摘要
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、HBVDNA〉1．0×10^7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600mg／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昔。两组婴儿产后均接受主、被动联合免疫，出生后12h内、15d注射乙型肝炎免疫球蛋白200IU及0、1、6个月注射乙型肝炎疫苗20μg。婴儿7月龄时HBsAg及HBVDNA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HBVDNA、HBeAg、ALT水平下降明显。替比夫定组HBVDNA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HBVDNA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、HBVDNA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HBVDNA定量，阻断HBV母婴传播，且耐受性和安全性良好。
Objeodve To evaluate the efficacy and safety of telbivudine use during the second and third trimester of pregnancy for reducing hepatitis B virus （I-IBV） 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 〉 1.0xl07 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 ~tg） at 0, 1 and 6 months. The I-IBV perinatal transmission rate was determined by measuring HBsAg and HBV DNA in infants at postpartum week 28. Results A total of 220 pregnant women were enrolled in our study, 120 chose the telbivudine arm and 100 chose the control arm. All telbivudine treated subjects were registered in the Antiretroviral Pregancy Registry. Telbivudine treatment was associated with a marked reduction in the mothers＇ serum HBV DNA, HBeAg and ALT levels before delivery. A striking decline of HBV DNA levels in treated mothers was observed at week 2 of treatment, which was followed by a gradual and steady decrease that continued until delivery. Thirty-seven （31%） of the telbivudine-treated mothers and none （0%） of the untreated controls had polymerase chain reaction-undetectable viremia at delivery. At week 28, 0% of the infants delivered from telbivudine-treated mothers were HBsAg＋ or HBV DNA＋, as compared to 8% HBsAg＋ or HBV DNA＋ in the untreated control arm （P = 0.002）. No telbivudine discontinuations occurred from adverse events, and no congenital deformities were observed in the infants delivered to telbivudine-treated mothers. Eighty mothers discontinued telbivudine at week 4 postpartum, and there were no cases of severe hepatitis. There were no significant differences between the two treatment arms for postpartum hemorrhage, adverse events during pregnancy, cesarean section, gestational age, or infants＇ height/weight or Apgar scores. Conclusions Telbivudine use during the second and third trimester of pregnancy in HBeAg＋ highly viremie mothers can safely reduce perinatal HBV transmission rates. Telbivudine was well-tolerated by our patient group. Furthermore, no safety concerns were observed in either the telbivudine-treated mothers or their delivered infants in short term follow-up.
出处
《中华肝脏病杂志》
CAS
CSCD
北大核心
2012年第3期201-205,共5页
Chinese Journal of Hepatology
基金
江苏省卫生厅基金资助项目（H200804）
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
Hepatitis B virus
Pregnancy
Disease transmission, vertical
Prevention＆control
Telbivudine
