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机构地区:[1]桂林医学院研究生学院,桂林541004 [2]合肥市第三人民医院感染科,合肥230022 [3]广西壮族自治区桂林市第三人民医院肝病科,桂林541002
出 处:《医药导报》2013年第7期894-898,共5页Herald of Medicine
基 金:广西壮族自治区卫生厅立项课题(Z2008241)
摘 要:目的比较拉米夫定(LAM)单药治疗与LAM和阿德福韦酯(ADV)联合治疗LAM停药后复发但未发生YMDD变异的B、C基因型慢性乙型肝炎(CHB)的临床疗效。方法将120例LAM停药复发的CHB患者按分为LAM单药治疗组58例,其中HBV基因B型30例,基因C型28例;LAM与ADV联合治疗组62例,其中HBV基因B型32例,基因C型30例。单药组应用LAM100 mg.d-1,联合组在其基础上加用ADV 10 mg.d-1,po,疗程均为1年。结果经1年治疗,单药组丙氨酸氨基转移酶(ALT)复常率B型和C型比较差异无统计学意义,联合组B型和C型比较差异无统计学意义,但联合组高于单药组(83.87%与55.17%,χ2=11.753,P<0.01);联合组和单药组HBV DNA检测不出率分别为77.42%和46.55%(χ2=12.182,P<0.01);联合组HBeAg血清学转换率为26.83%(11/41),而单药组为2.63%(1/38),差异有统计学意义(χ2=8.964,P<0.01)。单药组有10例出现病毒学突破。而联合组未出现病毒学突破。结论LAM单药或与ADV联合治疗对B、C基因型CHB患者疗效无区别。联合治疗LAM停药后复发但未发生YMDD变异B、C基因型CHB患者可迅速显著抑制HBV DNA复制,在病毒学、生物化学和HBeAg血清学转换方面具有更好的效果。Objective To compare clinical efficacy of lamivudine (LAM) monotherapy with LAM plus adefovir dipivoxil (ADV) in chronic hepatitis B (CHB) patients who relapsed after discontinuing LAM monotherapy with B or C genotype but no YMDD mutation. Methods One hundred and twenty CHB patients who relapsed after LAM withdrawal were randomized to receive LAM monotheray (n=58, 30 had genotype B and 28 had genotype C) , or LAM and ADV combination therapy (n = 62, 32 had genotype B and 30 had genotype C). The monotherapy group received LAMI00 mg daily and the combination therapy group received LAM 100 mg plus ADV 10mg every day. The treatemnt were continued for one year, comparing its efficacy. Results There was no difference between genotype B and C in either the monotherapy or combination therapy group. Compared to the monotherapy, the combination therapy achieved significantly higher transaminase normalization rate (83.87% vs 55.17% ,X2 = 11. 753, P〈0.01) , HBV DNA undetectable rate (77, 42% vs 46.55% ,X2 = 12. 182, P〈 0.01), and negative HBeAg serology rate (26.83% vs2.63% ,X2 = 8. 964, P〈0.01 ). During 1 year of treatment, the monotherapy group had 10 cases of viral breakthrough, as compared to zero in the combination group. Conclusion The genotype of CHB patients who relapsed from initial LAM treatment without YMDD mutation did not seem to affect the clinical outcome of either LAM monotherapy or LAM plus ADV combination therapy. The combination therapy is better than LAM monotherapy in suppression of viral DNA replication, biochemistry and HBeAg serological conversion.
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