Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway.
Headache. 2010 Apr;50(4):563-75. doi: 10.1111/j.1526-4610.2010.01619.x. Epub 2010 Jan 28.
To evaluate the safety of triptan therapy during pregnancy.
Information on the safety of triptan therapy during pregnancy is scarce and only available for sumatriptan, naratriptan, and rizatriptan. No associations with congenital malformations have been detected so far, but one study found a significant association between sumatriptan exposure during pregnancy and prematurity.
The study population consisted of 69,929 pregnant women and their newborn children for whom data on drug exposure and pregnancy outcome were available. Information on triptan therapy and potential socio-demographic and medical confounding factors was obtained from the Norwegian Mother and Child Cohort Study. Information on congenital malformations and other adverse pregnancy outcomes was obtained from the Norwegian Medical Birth Registry. The datasets were linked via the women's personal identification number. Pearson's chi(2) tests and logistic regression analyses were used to identify associations between triptan therapy and pregnancy outcome.
No significant associations between triptan therapy during the first trimester and major congenital malformations (unadjusted OR: 1.0; 95% CI 0.8-1.3, adjusted OR: 1.0; 95% CI 0.7-1.2) or other adverse pregnancy outcomes were found. Triptan therapy during the second and/or third trimesters was significantly associated with atonic uterus (unadjusted OR: 1.5; 95% CI 1.1-1.9, adjusted OR: 1.4; 95% CI 1.1-1.8), and blood loss >500 mL during labor (unadjusted OR: 1.3; 95% CI 1.1-1.5, adjusted OR: 1.3; 95% CI 1.1-1.5).
Triptan therapy during pregnancy was not associated with an overall increased risk of congenital malformations. It cannot, however, be excluded that a difference in the risk between triptan use and individual or rare congenital malformations may exist. A slight increase in the risk of atonic uterus and hemorrhage was associated with triptan use during the second and/or third trimesters. Although the present findings are reassuring, confirmation in independent studies is warranted.
评估曲坦类药物治疗在孕期的安全性。
关于曲坦类药物治疗在孕期的安全性信息有限，目前仅在舒马曲坦、那拉曲坦和利扎曲坦中得到证实。到目前为止，尚未发现与先天性畸形有任何关联，但有一项研究发现，舒马曲坦在孕期的暴露与早产之间存在显著关联。
研究人群由 69929 名孕妇及其新生儿组成，这些孕妇及其新生儿的药物暴露和妊娠结局数据均可获得。曲坦类药物治疗情况以及潜在的社会人口学和医学混杂因素信息均来自挪威母婴队列研究。先天性畸形和其他不良妊娠结局的信息来自挪威医学出生登记处。这些数据集通过女性的个人识别号码进行关联。采用 Pearson's chi(2)检验和 logistic 回归分析来识别曲坦类药物治疗与妊娠结局之间的关联。
在孕早期使用曲坦类药物与重大先天性畸形（未经调整的 OR：1.0；95%CI 0.8-1.3，调整后的 OR：1.0；95%CI 0.7-1.2）或其他不良妊娠结局之间无显著关联。在孕中期和/或孕晚期使用曲坦类药物与弛缓性子宫（未经调整的 OR：1.5；95%CI 1.1-1.9，调整后的 OR：1.4；95%CI 1.1-1.8）和分娩时出血量＞500mL（未经调整的 OR：1.3；95%CI 1.1-1.5，调整后的 OR：1.3；95%CI 1.1-1.5）显著相关。
在孕期使用曲坦类药物治疗与先天性畸形的总体风险增加无关。但是，不能排除曲坦类药物使用与个体或罕见先天性畸形之间存在风险差异的可能性。在孕中期和/或孕晚期使用曲坦类药物与弛缓性子宫和出血风险略有增加相关。尽管目前的发现令人安心，但仍需要在独立研究中加以证实。
