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J Drugs Dermatol:10%的艾氟康唑可有效且安全的治疗儿童甲真菌病

2021-08-23 MedSci原创 MedSci原创

由于治疗方案有限,小儿甲真菌病的治疗具有挑战性。近日,发表于J Drugs Dermatol的一项4期、多中心、开放标签研究(NCT02812771)评估了10%的艾氟康唑外用溶液对儿童癣病的治疗效果

由于治疗方案有限,小儿甲真菌病的治疗具有挑战性。近日,发表于J Drugs Dermatol的一项4期、多中心、开放标签研究(NCT02812771)评估了10%的艾氟康唑外用溶液对儿童癣病的治疗效果。

研究纳入了培养阳性、轻度至重度的远端外侧甲下癣,至少影响一个大脚趾甲20%的参与者。评估了艾氟康唑10%外用溶液在儿童参与者(6-16岁)中的安全性、药代动力学(PK)和疗效。艾氟康唑每天一次,持续48周,治疗后随访4周。PK子集包括12-16岁的参与者,中度至重度甲癣,至少影响到每个大脚趾甲的50%,并且至少还有4个脚趾甲的甲癣。

 

结果显示,在62名入选者中,60人纳入安全性分析人群,17人纳入PK人群。10%的艾氟康唑外用溶液的耐受性良好。艾氟康唑及其主要代谢物的浓度-时间曲线相对稳定,在24小时的给药时间间隔内只有轻微的波动。艾氟康唑的全身暴露量很低。到第52周,65.0%的参与者实现了霉菌学治愈,早在第12周就观察到36.7%的参与者实现了霉菌学治愈率。到第52周,共有40.0%的参与者达到完全治愈,50.0%达到临床疗效,88.3%达到真菌治愈。

 

综上,该研究结果表明,艾氟康唑对患有轻度至重度甲真菌病的儿童参与者来说是安全和有效的,与两项为期52周的研究中的成人相比,其霉菌学治愈率和完全治愈率有所提高。

 

原始出处:

 

Lawrence F Eichenfield, et al., Safety, Pharmacokinetics, and Efficacy of Efinaconazole 10% Topical Solution for Onychomycosis Treatment in Pediatric Patients. J Drugs Dermatol. 2020 Sep 1;19(9):867-872. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5401.

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    2023-09-08 侠胆医心 来自上海

    10%的#艾氟康唑#可有效且安全的治疗儿童#甲真菌病#

    0

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    2021-10-04 tsing_hit
  3. [GetPortalCommentsPageByObjectIdResponse(id=2156638, encodeId=512721566388e, content=10%的<a href='/topic/show?id=1257106605a6' target=_blank style='color:#2F92EE;'>#艾氟康唑#</a>可有效且安全的治疗儿童<a href='/topic/show?id=fd06106604b0' target=_blank style='color:#2F92EE;'>#甲真菌病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=106605, encryptionId=1257106605a6, topicName=艾氟康唑), TopicDto(id=106604, encryptionId=fd06106604b0, topicName=甲真菌病)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Fri Sep 08 00:18:32 CST 2023, time=2023-09-08, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=1784782, encodeId=a6ce1e8478242, content=<a href='/topic/show?id=e451626993' target=_blank style='color:#2F92EE;'>#drugs#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6269, encryptionId=e451626993, topicName=drugs)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dcaa509, createdName=tsing_hit, createdTime=Mon Oct 04 04:34:10 CST 2021, time=2021-10-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1862358, encodeId=ab831862358f3, content=<a href='/topic/show?id=1f0e626267' target=_blank style='color:#2F92EE;'>#Drug#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6262, encryptionId=1f0e626267, topicName=Drug)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=baf586, createdName=wangbingxhy, createdTime=Mon May 16 22:34:10 CST 2022, time=2022-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353815, encodeId=64381353815fd, content=<a href='/topic/show?id=dddce266537' target=_blank style='color:#2F92EE;'>#真菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=72665, encryptionId=dddce266537, topicName=真菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Wed Aug 25 06:34:10 CST 2021, time=2021-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603303, encodeId=8dcb1603303b4, content=<a href='/topic/show?id=ba9a6392545' target=_blank style='color:#2F92EE;'>#氟康唑#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63925, encryptionId=ba9a6392545, topicName=氟康唑)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d68c19021189, createdName=yhj-time, createdTime=Wed Aug 25 06:34:10 CST 2021, time=2021-08-25, status=1, ipAttribution=)]
    2022-05-16 wangbingxhy
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    2021-08-25 zhaojie88
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