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

Neonatal Outcomes of Prenatal Antidepressant Exposure: A National Health Insurance Research Database Study

林信成(Hsin-Cheng Lin)

指導教授 ： 吳姿樺

共同指導教授 ： 林恆慶(Herng-Ching Lin)

臺北醫學大學/藥學院/藥學研究所/碩士(2009年)

https://doi.org/10.6831/TMU.2009.00032

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(<2,500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=1.106; 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。

關鍵字

憂鬱症 ； 孕婦 ； 新生兒健康風險 ； 健保資料庫 ； 抗憂鬱劑

並列摘要

Objectives: The incidence of depressive disorders in women is two times higher compared to that 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 obstetrical care. Therefore, to clarify the drug-related problems for the maternal depression therapy with providing pharmacoepidemiological evidence, we conducted this study and used a nationwide database released by the Taiwa National Health Research Institute to link to the birth records. The study cohort consisted of the pregnant women who had delivered during 2001-2003 and met the research inclusion criteria (n=468,471). The risks of preterm birth, low birth weight, small for gestationa age of exposed pregnant women (n=1,713) were compared with those neonatal outcomes of non-exposed women (466,758). The statistical significance of the results showed that the neonate outcomes of maternal exposures to trazodone had high risks of preterm 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). Exposures to paroxetine had increaesd risks of low birth weight (odds ratio=2.163; 95% CI=1.077-4.343), 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 pregnant women need to be careful and long-term monitoing for those neonatal health is necessary.

並列關鍵字

antidepressants ； birth outcome ； depression ； neonate ； pregnant women

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