摘要
目的:利用美国FDA不良事件报告系统(FAERS)挖掘拉米夫定妊娠相关不良反应的风险信号,为该药的临床安全应用提供参考。方法:收集FAERS数据库中2004年第1季度-2021年第1季度的不良事件报告,根据首要怀疑药物,以替诺福韦酯为对照,利用报告比值比(ROR)法对拉米夫定妊娠相关不良事件(流产、自然流产、早产、低出生体重、死产和胎儿死亡、胎儿并发症)进行风险信号挖掘。并分别在HBV人群、HIV人群进行亚组分析。结果:以拉米夫定和替诺福韦酯为首要怀疑药物的妊娠期不良反应报告分别有4364例和3750例。与替诺福韦酯相比,拉米夫定妊娠相关不良反应风险信号未见升高。但在HBV人群中,拉米夫定所致的死产和胎儿死亡(ROR=2.09,95%CI:1.14~3.82)、胎儿并发症(ROR=3.04,95%CI:2.19~4.23)风险信号较替诺福韦酯显著增加,上述差异在HIV人群中并未观察到。结论:鉴于我国庞大的乙肝患者人群以及目前尚缺乏对两药妊娠期安全性的头对头系统性比较研究,基于FAERS的真实世界数据可为妊娠期乙肝患者个体化用药提供一定参考。
Objective: To excavate the risk signals related to adverse events(AEs) during pregnancy associated with lamivudine(LAM) based on the database of the US Food and Drug Administration(FDA) Adverse Event Reporting System(FAERS),and provide references for the clinical safety drug use. Methods: AEs reports from the first quarter of 2004 to the first quarter of 2021 in FAERS database were collected. According to the first suspected drug, method of the reporting odds ratio(ROR) was conducted to identify the risk signals of AEs(abortion, spontaneous abortion, preterm birth, low birth weight, stillbirth and foetal death, foetal complications) associated with LAM during pregnancy with tenofovir dipivoxil(TDF) as the control. Subgroup analysis were also performed in HBV and HIV populations respectively. Results: There were 4364 reports with the first suspected drug as LAM and 3750 reports with the first suspected drug as TDF. The risk signals of AEs associated with LAM were not increased compared with those of TDF. However, there were increased risk signals of stillbirth and foetal death(ROR = 2.09, 95%CI: 1.14 - 3.82)and foetal complications(ROR = 3.04, 95%CI: 2.19 - 4.23) associated with LAM in HBV populations compared with TDF. Whereas,no difference was found in HIV populations between LAM and TDF. Conclusion: In view of the large amount of patients with HBV infection in China and the lack of systematic head-to-head comparative studies on the safety of the two drugs during pregnancy,the real-world data based on FAERS could provide valuable references for the individualized therapy of patients with HBV infection during pregnancy.
作者
张杨
杨仁君
殷诺雅
赵莹
李丹丹
Francesco Faiola
ZHANG Yang;YANG Ren-jun;YIN Nuo-ya;ZHAO Ying;Li Dan-dan;Francesco Faiola(Department of Pharmacy,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;State Key Laboratory of Environmental Chemistry and Ecotoxicology,Research Center for Eco-Environmental Sciences,Chinese Academy of Sciences,Beijing 100085,China;College of Resources and Environment,University of Chinese Academy of Sciences,Beijing 100049,China)
出处
《中国药物应用与监测》
CAS
2022年第3期182-185,208,共5页
Chinese Journal of Drug Application and Monitoring
基金
国家自然科学基金青年科学基金项目(82104310)
北京友谊医院科研启动基金资助项目(yyqdktzx2020-1)。
关键词
拉米夫定
替诺福韦酯
妊娠
不良反应信号
报告比值比法
Lamivudine
Tenofovir dipivoxil
Pregnancy
Signal of adverse drug reaction
Reporting odds ratio
