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初治慢性乙型肝炎患者应用克来夫定的疗效。

Efficacy of initial treatment with clevudine in naive patients with chronic hepatitis B.

机构信息

Department of Internal Medicine, Eulji University School of Medicine, Daejeon, Korea.

出版信息

Korean J Intern Med. 2010 Dec;25(4):372-6. doi: 10.3904/kjim.2010.25.4.372. Epub 2010 Nov 27.

DOI:10.3904/kjim.2010.25.4.372
PMID:21179274
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2997965/
Abstract

BACKGROUND/AIMS: Clevudine, a pyrimidine nucleoside analogue, has potent antiviral effects in patients with chronic viral hepatitis B (CHB). We report the efficacy of initial treatment with clevudine in naïve patients with CHB living in Daejeon and Chungcheong Province, South Korea.

METHODS

One hundred five adults with CHB were administered 30 mg of clevudine per day for an average of 51 weeks. We evaluated viral markers and liver biochemistry retrospectively every 3 months.

RESULTS

Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and hepatitis B virus (HBV) DNA before the treatment were 184 ± 188 IU/L, 150 ± 138 IU/L, and 7.1 ± 1.2 log copies/mL, respectively. Undetectable rates (< 60 IU/mL) of DNA were 36.2%, 68.9%, 83.6%, 76.2%, and 75.8% at 12, 24, 36, 48, and 60 weeks, respectively. Seroconversion rates were 9.1%, 13.6%, 24.6%, 26.5%, and 26.1% and ALT normalization rates were 64.5%, 78.1%, 87.9%, 90.0% at 12, 24, 36, and 48 weeks, respectively. Six patients (5.7%) had a viral breakthrough.

CONCLUSIONS

Clevudine is a useful drug in the initial treatment of patients with CHB, with a potent antiviral effect and low incidence of viral breakthrough.

摘要

背景/目的:克来夫定是一种嘧啶核苷类似物,对慢性乙型病毒性肝炎(CHB)患者具有强大的抗病毒作用。我们报告了在韩国大田和忠清省接受初始克来夫定治疗的 CHB 初治患者的疗效。

方法

105 例成人 CHB 患者每天接受 30 毫克克来夫定治疗,平均治疗时间为 51 周。我们每 3 个月回顾性评估病毒标志物和肝功能。

结果

治疗前丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)和乙型肝炎病毒(HBV)DNA 分别为 184±188IU/L、150±138IU/L 和 7.1±1.2log 拷贝/mL。治疗 12、24、36、48 和 60 周时,HBV DNA 不可检测率(<60IU/mL)分别为 36.2%、68.9%、83.6%、76.2%和 75.8%。血清学转换率分别为 9.1%、13.6%、24.6%、26.5%和 26.1%,ALT 正常化率分别为 64.5%、78.1%、87.9%、90.0%,治疗 12、24、36 和 48 周时。6 例(5.7%)发生病毒突破。

结论

克来夫定是 CHB 初始治疗的一种有效药物,具有强大的抗病毒作用和低病毒突破发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3aeb/2997965/847b264d23db/kjim-25-372-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3aeb/2997965/847b264d23db/kjim-25-372-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3aeb/2997965/847b264d23db/kjim-25-372-g001.jpg

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本文引用的文献

1
[Efficacy of 48-week clevudine therapy for chronic hepatitis B].48周克来夫定治疗慢性乙型肝炎的疗效
Korean J Hepatol. 2009 Sep;15(3):331-7. doi: 10.3350/kjhep.2009.15.3.331.
2
[Development of clevudine resistance after switching from lamivudine in a patient with chronic hepatitis B].[一名慢性乙型肝炎患者从拉米夫定换用克来夫定后克来夫定耐药的发生情况]
Korean J Gastroenterol. 2008 Nov;52(5):325-8.
3
Clevudine is efficiently phosphorylated to the active triphosphate form in primary human hepatocytes.克来夫定在原代人肝细胞中能有效地磷酸化为活性三磷酸形式。
Antivir Ther. 2008;13(2):263-9.
4
Clinical trial: a phase II, randomized study evaluating the safety, pharmacokinetics and anti-viral activity of clevudine for 12 weeks in patients with chronic hepatitis B.临床试验:一项II期随机研究,评估克来夫定对慢性乙型肝炎患者12周的安全性、药代动力学及抗病毒活性。
Aliment Pharmacol Ther. 2008 Jun;27(12):1282-92. doi: 10.1111/j.1365-2036.2008.03686.x. Epub 2008 Mar 22.
5
Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression.克来夫定对乙肝e抗原阴性的慢性乙型肝炎具有高度疗效,可实现持久的停药后病毒抑制。
Hepatology. 2007 Oct;46(4):1041-8. doi: 10.1002/hep.21800.
6
Clevudine therapy for 24 weeks further reduced serum hepatitis B virus DNA levels and increased ALT normalization rates without emergence of viral breakthrough than 12 weeks of clevudine therapy.与12周的克来夫定治疗相比,24周的克来夫定治疗进一步降低了血清乙型肝炎病毒DNA水平,提高了谷丙转氨酶(ALT)正常化率,且未出现病毒突破。
Intervirology. 2007;50(4):296-302. doi: 10.1159/000105442. Epub 2007 Jul 9.
7
Twenty-four-week clevudine therapy showed potent and sustained antiviral activity in HBeAg-positive chronic hepatitis B.24周的克来夫定治疗在HBeAg阳性慢性乙型肝炎中显示出强效且持续的抗病毒活性。
Hepatology. 2007 May;45(5):1172-8. doi: 10.1002/hep.21629.
8
Entecavir for the treatment of chronic hepatitis B virus infection.恩替卡韦用于治疗慢性乙型肝炎病毒感染。
Clin Ther. 2006 Feb;28(2):184-203. doi: 10.1016/j.clinthera.2006.02.012.
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A 12-week clevudine therapy showed potent and durable antiviral activity in HBeAg-positive chronic hepatitis B.为期12周的克来夫定治疗在HBeAg阳性慢性乙型肝炎中显示出强效且持久的抗病毒活性。
Hepatology. 2006 May;43(5):982-8. doi: 10.1002/hep.21166.
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Molecular virology and the development of resistant mutants: implications for therapy.分子病毒学与抗性突变体的产生:对治疗的影响
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