...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Hepatology: Official Journal of the American Association for the Study of Liver Diseases >Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B.
【24h】

Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B.

机译：阿德福韦酯对乙型肝炎e抗原阳性的慢性乙型肝炎的长期疗效和安全性。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Treatment of 171 patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) with adefovir dipivoxil (ADV) 10 mg over 48 weeks resulted in significant histological, virological, serological, and biochemical improvement compared with placebo. The long-term efficacy and safety of ADV in a subset of these patients was investigated for up to 5 years. Sixty-five patients given ADV 10 mg in year 1 elected to continue in a long-term safety and efficacy study (LTSES). At enrollment, the 65 LTSES patients were a median 34 years old, 83% male, 74% Asian, 23% Caucasian, median baseline serum hepatitis B virus (HBV) DNA 8.45 log(10) copies/mL, and median baseline alanine aminotransferase (ALT) 2.0 x upper limit of normal. At 5 years on study, the median changes from baseline in serum HBV DNA and ALT for the 41 patients still on ADV were 4.05 log(10) copies/mL and -50 U/L, respectively. HBeAg loss and seroconversion were observed in 58% and 48% of patients by end of study, respectively. Fifteen patients had baseline and end of follow-up liver biopsies; improvements in necroinflammation and fibrosis were seen in 67% and 60% of these patients, respectively. Adefovir resistance mutations A181V or N236T developed in 13 LTSES patients; the first observation was at study week 195. There were no serious adverse events related to ADV. CONCLUSION: Treatment with ADV beyond 48 weeks was well tolerated and produced long-term virological, biochemical, serological, and histological improvement.
机译：与安慰剂相比，在48周内使用阿德福韦酯（ADV）10 mg治疗171例乙型肝炎e抗原（HBeAg）阳性的慢性乙型肝炎（CHB）患者，在组织学，病毒学，血清学和生化方面均有显着改善。在这些患者中，对ADV的长期疗效和安全性进行了长达5年的研究。在第一年中有65例接受ADV 10毫克治疗的患者选择继续进行长期安全性和有效性研究（LTSES）。入组时，这65名LTSES患者为中位年龄34岁，男性83％，亚洲人74％，白种人23％，基线血清乙肝病毒（HBV）DNA基线中位数8.45 log（10）拷贝/ mL和基线丙氨酸氨基转移酶中位数（ALT）2.0 x正常上限。在研究的5年中，仍然接受ADV的41例患者血清HBV DNA和ALT的基线中值变化分别为4.05 log（10）拷贝/ mL和-50 U / L。到研究结束时，分别在58％和48％的患者中观察到HBeAg丢失和血清转化。 15例患者进行了基线肝活检和随访。这些患者的坏死性炎症和纤维化改善分别达到67％和60％。 13例LTSES患者出现阿德福韦耐药性突变A181V或N236T;第一次观察是在研究第195周。没有与ADV相关的严重不良事件。结论：超过48周的ADV治疗耐受性良好，并在病毒学，生化，血清学和组织学方面取得了长期改善。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号