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Lancet:联合用药治疗糖尿病周围神经病变性疼痛的效果与单一用药相似,联合用药耐受性好

2022-08-25 影像小生 MedSci原创

这项研究对DPNP的治疗指南有很大的影响。

糖尿病周围神经病变性疼痛(Diabetic peripheral neuropathic pain, DPNP)是一种常见的疼痛性疾病。大多数指南推荐阿米替林、度洛西汀、普瑞巴林或加巴喷丁作为DPNP的初始镇痛治疗,但很少有比较证据表明哪一种是最好的或它们是否应该联合使用。柳叶刀杂志发表研究文章,评估不同的一线药物组合治疗DPNP的疗效和耐受性。

OPTION-DM是一项多中心、随机、双盲、交叉试验,研究对象为来自13个英国中心的平均每日疼痛数值评分(NRS)为4或更高(评分为0-10)的DPNP患者。参与者被随机分配(1:1:1:1:1),按照预先确定的随机分配计划,使用大小为6或12的排列块进行分层,接受三个治疗途径的六个有序序列中的一个:阿米替林加普瑞巴林(A-P),普瑞巴林加阿米替林(P-A),度洛西汀加普瑞巴林(D-P),每个途径持续16周。单药治疗6周,如疼痛缓解不理想,则加用联合药物(NRS>3),反映了目前的临床实践。两种治疗均按最大耐受剂量滴定(阿米替林75mg / d,度洛西汀120mg / d,普瑞巴林600mg / d)。主要结果是各通路最后一周7天平均每日疼痛的差异。该试验已在ISRCTN17545443注册。

在2017年11月14日-2019年7月29日期间,筛查了252例患者,随机分配了140例患者,其中130例开始了治疗途径(其中84例至少完成了两条途径),并分析了主要结局。

结果如下:

表1.试者的基线人口统计、糖尿病、既往用药情况和疼痛强度特征

1.       在所有三种途径中,第16周的7天平均NRS评分从基线时的平均6.6 (SD 1.5)下降到第16周时的平均3.3(1.8)。

2.       D-P与A-P的平均差异为-0.1(98.3% CI -0.5 ~ 0.3),P-A与A-P的平均差异为-0.1(-0·5 ~ 0·3),P-A与D-P的平均差异为0.0(-0.4 ~ 0.4),因此差异不显著。

表2.意向治疗分析,6周时和16周时对最大耐受剂量单药治疗的反应

3.       联合治疗组患者NRS平均降低量大于单药治疗组(1.0 [SD 1.3] vs 0.2[1.5])。

治疗途径的平均每日疼痛强度(A)和每个治疗途径的平均每日疼痛强度,比较开始联合治疗与继续单药治疗的参与者(B)

4.       单药治疗的不良事件是可预测的。观察到P-A通路的头晕、D-P通路的恶心和A-P通路的口干显著增加。

表4.在单药治疗期间(0-6周,前42天),联合治疗期间(7-16周,42天后),以及整个治疗途径中(0-16周),超过5%的患者报告了治疗急诊不良事件

这是有史以来规模最大、历时最长、面对面、跨界的神经性疼痛试验。该研究表明,所有三种治疗途径和单一治疗有相似的镇痛效果。联合治疗的耐受性良好,并能改善疼痛控制欠佳的患者的疼痛缓解。综上所述,这项研究对DPNP的治疗指南有很大的影响。

 

原文出处

Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial.

https://www.sciencedirect.com/science/article/pii/S0140673622014726.

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    2023-04-13 howi
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  5. 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encodeId=9b08151431e94, content=<a href='/topic/show?id=9d7c80e14b3' target=_blank style='color:#2F92EE;'>#联合用药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80714, encryptionId=9d7c80e14b3, topicName=联合用药)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Aug 26 12:45:28 CST 2022, time=2022-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1244084, encodeId=69f61244084e0, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Thu Aug 25 00:45:28 CST 2022, time=2022-08-25, status=1, ipAttribution=)]
    2022-08-26 huangdf
  6. 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2022, time=2022-08-25, status=1, ipAttribution=)]
    2022-08-26 axin012
  7. 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  8. 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encodeId=9b08151431e94, content=<a href='/topic/show?id=9d7c80e14b3' target=_blank style='color:#2F92EE;'>#联合用药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80714, encryptionId=9d7c80e14b3, topicName=联合用药)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Aug 26 12:45:28 CST 2022, time=2022-08-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1244084, encodeId=69f61244084e0, content=lancet上果然牛,感谢梅斯更新及时, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=younei, createdTime=Thu Aug 25 00:45:28 CST 2022, time=2022-08-25, status=1, ipAttribution=)]
    2022-08-25 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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