Diakonhjemmet Hospital Pharmacy, Oslo, Norway.
Scand J Rheumatol. 2012 May;41(3):196-201. doi: 10.3109/03009742.2011.626442. Epub 2012 Mar 9.
To study (i) the drug utilization pattern of anti-rheumatic drugs in pregnant women and expectant fathers and (ii) the association between the use of anti-rheumatic drugs during pregnancy and the risk of congenital malformations.
Pregnancies registered in the Medical Birth Registry of Norway (MBRN) were linked to the Norwegian Prescription Database (NorPD) in the period 2004-2007. Prescriptions for anti-rheumatic drugs issued to women 3 months prior to and during pregnancy and to men 3 months prior to conception were identified. Congenital malformations were recorded according to the European Surveillance of Congenital Anomalies (EUROCAT) guidelines.
In 154,976 singleton pregnancies, 1461 of the women (0.9%) and 1198 (0.8%) of the known fathers (150,530) were dispensed anti-rheumatic drugs at least once during the study period: 723 had non-steroidal anti-inflammatory drugs (NSAIDs), 633 prednisolone (CS), 119 sulfasalazine (SASP), 101 azathioprine (AZA), 58 hydroxychloroquine (HQC), 37 etanercept (ETAN), eight methotrexate (MTX), two leflunomide (LEF), and three adalumimab (ADA). Odds ratios (ORs) for malformations in children born of women (w) or men (m) who had received the drugs were OR(w) = 1.06 [95% confidence interval (CI) 0.85-1.32] and OR(m) = 1.19 (95% CI 0.93-1.51), respectively, and for major malformation OR(w) = 1.05 (95% CI 0.79-1.40) and OR(m) = 1.26 (95% CI 0.93-1.71), respectively. None of the children whose mother had received MTX, LEF, ETAN, or ADA were reported to be born with major malformations.
This study revealed no major malformations of the alert drugs MTX, LEF, ETAN, or ADA. Although the numbers are limited, this provides important population-based information to both expectant parents and prescribers.
研究（i）抗风湿药物在孕妇和准父亲中的药物利用模式，以及（ii）怀孕期间使用抗风湿药物与先天畸形风险之间的关系。
在 2004-2007 年期间，将挪威医学出生登记处（MBRN）中登记的妊娠与挪威处方数据库（NorPD）进行了关联。确定了女性在怀孕前 3 个月和怀孕期间以及男性在受孕前 3 个月开具的抗风湿药物处方。根据欧洲先天异常监测系统（EUROCAT）指南记录先天畸形。
在 154976 例单胎妊娠中，1461 名女性（0.9%）和 1198 名已知父亲（150530 名）在研究期间至少开具了一次抗风湿药物：723 名患者使用非甾体抗炎药（NSAIDs），633 名患者使用泼尼松龙（CS），119 名患者使用柳氮磺胺吡啶（SASP），101 名患者使用硫唑嘌呤（AZA），58 名患者使用羟氯喹（HQC），37 名患者使用依那西普（ETAN），8 名患者使用甲氨蝶呤（MTX），2 名患者使用来氟米特（LEF），3 名患者使用阿达木单抗（ADA）。接受药物治疗的女性（w）或男性（m）所生孩子的畸形发生率的比值比（OR）分别为 OR（w）=1.06（95%置信区间（CI）0.85-1.32）和 OR（m）=1.19（95% CI 0.93-1.51），主要畸形发生率的 OR（w）=1.05（95% CI 0.79-1.40）和 OR（m）=1.26（95% CI 0.93-1.71）。没有母亲服用 MTX、LEF、ETAN 或 ADA 的孩子报告患有重大畸形。
本研究未发现 MTX、LEF、ETAN 或 ADA 等警示药物的主要畸形。尽管数量有限，但这为准父母和处方医生提供了重要的基于人群的信息。
