替比夫定治疗慢性乙型肝炎的新进展

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安全性

综合007研究和015研究52周数据的安全性分析显示, LdT组不良事件的发生率与LAM 组相似。不良反应发生率5%以上的为上呼吸道感染、头痛、疲劳、鼻咽炎、血肌酸激酶(CK)升高、上腹痛、腹泻、恶心和头晕等。治疗52 周时LdT组发生的3～4级ALT(3级: > 3. 0～10 ×基线, 4级: > 10 ×基线和/或肝衰竭迹象)升高的比率为4% , LAM组为8% ( P < 0105) 。3～4级CK( 3级: > 7. 0～10. 0 ×ULN, 4级: > 10 ×ULN)升高的发生率, LdT治疗组为7. 5% ,LAM治疗组为3% ( P < 0. 05) 。但绝大多数CK升高的患者无症状,且在继续治疗的下一次随访时通常可明显降低。对发生CK升高的患者进行临床不良反应的分析表明, LdT治疗组与LAM治疗组未见显著差异。

小结

LdT作为一种新型的强效核苷类抗病毒药物,在CHB的治疗中具有独特的特点和优势。LdT不仅可以有效地抑制HBV 复制, 达到更高的HBVDNA 阴转率、HBeAg血清转换率和ALT复常率。与LAM相比,其安全性相似,耐药率更低。LdT口服给药、不受进食影响的优点也给临床使用带来了方便。尤其值得关注的是,LdT的临床研究中早期、快速的病毒抑制对远期(52周、104周)疗效和耐药详细的预测性数据,在现有的核苷类似物中是惟一的,将有助于理解和优化治疗方案。因此, LdT的诞生是核苷(酸)类似物研发进程中的又一个进步,为CHB的治疗提供了新的有力武器。

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