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妊娠期慢性乙型肝炎的临床过程和围生期传播:一项真实世界前瞻性队列研究。

Clinical course and perinatal transmission of chronic hepatitis B during pregnancy: A real-world prospective cohort study.

机构信息

Department of Clinical Pharmacy, Nantong Health College of Jiangsu Province, China.

Department of Obstetrics and Gynaecology, Nantong Third People's Hospital, Nantong University, Jiangsu, China.

出版信息

J Infect. 2017 Aug;75(2):146-154. doi: 10.1016/j.jinf.2017.05.012. Epub 2017 May 24.

Abstract

OBJECTIVE

To determine the clinical course and perinatal transmission of chronic hepatitis B during pregnancy in a real life setting.

METHODS

A total of 221 singleton pregnant women with detectable HBV-DNA levels (≥10 copies/mL) were enrolled during January 2011 to June 2015. Forty-three high viraemic patients (≥10 copies/mL) received telbivudine in the 2 or 3 trimester according to their intention, while 89 high viraemic and 79 low viraemic (≥10 and <10 copies/mL) patients were the control cohorts. Primary endpoint was the pregnancy outcomes and secondary endpoint the perinatal transmission including intrauterine infection, immunoprophylaxis failure and occult infection.

RESULTS

In all, 209 patients completed pregnancy with 209 infants, while 2 in telbivudine-treated cohort had unexplained late stillbirths. Twenty-nine (70.7%) of telbivudine-treated patients and 3 (3.4%) of untreated high viraemic controls achieved undetectable HBV-DNA levels prior delivery. At 7 months postpartum, immunoprophylaxis failure was significantly lower (2.4%) in telbivudine-treated cohort, compared with 16.9% and 10.1% in untreated high and low viraemic cohorts, respectively.

CONCLUSIONS

Low viraemic patients may also need antiviral therapy since they bear moderate risk for perinatal transmission of HBV. However, more multicenter, large-scale studies are required before antepartum antiviral therapy is routinely recommended in patients with detectable viral loads.

摘要

目的

在真实环境中确定妊娠期间慢性乙型肝炎的临床过程和围产期传播。

方法

2011 年 1 月至 2015 年 6 月共纳入 221 例可检测到 HBV-DNA 水平(≥10 拷贝/mL)的单胎孕妇。根据其意愿,43 例高病毒血症患者(≥10 拷贝/mL)在 2 或 3 个孕期接受替比夫定治疗,而 89 例高病毒血症和 79 例低病毒血症(≥10 和 <10 拷贝/mL)患者为对照组。主要终点是妊娠结局,次要终点是围产期传播,包括宫内感染、免疫预防失败和隐匿性感染。

结果

共有 209 例患者完成妊娠并分娩了 209 例婴儿,而替比夫定治疗组有 2 例原因不明的晚期死胎。29 例(70.7%)替比夫定治疗患者和 3 例(3.4%)未治疗的高病毒血症对照组在分娩前达到 HBV-DNA 水平不可检测。在产后 7 个月时,替比夫定治疗组的免疫预防失败率明显较低(2.4%),而未治疗的高病毒血症和低病毒血症组分别为 16.9%和 10.1%。

结论

低病毒血症患者也可能需要抗病毒治疗,因为他们有中度的 HBV 围产期传播风险。然而,在常规推荐有可检测病毒载量的患者进行产前抗病毒治疗之前,需要更多的多中心、大规模研究。

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