拉米夫定和阿德福韦酯初始联合与替诺福韦酯单药治疗慢性乙型肝炎48周疗效和安全性比较
投稿时间:2015-09-10  修订日期:2015-10-09  点此下载全文
引用本文:李忠斌,邵清,李梵,李冰,王春艳,陈松海,陈国凤.拉米夫定和阿德福韦酯初始联合与替诺福韦酯单药治疗慢性乙型肝炎48周疗效和安全性比较[J].医学研究杂志,2016,45(4):105-108
DOI: 10.11969/j.issn.1673-548X.2016.04.028
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作者单位E-mail
李忠斌 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心  
邵清 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心  
李梵 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心  
李冰 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心  
王春艳 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心  
陈松海 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心  
陈国凤 100039 北京, 中国人民解放军第302医院肝硬化诊疗二中心 guofengchen302@163.com 
中文摘要:目的 比较拉米夫定和阿德福韦酯初始联合与替诺福韦酯单药初治慢乙肝患者48周的临床治疗效果及安全性。方法 将80例未曾使用抗病毒药物,且符合抗病毒治疗指征的初治慢性乙型肝炎患者随机分为联合组40例和单药组40例。联合组给予拉米夫定(100mg/d)联合阿德福韦酯(10mg/d)治疗;单药组使用替诺福韦酯(300mg/d)治疗,所有患者均治疗48周。治疗基线、12、24和48周分别进行病毒学、生化学、血清学检测。回顾性分析,比较两组患者上述治疗时间点的HBV DNA转阴率、ALT复常率、病毒学突破率、HBeAg血清学转换率及观察药物不良反应。结果 联合组患者治疗48周后HBV DNA转阴率、ALT复常率分别为85.0%(34/40)、80.0%(32/40),单药组分别为87.5%(35/40)、80.0%(32/40),两组比较差异无统计学意义(P均>0.05)。而48周后,联合组与单药组的HBeAg血清学转换率分别为34.6%(9/26)和14.3%(4/28),两组比较差异均有统计学意义(P<0.05)。联合用药组累计发生病毒学突破2例(2/40,5.0%),单药组未发生病毒学突破,比较差异具有统计学意义(P<0.05)。两组患者耐受性均良好,无1例出现严重不良反应而导致停药。结论 拉米夫定和阿德福韦酯初始联合在HBV DNA转阴率、ALT复常率及安全性方面与替诺福韦酯单药治疗相似;HBeAg血清转换率方面优于替诺福韦酯单药治疗;然而病毒学突破率高于替诺福韦酯单药治疗。
中文关键词:慢性乙型肝炎  拉米夫定  阿德福韦酯  替诺福韦酯  抗病毒治疗
 
Efficacy and Safety Comparation Between Lamivudine Plus Adefovir Dipivoxil Initial Combination and Tenofovir Disoproxil Fumarate Initial Monotherapy in the Treatment of Chronic Hepatitis B for 48 Weeks
Abstract:Objective To compare the clinical efficacy and sfety of lamivudine(LAM) plus adefovir dipivoxil(ADV) initial combination therapy and tenofovir disoproxil fumarate(TDF) initial monotherapy in chronic hepatitis B patients for 48 weeks. Methods Forty patients of chronic hepatitis B on initial treatment with LAM(100mg/d) in combination with ADV(10mg/d) for 48 weeks served as group A were analyzed retrospectively.The serum HBV DNA levels, HBeAg, ALT and adverse events were evaluated at week 0, 12, 24, 48.In addition, data of 40 cases treated with TDF(300mg/d) initial monotherapy for 48 weeks served as group B were also collected. Results After 48 weeks follow up, the virological response(VR) rate, ALT normalization rate were 85.0%(34/40), 80.0%(32/40) in group A, respectively.Meanwhile, in group B, its were 87.5%(35/40), 80.0%(32/40), respectively, and P value did not show significant difference.But the seroeonversion rate(from HBeAg to HBeAb), virologic breakthrough (VB) rate were 34.6%(9/26), 5.0%(2/40) in group A and 16.7%(4/24), 0 in group B, respectively with P value all less than 0.05 when the two groups were compared. Both groups showed comparably tolerant and safe to therapy. Conclusion The therapy of combining LAM and ADV is similar with TDF monotherapy in terms of VR rate and ALT normalization rate, and LAM puls ADV combination is superior to TDF monotherapy in terms of HBeAg seroconversion rate, but it's inferior in terms of VB rate to TDF monotherapy.
keywords:Chronic hepatitis B  Lamivudine  Adefovir dipivoxil  Tenofovir disoproxil fumarate  Antiviral therapy
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