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目的开展此项基于医院的前瞻性研究,丰富国内乙型肝炎病毒(hepatitis B virus,HBV)携带者妊娠结局的相关数据,探讨HBV携带状态对妊娠结局的影响。方法采用队列研究方法,观察2012年7月1日至2015年9月30日南通市妇幼保健院收治孕妇的妊娠结局。此队列研究共纳入20 498位孕妇,其中HBV携带者497例(暴露组),非HBV感染者20 001例(非暴露组),研究开始于妊娠早期,随访至妊娠结局事件(或至2015年9月)。主要结局指标包括顺产、流产、死胎、早产、妊娠期糖尿病、妊娠期肝内胆汁淤积症、胎膜早破、低体重出生儿、小于胎龄儿以及Apgar评分等。结果 HBV携带者的死胎、早产、妊娠期糖尿病、妊娠期肝内胆汁淤积症、胎膜早破、低体重出生儿与小于胎龄儿发生率与非HBV感染者相似,差异无统计学意义。HBV携带者的流产发生率要高于非HBV感染者(9.66%vs 5.81%,P<0.001)。经过对基线资料与产科并发症等因素构建多因素模型调整后,HBV携带者流产发病率仍高于非HBV感染者(调整相对危险度RR为1.54,95%可信区间CI为1.11~2.06)。此外,其他孕妇与新生儿结局的发生率相似,差异无统计学意义。结论妊娠合并HBV携带状态可能是流产的一个独立危险因素,有必要对HBV携带孕妇进行监测。
Objective To carry out this hospital-based prospective study to enrich the pregnancy-related data of hepatitis B virus (HBV) carriers in China and explore the impact of HBV carrier status on pregnancy outcome. Methods A cohort study was conducted to observe the pregnancy outcomes of pregnant women in Nantong MCH from July 1, 2012 to September 30, 2015. A total of 20 498 pregnant women were enrolled in this cohort study, including 497 HBV carriers (exposed group) and 20 001 non-HBV infected patients (non-exposed group). The study started in early pregnancy and was followed up until pregnancy outcome (or until 2015 September). The primary outcome measures included natal abortion, miscarriage, stillbirth, premature labor, gestational diabetes mellitus, intrahepatic cholestasis of pregnancy, premature rupture of membranes, low birth weight infants, small gestational age children and Apgar scores. Results The incidence of stillbirth, premature birth, gestational diabetes mellitus, intrahepatic cholestasis of pregnancy, premature rupture of membranes, low birth weight infants and small infants born with HBV carriers were similar to those of non-HBV carriers in HBV carriers. There was no significant difference. HBV carriers had a higher rate of miscarriage than non-HBV carriers (9.66% vs 5.81%, P <0.001). After adjustment for baseline data and obstetric complications and other factors to construct a multi-factor model, the incidence of abortion in HBV carriers was still higher than that in non-HBV patients (adjusted relative risk RR was 1.54, 95% confidence interval CI was 1.11 to 2.06) . In addition, the incidence of other pregnant women and newborns with similar outcomes, the difference was not statistically significant. Conclusion Pregnancy with HBV status may be an independent risk factor for abortion. It is necessary to monitor HBV carriers pregnant women.