最小化风险。目的：评估两项AD相关的III期研究中(AD-301: NCT02118766; AD-302: NCT02118792)磷酸二酯酶4抑制剂crisaborole药膏的有效性和安全性。方法：两项研究均是安慰剂对照的双盲研究，按2：1将患者分到试验组和对照组，患者年龄≥2岁，调查者静态全球评估(ISGA)评分为轻度或中度，每

背景：对于特应性皮炎(AD)需要额外的局部治疗，在提供治疗的同时最小化风险。

目的：评估两项AD相关的III期研究中(AD-301: NCT02118766; AD-302: NCT02118792)磷酸二酯酶4抑制剂crisaborole药膏的有效性和安全性。

方法：两项研究均是安慰剂对照的双盲研究，按2：1将患者分到试验组和对照组，患者年龄≥2岁，调查者静态全球评估(ISGA)评分为轻度或中度，每天2次，持续28天。主要终点是29天时ISGA评分（清除 0；几乎清除 1），与基线相比改善≥2级。

结果：相比对照组，试验组达到目标ISGA评分的比例更高(清除/几乎清除伴≥2级改善; AD-301: 32.8% vs 25.4%, P = .038; AD-302: 31.4% vs 18.0%, P < .001)，达到清除/几乎清除的比例也更高(51.7% vs 40.6%, P = .005; 48.5% vs 29.7%, P < .001)。Crisaborole治疗组达到目标ISGA得分和瘙痒症的改善中，时间明显短于对照组。治疗相关的不良事件是罕见的，严重程度常为轻度至中度。研究的随访时间过短是局限性之一。

结论：Crisaborole在改善AD相关测量值和症状（疾病的严重程度、皮肤瘙痒和其他症状）表现出了良好的安全性和有效性。

原始出处：

Paller AS,et al.Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults.J Am Acad Dermatol. 2016 Jul 7. pii: S0190-9622(16)30330-9. doi: 10.1016/j.jaad.2016.05.046. [Epub ahead of print]

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    2016-10-21 lishizhe

    #ACA#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1651829, encodeId=9456165182996, content=<a href='/topic/show?id=3a3e1e9504' target=_blank style='color:#2F92EE;'>#ACA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1795, encryptionId=3a3e1e9504, topicName=ACA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=843c24278901, createdName=lishizhe, createdTime=Fri Oct 21 12:38:00 CST 2016, time=2016-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1950315, encodeId=9e931950315b2, content=<a href='/topic/show?id=a0f6520e44' target=_blank style='color:#2F92EE;'>#crisaborole#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5207, encryptionId=a0f6520e44, topicName=crisaborole)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e729101, createdName=huanbaofeng, createdTime=Sun Apr 02 01:38:00 CST 2017, time=2017-04-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1597953, encodeId=99a6159e953da, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1762, encryptionId=6c6f1e62c5, topicName=ABO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b6c918580135, createdName=闆锋旦, createdTime=Tue Jul 26 12:38:00 CST 2016, time=2016-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=94617, encodeId=56b39461ece, content=讲的很全面, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Mon Jul 25 16:25:00 CST 2016, time=2016-07-25, status=1, ipAttribution=)]
    2017-04-02 huanbaofeng

    #crisaborole#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1651829, encodeId=9456165182996, content=<a href='/topic/show?id=3a3e1e9504' target=_blank style='color:#2F92EE;'>#ACA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1795, encryptionId=3a3e1e9504, topicName=ACA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=843c24278901, createdName=lishizhe, createdTime=Fri Oct 21 12:38:00 CST 2016, time=2016-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1950315, encodeId=9e931950315b2, content=<a href='/topic/show?id=a0f6520e44' target=_blank style='color:#2F92EE;'>#crisaborole#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5207, encryptionId=a0f6520e44, topicName=crisaborole)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e729101, createdName=huanbaofeng, createdTime=Sun Apr 02 01:38:00 CST 2017, time=2017-04-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1597953, encodeId=99a6159e953da, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1762, encryptionId=6c6f1e62c5, topicName=ABO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b6c918580135, createdName=闆锋旦, createdTime=Tue Jul 26 12:38:00 CST 2016, time=2016-07-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=94617, encodeId=56b39461ece, content=讲的很全面, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Mon Jul 25 16:25:00 CST 2016, time=2016-07-25, status=1, ipAttribution=)]
    2016-07-26 闆锋旦

    #ABO#

    0

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    2016-07-25 oo902

    讲的很全面

    0