替比夫定对乙型肝炎病毒高载量孕妇母婴传播的阻断效果及其安全性.docVIP

替比夫定对乙型肝炎病毒高载量孕妇母婴传播的阻断效果及其安全性 韩国荣 江红秀 王根菊 岳欣 王翠敏 阚乃颖 吴岷岷 ? 目的 评价妊娠中晚期应用替比夫定阻断HBeAg阳性且高病毒载量孕妇母婴传播的安全性及有效性。 方法 选择孕20～32周，HBeAg阳性、HBV DNA 1.0×107拷贝/ml孕妇，按患者意愿分替比夫定组和对照组，替比夫定组予替比夫定600 mg/d口服抗病毒治疗直至产后4周或产后继续服用，对照组患者不用抗病毒药物，肝功能异常者使用复方甘草酸苷。两组婴儿产后均接受主、被动联合免疫，出生后12 h内、15 d注射乙型肝炎免疫球蛋白 200 IU及0、1、6个月注射乙型肝炎疫苗20μg。婴儿7月龄时HBsAg及HBV DNA阳性者为HBV宫内感染。 结果 共纳入220例孕妇，其中替比夫定组120例，对照组100例。替比夫定治疗者均在美国抗逆转录酶药物妊娠登记处注册。分娩前替比夫定组孕妇HBV DNA、HBeAg、ALT水平下降明显。替比夫定组HBV DNA定量于治疗2周迅速下降，之后缓慢下降直至分娩。至分娩前替比夫定抗病毒孕妇有37例HBV DNA定量转阴，转阴率达31%（37/120），而对照组无一例转阴。随访至7月龄，替比夫定组婴儿HBV宫内感染率为0，显著低于对照组8%（P = 0.002）。替比夫定组无一例母儿因不良反应或先天性畸形失访。80例替比夫定治疗者于产后4周停药，随访至产后28周无一例发生严重肝功能损害。两组孕妇产后出血、不良妊娠、剖宫产率及新生儿胎龄、身长、体质量、Apgar评分，差异无统计学意义。 结论 HBeAg阳性、HBV DNA高滴度孕妇妊娠中晚期应用替比夫定抗病毒治疗能明显降低母亲外周血HBV DNA定量，阻断HBV母婴传播，且耐受性和安全性良好。 【关键词】 肝炎病毒，乙型； 妊娠; 疾病传播，垂直； 预防和控制； 替比夫定 ? Efficacy and safety of telbivudine in pregnant women to prevent perinatal transmission of hepatitis B virus HAN Guo-rong, JIANG Hong-xiu, WANG Gen-ju, YUE Xin, WANG Cui-min, KAN Nai-ying, WU Min-min. Department of Gynecology and Obstetrics, the Second Affiliated Hospital of the Southeast University, Nanjing 210003, China Email: hgr518@163.com 【Abstract】 Objective To evaluate the efficacy and safety of telbivudine use during the second and third trimester of pregnancy for reducing hepatitis B virus (HBV) transmission from highly viremic hepatitis B e antigen-positive (HBeAg+) mothers to their fetuses. Methods Pregnant women, between weeks 20～32 of gestation, who were HBeAg+ and had HBV DNA 1.0×107 copies/mL were enrolled in our study. The women were offered inclusion into one of two treatment arms, based upon their personal preference: telbivudine or no telbivudine. The patients in the telbivudine treatment arm were adminstered 600 mg/d tebivudine at least until postpartum week 4. All delivered infants in both treatment arms were administered hepatitis B immune globulin (HBIG; 200 IU) within 12 hours of delivery and recombinant HBV vaccine (20 μg)