Andrews E B, Tilson H H, Hurn B A, Cordero J F
Epidemiology, Information and Surveillance Division, Burroughs Wellcome Co., Burroughs Research Triangle Park, North Carolina 27709.
Am J Med. 1988 Aug 29;85(2A):123-8.
Observational epidemiologic methods are being used to evaluate the safety of acyclovir in pregnancy. An essential component of this research is the establishment of a baseline expectation of pregnancy outcomes among women with herpes not receiving acyclovir. Continuing studies will be described in this report. To supplement these structured studies, an international case registration study was established. Through the Acyclovir in Pregnancy Registry, all cases of reported prenatal exposures to acyclovir are tracked to ascertain maternal exposure, risk factor, and pregnancy outcome information. The reports originate in all countries where oral acyclovir is marketed; data consolidation and analysis are coordinated at Burroughs Wellcome Co. with the assistance of a government/industry advisory panel. This presentation summarizes provisional data from the prospective reports, including trimester of exposure and reported outcomes of pregnancy. The total number of monitored pregnancies remains too small to support conclusions about the safety of acyclovir during pregnancy at this point. The potential for the registry and other epidemiologic studies to address the safety-in-pregnancy question will be discussed.
观察性流行病学方法正被用于评估阿昔洛韦在孕期的安全性。这项研究的一个重要组成部分是确定未接受阿昔洛韦治疗的疱疹女性的妊娠结局基线预期。本报告将描述后续的研究。为补充这些结构化研究，开展了一项国际病例登记研究。通过阿昔洛韦孕期登记处，追踪所有报告的产前暴露于阿昔洛韦的病例，以确定母亲暴露情况、危险因素和妊娠结局信息。报告来自口服阿昔洛韦上市的所有国家；数据整合与分析在百时美施贵宝公司进行，并由政府/行业咨询小组提供协助。本报告总结了前瞻性报告中的临时数据，包括暴露孕周和报告的妊娠结局。目前，监测到的妊娠总数仍然太少，无法支持关于阿昔洛韦在孕期安全性的结论。将讨论登记处及其他流行病学研究解决孕期安全性问题的可能性。
