全國透析病人透析前腎毒性中西藥處方之分析研究
王榮德
台灣大學
比利時的馬兜鈴酸腎病變後，全球世界各地，陸續發生類似之中藥腎病變，及導致之泌尿上皮腎臟癌、輸尿管癌及膀胱癌，加上實驗室的研究，更加確認馬兜鈴酸腎病變及致癌性，許多先進國家因對中藥安全疑慮而採取管制措施，間接影響國內中草藥產業的發展與外銷。近年來國內洗腎人口的增加造成人民傷痛及健保負擔沉重，馬兜鈴酸中藥是否扮演一部份角色，也需探討。所以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) 在控制可疑腎毒性西藥之變因下進行探討，以分析上述藥是否會導致慢性腎病及腎泌尿道癌。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20萬抽樣歸人檔資料及重大傷病名單，連結全國所有洗腎患者及腎泌尿道癌患者名單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2002年洗腎患者及腎泌尿道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A至K等20個中藥方劑與53個單味藥(即含細辛、馬兜鈴、天仙藤、廣防己、關木通、青木香中藥或方劑之濃縮中藥)及腎毒性西藥（非類固醇消炎藥(NSAIDs)、aminoglycoside、cisplatin三類藥）的情形。並且用分層分析，納入年齡、性別、糖尿病、高血壓及其他腎病等變項，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。
關鍵字：中草藥；末期腎病；馬兜鈴
The Analysis of the Suspected Nephrotoxic Prescriptions of Western Medicines and Chinese Herbs before Dialysis in All Dialysis Patients in Taiwan
Jung-Der Wang
National Taiwan University
The objective of the project is to determine if prescriptions of suspected nephrotoxic western medicines and Chinese herbs may lead to chronic renal disease and urinary tract cancer. The registries for patients with end stage renal disease (ESRD) and renal cancer in the reimbursement database of catastrophic illnesses from NHI (National Health Insurance) in Taiwan during 1997-2002 were collected as the cases, while a systematic random sample of 200,000 people would be used as controls after excluding patients with kidney diseases or cancer. Detailed data of prescriptions of Western medicines (including non-steroidal anti-inflammatory drugs (NSAIDs) and aminoglycosides), and Chinese herbs suspected to contain or adulterated with aristolochic acid (Ma-Dou-Ling, Tian-Xian-Teng, Xi-Xin, Mu-Tong, Fangchi, Mu-Xiang, and Wei-Ling-Xian) would be collected. Stratification, multiple logistic regression models, and Cox regression models will be constructed to explore the association between different risk factors and ESRD and renal cancer after control of potential confounders, including age, gender, hypertension, diabetes mellitus and above nephrotoxic Western and Chinese medicines. Detailed history of exposures to the above nephrotoxic medicines will be analyzed to assure the appropriate temporal sequence.
關鍵字：Chinese herb；end-stage renal disease (ESRD)；aristolochic acid
