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重磅!2020胃食管反流病专家共识发布,更新要点图表一览

2021-12-23 消化界 消化界

本文总结共识更新要点,与大家分享,具体内容还请参照共识全文。 

反流病(GERD)是常见的消化系统疾病,其发病率有逐年增高的趋势。近日,2020版《中国胃食管反流病专家共识》(以下简称“共识”)在最新一期《中华消化杂志》上正式发布。时隔6年之后共识再次更新,旨在推动中国GERD的规范诊治,提高学科医生的诊疗能力。本文总结共识更新要点,与大家分享,具体内容还请参照共识全文。
 
新旧共识对比:更改推荐
 
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注:标红为新版共识主要更新要点
全新抑酸机制P-CAB——获共识首选推荐
P-CAB破局质子泵抑制剂(PPI)治疗无法满足的临床困境
 
钾离子竞争性酸阻滞剂(Potassium-competitive acid blockers, P-CABs)是一类具有独特抑酸机制的新型抑酸剂,其代表药物为伏诺拉生。伏诺拉生也是第一个在中国上市的P-CAB,获批用于治疗反流性食管炎(RE)。
既往,在RE的治疗中,虽然PPI相较于最早的抑酸药物H2受体拮抗剂(H2RA)具有较好的抑酸效果。但由于其自身机制的特点,使其仍存在一定的局限性3-7:①PPI为前体药物且酸性条件下不稳定,需餐前半小时服用;②半衰期短,无法持久抑酸,需3~5天才能达到稳定抑酸效果,不能解决夜间酸分泌的问题;③只能与活化的H+/K+-ATP酶结合;④RE黏膜愈合率不达标;⑤停药后复发率较高;⑥由于其代谢受到CYP2C19基因多态性的影响,导致治疗药效个体差异大。因此,临床RE的治疗仍有未被满足的需求。

 

伏诺拉生临床优势显著,证据充分

 

 

作为首个进入中国临床的P-CAB,伏诺拉生独特的作用机制很好地克服了PPIs的局限性,使其成为可充分实现RE症状缓解和黏膜愈合治疗目标的优化治疗策略。
多项临床研究显示,伏诺拉生的抑酸作用在第1天即显示全效,抑酸效果持久,疗效明显优于PPI类药物。一项比较伏诺拉生20 mg与艾司奥美拉唑20 mg或雷贝拉唑10 mg在健康成年男性受试者中的抑酸作用研究(V-E-R研究)显示8,伏诺拉生第1天和第7天胃内24 h pH值曲线大部分重合;伏诺拉生强效抑酸,给药第1天和第7天全天胃内pH≥4持续时间所占的比例(%)(pH 4 HTR)高于艾司奥美拉唑和雷贝拉唑;另外,伏诺拉生可以持久抑制夜间酸分泌,给药第1天和第7天夜间胃内pH 4 HTR高于艾司奥美拉唑和雷贝拉唑。
一项日本的Ⅱ期临床研究显示9,随机给予伏诺拉生5 mg、10 mg、20 mg、40 mg qd或兰索拉唑30 mg qd进行8周的治疗,主要终点是4周黏膜愈合率,结果提示伏诺拉生治疗4周各剂量组黏膜愈合率均非劣效于兰索拉唑30 mg,且明显改善RE患者日间和夜间烧心症状,其中对于接受伏诺拉生20 mg治疗的洛杉矶分级(LA)C/D级RE患者4周时的黏膜愈合率为100%,因此,20 mg qd为伏诺拉生治疗RE的推荐剂量。
日本Ⅲ期临床研究表明10,伏诺拉生4周黏膜愈合率(96.6%)与兰索拉唑8周愈合率(95.5%)相当,同时在LA C/D级和CYP2C19快代谢RE患者中,伏诺拉生治疗4周、8周黏膜愈合率均显著高于兰索拉唑,且安全性良好,不良反应发生情况与兰索拉唑相似。
一项发表在GUT杂志上的亚洲多中心Ⅲ期临床研究,也进一步提示伏诺拉生20 mg在4周、8周的黏膜愈合率均不劣于兰索拉唑30 mg,安全性与兰索拉唑相似,提示伏诺拉生可助力RE患者完成高效达标治疗11。

 

 

与PPI相比,伏诺拉生兼顾便利与安全

 

 

与PPI不同,伏诺拉生作为新型抑酸药物,本身为活性药物,不需要酸激活,不受餐食影响,同时半衰期长12,1日1次给药即可维持良好的抑酸效果,良好的便利性和持久的疗效使得患者服药依从性大大提高。另外,伏诺拉生的安全性与PPI相似,在患者中应用耐受性良好。
伏诺拉生是否为“经济适用”型?我们来说说可能性
 
在选择药物治疗时,其费用是患者重点考虑的问题。在这一方面,伏诺拉生依然具有较大的竞争力。来自日本的一项RE初始治疗的药物经济学研究显示13,与兰索拉唑相比,伏诺拉生平均一年可减少1.5次就诊,减少49天用药时间,节约2901日元的用药费用,对于RE是更具性价比的优选方案。
另一项来自国际药物经济学和结果研究协会(ISPOR)的研究14,主要采用模型法外推了伏诺拉生的长期疗效和成本8。结果显示,与PPI组相比,伏诺拉生虽然日均费用高,但是由于可以更快地实现黏膜愈合,减少患者的就诊次数,长期来看治疗RE还节约了622元,增加了0.021个质量调整生命年(QALYs)这一健康产出指标。由此,与PPI相比,P-CAB伏诺拉生可为RE患者从临床、经济等多个维度带来获益。
伏诺拉生作为不同于PPIs的新型抑酸药物,治疗RE 4周即可达到黏膜愈合,首剂治疗症状即可缓解。另外,伏诺拉生的安全性及耐受性与PPI无明显差异,且其还具有显著的药物经济学优势。此次P-CAB获得新版GERD中国专家共识的首选推荐,体现出临床专家对P-CAB这类药物抑酸作用的肯定,希望未来其可以更好地被应用于中国临床,惠及更多患者。

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encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1571713, encodeId=4fd115e171338, content=<a href='/topic/show?id=41e33e76137' target=_blank style='color:#2F92EE;'>#反流#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37761, encryptionId=41e33e76137, topicName=反流)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=220d15750403, createdName=feifers, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=)]
    2022-03-24 ms9000001785445940

    学习了

    0

  4. 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  5. 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encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1571713, encodeId=4fd115e171338, content=<a href='/topic/show?id=41e33e76137' target=_blank style='color:#2F92EE;'>#反流#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37761, encryptionId=41e33e76137, topicName=反流)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=220d15750403, createdName=feifers, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=)]
    2022-02-06 TMFEI

    学习了,非常有用

    0

  6. 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GetPortalCommentsPageByObjectIdResponse(id=1437688, encodeId=4021143e6889c, content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549754, encodeId=e5311549e5435, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, 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  7. 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  8. 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encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1571713, encodeId=4fd115e171338, content=<a href='/topic/show?id=41e33e76137' target=_blank style='color:#2F92EE;'>#反流#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37761, encryptionId=41e33e76137, topicName=反流)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=220d15750403, createdName=feifers, createdTime=Sat Dec 25 07:39:15 CST 2021, time=2021-12-25, status=1, ipAttribution=)]
    2021-12-25 zhouqu_8
  9. 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    2021-12-25 xxxx1054
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    2021-12-25 feifers

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