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远离肝癌,口服抗乙肝病毒药物该如何用?

2017-08-22 伍俊妍, 李祥 PSM药盾公益

口服核苷(酸)类似物在慢性乙型肝炎抗病毒治疗中的"有效性"、"可行性"、"安全性"已获得临床的广泛认同,其显着改善了慢性乙肝和乙肝肝硬化患者的预后,提高了患者的生活质量,但患者对核苷(酸)类抗乙肝病毒药物的使用及认识上有一些误区,本文根据指南及文献,对一些患者的常见用药问题进行解惑。

我国肝癌的发病率高,“慢乙肝-肝硬化-肝癌”三部曲是长期萦绕在患者心头的巨大阴影,其中有的患者可以跳过肝硬化期直接发展为肝癌。同为慢乙肝患者,为何有的人能平安度过一生,有的人结局却很差呢? 台湾一项大型研究揭示:高乙肝表面抗原(HBsAg)水平、“大三阳”、高乙肝病毒(HBV)DNA载量的患者发生肝癌的风险大大增加,病毒持续复制是慢性乙肝疾病进展的根本原因,因此阻断乙肝病毒的复制(即抗病毒治疗)是治疗慢乙肝向肝硬化、肝细胞癌发展的关键。

口服核苷(酸)类抗乙肝病毒药物的研发和临床应用,是慢性乙肝治疗的一个重大进步。口服核苷(酸)类似物在慢性乙型肝炎抗病毒治疗中的"有效性"、"可行性"、"安全性"已获得临床的广泛认同,其显着改善了慢性乙肝和乙肝肝硬化患者的预后,提高了患者的生活质量,但患者对核苷(酸)类抗乙肝病毒药物的使用及认识上有一些误区,本文根据指南及文献,对一些患者的常见用药问题进行解惑。

一、如何开始抗乙肝病毒治疗?

乙肝人群一定要定期检查,至少每年要查一次肝脏B超和肝功能。2015年最新出版的《中国慢性乙型肝炎防治指南》指出抗乙肝病毒治疗主要根据血清HBV DNA水平、血清ALT和肝脏疾病严重程度决定,因此,并不是所有的乙肝患者都需要抗病毒治疗。对于首次进行抗病毒的患者,应该在专科医生的指导下,根据病人的身体素质等多种因素来选择治疗方案。新版指南推荐接受抗病毒治疗的人群需同时满足以下两个条件,这是进行抗病毒治疗的最佳时机:

1、 HBV DNA水平: HBe Ag阳性患者,HBV DNA≥20000U/ml (相当于105拷贝/ml);HBe Ag阴性患者,HBV DNA≥2000U/ml(相当于104拷贝/ml);

2、 ALT水平: 一般要求ALT>2×参考值上限(ULN)。

对持续 HBV DNA 阳性、达不到上述治疗标准、但有以下情形之一者,疾病进展风险较大,可考虑给予抗病毒治疗:

1、存在明显的肝脏炎症或纤维化,特别是肝纤维化2级以上。

2、 ALT 持续处于(1~2)×ULN,特别是年龄>40岁,建议行肝穿刺或无创性检查明确肝脏纤维化情况后给予抗病毒治疗。

3、ALT 持续正常(每3个月检查1次,持续12个月),年龄>30岁,伴有肝硬化或肝癌家族史,建议行肝穿刺或无创性检查明确肝脏纤维化情况后给予抗病毒治疗。

4、存在肝硬化的客观依据时,无论ALT和HBe Ag情况,均建议积极抗病毒治疗。

需要提醒的是,在开始抗病毒治疗前应排除合并其他病原体感染或药物、乙醇等因素所致的ALT水平升高,也应排除应用降酶药物后ALT水平暂时性正常,如不加以区分,盲目开始抗病毒治疗不但治疗效果不好,还会增加病毒耐药的风险,给后续治疗带来困难。

二、患者初始抗病毒治疗,该如何选药?

WHO 在 2015 年发布的《慢性乙型肝炎病毒感染预防、关怀和治疗指南》及我国2015年最新出版的《中国慢性乙型肝炎防治指南》中,优先推荐强效低耐药的恩替卡韦、替诺福韦酯作为治疗一线药物,特别是病毒载量高的患者,更应首选,这是因为强效低耐抗乙肝病毒药可以为患者带来见效快、耐药率低、长期疗效好的益处。多项研究表明,高病毒载量的乙肝病毒感染患者应用阿德福韦酯、拉米夫定或替比夫定等单药治疗时耐药变异发生率较高。

三、抗病毒治疗需要终身服药?

抗病毒治疗不需要终身服药。新版指南推荐的核苷(酸)类药物疗程较前有所延长,对 HBe Ag(乙肝e抗原)阳性的初始治疗患者总疗程建议至少4年,在HBV DNA低于检测下限、ALT复常、HBe Ag血清学转换达标后再巩固治疗至少3年(每隔6个月复查1次)仍保持不变者,可考虑停药,但延长疗程可减少复发;而 HBe Ag(乙肝e抗原)阴性的初始治疗患者建议达到HBs Ag消失且HBV DNA检测不到,再巩固治疗1年半(每隔6个月复查,至少3次)仍保持不变时才可考虑停药。停药后至少随访12个月,这一步骤必不可少,随访中如有病情变化,应缩短随访间隔。

四、停药后复发怎么办?

一旦发现乙肝复发,应积极再次开始抗病毒治疗。如何选择药物治疗,要看当初停药时是否达到了停药标准,同时建议进行病毒耐药位点的检测。对于初始时达到停药标准的患者复发,一般建议继续选用初治药物治疗;对于未达到停药标准的复发患者,特别是有耐药史者,再治时建议选用没有交叉耐药的药物或联合治疗。

五、出现严重药品不良反应如何处理?

长期用药不但要关注其耐药率问题,还要监测其不良反应的发生。口服抗乙肝病毒药物总体的安全性和耐受性良好,出现严重不良反应的毕竟是少数,但是在临床应用中确实有少见、罕见的不良反应的发生,比如肾功能不全(主要见于阿德福韦酯、替诺福韦酯治疗)、低磷性骨病(主要见于阿德福韦酯、替诺福韦酯治疗)、肌炎/横纹肌溶解(主要见于替比夫定治疗)、乳酸酸中毒等(可见于拉米夫定、恩替卡韦、替比夫定治疗)。因此,治疗前应评估患者是否存在潜在的风险因素。治疗期间需密切监测肾功能、血磷、肌酸激酶(CK)等指标,如出现以上药品不良反应或指标异常应该及时求助于专科医生,由医生评估是否调整用药方案并进行相应的处理。

六、儿童如何用药?

在美国,拉米夫定和恩替卡韦被批准用于2岁以上儿童,替诺福韦酯和阿德福韦酯被批准用于12岁以上儿童,在我国,未有儿童用药的相关指南,相关药品说明书的儿童用药也未明确,因此可以参考美国指南,在充分知情同意的基础上,2~11岁可选用恩替卡韦治疗,>12~17岁可选用恩替卡韦或替诺福韦酯治疗,并参照WHO的推荐剂量给药。

七、育龄期女性和妊娠期妇女如何用药?

在妊娠中、晚期应进行抗病毒治疗,主要是为了降低新生儿HBV 感染率。推荐HBV DNA载量>2×106U/m的孕妇于妊娠24~28周开始口服替比夫定、替诺福韦酯或拉米夫定抗病毒治疗,并于产后 1~3个月停药,停药后可以母乳喂养。

有生育要求的慢性乙型肝炎患者应尽量于孕前应用抗病毒药物治疗,以期于孕前6个月完成治疗。对于抗病毒治疗期间意外妊娠者,如应用干扰素-α治疗,建议终止妊娠,因为干扰素-α可能导致胎儿畸形 ;如口服妊娠B级药物(替比夫定/替诺福韦酯)或拉米夫定,可继续治疗,因为这些药物对胎儿是安全的。

八、如果病毒耐药了怎么办?

对于已经开始服用如拉米夫定、替比夫定或阿德福韦酯治疗的患者,建议在抗病毒治疗过程中定期监测HBV DNA,及时发现原发性无应答、应答不佳或病毒耐药的患者,合理调整用药,以提高疗效并降低耐药的发生。一旦发生病毒耐药,需要采血进行耐药相关基因突变的检测,并尽早给予挽救治疗:应用拉米夫定、替比夫定和恩替卡韦的患者推荐换用替诺福韦酯或加用阿德福韦酯治疗,阿德福韦酯耐药可换用恩替卡韦或替诺福韦酯或加用拉米夫定或替比夫定。对于发生了多药耐药突变如A181T+N236T+M204V患者,建议采用恩替卡韦联合替诺福韦酯治疗。

原始出处:


[2] Zoulim F,Perrillo R. Hepatitis B: reflections on the current approach to antiviraltherapy[J]. J Hepatol,2008,48 (Suppl 1):S2-S19.

[3]LI J,XUBG,HAN T. KASL clinical practice guidelines:managementof chronic hepatitis B(2016).Clin Mol Hepatol. 2016 Mar; 22(1): 18–75.

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    2017-08-23 明月清辉

    谢谢分享.学习了

    0

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    2017-08-23 清风拂面

    很好的文章.谢谢分享

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=2082997, encodeId=a9c2208299e36, content=<a href='/topic/show?id=4b345516348' target=_blank style='color:#2F92EE;'>#抗乙肝病毒药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55163, encryptionId=4b345516348, topicName=抗乙肝病毒药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eb32500176, createdName=luckyshitiancai_42705684, createdTime=Wed Nov 08 03:28:00 CST 2017, time=2017-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236266, encodeId=a99623626656, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 23 07:18:41 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236231, encodeId=989d236231e4, content=很好的文章.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Wed Aug 23 07:04:18 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236203, encodeId=6da223620343, content=内容丰富.值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Wed Aug 23 06:47:11 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236179, encodeId=9bce2361e94e, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Wed Aug 23 05:43:48 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236160, encodeId=8a64236160ee, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Wed Aug 23 00:33:35 CST 2017, time=2017-08-23, status=1, ipAttribution=)]
    2017-08-23 忠诚向上

    内容丰富.值得学习

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2082997, encodeId=a9c2208299e36, content=<a href='/topic/show?id=4b345516348' target=_blank style='color:#2F92EE;'>#抗乙肝病毒药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=55163, encryptionId=4b345516348, topicName=抗乙肝病毒药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6eb32500176, createdName=luckyshitiancai_42705684, createdTime=Wed Nov 08 03:28:00 CST 2017, time=2017-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236266, encodeId=a99623626656, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Wed Aug 23 07:18:41 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236231, encodeId=989d236231e4, content=很好的文章.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Wed Aug 23 07:04:18 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236203, encodeId=6da223620343, content=内容丰富.值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Wed Aug 23 06:47:11 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236179, encodeId=9bce2361e94e, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/21/72142930668371951a41ef4ea4b233e6.jpg, createdBy=dcbc1715228, createdName=刘煜, createdTime=Wed Aug 23 05:43:48 CST 2017, time=2017-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=236160, encodeId=8a64236160ee, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Wed Aug 23 00:33:35 CST 2017, time=2017-08-23, status=1, ipAttribution=)]
    2017-08-23 刘煜

    学习了谢谢分享

    0

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    2017-08-23 飛歌

    学习了很有用不错

    0

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