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目的:探讨孕晚期口服替比夫定对孕妇乙型病毒基因组(HBV-DNA)≥106copies/ml母婴阻断的疗效和安全性,为临床制定治疗方案提供依据。方法:选取2011年1月~2014年1月在该院就诊符合纳入标准的孕妇156例为研究对象,同意接受替比夫定治疗的76例孕妇为观察组,不同意接受替比夫定治疗的80例孕妇为对照组。对比两组孕妇干预前后的ALT水平、HBV-DNA载量以及两组新生儿的HBV感染率。通过随访对比两组新生儿7月龄时的HBs Ab阳性率。记录观察组孕妇服药过程中的不良反应,并对比两组新生儿的身长、头围、体质量以及Apgar评分。结果:观察组孕妇分娩即刻的ALT水平为(25.73±6.14)U/L,HBV-DNA载量为(5.58±9.46)×103ml,均显著低于对照组,差异有统计学意义(均P<0.05),观察组新生儿HBV感染率为0,显著低于对照组,差异有统计学意义(P<0.05),分娩后7个月的HBs Ab阳性率为100.00%,显著高于对照组,差异有统计学意义(P<0.05);观察组孕妇服用替比夫定过程中,未发现有明显胃肠道反应、肝肾功能损伤、过敏等不良反应发生。两组新生儿出生身长、头围、体质量、Apgar评分对比,差异无统计学意义(均P>0.05)。两组新生儿均未出现先天性畸形。结论:对于HBV-DNA≥106ml的孕妇在妊娠晚期口服替比夫定能够有效阻断HBV的母婴传播,保护孕妇的肝功能,且对孕妇和新生儿均有良好安全性。
Objective: To investigate the efficacy and safety of telbivudine in the third trimester of pregnancy in the prevention of maternal-fetal HBV DNA (HBV-DNA) ≥106copies / ml and to provide the basis for clinical treatment planning. Methods: From January 2011 to January 2014, 156 pregnant women who met the inclusion criteria in the hospital were enrolled in this study. 76 pregnant women who received telbivudine treatment were considered as the observation group and did not agree to receive telbivudine treatment 80 pregnant women as the control group. The levels of ALT, HBV-DNA load and the HBV infection rates of two groups of newborns were compared before and after intervention. The positive rate of HBs Ab at 7 months of age was compared between the two groups by follow-up. Adverse reactions in the observation group were recorded during pregnancy, and the body length, head circumference, body weight and Apgar score were compared between the two groups. Results: The ALT level of pregnant women immediately after delivery was (25.73 ± 6.14) U / L and HBV-DNA load was (5.58 ± 9.46) × 103 ml, both of which were significantly lower than those of the control group (all P < 0.05). The HBV infection rate in observation group was 0, which was significantly lower than that in control group (P <0.05). The positive rate of HBs Ab in 7 months after delivery was 100.00%, which was significantly higher than that in control group (P <0.05). During the course of taking telbivudine in pregnant women in the observation group, no obvious gastrointestinal reactions, liver and kidney dysfunction, allergic and other adverse reactions were found. There was no significant difference in birth weight, head circumference, body weight and Apgar score between the two groups (all P> 0.05). No congenital malformations occurred in both groups of newborns. Conclusion: For pregnant women with HBV-DNA≥106ml, telbivudine can effectively block the mother-to-child transmission of HBV in the third trimester of pregnancy, protect the liver function of pregnant women, and have good safety for both pregnant women and newborns.