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阿利维A酸用于严重难治性慢性湿疹的安全性——新药上市后监测

2015-04-20 范伟译 MedSci原创

背景: 阿利维A酸被批准用于强效的局部类固醇难治的严重慢性手部湿疹(CHE)的治疗。6年以来,大约有250 000名患者已经接受阿利维A酸的治疗。 摘要目的: 比较上市后阿利维A酸临床试验数据的安全性监测与其他类维生素A的关键安全问题。 方法: 阿利维A酸的关键研究以及从批准阿利维A酸进行分析以来,上市后不良反应(AE)报告的综合性安全分析。 结果: 在关键的试验中,头痛、红斑、恶心、增加的

背景: 阿利维A酸被批准用于强效的局部类固醇难治的严重慢性手部湿疹(CHE)的治疗。6年以来,大约有250 000名患者已经接受阿利维A酸的治疗。

摘要目的: 比较上市后阿利维A酸临床试验数据的安全性监测与其他类维生素A的关键安全问题。

方法: 阿利维A酸的关键研究以及从批准阿利维A酸进行分析以来,上市后不良反应(AE)报告的综合性安全分析。

结果: 在关键的试验中,头痛、红斑、恶心、增加的血甘油三酯和增加的血肌酐磷酸激酶是最常见的不良反应报告。头痛、高脂血症和恶心是上市后常见的不良反应报告,相比于关键的试验,抑郁症是相对更加频繁的报告。炎症性肠病和良性颅内高血压是罕见的,而且在上市后的监测病例报告中很少见。人类顺向胎儿暴露无致畸性的报告。

结论: 关键试验收集的安全数据和上市后的监测表明,阿利维A酸对于严重发病率相对较低的难治性慢性湿疹的耐受性良好。不良反应报告与其他上市的口服类维生素A的不良反应一致。

原始出处

Morris M1, Schifano L, Fong R, Graff O. Safety of alitretinoin for severe refractory chronic hand eczema: Clinical studies and postmarketing surveillance. J Dermatolog Treat. 2015 Apr 17:1-5

 

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1676906, encodeId=5ffb16e6906b8, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Tue Apr 28 23:28:00 CST 2015, time=2015-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1706604, encodeId=ebc91e0660432, content=<a href='/topic/show?id=0b4be9006e0' target=_blank style='color:#2F92EE;'>#维A酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79006, encryptionId=0b4be9006e0, topicName=维A酸)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef3531296461, createdName=膀胱癌, createdTime=Mon Jan 04 14:28:00 CST 2016, time=2016-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528286, encodeId=803e152828604, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Wed Apr 22 00:28:00 CST 2015, time=2015-04-22, status=1, ipAttribution=)]
    2016-01-04 膀胱癌
  3. [GetPortalCommentsPageByObjectIdResponse(id=1676906, encodeId=5ffb16e6906b8, content=<a href='/topic/show?id=086d586212a' target=_blank style='color:#2F92EE;'>#新药上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58621, encryptionId=086d586212a, topicName=新药上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=39db27401213, createdName=zchen, createdTime=Tue Apr 28 23:28:00 CST 2015, time=2015-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1706604, encodeId=ebc91e0660432, content=<a href='/topic/show?id=0b4be9006e0' target=_blank style='color:#2F92EE;'>#维A酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79006, encryptionId=0b4be9006e0, topicName=维A酸)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ef3531296461, createdName=膀胱癌, createdTime=Mon Jan 04 14:28:00 CST 2016, time=2016-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528286, encodeId=803e152828604, content=<a href='/topic/show?id=74b798601a1' target=_blank style='color:#2F92EE;'>#难治性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98601, encryptionId=74b798601a1, topicName=难治性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a1ef11916292, createdName=freve, createdTime=Wed Apr 22 00:28:00 CST 2015, time=2015-04-22, status=1, ipAttribution=)]
    2015-04-22 freve
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