A randomized, multi-central, controlled study of patients with hepatitis B e ant

StephenW

Hepatology International        
Volume 6, Number 2, 441-448, DOI: 10.1007/s12072-011-9294-7        

                        

Published in partnership with the

Asian Pacific Association for the Study of the Liver
        

               

Original Article

A randomized, multi-central, controlled study of patients with hepatitis B e antigen-positive chronic hepatitis B treated by adefovir dipivoxil or adefovir dipivoxil plus bicyclol               

Wen Xie, Guangfeng Shi, Hongfei Zhang, Guiming Zhao, Zujiang Yu, Zhenwei Lang, Hong Zhao, Jie Yan and Jun Cheng

Abstract
Objective  To evaluate the efficacy and safety profiles of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) treated with adefovir dipivoxil (ADV) or ADV plus bicyclol, and to optimize the treatment strategy for CHB patients.               

Patients and methods  A total of 250 patients with HBeAg-positive CHB were randomized to ADV plus bicyclol combination group and ADV monotherapy group. The patients in the ADV plus bicyclol combination therapy group (n = 125) received ADV 10 mg orally q.d. and bicyclol 25 mg orally t.i.d. for 48 weeks, and those in the ADV monotherapy group  (n = 125) were administered ADV 10 mg orally q.d. alone for 48 weeks. The serum aminotransferases (ALT/AST), HBV DNA, HBeAg/HBeAb,  and liver biopsy were conducted before and after therapy.               
Results
The serum aminotransferase levels were decreased significantly in both groups. The serum aminotransferase level in ADV plus bicyclol combination therapy group decreased greater than that in ADV monotherapy group (P < 0.01). The virological response rate in ADV plus bicyclol combination therapy group was not significantly different from that in ADV monotherapy group (P > 0.05). After treatment for 48 weeks, the Knodell necroinflammatory score of the two groups were all alleviated significantly, and the Knodell score in the combination group was significantly lower than that in the ADV monotherapy group (P < 0.05). There were no remarkable adverse events probably related to the drug in this study.
Conclusion
Adefovir dipivoxil plus bicyclol combination therapy is a safe and superior treatment regimen for patients with HBeAg-positive  CHB when compared with ADV monotherapy.               
            
         
      
        

StephenW

肝病国际
第6卷，第2号，441-448，DOI：10.1007/s12072-011-9294-7

发布与合作
标志

亚太肝脏研究协会

原创文章
多中心，随机，对照研究B型肝炎e抗原阳性慢性乙型肝炎治疗阿德福韦或阿德福韦酯加双环乙患者

温家宝谢，广丰县石，鸿飞张，赵陈桂明，Zujiang瑜，郎振威，赵宏，阎杰，成军


摘要

目标
到患者的疗效和安全性评价与B型肝炎e抗原（HBeAg）阳性的慢性乙型肝炎（CHB）治疗，阿德福韦（ADV），或副词加双环和优化慢性乙型肝炎患者的治疗策略。
病人和方法
共有250例HBeAg阳性慢性乙型肝炎患者随机分为ADV加双环组合组和ADV单药治疗组。在ADV加双环联合治疗组（N = 125）的患者接受ADV 10 mg口服QD双环醇25毫克口服每日三次48周，并在ADV单药治疗组（N = 125）ADV 10 mg口服QD独自为48周。进行了治疗前后血清转氨酶（ALT / AST）的，e抗原/ e抗体，乙肝病毒DNA，肝活检。
结果
血清转氨酶水平显着下降，在这两个群体。的ADV加双环组合治疗组血清中转氨酶水平下降大于ADV单药治疗组（P <0.01）。在ADV加双环联合治疗组的病毒学应答率没有显着不同，在ADV单药治疗组（P <0.05）。治疗48周后，两组的Knodell坏死性炎症评分均显著缓解，并在联合组Knodell评分比在ADV单药治疗组（P <0.05）显​​着较低。有可能与药物在这项研究中无明显不良反应事件。
结论
阿德福韦加双环联合治疗是用ADV单药治疗相比，HBeAg阳性慢性乙型肝炎患者的安全和优越的治疗方案。

咬牙硬挺

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