AIM: To determine the therapeutic effect of lamivudine in late pregnancy for the interruption of mother-to-child transmission (MTCT) of hepatitis B virus (HBV). METHODS: Studies were identified by searching available databases up to January 2011. Inclusive criteria were HBV-carrier mothers who had been involved in randomized controlled clinical trials (RCTs) with lamivudine treatment in late pregnancy, and newborns or infants whose serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) or HBV DNA had been documented. The relative risks (RRs) for interruption of MTCT as indicated by HBsAg, HBV DNA or HBeAg of newborns or infants were calculated with 95% confidence interval (CI) to estimate the efficacy of lamivudine treatment. RESULTS: Fifteen RCTs including 1693 HBV-carrier mothers were included in this meta-analysis. The overall RR was 0.43 (95% CI, 0.25-0.76; 8 RCTs; Pheterogeneity = 0.04) and 0.33 (95% CI, 0.23-0.47; 6 RCTs; Pheterogeneity = 0.93) indicated by newborn HBsAg or HBV DNA. The RR was 0.33 (95% CI, 0.21-0.50; 6 RCTs; Pheterogeneity = 0.46) and 0.32 (95% CI, 0.20-0.50; 4 RCTs; Pheterogeneity = 0.33) indicated by serum HBsAg or HBV DNA of infants 6-12 mo after birth. The RR (lamivudine vs hepatitis B immunoglobulin) was 0.27 (95% CI, 0.16-0.46; 5 RCTs; Pheterogeneity = 0.94) and 0.24 (95% CI, 0.07-0.79; 3 RCTs; Pheterogeneity = 0.60) indicated by newborn HBsAg or HBV DNA, respectively. In the mothers with viral load 6 copies/mL after lamivudine treatment, the efficacy (RR, 95% CI) was 0.33, 0.21-0.53 (5 RCTs; Pheterogeneity = 0.82) for the interruption of MTCT, however, this value was not significant if maternal viral load was > 106 copies/mL after lamivudine treatment (P = 0.45, 2 RCTs), as indicated by newborn serum HBsAg. The RR (lamivudine initiated from 28 wk of gestation vs control) was 0.34 (95% CI, 0.22-0.52; 7 RCTs; Pheterogeneity = 0.92) and 0.33 (95% CI, 0.22-0.50; 5 RCTs; Pheterogeneity = 0.86) indicated by newborn HBsAg or HBV DNA. The incidence of adverse effects of lamivudine was not higher in the mothers than in controls (P = 0.97). Only one study reported side effects of lamivudine in newborns. CONCLUSION: Lamivudine treatment in HBV carrier-mothers from 28 wk of gestation may interrupt MTCT of HBV efficiently. Lamivudine is safe and more efficient than hepatitis B immunoglobulin in interrupting MTCT. HBV MTCT might be interrupted efficiently if maternal viral load is reduced to 6 copies/mL by lamivudine treatment.
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机译：目的：确定拉米夫定在妊娠晚期对阻断乙型肝炎病毒（HBV）的母婴传播（MTCT）的治疗效果。方法：通过搜索截至2011年1月的可用数据库进行研究鉴定。纳入标准包括在晚期妊娠中参与了接受拉米夫定治疗的随机对照临床试验（RCT）的HBV携带者母亲，以及血清B型肝炎表面抗原的新生儿或婴儿（HBsAg），乙型肝炎e抗原（HBeAg）或HBV DNA已被记录。以95％的置信区间（CI）计算新生儿或婴儿的HBsAg，HBV DNA或HBeAg所指示的MTCT中断的相对风险（RRs），以评估拉米夫定治疗的有效性。结果：这项荟萃分析包括15项RCT，包括1693例HBV携带者母亲。总体RR为0.43（95％CI，0.25-0.76; 8个RCT; P 异质性 = 0.04）和0.33（95％CI，0.23-0.47; 6个RCT; P 异质性 = 0.93）表示为新生儿HBsAg或HBV DNA。 RR为0.33（95％CI，0.21-0.50; 6个RCT; P 异质性 = 0.46）和0.32（95％CI，0.20-0.50; 4 RCTs; P 异质性 = 0.33）由出生后6-12 mo的婴儿血清HBsAg或HBV DNA指示。 RR（拉米夫定与乙型肝炎免疫球蛋白）分别为0.27（95％CI，0.16-0.46; 5个RCT; P <异质性 = 0.94）和0.24（95％CI，0.07-0.79; 3个RCT; P新生儿HBsAg或HBV DNA分别表示 heterogeneity = 0.60）。拉米夫定治疗后病毒载量为6 / mL的母亲，其拉米夫定的疗效（RR，95％CI）为0.33，0.21-0.53（5 RCT; P 异质性 = 0.82）然而，如新生儿血清HBsAg所示，如果拉米夫定治疗后母亲病毒载量> 10 6 拷贝/ mL，则该值无统计学意义（P = 0.45，2个RCT）。 RR（从妊娠28周开始vs.对照组开始的拉米夫定）分别为0.34（95％CI，0.22-0.52; 7个RCT; P heterogeneity = 0.92）和0.33（95％CI，0.22-0.50; 5个RCT; P heterogeneity = 0.86），由新生儿HBsAg或HBV DNA指示。母亲中拉米夫定的不良反应发生率不高于对照组（P = 0.97）。只有一项研究报道了拉米夫定对新生儿的副作用。结论：妊娠28周后拉米夫定治疗HBV携带者母亲可有效中断HBV的MTCT。拉米夫定在阻断MTCT方面比乙肝免疫球蛋白安全，有效。如果通过拉米夫定治疗将孕妇的病毒载量降至6拷贝/ mL，则可能会有效中断HBV MTCT。
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