Sun Weihui, Zhao Shangfei, Ma Lei, Hao Anhua, Zhao Bo, Zhou Lin, Li Fengzhu, Song Mingquan
Department of Hepatology, Chengyang People's Hospital of Qingdao, Qingdao, 266109, Shandong Province, China.
Department of Gastroenterology, The Affiliated Hospital of Qingdao University, Qingdao, 266011, Shandong Province, China.
BMC Gastroenterol. 2017 Apr 13;17(1):51. doi: 10.1186/s12876-017-0608-7.
To evaluate the efficacy and safety of treating HBV-positive mothers with telbivudine in early and middle pregnancy to prevent mother-to-infant HBV transmission.
The subject population comprised pregnant women with chronic hepatitis B (CHB; n = 188) from January 2013 to June 2015, with HBV DNA ≥1.0 × 10copies/mL and increased alanine aminotransferase levels. Groups A (n = 62) and B (n = 61) were treated with telbivudine starting at 12 weeks or 20-28 weeks after gestation, respectively. Telbivudine was discontinued at postpartum 12 weeks. Group C (n = 65) received no antiviral. All infants were vaccinated with hepatitis B immunoglobulin (200 IU) and HBV vaccine (20 with hepatitis B The maternal HBV DNA levels of the groups were compared. Mother-to-infant transmission of HBV was indicated by the presence of HBsAg in infants 7 months after birth.
Before treatment, the HBV DNA levels of the 3 groups were similar. Before delivery and 12 weeks after delivery, the HBV DNA levels of groups A and B were similar, but both were significantly lower than that of group C (P < 0.01, all). No infants in groups A and B were HBsAg-positive, but the infection rate of group C was 18.4% (P < 0.01). The HBV infection rate of infants was positively associated with the HBV DNA levels of the pregnant mothers.
Administration of telbivudine to HBV-infected mothers, started during early and middle pregnancy, completely blocked mother-to-infant HBV transmission.
The study was registered retrospectively on Janurary 25 in 2016 at Chinese Clinical Trial Registry ( ChiCTR-OPC-16007899 ).
评估妊娠早中期使用替比夫定治疗乙肝病毒（HBV）阳性母亲以预防母婴HBV传播的疗效和安全性。
研究对象为2013年1月至2015年6月的慢性乙型肝炎（CHB）孕妇（n = 188），HBV DNA≥1.0×10拷贝/mL且丙氨酸转氨酶水平升高。A组（n = 62）和B组（n = 61）分别在妊娠12周或20 - 28周开始使用替比夫定治疗。产后12周停用替比夫定。C组（n = 65）未接受抗病毒治疗。所有婴儿均接种乙肝免疫球蛋白（200 IU）和乙肝疫苗（20μg）。比较各组母亲的HBV DNA水平。以出生7个月婴儿HBsAg阳性表示母婴HBV传播。
治疗前，3组的HBV DNA水平相似。分娩前及分娩后12周，A组和B组的HBV DNA水平相似，但均显著低于C组（P均<0.01）。A组和B组无婴儿HBsAg阳性，但C组感染率为18.4%（P<0.01）。婴儿的HBV感染率与孕妇母亲的HBV DNA水平呈正相关。
妊娠早中期开始对HBV感染母亲使用替比夫定，可完全阻断母婴HBV传播。
该研究于2016年1月25日在中国临床试验注册中心进行回顾性注册（ChiCTR - OPC - 16007899）。
