[英文临床表现]HBV基因型B型或C, 更短的持续时间与低剂量的

StephenW

<http://onlinelibrary.wiley.com/doi/10.1002/hep.24555/abstract>
HBV基因型B型或C, 更短的持续时间与低剂量的聚乙二醇干扰素α-2a
关系到伪劣HBeAg的血清转换率.
Shorter durations and lower doses of peginterferon alfa-2a are associated
with inferior HBeAg seroconversion rates in HBV genotypes B or C

Y-F Liaw1,*,?, J-D Jia2, HLY Chan3, KH Han4, T Tanwandee5, WL Chuang6, D
Tan7, XY Chen8, E Gane9, T Piratvisuth10, L Chen11, Q Xie12, JJY Sung3, C
Wat13, C Bernaards14, Y Cui15, P Marcellin16DOI: 10.1002/hep.24555

Copyright © 2011 American Association for the Study of Liver Diseases
Issue
Hepatology
Accepted Article (Accepted, unedited articles published online for future
issues)

Abstract
As there is currently a lack of consensus on the most appropriate dose and
duration of peginterferon alfa-2a (PEG-IFNα-2a) therapy in hepatitis B e
antigen (HBeAg)-positive patients, the efficacy and safety of either 24 or
48 weeks' duration and 90μg/week or 180μg/week doses were compared.
HBeAg-positive patients (n=544; 34% genotype B, 51% genotype C) were
randomized to receive PEG-IFNα-2a (2x2 factorial design) for 24 or 48
weeks and at 90 μg/week or 180 μg/week and included in the per protocol
population. The primary efficacy endpoint of the non-inferiority study was
HBeAg seroconversion 6 months post-treatment. The prespecified odds ratio
(OR) non-inferiority margin was 1.88 with a one-sided significance level of
0.025. The highest rates of HBeAg seroconversion 6 months post-treatment
were in the 180/48 arm (36.2% versus 14.1%-25.8% in the other arms). When
the dose and duration arms were pooled, the OR for non-inferiority of 24
weeks versus 48 weeks was 2.17 (95% confidence interval [CI] 1.43, 3.31; P=
0.749) and for 90 μg versus 180 μg was 1.79 (95% CI 1.18, 2.72; P=0.410).
As the upper limit of the 95% CI of the ORs were >1.88, 24 weeks were
inferior to 48 weeks and 90μg/week was inferior to 180μg/week. Highest
rates of response in the 180/48 arm were achieved by patients with HBsAg
<1500 IU/mL at Week 12 (58%) or Week 24 (57%), whilst patients with HBsAg
> 20,000 IU/mL did not respond. Adverse events were typical of those
> associated with PEG-IFNα-2a.

Conclusions:
Compared with lower doses and shorter durations, the licensed PEG-IFNα-2a
treatment regimen (180μg/48 weeks) was the most efficacious and beneficial
for HBeAg-positive patients predominantly infected with HBV genotype B or
C. (HEPATOLOGY 2011.)



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StephenW

谷歌翻译，不是100％准确，仅供参考使用。

摘要
由于目前还缺乏一个最适当的剂量共识与
持续时间聚乙二醇干扰素α- 2a（PEG-IFNα-2a）的治疗乙型肝炎e
抗原（HBeAg）阳性的患者的疗效和安全24或
48个星期的时间与90μg/week或180μg/week剂量进行比较。
HBeAg阳性患者（N =544;34％，B型，C基因型51％）
随机接受PEG-IFNα-2A（2 × 2析因设计为24或48）
周，其中包括在90微克/周或180微克/周与在每个协议
人口。非劣效性研究的主要疗效终点
HBeAg血清学转换6个月治疗后。预先设定的赔率比
（或）非劣一种片面的显着性水平的利润率为1.88
0.025。 HBeAg血清转换率最高的6个月后处理
在四十八分之一百八ARM（36.2％比14.1％-25.8％，在其他武器）。当
汇集的剂量和疗程的武器，或为24的非劣效
周与48周为2.17（95％可信区间[CI]1.43，3.31，P=
0.749）和1.79（95％CI1.18，2.72，P=0.410）为90微克和180微克。
由于上限的95％CI的ORS>1.88，24周
逊色于48周与90μg/week逊色180μg/week。最高
在四十八分之一百八手臂的响应率分别达到患者与HBsAg
<1500 IU/毫升在第12周（58％）或24周（57％），而患者与HBsAg
> 20,000 IU/ mL的没有回应。这些典型的不良事件
>与聚乙二醇干扰素α- 2a的。

结论：
低剂量与持续时间较短，持牌PEG-干扰素α- 2a的相比
治疗方案（180μg/48周）是最有效和有益的
HBeAg阳性患者主要感染HBV基因型B或
C.（肝脏病学2011年。）

lin12345

斯蒂芬  你的翻译 我看不懂  

StephenW

lin12345 发表于 2011-7-14 13:34
斯蒂芬  你的翻译 我看不懂

文件指出180μg/week,48个星期PEG-干扰素α- 2a是最有效和有益的.