Forty-eight-week efficacy of adefovir dipivoxil alone versus combined with lamivudine in treatment of lamivudine-resistant HBeAg-positive chronic hepatitis B
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摘要: 目的观察拉米夫定(LAM)与阿德福韦酯(ADV)联合应用和单用ADV治疗LAM耐药HBeAg阳性慢性乙型肝炎患者的疗效及安全性。方法收集2006年1月至2011年12月在本院就诊的LAM耐药HBeAg阳性慢性乙型肝炎患者40例,单药组与联合组各20例,分别以ADV与LAM联合或单用ADV进行治疗。观察治疗24周、48周时的血清HBV DNA水平及转阴率、HBeAg转阴率、ALT复常率以及治疗过程中药物的不良反应和耐药性。组间比较计量资料采用t检验,计数资料采用卡方检验。结果两组患者在性别、年龄、治疗前的HBV DNA及ALT水平上差异均无统计学意义(P>0.05);治疗结束时联合组的血清HBV DNA转阴率和ALT复常率分别为90%及95%,而单药组的血清HBV DNA转阴率和ALT复常率分别为60%及65%,两组比较差异有统计学意义(P<0.05);治疗结束时联合组血清HBeAg转阴率为45%,单药组为35%,两组比较差异无统计学意义(χ2=0.417,P=0.519)。结论 ADV联合LAM或ADV单药治疗LAM耐药HBeAg阳性慢性乙型肝炎患者均有较好的临床疗效,但A...Abstract: Objective To observe the therapeutic efficacy and safety of adefovir dipivoxil (ADV) alone versus combined with lamivudine (LAM) in the treatment of LAM- resistant HBeAg- positive chronic hepatitis B (CHB) . Methods Forty patients with LAM- resistant HBeAg- positive CHB were randomly assigned to monotherapy group (n = 20) and combination therapy group (n = 20) . The monotherapy group received ADV alone, while the combination therapy group received ADV combined with LAM. After 24 and 48 weeks of treatment, serum HBV DNA level, undetectable HBV DNA rate, HBeAg loss rate, alanine aminotransferase ( ALT) normalization rate, adverse reactions, and drug resistance were assessed. The two groups were compared by t- test for continuous data and chi- square test for categorical data. Results There were no significant differences in sex, age, and pretreatment levels of serum HBV DNA and ALT between the two groups (P > 0. 05) . After 48 weeks of treatment, serum undetectable HBV DNA rate and ALT normalization rate for the combination therapy group were 90% and 95%, respectively, significantly higher than those for the monotherapy group (60% and 65%) (P < 0. 05) ; there was no significant difference in HBeAg loss rate between the combination therapy group and monotherapy group (45% vs 35%, χ2= 0. 417, P =0. 519) . Conclusion ADV alone or combined with LAM has good clinical efficacy in the treatment of LAM- resistant HBeAg- positive CHB. However, the combination therapy can increase undetectable HBV DNA rate and ALT normalization rate and has good safety, and it holds promise for clinical application.
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Key words:
- hepatitis B, chronic /
- lamivudine /
- adefovir dipivoxil /
- drug resistance, viral
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