依非韦仑在妊娠早期的安全性评价

Safety of Efavirenz in First-trimester of Pregnancy

关键词:  依非韦仑  妊娠早期  胎儿畸形  安全性评价

Key words:  efavirenz  first trimester  birth defect  safety evaluation

摘要:

目的 评价非核苷逆转录酶抑制剂依非韦仑（efavirenz，EFV）在妊娠早期抗逆转录病毒治疗（antiretroviral therapy，ART）中的安全性。方法 以代表性meta分析为依据，介绍EFV用于妊娠早期的文献资料及各国指南修订变化，对比各指南中妊娠期ART方案中EFV的推荐级别，阐述EFV的药动学和妊娠期用法。结果 EFV对HIV-1病毒有显著抑制作用，早期动物实验和少量人类临床数据显示EFV会导致胎儿神经管畸形，被列为妊娠早期禁用药物。随着样本量增加，数据显示妊娠早期使用EFV不增加整体出生缺陷风险，神经管缺陷风险概率不高于一般人群。但由于人类数据较为有限，仅部分指南推荐妊娠早期使用EFV。结论 针对不同个体的妊娠早期ART方案，仍需针对具体问题进行分析评估。

Abstract:

OBJECTIVE To evaluate the safety of using efavirenz(EFV)-containing antiretroviral therapy(ART) regimens in the first trimester. METHODS This review was based on the representative meta-analysis data. It introduced the changes of guidelines in the context of EFV-exposed pregnant women, compared the recommendation level of EFV in the different guidance for pregnancy, expounded the pharmacokinetics of EFV and introduced the dosage during pregnancy. RESULTS The first introduced generation of non nucleoside reverse transcriptase inhibitor, EFV had significant effect on HIV-1 virus, but a few animal experiments and human clinical data at early stage showed fetal neural tube defects with EFV based regiments, which led to a restriction of EFV use in the first trimester. With the increasing of women exposed to EFV during the first trimester, some meta-analysis and the Antiretroviral Pregnancy Register data reported first-trimester exposure had no increased risk of overall congenital anomalies. The risk of neural tube defects associated with EFV remained low and was comparable to the general population. But human data remained so limited that just some guidance recommend EFV during the first trimester. CONCLUSION It's necessary to evaluate the individual condition for appropriate pregnant ART treatment.