CAJ | 학술논문

目的观察替比夫定阻断HBV DNA高载量孕妇宫内传播的效果及停药后的安全性.方法收集慢性HBV携带者且孕周24 ～ 30周孕妇资料,HBV DNA均≥1×106IU/ml;根据患者意愿将其分为“替比夫定治疗组”和“对照组”,替比夫定治疗组在孕妇孕26周时,给予替比夫定600 mg/d口服抗病毒治疗至产后1个月停用,对照组患者不用抗病毒药物.两组孕妇均接受剖宫产术,新生儿产后均接受主、被动联合免疫,出生后12h内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20 μ g.禁止母乳喂养.计量资料比较用t检验,计数资料比较用x2检验. 结果共收集157例HBV携带者孕妇资料,替比夫定治疗组82例,对照组75例,年龄20 ～ 40岁.替比夫定治疗组孕妇HBV DNA在产前下降均＞210g10,有效率为100％,至分娩前替比夫定治疗组有16例HBV DNA转阴,转阴率为19.5％ (16/82),而对照组无转阴,两组比较,差异有统计学意义(P＜0.05).两组新生儿及随访婴儿至6个月,替比夫定治疗组婴儿HBsAg、HBV DNA阳性率均为0,对照组婴儿HBsAg、HBV DNA阳性率均为5.3％,替比夫定治疗组与对照组HBV母婴传播的阻断率分别为100％和94.7％,两组比较,差异均有统计学意义(P值均＜0.05).替比夫定治疗组停药后随访至产后6个月,HBV DNA:(1.79× 107±4.20× 107) IU/ml,ALT:(31.72±9.89) U/L,AST:(31.49±9.93) U/L.两组均未发现有不良反应或先天性畸形.结论 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孕妇外周血HBV DNA载量,阻断HBV宫内传播,且近期疗效、耐受性和安全性良好.肝生物化学指标正常孕妇短程服用替比夫定停药后安全性好.
목적 관찰체비부정조단HBV DNA고재량잉부궁내전파적효과급정약후적안전성.방법 수집만성HBV휴대자차잉주24 ～ 30주잉부자료,HBV DNA균≥1×106IU/ml;근거환자의원장기분위“체비부정치료조”화“대조조”,체비부정치료조재잉부잉26주시,급여체비부정600 mg/d구복항병독치료지산후1개월정용,대조조환자불용항병독약물.량조잉부균접수부궁산술,신생인산후균접수주、피동연합면역,출생후12h내주사을형간염면역구단백200 IU급0、1、6개월주사을형간염역묘20 μ g.금지모유위양.계량자료비교용t검험,계수자료비교용x2검험. 결과 공수집157례HBV휴대자잉부자료,체비부정치료조82례,대조조75례,년령20 ～ 40세.체비부정치료조잉부HBV DNA재산전하강균＞210g10,유효솔위100％,지분면전체비부정치료조유16례HBV DNA전음,전음솔위19.5％ (16/82),이대조조무전음,량조비교,차이유통계학의의(P＜0.05).량조신생인급수방영인지6개월,체비부정치료조영인HBsAg、HBV DNA양성솔균위0,대조조영인HBsAg、HBV DNA양성솔균위5.3％,체비부정치료조여대조조HBV모영전파적조단솔분별위100％화94.7％,량조비교,차이균유통계학의의(P치균＜0.05).체비부정치료조정약후수방지산후6개월,HBV DNA:(1.79× 107±4.20× 107) IU/ml,ALT:(31.72±9.89) U/L,AST:(31.49±9.93) U/L.량조균미발현유불량반응혹선천성기형.결론 HBV DNA고적도잉부임신중만기응용체비부정항병독치료능명현강저잉부외주혈HBV DNA재량,조단HBV궁내전파,차근기료효、내수성화안전성량호.간생물화학지표정상잉부단정복용체비부정정약후안전성호.
Objective To determine the efficacy and safety oftelbivudine for blocking intrauterine transmission of hepatitis B virus (HBV) in pregnant women with high-load HBV DNA.Methods Women in general good health and pragnant were enrolled for study between the ages of 20 to 40 year-old,with a diagnosis of HBV infection with high-load HBV DNA level (≥ 1×106IU / ml).According to each participant's willingness,the women were divided into a telbivudine treatment group (82 women) and an untreated control group (75 women).The telbivudine treatment was initiated at gestation week 26 as oral dosing of 600 mg/d and continued until 1 month after the birth.Women in the control group had not gotten any antiviral drug treatment.All of the women delivered by cesarean section,and all of the neonates were administered the standard passive immunization therapy,which consisted of a hepatitis B immunoglobulin (200 1U) injection given within 12 hours of birth and an injection of hepatitis B vaccine (20 μg) at birth and at postnatal month 1 and 6.None of the mother's performed breastfeeding.Results The telbivudine-treated women showed a significant decrease in HBV DNA levels prior to delivery,as well as significantly decreased prenatal HBV DNA levels (＞2 logl0).Efficiency of the telbivudine treatment was 100％.Immediately prior to delivery,16 (19.5％) of the women in the telbivudine treatment group showed negative HBV DNA status,as opposed to the untreated control group in which no women showed negative status.The telbivudine treatment group had no case of maternal or fetal adverse reaction or of congenital malf ormation.Conclusion Use of telbivudine antiviral therapy during late pregnancy in women with high-load HBV DNA can significantly reduce level of HBV DNA in maternal peripheral blood,block HBV intrauterine transmission,and provide good short-term efficacy,with good tolerability and safety.