女性荷爾蒙療法與中藥科學中藥處方併用之副作用流行病學研究

賴榮年
台北市立聯合醫院
本研究目標為協助中醫藥委員會，針對其所列出之研究標的中藥(單味藥及複方) 在控制只服用雌激素、及同時在控制可疑導致乳癌與子宮內膜癌之西藥之變因下進行探討，以分析上述中藥是否會導致乳癌及子宮內膜癌。以期逐步建立國內中草藥更安全的使用環境，建立「中草藥安全性」把關的機制，如此更能促使國內中草藥產業進軍國際。作法如下： 
利用健保100萬抽樣歸人檔資料及重大傷病名單，挑出全國所有乳癌患者、子宮內膜癌患者、接受乳房手術的非乳癌患者、接受子宮相關手術的非子宮內膜癌患者的門診及住院醫療明細檔，採用個案對照研究法，分析過去1997至2004年乳癌患者、子宮內膜癌患者於罹病前在醫師處方模式下的中西藥使用的狀況，包括研究標的的中藥方劑與單味藥(與雌激素有交互作用之含人參、當歸、甘草、白芷、胡麻等之科學中藥及含植物雌激素之科學中藥。並以這些中藥及雌激素西藥個人服用累積劑量來進一步分層分析，納入年齡、糖尿病、投保類別、投保地區及給藥次數..等變項，再使用多變數羅吉式迴歸（multi-variant logistic regression）來分析這些決定因子的勝算比。所得結果提供促進中草藥安全性之參考。 
在目前台灣缺乏服用雌激素西藥致乳癌、子宮內膜癌的流行病學研究，全世界仍缺乏有系統雌激素及合併服用疑與雌激素有中西藥交互作用之中藥方劑使用毒性研究的同時，研究結果可以提供臨床醫師用中、西藥及衛生署中醫藥委員會擬定藥物安全管理政策之參考。能讓台灣健保給付中西藥使用的安全性更為確立，讓台灣用藥環境更為安全。
關鍵字：女性荷爾蒙、雌激素、中西藥交互作用、乳癌、子宮內膜癌、當歸、人參、白芷、胡麻、甘草

The pharmacoepidemiologic analysis of the potential drug-herb interaction between finished herbal products and hormonal therapies

Jung-Nien Lai
Taipei City Hospital
Breast cancer resulted from taking hormonal therapies has been documented with human and animal studies. The National Health Insurance of Taiwan has regularly reimbursed both hormonal therapies and Chinese herbs mixture products prescribed by gynecologists and Chinese medicine doctors since 1996. The objective of this study is to determine if there is an increased risk of breast cancer endometrial cancer which associated with such prescriptions. Then, we can construct a safer environment for the use of hormonal therapies and traditional Chinese medicines.
We conducted a retrospective follow-up study through a systematic random sample of 1000,000 people from the National Health Insurance (NHI) reimbursement database in Taiwan. The database provided all the transactions of health care services for each patient, including every diagnosis for outpatient visits, hospitalizations and all prescriptions both of hormonal therapies and potentially drug-herb interaction of finished herbal products. The incidence rates of breast cancer and endometrial cancer were calculated during 1997 – 2004 for the whole sample and those ever used following hormonal therapies and finished herbal products suspected interact with hormonal therapies: Dang Gui, Gin Seng, Bai Zhi, Gan Cao, and Saseme.
關鍵字：estrogen, isoflavon-contained herbs, pharmacoepidemiology ,breast cancer, endometrial cancer, Dang Gui, Gin Seng, Bai Zhi, Saseme, Gan Cao