替比夫定治疗妊娠慢性乙型肝炎患者生育子女远期疗效与安全性  

Long-term efficacy and safety of telbivudine in the treatment of childbearing patients with chronic hepatitis B

作　　者：周岳进[1] 郑金莉[1] 潘华将[1] 卢成鸿[1] 

机构地区：[1]温州解放军第一一八医院南京军区肝病中心,325000

出　　处：《中华肝脏病杂志》2014年第8期573-576,共4页Chinese Journal of Hepatology

摘　　要：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LdT 600mg，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x^2。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1例，6例未孕，成功妊娠34例，LdT组与对照组比较，妊娠成功率（X^2=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（x^2=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，HBVDNA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（x^2=5．10，P＜0．05）。LdT组1周岁时抗-HBs产生率98．1％（52／53），对照组抗～HBs产生率82．4％（28／34）（x^2=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，l例偏低。结论LdT治疗妊娠CHB患者妊娠成功率、阻断官内感染率、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。Objective To observe the long-term efficacy and safety of telbivudine （LdT） for pregnant women with chrorfic hepatitis B （CHB） and their children born fi＇om 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 trealment group （n = 73; LdT 600 mg once daily, starting in early pregnancy and continued until after delivery） or in the control group （n = 45; no LdT Ireatment）. All newborns were given active and passive immunization upon birth and tested for serum hepatitis B surface antigen （HBsAg）, hepatitis B e antigen 0-IBeAg）, 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 agein 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 （x^2 = 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,2,2 = 6.38,P 〈0.05）. The neonates bom to the women in the LdT group included 53 cases of weakly-negative I-IBsAg at birth and 1 case at 1 month old, as well as negativity for HBV DNA, and HBsAg remaining weakly positive at 6 mont

关 键 词：肝炎 乙型 慢性 妊娠 替比夫定 

分 类 号：R714.251[医药卫生—妇产科学]