The Lancet Gastroenterology & Hepatology:不必活检“受罪”,识别高危脂肪肝,无创血检技术带来希望

2020-08-06 药明康德内容团队 医学新视点

说到脂肪肝[非酒精性脂肪性肝病(NAFLD),最近国际共识提议更名为“代谢相关性脂肪性肝病(MAFLD)”],最要紧的不止是“脂肪”,而是与肝脂肪变相关

说到脂肪肝[非酒精性脂肪性肝病(NAFLD),最近国际共识提议更名为“代谢相关性脂肪性肝病(MAFLD)”],最要紧的不止是“脂肪”,而是与肝脂肪变相关的肝脏炎症损伤、纤维化等一系列病变:从非酒精性单纯性肝脂肪变,非酒精性脂肪性肝炎(NASH),逐渐引起肝纤维化,最终可能发展为肝硬化、肝功能衰竭甚至肝癌。

其中,非酒精性脂肪性肝炎(NASH)是单纯性脂肪肝进展至肝硬化和肝细胞癌的中间阶段,大约40.8%的NASH患者会发生肝纤维化进展。NASH难以自行康复,需要通过治疗改善脂肪性肝炎和纤维化程度。但NASH在早期又通常没有明显症状,因此,识别出这部分患者具有重要意义。然而,现有影像学技术和实验室检查等无创方法尚不能准确诊断NASH。尽管存在创伤和并发症,以及取样误差和病理观察者之间差异等缺点,定期肝活检目前仍是诊断NASH 的“金标准”。

鉴于脂肪肝患者已经“遍地都是”,更广泛可用的无创检测手段,将有助于让NASH患者得到充分诊断。一项在研血液检测技术NIS4有望带来改变,这项技术的验证研究结果最新发表在《柳叶刀-胃肠病学和肝病学》。

NIS4技术来自专注代谢和肝脏疾病创新诊疗方案研发的生物制药GENFIT。基于血液中的一系列生物标志物进行分析,NIS4技术可用于识别合并代谢风险因素的高危NASH患者(NAFLD活动评分NAS≥4,肝纤维化评分≥F2),这些患者发生不良临床结果的风险尤其高。

具体来说,研究团队通过3个独立队列总共近一千名的未经诊治的疑似NAFLD患者的数据,分析了100多种用于血液检测的生物标志物,并结合其临床数据和肝脏活检结果,对这项技术进行开发和验证,最终筛选出4个独立且能形成最佳整体诊断性能的生物标志物:
(1)miR-34a -5p,与脂肪变性/炎症/肝细胞气球样变有关
(2)alpha-2巨球蛋白,肝纤维化标志物
(3)YKL-40,肝纤维化标志物
(4)糖化血红蛋白(HbA1c),代谢/胰岛素抵抗标志物

值得注意的是,NIS4技术在这4个标志物综合分析的基础上,无需再结合年龄、性别、体重指数(BMI)或转氨酶浓度这些指标进行评估。

基于上述4个标志物的血检结果,NIS4技术会通过GENFIT专有的算法来生成一个分数,最终NIS4评分小于0.36的被判定为非高危NASH患者,NIS4评分大于0.63为高危NASH患者。

将这4个标准及NIS4评分临界值在702名NAFLD患者中进行验证的结果表明:

对于实际非高危患者,NIS4整体预测准确性为77.9%。其中灵敏度(真阳性率,不漏判)为81.5%(95%CI 76.9%–85.3%),特异性(真阴性率,不误判)为63.0%(95%CI 57.8%–68.0%)。

对于实际高危患者,NIS4整体预测准确性为79.2%。其中灵敏度为50.7%(95%CI 45.3%–56.1%),特异性为87.1%(95%CI 83.1%–90.3%)。

基于这些数据,研究团队认为NIS4技术在目标患者群中表现出了优秀的诊断性能,为高危NASH患者提供了一种有效的无创诊断方法,有助于减少低危患者不必要的肝脏活检。

原始出处:

ProfStephen AHarrisonMD,ProfVladRatziuMD,ProfJérmeBoursierMD,et al.A blood-based biomarker panel (NIS4) for non-invasive diagnosis of non-alcoholic steatohepatitis and liver fibrosis: a prospective derivation and global validation study.The Lancet Gastroenterology & Hepatology.Available online 5 August 2020https://doi.org/10.1016/S2468-1253(20)30252-1

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    2020-08-17 许安
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  4. [GetPortalCommentsPageByObjectIdResponse(id=2065118, encodeId=264320651188c, content=<a href='/topic/show?id=94ffe853a7' target=_blank style='color:#2F92EE;'>#Gastroenterol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7853, encryptionId=94ffe853a7, topicName=Gastroenterol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0bed488, createdName=jktdtl, createdTime=Tue Dec 15 11:46:05 CST 2020, time=2020-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2073067, encodeId=993420e306771, content=<a href='/topic/show?id=9d4ee84647' target=_blank style='color:#2F92EE;'>#GAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7846, encryptionId=9d4ee84647, topicName=GAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e2dd327, createdName=许安, createdTime=Mon Aug 17 23:46:05 CST 2020, time=2020-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1712503, encodeId=f7c51e12503d4, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Fri Feb 05 02:46:05 CST 2021, time=2021-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1830771, encodeId=38cc1830e710c, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Feb 11 05:46:05 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278197, encodeId=2a3712e8197b6, content=<a href='/topic/show?id=d34e6523544' target=_blank style='color:#2F92EE;'>#活检#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65235, encryptionId=d34e6523544, topicName=活检)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1427441, encodeId=8b6a142e441ba, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1447042, encodeId=e7dd144e04252, content=<a href='/topic/show?id=549489135c5' target=_blank style='color:#2F92EE;'>#血检#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89135, encryptionId=549489135c5, topicName=血检)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cc1f5300484, createdName=Luyuxie_11, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1505052, encodeId=d326150505267, content=<a href='/topic/show?id=7730e85412' target=_blank style='color:#2F92EE;'>#Gastroenterology#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7854, encryptionId=7730e85412, topicName=Gastroenterology)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5fc29706655, createdName=chaojitidian, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033915, encodeId=e59f1033915af, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Aug 06 18:46:05 CST 2020, time=2020-08-06, status=1, ipAttribution=)]
    2021-02-11 howi
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    2020-08-08 gwc384
  7. [GetPortalCommentsPageByObjectIdResponse(id=2065118, encodeId=264320651188c, content=<a href='/topic/show?id=94ffe853a7' target=_blank style='color:#2F92EE;'>#Gastroenterol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7853, encryptionId=94ffe853a7, topicName=Gastroenterol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0bed488, createdName=jktdtl, createdTime=Tue Dec 15 11:46:05 CST 2020, time=2020-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2073067, encodeId=993420e306771, content=<a href='/topic/show?id=9d4ee84647' target=_blank style='color:#2F92EE;'>#GAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7846, encryptionId=9d4ee84647, topicName=GAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e2dd327, createdName=许安, createdTime=Mon Aug 17 23:46:05 CST 2020, time=2020-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1712503, encodeId=f7c51e12503d4, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Fri Feb 05 02:46:05 CST 2021, time=2021-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1830771, encodeId=38cc1830e710c, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Feb 11 05:46:05 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278197, encodeId=2a3712e8197b6, content=<a href='/topic/show?id=d34e6523544' target=_blank style='color:#2F92EE;'>#活检#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65235, encryptionId=d34e6523544, topicName=活检)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1427441, encodeId=8b6a142e441ba, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1447042, encodeId=e7dd144e04252, content=<a href='/topic/show?id=549489135c5' target=_blank style='color:#2F92EE;'>#血检#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89135, encryptionId=549489135c5, topicName=血检)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cc1f5300484, createdName=Luyuxie_11, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1505052, encodeId=d326150505267, content=<a href='/topic/show?id=7730e85412' target=_blank style='color:#2F92EE;'>#Gastroenterology#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7854, encryptionId=7730e85412, topicName=Gastroenterology)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5fc29706655, createdName=chaojitidian, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033915, encodeId=e59f1033915af, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Aug 06 18:46:05 CST 2020, time=2020-08-06, status=1, ipAttribution=)]
    2020-08-08 Luyuxie_11
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  9. [GetPortalCommentsPageByObjectIdResponse(id=2065118, encodeId=264320651188c, content=<a href='/topic/show?id=94ffe853a7' target=_blank style='color:#2F92EE;'>#Gastroenterol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7853, encryptionId=94ffe853a7, topicName=Gastroenterol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0bed488, createdName=jktdtl, createdTime=Tue Dec 15 11:46:05 CST 2020, time=2020-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2073067, encodeId=993420e306771, content=<a href='/topic/show?id=9d4ee84647' target=_blank style='color:#2F92EE;'>#GAS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7846, encryptionId=9d4ee84647, topicName=GAS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e2dd327, createdName=许安, createdTime=Mon Aug 17 23:46:05 CST 2020, time=2020-08-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1712503, encodeId=f7c51e12503d4, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Fri Feb 05 02:46:05 CST 2021, time=2021-02-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1830771, encodeId=38cc1830e710c, content=<a href='/topic/show?id=1b6210686b2' target=_blank style='color:#2F92EE;'>#Lancet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10686, encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Thu Feb 11 05:46:05 CST 2021, time=2021-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1278197, encodeId=2a3712e8197b6, content=<a href='/topic/show?id=d34e6523544' target=_blank style='color:#2F92EE;'>#活检#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65235, encryptionId=d34e6523544, topicName=活检)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1427441, encodeId=8b6a142e441ba, content=<a href='/topic/show?id=221d685172' target=_blank style='color:#2F92EE;'>#EPA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6851, encryptionId=221d685172, topicName=EPA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4a9b4077760, createdName=gwc384, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1447042, encodeId=e7dd144e04252, content=<a href='/topic/show?id=549489135c5' target=_blank style='color:#2F92EE;'>#血检#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89135, encryptionId=549489135c5, topicName=血检)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cc1f5300484, createdName=Luyuxie_11, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1505052, encodeId=d326150505267, content=<a href='/topic/show?id=7730e85412' target=_blank style='color:#2F92EE;'>#Gastroenterology#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7854, encryptionId=7730e85412, topicName=Gastroenterology)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=5fc29706655, createdName=chaojitidian, createdTime=Sat Aug 08 06:46:05 CST 2020, time=2020-08-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1033915, encodeId=e59f1033915af, content=顶刊就是不一样,质量很高,内容精彩!学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=goodbing, createdTime=Thu Aug 06 18:46:05 CST 2020, time=2020-08-06, status=1, ipAttribution=)]
    2020-08-06 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0