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双语推荐：国产恩替卡韦

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比较进口与国产恩替卡韦治疗慢性乙型肝炎的成本-效果。方法:选取我院收治的50例慢性乙型肝炎患者,随机分为研究1组与研究2组各25例。研究1组给予国产恩替卡韦分散片进行治疗;研究2组采用进口恩替卡韦片进行治疗。结果:研究1组与研究2组的总有效率分别为64.0%、68.0%;治疗成本分别为2784元、5712元;成本-效果比较比(C/E)分别为43.5、84。结论:国产与进口恩替卡韦在治疗慢性乙型肝炎方面均具有显著疗效,且国产恩替卡韦治疗成本较低,具有临床推广应用价值。
Objective:To compare cost-effectiveness import and domestic entecavir for therapy of chro-nic hepatitis B .Method:50 cases of chronic hepatitis B patients were selected ,they were randomly divided into study 1 group and study 2 group, each group with 25 cases.Study 1 group were given domestic entecavir dispersible tablet;Study 2 group were given imported entecavir tablets .Result: The total effective rate of Study 1 group and Study 2 group was 64.0%and 68.0%; the treatment cost was respectively 2788.8 yuan and 5712 yuan;cost-effectiveness ratio ( C/E) was 43.6 and 84.Conclusion:Domestic and imported ente-cavir have significant effect on chronic hepatitis B , and domestic entercavir lower cost in treatment , It''s wor-thy of clinical application .

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目的：评价国产恩替卡韦分散片（润众）治疗慢性乙型肝炎患者的疗效及其与血药浓度之间的关系。方法将46例慢性乙型肝炎患者分为试验组和对照组，试验组23例服用国产恩替卡韦分散片，对照组23例服用恩替卡韦（博路定）。比较在4、12、24、48周时试验组与对照组病毒学应答、血清学应答、生化学应答及安全性指标，并对试验组患者血清HBeAg、ALT、HBV DNA 进行分层评价。进行24周时间点恩替卡韦血药浓度检测。结果试验组和对照组治疗4、12、24、48周时病毒学应答率、HBeAg 转阴率、HBeAg 血清学转换率 ALT 复常率两组之间差异无统计学意义。试验组和对照组均未发生任何严重不良事件。试验组分层评价中，HBeAg 阳性、HBeAg 阴性、不同 ALT 水平组间病毒学应答率差异无统计学意义。两组患者在24周时恩替卡韦血药浓度与病毒学应答之间无明显相关性。结论国产恩替卡韦分散片治疗慢性乙型肝炎患者48周时疗效及不良事件发生率与恩替卡韦（博路定）差异无统计学意义。恩替卡韦血药浓度与其治疗效果无明显相关性。
Objective To observe the efficacy and safety of entecavir dispersible tablets in chronic hepatitis B patients;to establish an high performance liquid coupled with tandem mass spectrometry (HPLC-MS)method for the measurement of plasma concentration;to analyze the relationship between plasma concentration and antiviral efficacy. Methods In test group,23 patients took generic entecavir dispersible tablet,while in control group,23 patients took Baraclude.Virological responses (HBeAg/HBeAb),biochemistry changes [alanine aminotransferase (ALT)normalization rate],and safety parameters of both groups at week 4,12,24 and 48 were compared.Plasma concentration of entecavir in chronic hepatitis B patients was detected by HPLC-MS.Ganciclovir was marked as internal reference.HPLC-MS method was used to detect patients''plasma concentrations of entecavir dispersible tablets and Baraclude at week 24.Results There were no significant differences in virological response rate,HBeAg seroconversio

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目的 观察国产恩替卡韦治疗慢性乙型肝炎的临床疗效并评估影响疗效的因素.方法 应用国产恩替卡韦治疗浙江省绍兴市第六人民医院2010年12月至2012年12月门诊或住院200例慢性乙型肝炎患者,分别于12、24、48周进行病毒学、血清学及生化学指标的检测,并将包括乙型肝炎e抗原(HBeAg)阳性或阴性、基线丙氨酸转氨酶(ALT)水平、乙型肝炎病毒脱氧核糖核酸(HBV DNA)转阴时间、基线HBV DNA水平及肝组织病理特征等因素对疗效的影响进行评估.结果 国产恩替卡韦治疗48周,ALT复常率为78.5％ (157/200),HBV DNA转阴率为84.5％(169/200),HBeAg血清转换率23.4％(33/141,耐药率为0％;基线ALT ＞5倍正常值上限(ULN)患者的HBeAg血清学转换率高于2～5 ULN的患者[分别为35.4％ (19/54)和16.1％(14/87),P＜0.05];治疗24周后HBV DNA阴转的患者与未阴转的患者相比,其48周HBV DNA阴转、ALT复常和HBeAg血清学转换的比例明显增高[分别为92.4％(134/145)、86.2％(125/145)、20.7％ (30/145)和63.6％ (35/55)、58.2％(32/55)、5.5％(3/55),均P＜0.05];炎症活动分级(G)＞2,HBeAg血清转换率高于G≤2[分别为37.5％(12/32)和15.0％(3/20),P＜0.05];基线病毒载量高低与48周疗效差异无统计学意义(P＞0.05).在治疗48周过程中8例发生一过性ALT升高,无患者因发生不良事件而停药.结论 国产恩替卡韦能明显抑制HBV DNA复制,促进ALT复常及HBeAg血清转换,有效改善肝功能,耐药率低,安全性良好.且基线ALT＞5 ULN、炎症活动分级G＞2及治疗24周后HBV DNA阴转的患者在48周时有更好的疗效.
Objective To investigate the effect of domestic entecavir on chronic hepatitis B.Methods The virology,serology and biochemical indicators of 200 patients who received entecavir for the treatment of chronic hepatitis B were analyzed before treatment and 12,24 and 48 weeks after treatment.Results After 48 weeks of treatment,hepatitis B virus(HBV) DNA negative rate was 84.5％ (169/200) ; hepatitis B e antigen(HBeAg) seroconversion rate was 23.4％ (33/141) ; alanime transaminase (ALT) normolization rate was 78.5％ (157/200)and drug resistant rate was 0.The rate of HBeAg seroconversion in patients with baseline ALT ＞ 5 ULN was significantly higher than tht in patients with 2 to 5 ULN[35.4％ (19/54) vs 16.1％ (14/87),P ＜0.05].Compared with patients with no HBV DNA negative conversion at 24 weeks,ratio of HBV DNA negative conversion,ALT normalization and HBeAg seroconversion were significantly higher in patients with HBV DNA negative 48 weeks after treatment [92.4％ (134/145) vs 6

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