Safety of artemisinins in first trimester of prospectively followed pregnancies: an observational study
Safety of artemisinins in first trimester of prospectively followed pregnancies: an observational study
复制标题
DOI：
10.1016/s1473-3099(15)00547-2
复制
发表时间：
2016-05-01
影响因子：
56.3
通讯作者：
McGready, Rose
中科院分区：
文献类型：
--
作者：
Moore, Kerryn A.;Simpson, Julie A.;McGready, Rose
青蒿素是目前最有效的抗疟药，但出于安全考虑，不建议在妊娠前三个月使用。因此，尽管效果不佳，但仍使用奎宁。评估青蒿素的安全性需要权衡疟疾及其治疗的风险。我们的目的是评估妊娠早期疟疾和青蒿素治疗对流产和主要先天畸形的影响。方法在这项观察性研究中，我们评估了1994年1月1日至2013年12月31日期间泰缅边境产前诊所的数据。我们纳入了在妊娠早期到产前诊所就诊的有存活胎儿的妇女。对妇女进行了疟疾筛查，并收集了关于疟疾、抗疟治疗和分娩结果的数据。青蒿素治疗（青蒿琥酯，双氢青蒿素，或蒿甲醚）和流产或畸形之间的关系进行了评估，使用考克斯回归左截断和随时间变化的exposation.Findings之间的55 636怀孕登记1994年和2013年，25 485怀孕进行了分析，为早期妊娠疟疾和流产，其中2558（10%）有早期妊娠疟疾。妊娠早期恶性疟原虫发作后流产风险增加1.61倍（95%CI 1.32-1.97; p
Background Artemisinins, the most effective antimalarials available, are not recommended for falciparum malaria during the first trimester of pregnancy because of safety concerns. Therefore, quinine is used despite its poor effectiveness. Assessing artemisinin safety requires weighing the risks of malaria and its treatment. We aimed to assess the effect of first-trimester malaria and artemisinin treatment on miscarriage and major congenital malformations.Methods In this observational study, we assessed data from antenatal clinics on the Thai-Myanmar border between Jan 1, 1994, and Dec 31, 2013. We included women who presented to antenatal clinics during their first trimester with a viable fetus. Women were screened for malaria, and data on malaria, antimalarial treatment, and birth outcomes were collected. The relationship between artemisinin treatments (artesunate, dihydroartemisinin, or artemether) and miscarriage or malformation was assessed using Cox regression with left-truncation and time-varying exposures.Findings Of 55 636 pregnancies registered between 1994 and 2013, 25 485 pregnancies were analysed for first-trimester malaria and miscarriage, in which 2558 (10%) had first-trimester malaria. The hazard of miscarriage increased 1.61-fold after an initial first-trimester falciparum episode (95% CI 1.32-1.97; p