Clinical trial of telbivudine in the treatment of chronic hepatitis B in patients during the third trimester of pregnancy
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摘要:
目的研究慢性乙型肝炎孕妇妊娠晚期予替比夫定(LdT)抗病毒治疗对控制肝炎活动、阻断HBV母婴传播的意义。方法把116例HBsAg、HBeAg、抗-HBc阳性,HBV DNA≥1×105拷贝/ml,ALT≥2×ULN,伴或不伴TBil升高的慢性乙型肝炎孕妇,根据自愿原则分为两组,治疗组65例(孕28±2周)在护肝降酶的基础上服用LdT,600 mg/d,对照组51例仅予护肝降酶治疗,两组新生儿出生后均予主被动联合免疫。比较两组患者在分娩前及产后7个月HBV DNA、ALT、TBil水平的变化,比较两组新生儿在7个月时HBsAg携带率、抗-HBs阳转率,观察母婴并发症发生情况。结果治疗组孕妇分娩前及产后7个月HBV DNA、ALT、TBil值明显低于对照组,差异有统计学意义(P<0.05);治疗组和对照组新生儿7个月时HBsAg携带率分别为1.5%和15.7%,抗-HBs阳性率分别为95.4%和78.4%,差异有统计学意义(P<0.05)。治疗组母婴并发症发生明显少于对照组。结论 LdT能有效控制肝炎活动,快速降低慢性乙型肝炎孕妇的HBV DNA水平,同时减少HBV母婴垂直传播...
Abstract:Objective To investigate the significance of telbivudine (LdT) in controlling hepatitis activity and blocking mother-to-infant transmission of hepatitis B virus (HBV) in women with chronic hepatitis B (CHB) during late pregnancy.Methods A total of 116 pregnant women were enrolled.Each was positive for hepatitis B surface antigen (HBsAg) , hepatitis B e-antigen (HBeAg) and hepatitis B core antibody (anti-HBc) .They all also had HBV DNA levels of ≥105 copies/ml and alanine amino transferase (ALT) levels of ≥2×ULN, with or without total bilirubin (TBil) increase.They were divided into two groups based upon their personal preference, the treatment group (n=65) and control group (n=51) .The patients in the treatment group were (28±2) weeks pregnant and received LdT 600 mg once daily in addition to liver-protecting and enzyme-reducing treatments, while the patients in the control group received only the standard liver-protecting and enzyme-reducing treatment.All infants delivered by the participants received both active and passive immunization after birth.The women in the two groups were compared in terms of the HBV DNA, ALT and TBIL levels before delivery and at 7 months after delivery;positive rates of HBsAg and hepatitis B surface antibody (anti-HBs) were compared in the infants in both groups at 7 months after birth.Furthermore, maternal and neonatal complications were observed.Results The levels of serum HBV DNA, ALT and TBIL in the treatment group were significantly lower than those in the control group before delivery and at 7 months after delivery (P<0.05) .At 7 months after birth, the infants in the treatment group had a significantly lower positive rate for HBsAg (1.5% vs.15.7%, P<0.05) and a significantly higher anti-HBs-positive rate (95.4% vs.78.4%, P<0.05) compared with those in the control group.Maternal and neonatal complications occurred significantly less frequently in the treatment group than in the control group.Conclusion LdT is effective in controlling hepatitis activity in pregnant women with CHB, as it rapidly decreases HBV DNA levels and reduces mother-to-infant transmission of HBV.Its use is therefore beneficial to both mothers and infants.
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Key words:
- telbivudine /
- hepatitis B /
- chronic /
- pregnancy
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