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分析核苷(酸)类似物治疗慢性乙型肝炎在整个孕期的长期安全性和疗效。

Analysis of long-term safety and efficacy of nucleos(t)ide analogue therapy for chronic hepatitis B throughout pregnancy.

机构信息

Centre of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

Centre of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

出版信息

Int J Infect Dis. 2021 Apr;105:626-631. doi: 10.1016/j.ijid.2021.03.023. Epub 2021 Mar 17.

DOI:10.1016/j.ijid.2021.03.023
PMID:33722684
Abstract

BACKGROUND

Limited data exist regarding the efficacy and long-term safety of nucleos(t)ide analogue therapy throughout pregnancy for women with chronic hepatitis B and their children.

METHODS

This retrospective cohort study included 165 women in total: 91 women received telbivudine (LDT) and 74 women received tenofovir (TDF) throughout pregnancy. The virological response and safety in women were recorded, and the physical development and bone mineral density in children were evaluated up to 5 years of age.

RESULTS

The rate of virological breakthrough in women was 4.24% overall (7.70% in LDT group and 0% in TDF group; P < 0.05). No cases of renal injury or other obstetric adverse events occurred in either group of women. Among the children, only one child had a significantly low Z score for weight for age (<-2), and no children had a significantly low Z score for height for age or bone mineral density. No significant difference was found between the children in the two groups.

CONCLUSIONS

Nucleos(t)ide analogue therapy with TDF or LDT throughout pregnancy had no effect on the long-term physical development and bone development of children. In addition, the use of TDF throughout pregnancy had better long-term antiviral efficacy than LDT in women, with no evidence of renal toxicity.

摘要

背景

关于核苷(酸)类似物治疗在整个妊娠期间对慢性乙型肝炎女性及其子女的疗效和长期安全性的数据有限。

方法

本回顾性队列研究共纳入 165 名女性:91 名女性接受替比夫定(LDT)治疗,74 名女性接受替诺福韦(TDF)治疗。记录女性的病毒学应答和安全性,评估儿童的体格发育和骨密度至 5 岁。

结果

女性的病毒学突破率总体为 4.24%(LDT 组为 7.70%,TDF 组为 0%;P<0.05)。两组女性均未发生肾损伤或其他产科不良事件。在儿童中,仅有 1 名儿童的体重年龄 Z 评分明显较低(<-2),无儿童的身高年龄 Z 评分或骨密度明显较低。两组儿童之间无显著差异。

结论

整个妊娠期间使用 TDF 或 LDT 的核苷(酸)类似物治疗对儿童的长期体格发育和骨发育没有影响。此外,TDF 在整个妊娠期间的长期抗病毒疗效优于 LDT,且无肾毒性证据。

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