替比夫定阻断HBV母婴传播的效果和短期安全性  

Clinical effect and short-term safety of telbivudine in blocking mother-to-child transmission of HBV

作　　者：潘禹辰[1] 王崇[2] 文思敏[1] 王川[3] 孔菲[2] 牛俊奇[2] 姜晶[1] PAN Yuchen WANG Chong WEN Simin et al(Research Center of Clinical Epidemiology, The First Hospital of Jilin University, Changchun 130021, China)

机构地区：[1]吉林大学第一医院临床研究部,北京100026 [2]吉林大学第一医院肝胆胰内科,长春130021 [3]北京市朝阳区妇幼保健院,北京100026

出　　处：《临床肝胆病杂志》2017年第9期1707-1712,共6页Journal of Clinical Hepatology

基　　金：十二五国家科技重大专项课题子课题(2012ZX10002001-001);吉林省卫生计生科研计划(20152003);中国肝炎防治基金会-天晴肝病基金资助课题(TQGB 20140137)

摘　　要：目的观察高病毒载量乙型肝炎孕妇在孕晚期服用替比夫定对HBV母婴传播的阻断效果和短期安全性。方法募集2012年7月-2015年6月在吉林大学第一医院接受母婴阻断的HBsAg和HBe Ag均阳性,HBV DNA≥2×10~6IU/ml的孕妇;向孕妇说明目前乙型肝炎母婴传播阻断所采用的方法,根据其意愿分为主被动免疫阻断+替比夫定组(替比夫定组)和主被动免疫阻断组(免疫阻断组)。替比夫定组孕妇从妊娠32周开始,口服替比夫定(600 mg,1次/d)至分娩时停药,免疫阻断组孕妇孕期不接受任何抗病毒治疗;2组婴儿产后均接受20μg乙型肝炎疫苗联合100单位乙型肝炎免疫球蛋白的主被动免疫;7月龄时婴儿检测HBsAg阳性者为母婴传播阻断失败。符合正态分布的计量资料组间比较采用t检验;不符合正态分布的计量资料组间比较采用Wilcoxon秩和检验。计数资料组间比较采用χ~2检验或Fisher精确检验。结果符合纳入标准的孕妇447例,其中替比夫定组81例,免疫阻断组366例。替比夫定组孕妇平均年龄高于免疫阻断组[(28.8±3.3)岁vs(27.6±3.8)岁,t=-2.55,P=0.01);替比夫定组HBV DNA载量>10~8IU/ml的孕妇所占比例高于免疫阻断组(82.7%vs 61.5%,χ~2=13.21,P<0.001);2组孕妇在ALT水平、分娩方式和喂养方式方面的差异均无统计学意义(P值均>0.05)。替比夫定组婴儿81例,在7月龄时无HBsAg阳性者;免疫阻断组婴儿370例,7月龄时HBsAg阳性者21例,2组阳性率比较差异有统计学意义(0 vs 5.7%,P=0.02)。2组孕妇均未出现子痫、胎膜早破、产后出血等现象;2组婴儿在早产率、身长、体质量、Apgar评分方面差异均无统计学意义(P值均>0.05)。结论在新生儿接受主被动免疫的基础上,如在孕晚期对高病毒载量孕妇进行抗病毒干预,可显著提高HBV母婴阻断率,达到HBV母婴零传播,且新生儿的短期安全性良好。Objective To evaluate the clinical effect and short-term safety of telbivudine administered in late pregnancy for blocking mother-to-child transmission of HBV in pregnant women with high HBV DNA load. Methods Pregnant women with positive HBsAg and HBe Ag and HBV DNA ≥2 × 10~6 IU/ml who underwent blockade of mother-to-child transmission in The First Hospital of Jilin University from July 2012 to June 2015 were enrolled. These patients were informed of current methods for blocking mother-to-child transmission of hepatitis B,and according to their own will,they were divided into active/passive immunization ＋ telbivudine（ telbivudine group） and active/passive immunization group（ immunization group）. The patients in the telbivudine group were given oral telbivudine（ 600 mg,once a day） from week 32 of pregnancy to delivery,and those in the immunization group were not given antiviral therapy. The infants in both groups were given 20 μg hepatitis B vaccine combined with 100 IU hepatitis B immunoglobulin after birth. Positive HBsAg in infants at an age of 7months was defined as failed blockade of mother-to-child transmission. The t-test was used for comparison of normally distributed continuous data between groups,and the Wilcoxon rank sun test was used for comparison of non-normally distributed continuous data between groups; the chi-square test or the Fisher＇s exact test was used for comparison of categorical data between groups. Results A total of 447 pregnant women were enrolled,and there were 81 pregnant women in the telbivudine group and 366 women in the immunization group. Compared with the immunization group,the telbivudine group had a significantly higher mean age（ 28. 8 ± 3. 3 years vs 27. 6 ± 3. 8 years,t =-2. 55,P = 0. 01） and a significantly higher proportion of pregnant women with HBV DNA load 10~8 IU/ml（ 82. 7% vs 61. 5%,χ~2=13. 21,P〈0. 001）. There were no significant differences in alanine aminotransferase level,delivery mode,and feeding pattern between the two groups（ al

关 键 词：肝炎病毒 乙型 母婴传播 替比夫定 孕妇 

分 类 号：R714.251[医药卫生—妇产科学]