Division of Epidemiology and Communicable Diseases, University of Zurich Centre for Travel Medicine, Institute for Social and Preventive Medicine, Zurich, Switzerland.
Clin Infect Dis. 2012 Jun;54(11):e124-31. doi: 10.1093/cid/cis215. Epub 2012 Apr 10.
Pregnant women who travel to malarious areas and their clinicians need data on the safety of malaria chemoprophylaxis.
The effect of exposure to mefloquine on pregnancy and offspring outcomes was evaluated using the F. Hoffmann-La Roche global drug safety database for the time frame 31 January 1986 through 26 October 2010. We investigated pregnancy and fetal outcomes in maternal, paternal, and both-parent exposure cases with a focus on congenital malformations and fetal loss. The main outcome measures were birth defect prevalence and types of malformations.
A total of 2506 cases of mefloquine exposure during pregnancy or in the pre- and periconception period were evaluated. Most cases were maternal prospective (outcome of the pregnancy unknown at the time of reporting; n = 2246 [89.6%]) followed by maternal retrospective cases (outcome of the pregnancy known at the time of reporting; n = 227 [9.0%]), with small numbers of paternal and both-parent exposure cases. Of the total 2246 mefloquine maternal prospective exposures (95.2%), 2139 occurred before conception and/or during the first trimester. Of 1383 maternal prospective cases with known outcome, 978 (70.7%) resulted in delivery, 405 (29.3%) resulted in abortion (112 spontaneous, 293 therapeutic), and 43 resulted in birth defects, corresponding to a birth defect prevalence of 4.39% (43 of 978). Prospective cases overall showed no specific pattern of birth malformations.
The drug safety database analysis of mefloquine exposure in pregnancy showed that the birth defect prevalence and fetal loss in maternal, prospectively monitored cases were comparable to background rates.
前往疟疾流行地区的孕妇及其临床医生需要了解疟疾化学预防的安全性数据。
使用罗氏全球药物安全数据库，评估了在 1986 年 1 月 31 日至 2010 年 10 月 26 日期间，孕妇接触甲氟喹对妊娠和后代结局的影响。我们调查了母体、父体和双亲暴露病例的妊娠和胎儿结局，重点关注先天性畸形和胎儿丢失。主要结局指标为出生缺陷的患病率和畸形类型。
共评估了 2506 例妊娠期间或妊娠前和围孕期甲氟喹暴露病例。大多数病例为母体前瞻性（报告时妊娠结局未知；n=2246[89.6%]），其次为母体回顾性病例（报告时妊娠结局已知；n=227[9.0%]），父体和双亲暴露病例数量较少。在 2246 例母体前瞻性甲氟喹暴露病例中（95.2%），2139 例发生在受孕前和/或孕早期。在 1383 例已知结局的母体前瞻性病例中，978 例（70.7%）分娩，405 例（29.3%）流产（112 例自然流产，293 例人工流产），43 例出生缺陷，出生缺陷患病率为 4.39%（978 例中的 43 例）。总体而言，前瞻性病例未显示出特定的出生畸形模式。
对妊娠中甲氟喹暴露的药物安全性数据库分析表明，母体前瞻性监测病例的出生缺陷患病率和胎儿丢失率与背景率相当。
