富马酸丙酚替诺福韦用于预防乙型肝炎病毒母婴传播有效性和安全性的系统评价

Efficacy and safety of tenofovir alafenamide fumarate on the prevention of mother-tochild transmission of hepatitis B virus:a systematic review and Meta-analysis

目的探讨富马酸丙酚替诺福韦(tenofovir alafenamide fumarate,TAF)预防乙型肝炎病毒(hepatitis B virus,HBV)母婴传播的有效性和安全性。方法计算机检索PubMed、Cochrane Library、Embase、CNKI、WanFang Data、VIP数据库,检索TAF用于妊娠期妇女的研究,检索时限均为建库至2022年2月。由2名研究者独立完成筛选文献、提取资料、评价纳入研究的偏移风险后,采用Rev Man 5.4软件进行Meta分析。结果共纳入6篇文献,包括596例孕妇。Meta分析表明,TAF组母婴传播阻断率(RR=0.67,95%CI:0.12~3.75,P=0.65)、新生儿先天畸形率(RR=0.33,95%CI:0.01~7.91,P=0.50)及母亲产前HBV DNA水平(SMD=0.09,95%CI:-0.09~0.26,P=0.34)与富马酸替诺福韦二吡呋酯(tenofovir disoproxil fumarate,TDF)组相当。TAF组无严重不良反应发生,一般不良反应发生率低于TDF组,对肌酐影响(SMD=-0.90,95%CI:-3.22~1.42,P=0.45)与TDF组相似,但对尿β_(2)微球蛋白的影响较TDF组小。结论当前有限证据表明,TAF用于预防HBV母婴传播疗效与TDF相似,对肾功能影响较TDF小,提示针对HBV感染合并肾功能受损孕妇,TAF可能比TDF更合适。

Objective To investigate the efficacy and safety of tenofovir alafenamide fumarate(TAF)on the prevention of mother-to-child transmission of hepatitis B virus(HBV).Methods CNKI,VIP,WanFang Data,PubMed,ScienceDirect,The Cochrane Library and EMbase databases were electronically searched to collect studies of TAF used in pregnant women from inception to February 2022.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Meta-analysis was then performed by using RevMan 5.4 software.Results A total of 6 studies involving 596 patients were included.The results of Meta-analysis showed that TAF and tenofovir disoproxil fumarate(TDF)may have similar effects on preventing mother-to-child transmission of HBV(RR=0.67,95%CI:0.12~3.75,P=0.65),the incidence of congenital malformations(RR=0.33,95%CI:0.01~7.91,P=0.50)and maternal prenatal HBV DNA level(SMD=0.09,95%CI:-0.09~0.26,P=0.34).No serious adverse reactions occurred in TAF group.The effect of TAF on creatinine(SMD=-0.90,95%CI:-3.22~1.42,P=0.45)was similar to that of TDF,however,the effect on urineβ_(2) glycoprotein was smaller than that of TDF.Conclusions Current evidence showed that TAF and TDF might have similar effects on preventing mother-tochild transmission of HBV,and TAF had less effect on renal function than TDF.It is suggested that TAF might be more suitable for pregnant woman with HBV infection complicated with renal function impairment than TDF.