慢性乙型肝炎患者妊娠全程替比夫定治疗的疗效及母婴阻断的有效性

Clinical observation on antiviral efficacy and blocking of mother-to-infant transmission by telbivudine in women with chronic hepatitis B throughout pregnancy

目的:研究慢性乙型肝炎(CHB)妇女妊娠全程使用替比夫定(Ld T)抗病毒的疗效、阻断母婴垂直传播的有效性及安全性。方法:选择CHB妇女64例,治疗组31例,对照组33例。两组婴儿均接受标准免疫预防,人工喂养。观察整个孕期生化、HBV标志物、HBVDNA的变化及不良反应。检测婴儿出生时、1、6及12月龄时HBVDNA、HBs Ag及婴儿生长发育情况。结果:治疗组和对照组在孕24周及分娩前ALT复常率比较差异有统计学意义,在孕12、24周及分娩前HBVDNA阴转率比较差异有统计学意义,分别是48.39%vs.3.03%(P=0.000)、83.87%vs.6.06%(P=0.000)、90.32%vs.6.25%(P=0.000);两组婴儿在出生时HBs Ag阳性率是12.90%vs.37.50%(P=0.025),出生后1、6、12个月均为0 vs.18.75%(P=0.035);HBVDNA阳性率在出生时是0 vs.21.88%(P=0.018)、出生后1、6、12个月均为0 vs.18.75%(P=0.035)。两组新生儿生长发育情况比较差异无统计学意义。结论:CHB患者妊娠全程使用Ld T有较好的抗病毒疗效,可有效阻断母婴垂直传播,无明显不良反应。

Objective To explore antiviral efficacy, safety and blocking of mother-to-infant transmission by administrating telbivudine in pregnant patients with chronic hepatitis B （CHB） throughout pregnancy. Methods Sixty-four cases of female patients were enrolled. The study participants were divided into the telbivudiue treatment group （n = 31） and the control group （n = 33）. Data were recorded from beginning of administration to ending pregnancy, as well as notation of any adverse reactions. The neonates and infants were evaluated in HBV infection, parameters of growth and development. Results The recovery rates of ALT, respectively, were 90.32% vs. 57.58% （P = 0.003）, 93.55% vs. 62.50% （P = 0.003） at 24 weeks and ante partum and the HBVDNA-negative conversion rates, respectively, were 48.39% vs. 3.03% （P = 0.000）, 83.87% vs. 6.06% （P = 0.000）, 90.32% vs. 6.25% （P = 0.000） respectively, at 12, 24 weeks of pregnancy and at ante partum between the treatment and control groups. The HBsAg-positive and HBVDNA-positive rates of the infants, respectively, were 12.90% vs. 37.50% （P = 0.025） and 0 vs. 21.88% （P = 0.018） at birth, and respectively, were all 0 vs. 18.75% （P = 0.035） and 0 vs. 18.75% （P = 0.035） at 1, 6, 12 months old between the treatment and control groups. The treatment group showed lower incidence of intrauterine HBV infection（0 vs. 18.75%, P = 0.035）. The gestational ages, fetal weights and Apgar scores were not significant different in the children born in the mothers from the two groups. Conclusions Telbivudine administration showed a good antiviral curative effect and effectively blocked mother-to-infant transmission in women with CHB. The treatment was safe and caused no obvious adverse reaction.