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目的:系统评价妊娠中晚期服用富马酸替诺福韦二吡呋酯（TDF）预防乙型肝炎病毒（HBV）母婴传播的有效性和安全性。方法:检索国内外有关数据库（截至2019年7月20日），收集妊娠中晚期服用TDF预防HBV母婴传播疗效和安全性的随机对照试验（RCT）和队列研究，以Cochrane协作网的偏倚风险评估工具对RCT、纽卡斯尔-渥太华量表对队列研究进行质量评价，采用RevMan 5.3软件进行meta分析。连续性变量分析的效应值以标准化均数差（n SMD）及其95%置信区间（n CI）表示，二分类变量分析的效应值以比值比（n OR）或危险度（n RR）及其95n %CI表示。n 结果:共12项研究纳入分析，2项为RCT，10项为队列研究，共包括HBV感染母亲1 326例及其婴儿1 281例，妊娠中晚期服用TDF者729例（TDF组），未干预或应用安慰剂者597例（对照组）。质量评价结果显示，2项RCT中1项为“低偏倚风险”，1项为“高偏倚风险”；10项队列研究中9项为高质量，1项为中等质量。有效性结局的meta分析结果显示，TDF组母亲基线HBV DNA水平明显高于对照组（n SMD=0.15，95n %CI：0.04~0.26，n P=0.008），产前HBV DNA水平明显低于对照组（n SMD=n -5.41，95n %CI：n -7.26~ n -3.56，n P0.05）；1项研究结果显示TDF组母亲中1~2级无症状性血清肌酸激酶水平升高者占比高于对照组[7.2%（7/97）比0（0/100），n P=0.006]，其他妊娠不良事件、并发症发生率与对照组比较差异均无统计学意义（均n P>0.05）。n 结论:妊娠中晚期服用TDF可有效预防HBV母婴传播，对胎儿生长发育无明显影响。“,”Objective:To systematically evaluate the efficacy and safety of tenofovir disoproxil fumarate(TDF) treatment during the second or third trimester of pregnancy for preventing mother-to-infant transmission of hepatitis B virus (HBV).Methods:Randomized controlled trials (RCTs) and cohort studies on efficacy and safety of TDF in the second and third trimester of pregnancy for the prevention of mother-to- infant transmission of HBV were collected by searching related databases at home and abroad (up to July 20, 2019). Quality of RCTs and cohort studies were evaluated using bias risk assessment tool of Cochrane collaboration networks and Newcastle-Ottawa Scale, respectively. Meta-analysis was performed using RevMan 5.3 software. The continuous data were expressed using standardized mean difference (n SMD) and its 95% confidence interval (n CI). The effect values of meta-analysis of dichotomous variables were expressed using odds ratio (n OR) and its 95n %CI for effectiveness outcome or risk ratio (n RR) and 95n %CI for safety outcome.n Results:A total of 12 studies (2 RCTs and 10 cohort studies) were entered, including 1 326 HBV-infected mothers and their 1 281 infants, of which 729 mothers took TDF (the TDF group) and 597 mothers were without intervention or took placebo (the control group) in the second or third trimester of pregnancy. The results of quality evaluation showed that one of the 2 RCTs was at low risk of bias and the other one was at high risk of bias; 9 of the 10 cohort studies were of high quality and one was of medium quality. The meta analysis for effectiveness outcomes showed that the baseline HBV DNA level in patients in the TDF group was significantly higher than that in the control group (n SMD=0.15, 95n %CI: 0.04-0.26, n P=0.008), the prenatal HBV DNA level in patients in the TDF group was significantly lower than that in the control group (n SMD=n -5.41, 95n %CI: n -7.26--3.56, n P0.05); the results of one study showed that the proportion of mothers with grade 1-2 asymptomatic creatine kinase increase in the TDF group was higher than that in the control group [7.2% (7/97) n vs. 0 (0/100), n P=0.006] and the differences in the incidence of other adverse pregnancy events and complications in the 2 groups were not statistically significant (n P>0.05 for all).n Conclusion:The treatment of TDF in the second and third trimester of pregnancy can effectively prevent mother-to-infant transmission of HBV and has no significant impact on growth and development of the fetus.