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目的评价阿德福韦酯(Adefovir dipivoxil,AD)单独或联合拉米夫定(Lamivudine,LAM)对拉米夫定耐药的慢性乙型肝炎患者的疗效差异。方法根据纳入标准,摘录7篇随机对照试验(RCT)的研究结果,用RevMan 4.2软件进行分析。结果与单用AD(10mg/d)相比,AD(10 mg/d)+LAM(100 mg/d)能更显著地提高HBV-DNA、HBeAg转阴率,HBeAg血清学转换率和ALT复常率:RR(95%CI,P)分别为1.39(1.26~1.54,<0.00001),2.28(1.58~3.30,<0.0001),2.58(1.61~4.14,<0.0001),1.29(1.17~1.42,<0.00001);显著降低病毒学突破发生率和耐AD基因突变发生率:RR(95%CI,P)分别为0.10(0.03~0.34,0.0002)和0.12(0.02~0.95,0.04);而两组药物副作用发生率的差异无统计学意义(RR=0.94,95%CI0.75~1.17,P=0.57)。结论采用AD+LAM联合治疗LAM耐药的慢性乙肝患者,较之单用AD,能更显著地提高HBV-DNA、HBeAg转阴率、血清学转换率和ALT复常率,降低病毒学突破发生率和耐AD基因突变发生率,且不增加药物副作用,值得临床推广。
Objective To evaluate the efficacy of Adefovir dipivoxil (AD) alone or in combination with lamivudine (LAM) in patients with lamivudine-resistant chronic hepatitis B. Methods According to the inclusion criteria, the results of seven randomized controlled trials (RCTs) were extracted and analyzed using RevMan 4.2 software. Results AD (10 mg / d) + LAM (100 mg / d) increased HBV DNA, HBeAg negative rate, HBeAg seroconversion rate and ALT complex more significantly than AD alone (10 mg / d) The rates of RR (95% CI, P) were 1.39 (1.26-1.54, <0.00001), 2.28 (1.58-3.30, <0.0001), 2.58 (1.61-4.14, 0.00001). Significantly reduce the incidence of virological breakthrough and AD gene mutations: RR (95% CI, P) were 0.10 (0.03-0.34,0.0002) and 0.12 (0.02-0.95,0.04) The incidence of side effects was not statistically different (RR = 0.94, 95% CI 0.75 to 1.17, P = 0.57). Conclusions The combination of AD + LAM and LAM-resistant chronic hepatitis B patients can significantly improve HBV-DNA, HBeAg negative conversion rate, seroconversion rate and ALT normalization rate and reduce virological breakthrough compared with AD alone Rate and resistance to AD gene mutations, and does not increase the side effects of drugs, is worth clinical promotion.