核苷(酸)类似物在妊娠期乙型肝炎患者中的安全性研究进展

The safety research progress of nucleoside/nucleotide analogues used in HBV-infected pregnant women

慢性乙型肝炎病毒(hepatitis B virus,HBV)感染是严重危害人类健康的世界性公共卫生问题。母婴传播是HBV感染的主要途径之一,妊娠女性高病毒载量是HBV母婴传播的高危因素,因此,有必要在妊娠期通过有效、安全的抗病毒治疗来降低高病毒载量母体血清HBV DNA水平,降低胎儿感染HBV的风险。本文通过检索国内外文献资料,从临床前的动物试验和人类妊娠期的使用经验两个方面对核苷(酸)类似物(nucleoside/nucleotide analogues,NAs)在妊娠期乙型肝炎患者中的安全性研究进展进行了归纳和总结。目前而言,所有NAs在妊娠期使用仍然存在潜在的风险,基于现有数据,替诺福韦酯、替比夫定和拉米夫定是妊娠期相对风险较低的NAs,但NAs暴露对婴儿发育是否存在远期风险仍需更多临床数据进行评估。

Chronic hepatitis B virus(HBV)infection is a worldwide public health problem which is severely harm to health.The mother-to-child transmission is one of the main transmission routes of HBV infection,and pregnant woman with high viral load is a high risk factor of HBV transmission.So it is necessary to decrease the high serum level of HBV DNA in pregnant women with subsequent reduction in the risk of infant HBV infections by effective and safe antiviral therapy.Based on domestic and abroad literature,the safety research progress of nucleoside/nucleotide analogues(NAs)for HBV-infected pregnant women was summarized focusing on two aspects of preclinical animal experiments and experience of drug use in pregnant women.At present,all the NAs have potential risk for pregnant women,among which tenofovir disoproxil,telbivudine and lamivudine are relatively safe.But it is still necessary to carry out more studies to evaluate the long-term risk of NAs exposure for infant development.