馬兜鈴酸腎病變及泌尿上皮癌，自1993年的比利時事件後，在世界各地已有許多相關研究，也讓 世人更加重視中醫藥的安全性。為了能有效的取得中藥安全及療效資訊，在此我們提出兩種研究方法， 一為我國健保資料庫或其他醫師或醫院建構的世代研究資料庫，進行回溯性研究；二為中醫師於臨床服 務採主動監控，追蹤觀察病患用藥後的安全資訊，即前瞻性觀察臨床研究。研究後我們發現含馬兜鈴酸 藥材的危險劑量(慢性腎臟病:木通>30克或防己>60克；泌尿道上皮癌:木通>60克或馬兜鈴酸>150毫 克），及不含馬兜鈴酸藥材經中醫師處方對腎臟的保護作用。有中藥廠加強上市前評估品質及安全性，及 中醫師臨床嚴謹的觀察，才能避免藥材誤用，產生藥效不良反應的悲劇發生。

There are many studies about aristolochic acid (AA) nephropathy and aristolochic acid-related urothelial cancers after the herbal product usage, which prompted people to pay much attention to the safety issues of traditional Chinese medicine (TCM), happened in Belgium in 1993. We propose two major types of outcome research that can be useful to generate evidence for the safety profile of TCM therapies: retrospective exploration of national or currently existing databases, and prospective observational clinical studies targeted on the active surveillance of safety profiles and the effectiveness of TCM. In these of studies, we found the risk doses of herbs containing AA (chronic kidney disease: Mu-Tong>30g, Fang-Chi>60g; urothelial cancer: Mu-Tong>60g, AA>150mg). In addition, renal protective effect of some Chinese herbal remedies (not containing AA) was identified. Only through the strengthening pre-market assessment of quality and safety in herbal product manufacturers and close observation of clinical practice by TCM practitioners, we can prevent the misuse of toxic herbs and the tragedy from adverse effects.