拉米夫定或替比夫定的安全性和有效性在妊娠早期为有活动

StephenW

Hepatol Int. 2018 Jan 17. doi: 10.1007/s12072-017-9839-5. [Epub ahead of print]
Safety and efficacy of lamivudine or telbivudine started in early pregnancy for mothers with active chronic hepatitis B.
He T1, Bai Y2, Cai H3, Ou X1, Liu M2, Yi W4, Jia J5.
Author information

1
    Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Liver Research Center, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong-an Road, Xicheng District, Beijing, 100050, China.
2
    Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University, No. 8 Jing-shun East Street, Chaoyang District, Beijing, 100015, China.
3
    Department of Hepatology, Beijing Ditan Hospital, Capital Medical University, Beijing, China.
4
    Department of Obstetrics and Gynecology, Beijing Ditan Hospital, Capital Medical University, No. 8 Jing-shun East Street, Chaoyang District, Beijing, 100015, China. [email protected].
5
    Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, National Clinical Research Center of Digestive Diseases, Liver Research Center, Beijing Friendship Hospital, Capital Medical University, No. 95 Yong-an Road, Xicheng District, Beijing, 100050, China. [email protected].

Abstract
BACKGROUND:

Few data exist regarding use of nucleos(t)ide analogs started in early pregnancy for mothers with active chronic hepatitis B (CHB). We assessed the safety and efficacy of lamivudine/telbivudine initiated in the first trimester versus no treatment in mothers with active CHB.
METHODS:

We retrospectively enrolled 94 mothers newly diagnosed with active CHB in the first trimester of pregnancy. Patients with or without antiviral therapy were followed until postpartum week 28. All newborns received immunoprophylaxis. The primary endpoint was the safety of mothers and infants. The secondary endpoints were hepatitis B virus (HBV) DNA suppression and mother-to-child transmission (MTCT) rate.
RESULTS:

Fifty-nine of the 94 mothers initiated lamivudine/telbivudine (27/32) in the first trimester of pregnancy; 35 received no treatment. At delivery, the viral load reduction was similar between lamivudine and telbivudine. Early initiation of lamivudine/telbivudine significantly increased the proportion of mothers achieving HBV DNA <106 copies/ml compared with those with no treatment (100 versus 42.42 %, p < 0.001). At postpartum week 28, the MTCT rate was significant lower in the treated group than in the control group (0/61 or 0 versus 4/34 or 11.76 %, p = 0.028). Lamivudine and telbivudine were well tolerated in the mothers except mild creatine kinase (CK) elevation. There existed no differences in gestational age, infant length and weight, Apgar score, adverse events, or birth defect rates between infants from treated and untreated mothers.
CONCLUSIONS:

Treatment with lamivudine or telbivudine for active CHB in early pregnancy appears to be safe and effective for controlling maternal disease as well as interrupting MTCT.
KEYWORDS:

Chronic hepatitis B; Early; Lamivudine; Mother-to-child transmission; Telbivudine

PMID:
    29344772
DOI:
    10.1007/s12072-017-9839-5

StephenW

Hepatol Int。 2018年1月17日，doi：10.1007 / s12072-017-9839-5。 [电子版提前打印]
拉米夫定或替比夫定的安全性和有效性在妊娠早期为有活动性慢性乙型肝炎的母亲开始。
He T1，Bai Y2，Cai H3，Ou X1，Liu M2，Yi W4，Jia J5。
作者信息

1
    北京市西城区永安路95号，首都医科大学附属北京友谊医院肝病研究中心消化内科临床研究中心北京市肝病肝病转化医学重点实验室，北京100050
2
    北京市朝阳区京顺东街8号，首都医科大学附属北京地坛医院妇产科，100015
3
    首都医科大学附属北京地坛医院肝病科，北京，中国。
4
    北京市朝阳区京顺东街8号，首都医科大学附属北京地坛医院妇产科，100015 [email protected]。
五
    北京市西城区永安路95号，首都医科大学附属北京友谊医院肝病研究中心消化内科临床研究中心北京市肝病肝病转化医学重点实验室，北京100050 [email protected]。

抽象
背景：

很少有关于孕早期开始使用核苷（酸）类似物的数据，这些数据用于有活动性慢性乙型肝炎（CHB）的母亲。我们评估了拉米夫定/替比夫定在孕中期开始治疗的安全性和有效性，而在有活动性慢性乙型肝炎的母亲中则不治疗。
方法：

我们回顾性地招募了94名母亲，在妊娠的头三个月初次诊断为活动性CHB。所有新生儿均接受免疫预防。主要终点是母亲和婴儿的安全。次要终点是乙型肝炎病毒（HBV）DNA抑制和母婴传播（MTCT）率。
结果：

94名母亲中有59名在怀孕的头三个月开始拉米夫定/替比夫定（27/32） 35没有接受治疗。在分娩时，拉米夫定和替比夫定的病毒载量降低相似。拉米夫定/替比夫定的早期启动显着提高了HBV DNA <106拷贝/ ml的母亲比例，与未治疗者相比（100比42.42％，P <0.001）。在产后第28周，治疗组MTCT率显着低于对照组（0/61或0对比4/34或11.76％，P = 0.028）。除轻度肌酸激酶（CK）升高外，拉米夫定和替比夫定耐受良好。在治疗和未治疗的母亲的婴儿之间，孕龄，婴儿体重，Apgar评分，不良事件或出生缺陷率没有差异。
结论：

妊娠早期使用拉米夫定或替比夫定治疗活动性CHB似乎对控制母亲疾病以及中断MTCT是安全有效的。
关键词：

慢性乙型肝炎;早;拉米夫定;母婴传播;替比夫定

结论：
    29344772
DOI：
    10.1007 / s12072-017-9839-5