CAJ | 학술논문

目的探讨慢性乙型肝炎妇女妊娠早期使用替比夫定抗病毒的疗效、安全性及母婴阻断有效性. 方法慢性乙型肝炎妊娠早期妇女84例,HBsAg、HBeAg均阳性、HBV DNA≥107拷贝/ml,血清ALT≥4 ULN,拒绝终止妊娠.分为治疗组43例,在妊娠早期使用替比夫定治疗,600 mg/d;对照组41例,在妊娠期不接受抗病毒治疗.两组婴儿出生后均注射乙型肝炎免疫球蛋白和乙型肝炎疫苗.所生婴儿均采用人工喂养.观察孕期肝、肾功能、心肌酶谱、血常规、尿常规,HBV血清标志物、HBV DNA及不良反应.检测婴儿6个月及12月时HBV DNA、HBsAg及生长发育情况、并发症,并进行Apgar评分.采用SPESS 13.0统计软件进行数据处理和分析,率的比较采用x2检验或Fisher精确概率检验法. 结果治疗组有1例在妊娠36周出现rtM204I变异,对照组有l例在妊娠28周发生重型肝炎而加用替比夫定抗病毒治疗.在妊娠12、24周、分娩前的ALT复常率:治疗组分别为62.8％、76.7％和88.1％;对照组分别为29.3％、46.3％和60.0％,P值分别为0.002、0.000和0.004.HBV DNA阴转率治疗组分别为20.9％、37.2％和78.6％;对照组均为0,P值分别为0.006、0.001和0.000.e抗原血清学转换率治疗组分别为2.3％、9.3％和21.4％;对照组均为0,P值分别为1.000、0.116和0、002.婴儿6个月HBsAg阳性率和HBV DNA阳性率治疗组分别为2.4％和0;对照组均为17.5％,P值分别为0.027和0.005.12个月HBsAg阳性率及HBV DNA阳性率治疗组均为0;对照组均为17.5％,P值均为0.005. 结论妊娠早期开始使用替比夫定有较好的抗病毒疗效,可安全有效地阻断乙型肝炎病毒垂直传播.
목적 탐토만성을형간염부녀임신조기사용체비부정항병독적료효、안전성급모영조단유효성. 방법 만성을형간염임신조기부녀84례,HBsAg、HBeAg균양성、HBV DNA≥107고패/ml,혈청ALT≥4 ULN,거절종지임신.분위치료조43례,재임신조기사용체비부정치료,600 mg/d;대조조41례,재임신기불접수항병독치료.량조영인출생후균주사을형간염면역구단백화을형간염역묘.소생영인균채용인공위양.관찰잉기간、신공능、심기매보、혈상규、뇨상규,HBV혈청표지물、HBV DNA급불량반응.검측영인6개월급12월시HBV DNA、HBsAg급생장발육정황、병발증,병진행Apgar평분.채용SPESS 13.0통계연건진행수거처리화분석,솔적비교채용x2검험혹Fisher정학개솔검험법. 결과 치료조유1례재임신36주출현rtM204I변이,대조조유l례재임신28주발생중형간염이가용체비부정항병독치료.재임신12、24주、분면전적ALT복상솔:치료조분별위62.8％、76.7％화88.1％;대조조분별위29.3％、46.3％화60.0％,P치분별위0.002、0.000화0.004.HBV DNA음전솔치료조분별위20.9％、37.2％화78.6％;대조조균위0,P치분별위0.006、0.001화0.000.e항원혈청학전환솔치료조분별위2.3％、9.3％화21.4％;대조조균위0,P치분별위1.000、0.116화0、002.영인6개월HBsAg양성솔화HBV DNA양성솔치료조분별위2.4％화0;대조조균위17.5％,P치분별위0.027화0.005.12개월HBsAg양성솔급HBV DNA양성솔치료조균위0;대조조균위17.5％,P치균위0.005. 결론 임신조기개시사용체비부정유교호적항병독료효,가안전유효지조단을형간염병독수직전파.
Objective To explore the antiviral efficacy,safety and protective ability against mother-to-infant transmission of telbivudine in pregnant patiets with chronic hepatitis B (CHB) during the first trimester.Methods Eightyfour gravid women who were diagnosed with CHB,in their first trimester of pregnancy,and had refused to terminate their pregnancies were enrolled; all study participants were clinically classified as active hepatitis cases with positivity for both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg),HBV DNA ≥ 107 copies/mL and serum level of alanine aminotarnsferase (ALT) of ≥ 4 ULN.Patients with YMDD mutations were excluded from the study.The study participants were divided into a telbivudine treatment group (n =43; administered in the first trimester of pregnancy) and a control group (n =41,consisting of patients who refused to take antivirals).All babies bom to the women in both groups of the study received standard immune prevention (anti-hepatitis B immunoglobulin plus hepatitis B vaccine) and artificial feeding.Data recorded for the women during pregnancy included clinical findings for tests of hepatic and renal function,myocardial enzymes,blood and urine clinical parameters,hepatitis B virus makers and HBV DNA,as well as notation of any adverse reactions.The neonaes were evahated for presence of HBV infection,paramers of growth and development,presence of complications,and Apgar score.At 6 and 12 months old,all infants were evaluated for HBV DNA level and HBsAg presence.Results The genetic variant rtM204I was detected in one of the women in the treatment group at 36 weeks of pregnancy.One woman in the control group developed severe hepatitis at 28 weeks of pregnancy and was put on the lelbivudine treatment The treatment group showed greater recovery rates of ALT than the control group at 12 weeks of pregnancy (62.8％ vs.29.3％,P =0.002),24 weeks ofpregnancy (76.7％ vs.46.3％,P =0.000),and at ante partum (88.1％ vs.60.0％,P =0.004).The treatment group also showed greater HBV DNA-negative conversion rates at 12 weeks of pregnanay (20.9％ vs.0,P=0.006),at 24 weeks of pregnancy (37.2％ vs.0,P =0.001) and at ante partum (78.6％ vs.0,P=0.000),and greater HBeAg seroconversion rates at 12 weeks of pregnancy (2.3％ vs.0,P=1.000),at 24 weeks ofpregnancy (9.3％ vs.0,P=0.1 1 6) and at ante partum (2 1.4％ vs.0,=0.002).The HBsAg-positive rates and HBV DNA-positive rates among the infants born to the mothers in the treatment and control groups,respectively,were 2.4％ vs.17.5％ (P =0.027) at birth,0 vs.17.5％(P=0.005)at 6months old and 0 vs.17.5％ (P=0.005)at 12 months old.The Apgar scores were not significantly different for the children born to the mothers from the two groups,and all the children showed parameters of growth development within normal limits.Conclusion Telbivudine administration in the first trimester had a good antiviral curative effect and effectively blocked mother-to-infant transmission in women with CHB.The treatment was safe,causing no obvious adverse reaction in the gravid women or developnental effects on the infaants.