替比夫定对高载量慢性乙型肝炎病毒感染孕妇母婴阻断疗效及安全性评价

Efficacy and safety of telbivudine for maternal-infant blockade in pregnant women with high-load chronic hepatitis B virus infection

目的探讨替比夫定对高载量慢性乙型肝炎病毒感染孕妇母婴阻断效果,为高载量慢性乙型肝炎病毒感染的治疗提供安全的母婴阻断药物。方法选取自2015年7月—2016年7月间在驻马店市中医院就诊的高载量慢性乙型肝炎病毒感染的孕妇82例作为研究对象,根据用药不同采用随机数字表法将所有患者随机分为两组,每组41例患者,对照组给予常规保肝药物治疗,并在孕期的第7、8、9个月各肌肉注射乙型肝炎高效价免疫球蛋白,新生儿出生后立即注射200 IU乙型肝炎免疫球蛋白,新生儿在分娩第1、6个月注射重组乙型肝炎疫苗,每次10μg。观察组在对照组治疗的基础上,从孕期的第7个月开始每天口服替比夫定600 mg进行治疗。采用SPSS19.0软件统计两组临床疗效,比较治疗前与治疗后血清HBcAb、HBeAg、HBV-DNA水平变化,并于婴儿出生24 h内及6、12月龄取血测HsBAg,比较两组阳性率差异。观察两组患者在用药后是否出现头痛头晕、疲劳、腹痛、腹泻、恶心、肌肉疼痛等不良反应。对两组新生儿是否出现早产、新生儿畸形等并发症进行统计,并比较两组新生儿平均Apgar评分。结果观察组显效率(53.66%)、总有效率(80.49%)均高于对照组(31.71%、65.85%),差异均有统计学意义(P<0.05)。观察组治疗前HBcAb、HBeAg、HBV-DNA水平与对照组相比较差异均不具有统计学意义;观察组及对照组患者在治疗后HBeAg、HBV-DNA水平均较治疗前有所下降,同组治疗前后比较差异有统计学意义(P<0.05);观察组患者治疗后HBV-DNA水平显著低于对照组,差异有统计学意义(P<0.05)。观察组婴儿出生后12个月的HsBAg及6个月、12个月的HBV-DNA阳性率均低于对照组,差异有统计学意义(P<0.05)。对照组及观察组婴儿随着时间的延长,HsBAg、HBV-DNA的阳性率均呈现逐渐降低的趋势。观察组患者治疗后头痛头晕、腹痛腹泻、恶心的发生率均高于对照组,差异有统计学意义(P<0.05)。两组新生儿均无畸形出现,观察组新生儿的Apgar评分(9.97±0.21)稍高于对照组(9.93±0.24),但差异无统计学意义。结论替比夫定对高载量慢性乙型肝炎具有良好的疗效,并且可以较为理想的阻断母婴传播,但具有头痛头晕、腹痛腹泻、恶心等不良反应。

Objective To investigate the effect of telbivudine on mother-to-infant blockade of pregnant women with high-load chronic hepatitis B virus infection, and to provide safe mother-to-child blockage drugs for the treatment of high-load chronic hepatitis B virus infection. Methods 82 patients with high-load chronic hepatitis B virus infection from July 2015 to July 2016 in Zhumadian TCM Hospital were selected as subjects. Randomized digital table was used to randomly divide all patients into two groups according to their medications. Each group included 41 patients. Patients in the control group were given routine hepatoprotective drugs, and intramuscular injection of high-titer hepatitis B immunoglobulin at the 7 th, 8 th and 9 th months of gestation. Immediate injection of 200 IU hepatitis B immunoglobulin was given to the newborns after birth, and the recombinant hepatitis B vaccine was given to the newborns at the 1 st and 6 th months of delivery, 10 μg each time. Patients in the study group received 600 mg of tibivudine daily from the seventh month of gestation on the basis of treatment in the control group. The clinical effects of the two groups were analyzed by SPSS19.0 software. The serum levels of HBcAb, HBeAg and HBV-DNA were measured before and after treatment. The positive rates of HsBAg were compared between the two groups. The adverse reactions such as headache, dizziness, fatigue, abdominal pain, diarrhea, nausea and muscle pain were observed. The neonatal complications such as premature delivery and neonatal malformation were statistically analyzed, and the Apgar scores of the two groups were compared.Results The significant effective rate(53.66%) and total effective rate(80.49%) of the study group were higher than those of the control group(31.71% and 65.85%), the difference was statistically significant(P < 0.05). The levels of HBcAb, HBeAg and HBVDNA in the study group before and after treatment were not significantly different from those in the control group; the levels of HBeAg and HBV-DNA in the study group and the control group after treatment were lower than those before treatment, and there was a significant difference between the same group before and after treatment(P < 0.05). The level was significantly lower than that of the control group(P < 0.05). The positive rates of HsBAg, HBV-DNA at 12 months, 6 months and 12 months after birth in the study group were lower than those in the control group(P < 0.05). The positive rates of HsBAg and HBV-DNA in the control group and the study group decreased gradually with time. The incidence of headache, dizziness, abdominal pain, diarrhea and nausea in the study group was higher than that in the control group(P < 0.05). There was no abnormality in the two groups. The APgar score of the study group was slightly higher than that of the control group, but there was no significant difference between the two groups. Conclusion Telbivudine has a good effect on high-load chronic hepatitis B, and it can better block mother-to-child transmission, but it has headache, dizziness, abdominal pain, diarrhea and nausea and other adverse reactions.