目的 观察妊娠慢性乙型肝炎(CHB)患者应用替比夫定(LdT)治疗所生育子女远期疗效与安全性. 方法 118例妊娠CHB患者按照意愿分为两组,73例选择妊娠初期服用LdT600mg,1次/d,至分娩后作为治疗组;45例选择非LdT治疗作为对照组.新生儿出生均予以主、被动免疫,检测新生儿0、1、7、12个月龄血清HBsAg,HBeAg,抗-HBc,抗-HBs,HBVDNA.用首都儿科研究所编制的0～6岁儿童神经心理发育量表观察动作能(大动作,精细动作)、适应能、语言能及社交行为5项;总智商以发育智商(DQ)表示,DQ=5项分/实际月龄×100.计量资料用t检验表示,计数资料用x2检验比较.结果 LdT组妊娠70例(失访3例),流产1例,成功妊娠69例;对照组妊娠39例,流产4例,死亡l例,6例未孕,成功妊娠34例,LdT组与对照组比较,妊娠成功率(x2=6.28,P＜ 0.05)差异有统计学意义,LDT组足月分娩53例,对照组足月分娩34例,LdT组与对照组比较,足月分娩安全率(x2=6.38,P＜0.05)差异有统计学意义.治疗组53例新生儿和1个月龄时1例HBsAg弱阴性,HBV DNA均为阴性,6个月龄时HBsAg仍弱阳性,宫内感染率为1.8％,无畸形,与对照组34例新生儿,1个月龄时6例HBsAg阳性,6个月龄时6例HBsAg仍阳性,宫内感染率(16.6％)差异有统计意义(x2=5.10,P＜0.05).LdT组l周岁时抗-HBs产生率98.1％ (52/53),对照组抗-HBs产生率82.4％ (28/34)(x2=4.87,P＜ 0.05),差异有统计学意义.LdT治疗组53例幼儿生长发育正常,智商3例优秀,8例聪明,40例正常水平,2例偏低.对照组34例幼儿生长发育正常,智商2例优秀,4例聪明,27例正常水平,1例偏低. 结论 LdT治疗妊娠CHB患者妊娠成功率、阻断宫内感染率、抗-HBs产生率均优于对照组,幼儿远期生长发育安全,总DQ与对照组相比无差异.
目的 觀察妊娠慢性乙型肝炎(CHB)患者應用替比伕定(LdT)治療所生育子女遠期療效與安全性. 方法 118例妊娠CHB患者按照意願分為兩組,73例選擇妊娠初期服用LdT600mg,1次/d,至分娩後作為治療組;45例選擇非LdT治療作為對照組.新生兒齣生均予以主、被動免疫,檢測新生兒0、1、7、12箇月齡血清HBsAg,HBeAg,抗-HBc,抗-HBs,HBVDNA.用首都兒科研究所編製的0～6歲兒童神經心理髮育量錶觀察動作能(大動作,精細動作)、適應能、語言能及社交行為5項;總智商以髮育智商(DQ)錶示,DQ=5項分/實際月齡×100.計量資料用t檢驗錶示,計數資料用x2檢驗比較.結果 LdT組妊娠70例(失訪3例),流產1例,成功妊娠69例;對照組妊娠39例,流產4例,死亡l例,6例未孕,成功妊娠34例,LdT組與對照組比較,妊娠成功率(x2=6.28,P＜ 0.05)差異有統計學意義,LDT組足月分娩53例,對照組足月分娩34例,LdT組與對照組比較,足月分娩安全率(x2=6.38,P＜0.05)差異有統計學意義.治療組53例新生兒和1箇月齡時1例HBsAg弱陰性,HBV DNA均為陰性,6箇月齡時HBsAg仍弱暘性,宮內感染率為1.8％,無畸形,與對照組34例新生兒,1箇月齡時6例HBsAg暘性,6箇月齡時6例HBsAg仍暘性,宮內感染率(16.6％)差異有統計意義(x2=5.10,P＜0.05).LdT組l週歲時抗-HBs產生率98.1％ (52/53),對照組抗-HBs產生率82.4％ (28/34)(x2=4.87,P＜ 0.05),差異有統計學意義.LdT治療組53例幼兒生長髮育正常,智商3例優秀,8例聰明,40例正常水平,2例偏低.對照組34例幼兒生長髮育正常,智商2例優秀,4例聰明,27例正常水平,1例偏低. 結論 LdT治療妊娠CHB患者妊娠成功率、阻斷宮內感染率、抗-HBs產生率均優于對照組,幼兒遠期生長髮育安全,總DQ與對照組相比無差異.
목적 관찰임신만성을형간염(CHB)환자응용체비부정(LdT)치료소생육자녀원기료효여안전성. 방법 118례임신CHB환자안조의원분위량조,73례선택임신초기복용LdT600mg,1차/d,지분면후작위치료조;45례선택비LdT치료작위대조조.신생인출생균여이주、피동면역,검측신생인0、1、7、12개월령혈청HBsAg,HBeAg,항-HBc,항-HBs,HBVDNA.용수도인과연구소편제적0～6세인동신경심리발육량표관찰동작능(대동작,정세동작)、괄응능、어언능급사교행위5항;총지상이발육지상(DQ)표시,DQ=5항분/실제월령×100.계량자료용t검험표시,계수자료용x2검험비교.결과 LdT조임신70례(실방3례),유산1례,성공임신69례;대조조임신39례,유산4례,사망l례,6례미잉,성공임신34례,LdT조여대조조비교,임신성공솔(x2=6.28,P＜ 0.05)차이유통계학의의,LDT조족월분면53례,대조조족월분면34례,LdT조여대조조비교,족월분면안전솔(x2=6.38,P＜0.05)차이유통계학의의.치료조53례신생인화1개월령시1례HBsAg약음성,HBV DNA균위음성,6개월령시HBsAg잉약양성,궁내감염솔위1.8％,무기형,여대조조34례신생인,1개월령시6례HBsAg양성,6개월령시6례HBsAg잉양성,궁내감염솔(16.6％)차이유통계의의(x2=5.10,P＜0.05).LdT조l주세시항-HBs산생솔98.1％ (52/53),대조조항-HBs산생솔82.4％ (28/34)(x2=4.87,P＜ 0.05),차이유통계학의의.LdT치료조53례유인생장발육정상,지상3례우수,8례총명,40례정상수평,2례편저.대조조34례유인생장발육정상,지상2례우수,4례총명,27례정상수평,1례편저. 결론 LdT치료임신CHB환자임신성공솔、조단궁내감염솔、항-HBs산생솔균우우대조조,유인원기생장발육안전,총DQ여대조조상비무차이.
Objective To observe the long-term efficacy and safety of telbivudine (LdT) for pregnant women with chronic hepatitis B (CHB) and their children born from the treatment period.Methods A total of 118 pregnant women with CHB were enrolled in the study and provided informed consent for participation.The women opted for participation in the treatment group (7 =73; LdT 600 mg once daily,starting in early pregnancy and continued until after delivery) or in the control group (n =45; no LdT treatment).All newborns were given active and passive immtnization upon birth and tested for serum hepatitis B surface antigen (HBsAg),hepatitis B e antigen (HBeAg),anti-hepatitis B core antibody (anti-HBc),anti-hepatitis B surface antibody (anti-HBs) and HBV DNA at 0,1,7 and 12 months of age.The Paediatrics Neuropsychological Development Scale for Children aged 0-6 (5 items) established by the Capital Institute was used to test the children; in addition,the children were evaluated by observation for action ability (fine and gross motor skills),adaptability,language ability and social behaviour.Total IQ was estimated as a developmental quotient (DQ) by using the equation:points from the 5 scale items / actual age in months × 100.Results The LdT group included 69 women with successful pregnancies,1 case of miscarriage and 3 cases that were lost to follow-up.The control group included 34 women with successful pregnancies,4 cases of miscarriage,1 case with fatal outcome,and 6 cases of no pregnancy.Compared to the control group,the LdT group had a significantly higher successful pregnancy rate (x2 =4.86 in the LdT group,P ＜0.05).In addition,the LdT group had a significantly higher rate of term delivery (53 cases vs.34 cases,x2 =6.38,P ＜ 0.05).The neonates born to the women in the LdT group included 53 cases of weakly-negative HBsAg at birth and 1 case at 1 month old,as well as negativity for HBV DNA,and HBsAg remaining weakly positive at 6 months old; the intrauterine infection rate was 1.8％ and no case of deformity occurred.Among the 34 neonates in the control group,6 showed HBsAg positivity at 1 month old,and the HBsAg positivity remained for all 6 at 6 months old; the intrauterine infection rate was 16.6％,which was significantly higher than that of the LdT group (x2 =5.10,P＜ 0.05).The neonates in the LdT group had a significantly higher anti-HBs production rate at 1 year old than those in the control group (98.1％ (52/53 vs.82.4％ (28/34).x2 =4.87,P ＜ 0.05).The neonates in the LdT group showed normal growth and development for all 53 cases of young children,and IQ levels of excellent for 3 cases,smart for 8 cases,normal for 40 cases,and low for 2 cases.The neonates in the control group showed normal growth and development for all 34 cases of young children,and IQ levels of excellent for 2 cases,smart for 4 cases,normal for 27 cases,and low for 1 case.Conclusion Childbearing chronic HBV patients treated with LdT had higher rates of successful pregnancy,blocking of intrauterine infection and anti-HBs reduction compared to their untreated counterparts.The children bom to LdT-treated women showed no difference in long-term growth and development and total IQ from the children born to the untreated women with chronic HBV.
