應用全民健保資料庫研究懷孕期婦女使用抗憂鬱藥對胎兒的影響
中文摘要
女性憂鬱症的發生率是男性的兩倍。且好發的年齡層在 25 歲到 44 歲之間；又不論是憂
鬱症本身或是用於治療憂鬱症藥物皆有報導可能與造成胎兒或新生兒健康指標不良的風 險有關。為了能提出更有力的藥物流行病學研究實證以期能了解懷孕期服用抗憂鬱藥的 用藥安全問題，本研究應用台灣全民健保資料庫探討懷孕期婦女使用抗憂鬱藥對胎兒的 影響。首先利用民國 2001-2003 年健保資料庫並串聯出生檔，剔除多胞胎新生兒後及懷 孕期間使用抗憂鬱藥累計未達 14 天之病患，取得樣本數 468,471 人；之後比較懷孕期 使用抗憂鬱藥 (n=1,713) 孕婦分娩胎兒及懷孕期間未使用抗憂鬱藥孕婦分娩新生兒 (466, 758) 健康指標。並設定依變項為胎兒之早產與否 ( 出生周數 <37 週 ) 、出生體重 (<2,50 0 公克 ) 及出生體重小於妊娠年齡 (SGA) ，自變項為孕婦於懷孕期間使用抗憂鬱。繼而 以頻率（百分比）描述樣本特性，其次再透過卡方檢定 (Chi-square) 檢定關聯性最後利 用羅吉氏迴歸 (logistic regression) 分析不同成分抗憂鬱藥的勝算比。研究結果發現懷孕 期間有使用 trazodone 抗憂鬱藥所分娩胎兒相較於孕婦於懷孕期間沒有使用抗憂鬱藥所 分娩胎兒三項新生兒出生指標 : 早產 (odds ratio=1.243;95% CI=1.151-1.34) 、出生體重過 輕 (odds ratio=1.157; 95% CI=1.059-1.263) 及出生體重小於小於妊娠年齡 ) (odds ratio=1.1 06; 95%CI=1.041-1.175) 的風險；而使用 paroxetine 的孕婦對其所分娩的胎兒具出生體 重過輕及出生體重小於妊娠年齡兩指標之關聯性，且均達到統計顯顯著之差異。本研究 推論懷孕期間臨床上應避免抗憂鬱藥品投予懷孕婦女，若於病症無其他更適合控制病情 之藥品選擇時，應提醒注意定期追蹤胎兒成長與健康情形。
Neonatal Outcomes of Prenatal Antidepressant Exposure: A National Health Insurance Research Database Study
英文摘要
Objectives: The incidence of depressive disorders in women is two times higher compared to t hat in men. The prevalence in women is the highest during their childbearing years. Maternal depression is associated with perinatal risk related to physiological sequelae or inadequate obs tetrical care. Therefore, to clarify the drug-related problems for the maternal depression therap y with providing pharmacoepidemiological evidence, we conducted this study and used a nati onwide database released by the Taiwa National Health Research Institute to link to the birth r ecords. The study cohort consisted of the pregnant women who had delivered during 2001-20 03 and met the research inclusion criteria (n=468,471). The risks of preterm birth, low birth w eight, small for gestationa age of exposed pregnant women (n=1,713) were compared with tho se neonatal outcomes of non-exposed women (466,758). The statistical significance of the res ults showed that the neonate outcomes of maternal exposures to trazodone had high risks of pr eterm birth (odds ratio=1.243; 95% CI= 1.151-1.34), low birth weight (odds ratio=1.157; 95%
CI=1.059-1.263), and small for gestational age (odds ratio=1.106; 95% CI=1.041-1.175). Exp osures to paroxetine had increaesd risks of low birth weight (odds ratio=2.163; 95% CI=1.07 7-4.343), small for gestationa age (odds ratio=1.816; 95% CI=1.078-3.058). The result of this study suggest that the uses of antidepressants particularly trazodone and paroxetine during pre gnant women need to be careful and long-term monitoing for those neonatal health is necessar y.
