替比夫定对妊娠合并慢性乙型肝炎的疗效及婴儿发育的影响

Effect of telbivudine on pregnancy with CHB and infant development

目的探讨孕期全程应用替比夫定进行抗病毒治疗对妊娠合并慢性乙型肝炎(CHB)患者的临床疗效及其对婴儿生长发育的影响。方法收集2015年6月至2017年6月杭州市西溪医院收治的68例妊娠合并CHB患者为研究对象,随机分为对照组和观察组各34例。对照组患者给予常规内科治疗,观察组患者在对照组治疗基础上给予替比夫定进行抗病毒治疗。两组孕妇所产新生儿均给予常规、标准免疫预防,并行人工喂养。比较两组妊娠期谷氨酸转氨酶(ALT)复常率、乙型肝炎病毒-DNA(HBV-DNA)转阴率、HBV标志物等变化和药物不良反应的发生情况,并比较两组新生儿不同时间乙型肝炎表面抗原(HbsAg)、HBV-DNA阳性率及婴儿生长发育状况的差异。结果观察组在孕28周和分娩前ALT复常率较对照组显著升高(χ2值分别为9.14、8.55,均P<0.05)。观察组在孕14周、28周和分娩前HBV-DNA转阴率较对照组明显升高(χ2值分别为14.32、28.69、29.10,均P<0.05)。观察组新生儿在不同时间(出生时、生后1个月、生后6个月、生后12个月)的HBV-DNA阳性率均为0,较对照组显著降低(Fisher确切概率法,均P<0.05)。观察组出生时HbsAg阳性率为11.76%,低于对照组44.12%,组间比较差异有统计学意义(χ2=7.30,P<0.05),观察组生后1、6、12个月HbsAg阳性率为0,均显著低于对照组,组间比较差异有统计学意义(Fisher确切概率法,均P<0.05)。两组治疗期间未见严重不良反应的发生,均无畸形儿病例。两组婴儿生长发育状况(胎龄、出生体质量、Apgar评分)比较差异均无统计学意义(t值分别为1.52、0.32、1.47,均P>0.05)。结论孕期全程应用替比夫定进行抗病毒治疗对妊娠合并CHB患者具有良好的治疗效果,能够有效抑制母婴垂直传播,并且不会引起明显的不良反应,具有良好的安全性,因此值得临床应用和推广。

Objective To investigate the clinical efficacy of telbivudine as antiviral therapy on pregnancy with chronic hepatitis B(CHB)and effect on the growth and development of infants.Methods A total of 68 pregnant women with CHB were selected in study in Xixi Hospital of Hangzhou from June 2015 to June 2017,and they were randomly divided into control group and observation group with 34 cases in each group.The control group was given conventional medical treatment,while the observation group was given telbivudine antiviral treatment on the basis of the control group.Two groups of neonates were given routine and standard immunoprophylaxis,and they were given artificial feeding.The normalizing rate of glutamic aminotransferase(ALT),hepatitis B virus-DNA(HBV-DNA)negative rate,HBV markers,and adverse drug reactions were compared between two groups,and the differences in hepatitis B surface antigen(HbsAg),HBV-DNA positive rate and the growth and development of infants were compared between two groups at different time.Results The normalizing rate of ALT in the observation group was significantly higher than that in the control group at 28 weeks of gestation and before delivery(χ2 value was 9.14 and 8.55,respectively,both P<0.05).The negative conversion ratio of HBV-DNA in the observation group was significantly higher than that in the control group at 14 weeks,28 weeks of gestation and before delivery(χ2 value was 14.32,28.69 and 29.10,respectively,all P<0.05).The positive rate of HBV-DNA in the observation group was 0% at different time points(at birth,1 month after birth,6 months after birth,and 12 months after birth),which was significantly lower than that in the control group(Fisher’s exact test,all P<0.05).The positive rate of HbsAg at birth in the observation group was 11.76%,which was lower than 44.12%in the control group.There was significant difference between two groups(χ2=7.30,P<0.05).The positive rate of HbsAg in the observation group was 0 at 1,6 and 12 months after birth,which was significantly lower than that in the control group(Fisher’s exact test,all P<0.05).No serious adverse reactions occurred in two groups during treatment,and there was no case of malformation.There was no significant difference in growth and development(gestational weeks,birth weight,Apgar scores)of infants between two groups(t value was 1.52,0.32 and 1.47,respectively,all P >0.05).Conclusion The application of telbivudine in the whole course of pregnancy has good therapeutic effect on pregnant women with CHB.It can effectively inhibit the vertical transmission of mother to infants,and will not cause obvious adverse reactions with safety.Therefore,it is worthy of clinical application and popularization.