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

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

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、HBe Ag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HBe Ag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;HBe Ag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。

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.