CAJ | 학술논문

目的观察替比夫定(LdT)在CHB妇女全孕期应用的安全性,为CHB生育年龄妇女治疗方案的选择提供依据.方法前瞻性研究孕前或孕早期服用LdT的HBV感染者,观察孕产期母亲及其胎儿的不良事件.所有新生儿出生后均行母婴阻断,对新生儿进行短期和长期随访,观察新生儿出生后异常及HBV母婴阻断的情况.结果 145例患者中,143例为CHB,2例为代偿性肝硬化,HBVDNA＜500拷贝/mL者105例,占72.4％;HBeAg阳性125例,占86.0％.服用LdT治疗的妇女共妊娠154孕次,17例自然流产,4例异位妊娠,9例流产后再次妊娠.101例结束妊娠,100例为足月分娩,双胎妊娠2例,早产1例,活产103胎.发现胎儿唇颚裂1例,孕24周引产终止妊娠.出生后发现右耳附耳、左耳下良性淋巴结和先天性心脏病各1例.7例患者孕期CK增高,8例孕期出现病毒耐药,无一例在孕期发生肝病进展.63例婴儿随访时间≥6月龄,无一例HBsAg阳性,母婴阻断成功率为100.0％.结论 CHB患者全孕期应用LdT治疗安全、有效.
목적 관찰체비부정(LdT)재CHB부녀전잉기응용적안전성,위CHB생육년령부녀치료방안적선택제공의거.방법 전첨성연구잉전혹잉조기복용LdT적HBV감염자,관찰잉산기모친급기태인적불량사건.소유신생인출생후균행모영조단,대신생인진행단기화장기수방,관찰신생인출생후이상급HBV모영조단적정황.결과 145례환자중,143례위CHB,2례위대상성간경화,HBVDNA＜500고패/mL자105례,점72.4％;HBeAg양성125례,점86.0％.복용LdT치료적부녀공임신154잉차,17례자연유산,4례이위임신,9례유산후재차임신.101례결속임신,100례위족월분면,쌍태임신2례,조산1례,활산103태.발현태인진악렬1례,잉24주인산종지임신.출생후발현우이부이、좌이하량성림파결화선천성심장병각1례.7례환자잉기CK증고,8례잉기출현병독내약,무일례재잉기발생간병진전.63례영인수방시간≥6월령,무일례HBsAg양성,모영조단성공솔위100.0％.결론 CHB환자전잉기응용LdT치료안전、유효.
Objective To observe the safety of telbivudine (LdT) application throughout pregnancy in women with chronic hepatitis B (CHB),and to provide evidence-based treatment recommendations for women of childbearing age with chronic hepatitis B.Methods Women with hepatitis B virus (HBV) infection who took LdT before pregnancy and in early pregnancy were followed up prospectively for evaluating maternal and newborn adverse events.All newborns received block of HBV mother-to-child transmission (MTCT) after birth and were followed up for neonatal disorders and effects of maternal and child block.Results Among the 145 cases of pregnant women,143 were diagnosed as CHB and 2 decompensated cirrhosis.One hundred and five (72.4％) patients had HBV DNA＜500 copy/mL and 125 (86.0％) had positive hepatitis B e antigen.There were total 154 times pregnancies including 17 spontaneous abortions,4 ectopic gestation and 9 pregnancies after abortion.One hundred and one cases finished pregnancy,with 100 full term deliveries,1 preterm delivery and 2 twin pregnancies.One fetal with cleft lip and palate was aborted by induced labor in 24 weeks gestation.One baby was born with right double ears; one had benign lymph node under the left ear; and another one was diagnosed with congenital heart disease.Seven of the pregnant women had creatine kinase increased.Eight developed drug resistance.However,none had disease progression during pregnancy.None of the 63 infants was hepatitis B surface antigen positive over the 6 months of follow-up.The prevention of HBV MTCT was 100％ successful.Conclusion It is safe and effective for women with chronic HBV infection to receive LdT treatment throughout pregnancy.