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Both these studies come from the same geographical areas, Asia, in patients with similar clinical profile, HBeAg negative CHB, infected by the same viral genotypes, B or C, treated with the same strategy, ETV monotherapy, and managed with similar treatment cessation rules, the APASL guidelines. The question is, how did these two papers reach opposite conclusions? What lessons can be drawn? Although these two publications differ in terms of study design and patient profile, the most important issue is the definition of the endpoint of the study which triggered re-treatment: a ‘virological relapse’ for the Hong Kong study and a ‘clinical relapse’ for the Taiwan study. Rescue was clearly too anticipated in the Hong Kong study, as ETV was restarted as soon as HBV DNA peaked above 2000 IU/mL, that is, patients were not given any chance to achieve HBsAg loss after ALT flare.
这两项研究都来自同一个地理区域,亚洲患者相似的临床轮廓,HBeAg阴性慢性乙型肝炎,感染了相同的病毒基因型,B或C,用同样的策略,恩替卡韦单药治疗,并与类似的戒烟治疗管理规则,在APASL指南。现在的问题是,怎么这两篇论文达到相反的结论?有什么经验教训可以得出?虽然这两个刊物的研究设计和患者个人资料方面的不同,其中最重要的问题就是研究它引发的再治疗的端点的定义:“病毒学复发”为香港的研究和“临床复发”的台湾的研究。救援显然也预计在香港学习,为ETV是尽快重新启动的HBV-DNA见顶2000以上的国际单位/毫升,也就是患者没有机会ALT耀斑后达到HBsAg消失。
Indeed, the whole dispute started few years ago when S. Hadziyannis and colleagues provided the first evidence that NUC cessation could be attempted before HBsAg clearance. Although all patients had an initial virological rebound, and this is a critical observation, high rates of immune control (55%) and HBsAg loss (39%) could be achieved during long-term post-treatment follow-up among 33 HBeAg negative, genotype D infected, NUC-naive Greek patients who had stopped adefovir (ADV) monotherapy after 4–5 years of successful treatment.[13] None of the patients with >1000 IU/mL HBsAg at the end of ADV treatment cleared HBsAg loss during follow-up, suggesting that qHBsAg levels at the end of treatment could be used to stratify the risk of relapse.
事实上,整个争端开始几年前,当南Hadziyannis和同事提供了第一个证据表明,国统会终止HBsAg清除之前尝试。虽然所有患者最初的病毒学反弹,这是一个关键的观察,可以在长期治疗后随访中33 HBeAg阴性实现免疫控制(55%)和HBsAg消失(39%)的高利率, D基因型感染了,谁已经停止阿德福韦NUC-天真希腊例(ADV)单药治疗后4-5年的成功治疗。[13]无的患者> 1000 IU/ mL的乙肝表面抗原为ADV治疗结束时清除HBsAg消失后续,表明qHBsAg水平在治疗结束时,可以使用分层的复发的风险
Additional studies have more recently looked at the same issue for HBeAg negative CHB patients. Among 64 Chinese, genotype B and C infected patients, treated with different NUC, the virological and clinical relapse rates were 30% and 10%, respectively.[14 ] Among 45 Korean patients fulfilling the APASL stopping rules after approximately 3 years of NUC treatment, 73% had a virological relapse while 53% had a clinical relapse.[15] In another study from Taiwan, the cumulative rates of HBV relapse after lamivudine discontinuation among 105 HBeAg negative CHB patients were 43%, 60% and 68% at year 1, 3 and 6.[16] Old age, male gender and qHBsAg levels at the end of treatment independently predicted HBV relapse. The likelihood of a sustained immune control was 93% for patients with HBsAg levels <200 IU/mL at the end of treatment, while the probability of HBsAg clearance was 79% for those with qHBsAg <120 IU/mL at the end of therapy.[16]
进一步的研究,最近看了看同一个问题的负面大三阳略去慢性乙型肝炎患者。其中64中国,B,C基因型感染患者,用不同的NUC治疗,病毒学和临床复发率分别为30%和 10%,分别为[14]在45例患者朝鲜履行APASL停止规则大约3年后国统会的治疗,73%有一位病毒学复发,而53%的患者临床复发。[15]来自台湾的另一项研究中,累计乙肝复发的105间HBeAg阴性慢性乙型肝炎患者拉米夫定停药后分别为43%,60%和68%,在今年1,3和6。[16]老年,男性和qHBsAg水平在治疗结束独立预测乙肝复发。持续的免疫控制的可能性是为患者HBsAg水平<200国际单位/毫升,在治疗结束时的93%,而HBsAg清除的概率是对于那些具有qHBsAg<120国际单位/毫升,在治疗结束时为79%。 [16]
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