Objective To evaluate the safety and efficacy of telbivudine (LdT)treatment in pregnant women with chronic hepatitis B.Methods Twenty therapy-naïve pregnant (PW)and 20 non-pregnant (NPW)CHB patients were enrolled into a prospective,single-center,non-randomized clinical study with administration of LdT 600 mg/d for 96 weeks.Etiology and biochemical indexes were detected every 1 2 weeks.Maternal and newborn health assessment was compared between two groups.The mean age of NPW/PW was 28.65/27.78 years,ALT level was 275.24/344.52 (IU/L),HBV DNA level was 6.19/5.95 (Log copies/mL),HBsAg level was 3.27/4.33 (Log IU/mL),and percentage of HBeAg-positive was 66.7%/70%.The endpoints of treatment included HBV DNA undetectable (<500 copies/mL), HBeAg seroconversion,virological breakthrough (HBV DNA increased by >1 log)and resistance.Results After two years'treatment,HBeAg seroconversion rate was 35.7% in PW group and 38.4% in NPW group.HBV DNA undectable of PW and NPW groups was 85.0% and 78.9%,respectively.Cumulative rate of ALT normalization from PW and NPW groups was 85% and 89% (P>0.05),respectively.Two cases experienced virologic breakthrough (rtM204I mutation) with LdT in NPW.Mild elevation of creatine kinase (CK)was occurred in 1 of 20 patients in PW (325 U/L),and 2 of 19 patients in NPW (273 U/L and 412 U/L).CK levels did not continue to rise after continuous LdT treatment.All pregnant women delivered their infants after a full-term pregnancy.Newborns were normal.Conclusion LdT had the same curative effect for pregnant and non-pregnant CHB patients and no adverse reactions were observed.%目的：探讨替比夫定(LDT)治疗妊娠合并慢性乙型肝炎的价值。方法采用前瞻性、单中心和非随机对照研究。选择慢性乙型肝炎患者40例,其中合并妊娠20例作为妊娠组,未合并妊娠20例作为无妊娠组。均经 LDT 600 mg/d治疗96周,检测治疗12、24、48和96周时 HBeAg、HBV DNA及 ALT的变化。孕产妇及新生儿健康评估与正常孕产妇对照。结果 LDT治疗96周后,妊娠组和无妊娠组 HBeAg血清学转换为5/14例和5/13例；HBV DNA<500拷贝/mL分别占17/20例和14/19例；ALT 正常17/20例和14/19例；两组比较,差异无统计学意义(P>0.05)。无妊娠组有2例病毒学突破(rtM204I突变)。妊娠组和无妊娠组各发生肌酸肌酶升高1例(325 U/L)和2例(273 U/L,412 U/L)。所有孕妇足月分娩,新生儿正常。结论 LDT用于妊娠慢性乙型肝炎疗效与非妊娠肝炎相同,未发现明显不安全因素。
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