Health Technol Assess:难治性抑郁,SSRI或SNRI加用米氮平无效

2019-01-10 贾朝娟 环球医学

抗抑郁药物常是抑郁患者首选治疗,但是很多患者对单一药物治疗不应答。2018年11月,发表在《Health Technol Assess》的一项研究显示,对于难治性抑郁(TRD)患者,在常规治疗中添加米氮平,不能改善疗效。

抗抑郁药物常是抑郁患者首选治疗,但是很多患者对单一药物治疗不应答。2018年11月,发表在《Health Technol Assess》的一项研究显示,对于难治性抑郁(TRD)患者,在常规治疗中添加米氮平,不能改善疗效。

背景:抑郁症常在基层医疗机构管理,抗抑郁药常为一线治疗,但是仅有一半的患者对单一抗抑郁药治疗应答。

目的:旨在探究对于难治性抑郁患者,将米氮平与5-羟色胺-去甲肾上腺素再摄取抑制剂(SNRI)或选择性5羟色胺再吸收抑制剂(SSRI)联用,是否比SSRI或SNRI单药治疗结局更好或使得NHS治疗更高效。

设计:MIR试验是一项在个体水平分组的两平行组多中心实用安慰剂对照随机试验。

地点:布里斯托尔、埃克塞特、赫尔/约克和曼彻斯特/基尔的基层医疗机构招募的参与者。

参与者:入组标准为≥18岁,足量服用SSRI或SNRI抗抑郁药至少6周,贝克抑郁量表II(BDI-II)评分≥14分,对药物依从,满足第十版疾病和相关健康问题国际统计分类的抑郁症标准。

干预:使用电脑产生的编码,将常规服用抑郁药的参与者随机分配到口服米氮平或配对的安慰剂组,开始剂量为每天15mg,共2周,然后增加剂量至每天30mg,直到12个月。参与者、他们的全科医生(GP)和研究团队对分组设盲。

主要结局测量指标:首要结局为随机分组后12周时与基线相比抑郁症状情况,

使用BDI-II以连续变量进行测量。次要结局(12、24、52周)包括应答、抑郁缓解、焦虑症状的改变、不良事件(AE)、生活质量、药物依从性、健康和社会医疗使用、成本效果。基于意愿治疗分析结局。定性研究探讨了患者的观点和管理抑郁的经验,以及全科医生对处方第二种抗抑郁药的观点。

结果:480名患者被随机分组(米氮平+常规医疗组241人,安慰剂+常规医疗组239人),其中的431人(89.8%)随访了12周。12周时,调整了基线BDI-II评分和最小化和分层变量后,米氮平组的BDI-II评分低于安慰剂组(差异,-1.83分;95% CI,-3.92~0.27;P=0.087)。差异没有临床意义,并且可信区间包括空值。随后时间点时,差异变小(24周:-0.85分(95% CI,-3.12~1.43);12月:0.17(-2.13~2.46))。米氮平组更多的参与者停止试验药物,报告轻度AE(46 vs 9人)。

结论:本研究未发现令人信服的证据表明,在基层医疗的TRD患者中SSRI或SNRI抗抑郁药联合米氮平比联合安慰剂具有重要的临床获益。无证据显示添加米氮平是一种具有成本效果的NHS资源使用。全科医生和患者都对额外增加抗抑郁药表示担忧。

局限性:12周时首要结局后参与者自愿揭盲使得判断长期结局更加困难。

将来的工作:治疗难治性抑郁仍然是重要的需求未被满足领域,治疗有效的证据有限。具有前景的干预措施包括增加非典型抗精神病药物和使用经颅磁刺激进行治疗。

原始出处:

Kessler D, Burns A, Tallon D, et.al. Combining mirtazapine with SSRIs or SNRIs for treatment-resistant depression: the MIR RCT. Health Technol Assess. 2018 Nov;22(63):1-136. doi: 10.3310/hta22630.

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    2019-05-03 shock_melon
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    2019-02-13 rgjl
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    2019-05-09 shizhenshan
  4. [GetPortalCommentsPageByObjectIdResponse(id=1652314, encodeId=b16b165231447, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Fri May 03 01:09:00 CST 2019, time=2019-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1780207, encodeId=803e1e80207df, content=<a href='/topic/show?id=fc3e2893e3' target=_blank style='color:#2F92EE;'>#asses#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2893, encryptionId=fc3e2893e3, topicName=asses)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b48400, createdName=rgjl, createdTime=Wed Feb 13 21:09:00 CST 2019, time=2019-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861294, encodeId=d14f1861294d6, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, encryptionId=401a23e102, topicName=ALT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Thu May 09 10:09:00 CST 2019, time=2019-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1445753, encodeId=c1ae1445e5374, content=<a href='/topic/show?id=7da8e61022e' target=_blank style='color:#2F92EE;'>#米氮平#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76102, encryptionId=7da8e61022e, topicName=米氮平)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/g?b=oidb&k=QsAdw9VPoRJYYKsEgQr5iag&s=100&t=1556575911, createdBy=c7cd5178211, createdName=lifestar, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528543, encodeId=ccb115285435c, 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=45, 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=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545473, encodeId=397815454e3a2, content=<a href='/topic/show?id=61d416e15a9' target=_blank style='color:#2F92EE;'>#SSRI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16715, encryptionId=61d416e15a9, topicName=SSRI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d1ea13741643, createdName=ms7474195563676018, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1569752, encodeId=60881569e5284, content=<a href='/topic/show?id=49e0161680c' target=_blank style='color:#2F92EE;'>#SES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16168, encryptionId=49e0161680c, topicName=SES)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6fc215562628, createdName=dongjia2015, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621779, encodeId=71071621e790f, content=<a href='/topic/show?id=5f1386329e' target=_blank style='color:#2F92EE;'>#Health#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8632, encryptionId=5f1386329e, topicName=Health)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1652314, encodeId=b16b165231447, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Fri May 03 01:09:00 CST 2019, time=2019-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1780207, encodeId=803e1e80207df, content=<a href='/topic/show?id=fc3e2893e3' target=_blank style='color:#2F92EE;'>#asses#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2893, encryptionId=fc3e2893e3, topicName=asses)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b48400, createdName=rgjl, createdTime=Wed Feb 13 21:09:00 CST 2019, time=2019-02-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861294, encodeId=d14f1861294d6, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, encryptionId=401a23e102, topicName=ALT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Thu May 09 10:09:00 CST 2019, time=2019-05-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1445753, encodeId=c1ae1445e5374, content=<a href='/topic/show?id=7da8e61022e' target=_blank style='color:#2F92EE;'>#米氮平#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76102, encryptionId=7da8e61022e, topicName=米氮平)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdqq.qlogo.cn/g?b=oidb&k=QsAdw9VPoRJYYKsEgQr5iag&s=100&t=1556575911, createdBy=c7cd5178211, createdName=lifestar, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1528543, encodeId=ccb115285435c, 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=45, 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=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1545473, encodeId=397815454e3a2, content=<a href='/topic/show?id=61d416e15a9' target=_blank style='color:#2F92EE;'>#SSRI#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16715, encryptionId=61d416e15a9, topicName=SSRI)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d1ea13741643, createdName=ms7474195563676018, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1569752, encodeId=60881569e5284, content=<a href='/topic/show?id=49e0161680c' target=_blank style='color:#2F92EE;'>#SES#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16168, encryptionId=49e0161680c, topicName=SES)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6fc215562628, createdName=dongjia2015, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621779, encodeId=71071621e790f, content=<a href='/topic/show?id=5f1386329e' target=_blank style='color:#2F92EE;'>#Health#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8632, encryptionId=5f1386329e, topicName=Health)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d2020283215, createdName=yyanpro@28cn.c, createdTime=Sat Jan 12 05:09:00 CST 2019, time=2019-01-12, status=1, ipAttribution=)]
    2019-01-12 freve
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    2019-01-12 dongjia2015
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