拉米夫定阻断乙型肝炎病毒母婴传播的荟萃分析。
A meta-analysis of lamivudine for interruption of mother-to-child transmission of hepatitis B virus.
机构信息
Department of Epidemiology, Second Military Medical University, Shanghai 200433, China.
出版信息
World J Gastroenterol. 2011 Oct 14;17(38):4321-33. doi: 10.3748/wjg.v17.i38.4321.
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; P(heterogeneity) = 0.04) and 0.33 (95% CI, 0.23-0.47; 6 RCTs; P(heterogeneity) = 0.93) indicated by newborn HBsAg or HBV DNA. The RR was 0.33 (95% CI, 0.21-0.50; 6 RCTs; P(heterogeneity) = 0.46) and 0.32 (95% CI, 0.20-0.50; 4 RCTs; P(heterogeneity) = 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; P(heterogeneity) = 0.94) and 0.24 (95% CI, 0.07-0.79; 3 RCTs; P(heterogeneity) = 0.60) indicated by newborn HBsAg or HBV DNA, respectively. In the mothers with viral load < 10⁶ copies/mL after lamivudine treatment, the efficacy (RR, 95% CI) was 0.33, 0.21-0.53 (5 RCTs; P(heterogeneity) = 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; P(heterogeneity) = 0.92) and 0.33 (95% CI, 0.22-0.50; 5 RCTs; P(heterogeneity) = 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 < 10⁶ copies/mL by lamivudine treatment.
目的
确定拉米夫定在妊娠晚期对乙型肝炎病毒（HBV）母婴传播（MTCT）的阻断作用。
方法
通过检索截至 2011 年 1 月的可用数据库，确定研究。纳入标准为：接受拉米夫定治疗的 HBV 携带者母亲参与了随机对照临床试验（RCT），且新生儿或婴儿的血清乙型肝炎表面抗原（HBsAg）、乙型肝炎 e 抗原（HBeAg）或 HBV DNA 已被记录。通过计算新生儿或婴儿 HBsAg、HBV DNA 或 HBeAg 的相对风险（RR），计算 95%置信区间（CI），以评估拉米夫定治疗的疗效。
结果
本荟萃分析纳入了 15 项 RCT，共计 1693 例 HBV 携带者母亲。总的 RR 为 0.43（95%CI，0.25-0.76；8 项 RCT；P（异质性）=0.04）和 0.33（95%CI，0.23-0.47；6 项 RCT；P（异质性）=0.93），提示新生儿 HBsAg 或 HBV DNA。RR 为 0.33（95%CI，0.21-0.50；6 项 RCT；P（异质性）=0.46）和 0.32（95%CI，0.20-0.50；4 项 RCT；P（异质性）=0.33），提示婴儿出生后 6-12 个月的血清 HBsAg 或 HBV DNA。RR（拉米夫定与乙型肝炎免疫球蛋白）为 0.27（95%CI，0.16-0.46；5 项 RCT；P（异质性）=0.94）和 0.24（95%CI，0.07-0.79；3 项 RCT；P（异质性）=0.60），提示新生儿 HBsAg 或 HBV DNA。在拉米夫定治疗后病毒载量<10⁶ 拷贝/ml 的母亲中，阻断 MTCT 的疗效（RR，95%CI）为 0.33，0.21-0.53（5 项 RCT；P（异质性）=0.82），但如果拉米夫定治疗后母亲的病毒载量>10⁶ 拷贝/ml，则该值无统计学意义（P=0.45，2 项 RCT），提示新生儿血清 HBsAg。RR（拉米夫定从 28 孕周开始治疗与对照组）为 0.34（95%CI，0.22-0.52；7 项 RCT；P（异质性）=0.92）和 0.33（95%CI，0.22-0.50；5 项 RCT；P（异质性）=0.86），提示新生儿 HBsAg 或 HBV DNA。拉米夫定组母亲的不良反应发生率并不高于对照组（P=0.97）。只有一项研究报告了拉米夫定在新生儿中的副作用。
结论
从 28 孕周开始对 HBV 携带者母亲进行拉米夫定治疗可能会有效阻断 HBV 的母婴传播。拉米夫定在阻断母婴传播方面比乙型肝炎免疫球蛋白更安全、更有效。如果通过拉米夫定治疗将母亲的病毒载量降低至<10⁶ 拷贝/ml，则可能会有效阻断 HBV 的母婴传播。
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