簡淑真 臺北醫學大學藥學系
雖然現有的古籍與文獻中有列出各種中藥可能帶來的影響，但尚未有深入探討孕婦在孕前或孕後在不知情的情形下服用孕婦禁忌中藥或含禁用中藥之方劑可能帶來之影響；本研究擬用健保資料庫歸人檔針對孕婦特定族群進行孕婦禁用藥物與妊娠、生產及產褥期之併發症的相關性風險評估，並針對風險評估之結果進行孕婦禁忌用藥之仿單規劃與設計 本研究的研究目標如下： 目標一：利用健保資料庫之2010年承保抽樣歸人檔，以從 1996年至2010年中，懷孕且有領取孕婦手冊的民眾為研究族群，分析其用藥內容與妊娠、生產及產褥期之併發症之相關性。 目標二：針對目標一之研究結果，藉由專家會議與問卷訪談的方式，進行孕婦禁忌中藥之相關仿單的規劃與製作。 少腹逐瘀湯(p =0.0099 )、Shao Fu Chu Yu Tang (p =0.0466 )、紅花(p =0.0004 )和生化湯(p <0.0001 )等四種中藥在健保資料庫分析結果中流產組的流產風險顯著高於順產組，而且以上四種中藥皆曾被台灣傳統藥典與中國藥典禁忌藥列入孕婦禁忌用藥清單中，故本研究建議需在仿單/標籤上加註為孕婦謹慎使用中藥。澤蘭、阿膠、黃連、川芎茶調散、甘草、澤瀉、銀花清胃散、旱蓮草、豬苓湯、草決明、甘麥大棗湯(甘草小麥大棗湯) 、 肉蓯蓉、大腹皮、枸杞子、黃芩、山茱萸、補中益氣湯(丸)、柴胡清肝湯、桂枝湯、酸棗仁湯、一貫煎、普濟消毒飲、四物湯、五苓散、炙甘草湯和歸脾湯等皆未曾被歌訣、台灣傳統藥典與中國藥典禁忌藥列入孕婦禁忌用藥，未來必須深入討論。
關鍵詞： 孕婦禁忌用藥、健保資料庫、妊娠、生產及產褥期之併發症、風險評估、風險管理
The Risk Evaluation and Management of Herbs Contraindicated in Pregnancy Shu-Chen Chien Taipei Medical University The ancient books and literature of Chinese medicine has already listed numbers of herbs contraindicated in pregnancy, and they also indicated the impacts of those herbs to the pregnant women. However, due to the complexity of Chinese therapy, the pregnant women may have chance to take those herbs by ignorance, and the risks and damages of those errors are rarely discussed in the previous studies. The purposes of this study are 1. To conduct a risk evaluation of the relationship between the herbs contraindicated in pregnancy and the pregnant women; 2.To design the patient information leaflet of the herbs contraindicated in pregnancy by the results of risk evaluation. The objectives of this study are: 1. To evaluate the relationship between the herbs contraindicated in pregnancy and the pregnant women by analyzing 2010 claims data of beneficiaries of National Health Insurance. 2. To design the patient information leaflet of the herbs contraindicated in pregnancy for the pregnant women by applying the previous risk evaluation results and conducting expert panels, questionnaire survey. Because Shao Fu Chu Yu Tang, Shao Fu Zhu Yu Tang, Safflower and Shenghua decoction were found have potential risks to cause an abortion of pregnant women, so we suggested these four herbs should be described with red word clearly on the label or patient information leaflet.
