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研究生: 王重隆
Wang, Chung-Lung
論文名稱: 懷孕期間的抗癲癇用藥
The Use of Anti-epileptic Drugs During Pregnancy
指導教授: 蔡景仁
Tsai, Jing-Jane
蔡瑞真
Tsai, Jui-Chen
葉鳳英
Yeh, Fong-Ying
學位類別: 碩士
Master
系所名稱: 醫學院 - 臨床藥學研究所
Institute of Clinical Pharmacy
論文出版年: 2004
畢業學年度: 92
語文別: 中文
論文頁數: 124
中文關鍵詞: 生產懷孕癲癇致畸胎性抗癲癇藥
外文關鍵詞: teratogenicity, anti-epileptic drugs, delivery, pregnancy, epilepsy
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  • 【研究背景與文獻回顧】癲癇是神經內科常見的一種神經系統的疾病,台灣目前約有20萬左右,其中約40%是生育齡的女性。癲癇婦女懷孕期間約有1/4~1/3的病患其癲癇發作的頻率會增加,此與癲癇的型態、發病時間的長短或前次懷孕期間發作的頻率無關,但與癲癇婦女懷孕時之服藥順從性有關。癲癇女性在懷孕期間臨床處置上的考量除了要包括癲癇疾病本身、更要加上懷孕對癲癇的影響、抗癲癇藥物於懷孕期間的代謝、懷孕期間抗癲癇藥物的選擇、抗癲癇藥物對胎兒的影響、懷孕及生產時的併發症、癲癇遺傳的可能性、藥物與產後哺乳的問題、新生兒成長發育可能的影響等。這些因素都可能影響癲癇婦女懷孕時之服藥順從性,文獻回顧顯示癲癇婦女懷孕生產時較易有胎兒的死亡(死產或流產)、早產及低體重新生兒(<2500g);其子女易有發育及發展遲緩(精神遲鈍、智能缺陷),和將來癲癇發作的危險性增加等問題。目前使用的傳統抗癲癇藥物均具致畸胎性,常見的輕微先天性畸形有唇裂/或顎裂、手指異常、尿道下裂等;嚴重畸形有先天性心臟缺陷和神經管缺陷等。正常婦女之嬰兒出現畸形的機率約2-4﹪,暴露於抗癲癇藥物母親的嬰兒發生畸形的機率可高至4-11﹪。因此,必須特別提供適當的藥物諮詢,以減少即將懷孕之癲癇婦女或癲癇孕婦在資訊不足的焦慮下做出錯誤的選擇。
    【研究目的】探討癲癇婦女對懷孕時所關心的議題,設計相關藥物諮詢的內容,從而給予正確的觀念與認知,以期表現最適當的醫療行為,而改善癲癇婦女懷孕時之醫療品質。
    【研究方法】篩選在國立成功大學醫學院附設醫院神經科部癲癇特別門診規則就醫之台南地區女性,年齡介於18至40歲者為研究對象,接受問卷調查。
    【研究結果】在癲癇特別門診以面對面的方式(32份),與以電話訪談的方式(68份)進行問卷調查,共收集100份有效問卷。癲癇婦女在懷孕期間不規則服藥者占9.1%,而在懷孕及生產時的併發症只佔極少數,而且是一般常見的。有65%會擔心或曾經擔心癲癇影響生育問題。擔心議題以「畸形兒的可能性」(78.46 %)以及「藥物影響胎兒發育」(78.46 %)兩個問題為主。在希望獲得的資訊或幫助方面則顯示,「藥物諮詢」(93.85 %)與「懷孕或生產併發症的了解」(89.23 %)兩項為最高需求。
    【結論】本研究之結果顯示癲癇婦女確實對藥物影響懷孕與生產安全極為擔心,而且對於希望獲得「藥物諮詢」和「懷孕或生產之併發症」資訊之需求很高。未來需要進一步探討癲癇婦女取得其所需求的資訊與協助後,追蹤評估介入之成效,以求進一步來改善與癲癇婦女相關之癲癇醫療教育與藥物諮詢。

    [Background and Literature Review] Epilepsy is one of the common diseases in neurology. In Taiwan, there are around 200,000 people af-fected by epilepsy. 40% of them are women in childbearing age. There are about 1/4 ~ 1/3 of epileptic women whose frequency of seizure in-creases during pregnancy. The increase in frequency of seizure shows no relevance to the type and the duration of seizure during pregnancy, and the frequency of seizure during previous pregnancy. However, the com-pliance is one of the most influential factors, which is determined by not only epilepsy itself, but the choice of anti-epileptic drugs during preg-nancy, the metabolism of anti-epileptic drugs during pregnancy, the ef-fects of anti-epileptic drugs on fetus, the complications in labor, the he-redity of epilepsy, the compatibility of anti-epileptic drugs during lacta-tion, the possible effects on newborn growth and others are topics in women with epilepsy during pregnancy. Review in the literature showed that pregnant women with epilepsy are associated with increased fre-quency of the fetal death (stillbirth or abortion), pre-term laboring, low birth-weight newborns (< 2500g), growth and mental retardation, and the increasing probability of seizure in their children. All of the currently used conventional anti-epileptic drugs are teratogenic. Common minor congenital malformations include orofacial malformations, finger mal-formations, hypospadias and etc. Major congenital malformations include congenital heart defects, neural tube defects and etc. In comparison with the malformation incidence (2 ~ 4%) in general population, those women who have been exposed to anti-epileptic drugs have higher malformation incidence (4 ~ 11%). Thus we need to provide suitable drug consultation to decrease the wrong decision-making among the anxious women with epilepsy due to lack of information.

    [Objective] The objective of the study was to survey pregnancy-related issues among women with epilepsy. In order to give women with epilepsy correct conceptions, we designed drug consultation information. We hope they can obtain the correct conceptions and the most appropriate attitude to improve the quality of medical care among women with epilepsy.

    [Methods] Women of age from 18 to 40 living in Tainan area and regu-larly visiting epilepsy clinic in NCKUH were randomly selected as our questionnaire subjects.

    [Results] One hundred effective questionnaires in total were collected, 32 of them being surveyed by face-to-face interview in epilepsy clinic and 68 of them by telephone interview. 9.1% of pregnant women showed noncompliance. The complications during pregnancy and delivery were rare and were considered as common in general. The survey demon-strated 65% of subjects concerned, or ever concerned about the effects of epilepsy on pregnancy. “The risk of teratogenicity”(78.46%) and “the in-fluence of anti-epileptic drug on fetus”(78.46%) were the most concerned issues. The most needed information or helps were “the drug consulta-tion”(93.85%) and “the knowledge of pregnancy complica-tions”(89.23%).

    [Conclusion] Our study showed women with epilepsy were highly con-cerned with the influence of anti-epileptic drug on fetus and demanding on obtaining drug consultation as well as information about the complica-tion during pregnancy and delivery. Based on this study, further evalua-tion of the effect of intervention is indispensable for the promotion of the quality care among women with epilepsy.

    前言 第一章 癲癇婦女與懷孕 第一節 懷孕對癲癇婦女的影響 第二節 癲癇對婦女懷孕的影響 第二章 懷孕期間的臨床藥理學 第一節 懷孕期間抗癲癇藥藥物動力學 第二節 抗癲癇藥物相關的致畸胎作用 第一項 抗癲癇藥物和先天性畸形 第二項 致畸胎作用的機轉 第二項 懷孕期間抗癲癇藥物的使用 第三章 臨床處理 第四章 總結 第五章 問卷調查-癲癇婦女對懷孕時所關心的議題 第一節 研究目的 第二節 研究架構以及流程步驟 第三節 研究方法與材料 第一項 研究設計 第二項 研究單位 第三項 研究期間 第四項 研究對象以及方法 第五項 研究工具 第六項 統計方法 第四節 研究結果 第一項 研究對象之特徵 第二項 對於癲癇的了解與態度 第三項 癲癇婦女交友狀況 第四項 抗癲癇用藥與服藥狀況 第五項 生育意願以及癲癇婦女避孕狀況 第六項 懷孕狀況以及其間用藥和併發症相關狀況 第七項 癲癇婦女生育結果 第八項 癲癇婦女對懷孕時所關心的議題與所需要之資訊 第五節 討論與建議 第六章 門診藥事服務 第一節 癲癇門診藥事服務 第二節 學習主題相關的藥物諮詢

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