Marchenko Alexander, Etwel Fatma, Olutunfese Olukayode, Nickel Cheri, Koren Gideon, Nulman Irena
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Headache. 2015 Apr;55(4):490-501. doi: 10.1111/head.12500. Epub 2015 Feb 3.
Migraine is a common disorder among women of childbearing age. Triptan medications are effective and commonly used to treat migraines in pregnancy. However, the reproductive safety of this group of drugs has not yet been confirmed. The aim of this study was to determine the reproductive safety of triptan medications by performing a literature review and a meta-analysis.
Available publications regarding pregnancy outcomes following prenatal exposure to triptans from 1991 to 2013 were identified and reviewed according to the inclusion criteria. A random-effects meta-analysis model was implemented to combine the available pregnancy outcome data for the exposed and comparison groups.
One case-control study and 5 cohort studies met the inclusion criteria. The included studies provided information on duration of gestation, major congenital malformations, and spontaneous abortions of infants following prenatal triptan exposure. The 6 studies included 4208 infants of women who used sumatriptan or other triptan medications, and 1,466,994 children of women who did not use triptans during pregnancy. No significant increases in rates for major congenital malformations (MCMs), prematurity, or spontaneous abortions were found when comparing the triptan-exposed group to the migraine - no triptans control group (odds ratio [OR] = 0.84 [0.61-1.16]; OR = 0.90 [0.35-2.30]; OR = 1.27 [0.58-2.79], respectively). There were no increased rate of MCMs (OR = 1.18 [0.97-1.44]) or prematurity (OR = 1.16 (0.67-1.99) when the triptan-exposed group was compared with the healthy controls; however, there was a significant increase in the rates of spontaneous abortions (OR = 3.54 [2.24-5.59]). When the migraine no-triptan group was compared with healthy controls, a significant increase in the rates of MCMs was found (OR = 1.41 [1.11-1.80]).
The use of triptans during pregnancy does not appear to increase the rates for MCMs or prematurity. The increased rates of spontaneous abortions in the triptan-exposed group and the increased rates of MCM in the migraine no-triptan group require further research.
偏头痛是育龄女性中的常见疾病。曲坦类药物有效且常用于治疗孕期偏头痛。然而,这类药物的生殖安全性尚未得到证实。本研究的目的是通过进行文献综述和荟萃分析来确定曲坦类药物的生殖安全性。
根据纳入标准,识别并回顾了1991年至2013年期间有关产前暴露于曲坦类药物后的妊娠结局的现有出版物。采用随机效应荟萃分析模型来合并暴露组和对照组的现有妊娠结局数据。
一项病例对照研究和五项队列研究符合纳入标准。纳入的研究提供了关于产前暴露于曲坦类药物后婴儿的妊娠期、主要先天性畸形和自然流产的信息。这六项研究包括4208名使用舒马曲坦或其他曲坦类药物的女性所生的婴儿,以及1466994名在孕期未使用曲坦类药物的女性所生的孩子。将曲坦类药物暴露组与未使用曲坦类药物的偏头痛对照组进行比较时,未发现主要先天性畸形(MCM)、早产或自然流产率有显著增加(比值比[OR]分别为0.84[0.61 - 1.16];OR为0.90[0.35 - 2.30];OR为1.27[0.58 - 2.79])。将曲坦类药物暴露组与健康对照组进行比较时,MCM率(OR = 1.18[0.97 - 1.44])或早产率(OR = 1.16[0.67 - 1.99])没有增加;然而,自然流产率有显著增加(OR = 3.54[2.24 - 5.59])。当将未使用曲坦类药物的偏头痛组与健康对照组进行比较时,发现MCM率有显著增加(OR = 1.41[1.11 - 1.80])。
孕期使用曲坦类药物似乎不会增加MCM或早产的发生率。曲坦类药物暴露组自然流产率的增加以及未使用曲坦类药物的偏头痛组MCM率的增加需要进一步研究。