誤用馬兜鈴科植物為中藥材之省思

The Introspection of Misusing Aristolochia Species Herbs as Medicine

臺灣末期腎病（End-Stage Renal Disease, ESRD）高居世界第一，在慢性腎病（ChronicKidney Disease, CKD）方面，從1996 年盛行率為1.99%上升到2003 年的9.83%，比起世界各國明顯高出許多1,2，造成此現象的原因眾多，其中馬兜鈴酸藥材的使用是其中一項可能的原因。各種中藥材常常同時具備了有效成份和毒性成份，馬兜鈴類藥材因含有馬兜鈴酸成份對人體產生嚴重傷害，在最近的十多年中受到世界各國陸續發布命令禁止進口使用。不當的使用馬兜鈴酸藥材將造成快速的腎小管間質纖維化及萎縮甚至造成泌尿道上皮細胞癌。避免中藥材誤用及混用，就是確保中藥製劑的品質、療效及安全。落實中藥不良反應通報系統計畫，以建立更完善的用藥環境。藉由整理健保資料庫可了解馬兜鈴酸與腎病變、泌尿道癌之關聯，並可經由資料庫計算出超過多少劑量以上是有危害的，根據學者利用健保20 萬抽樣歸人檔資料及全台灣所有末期腎病病人58,121 人及泌尿道癌病人20,777 人計算過去1997 年到2002年之間發現，使用木通超過30g 或防己超過60g 會增加慢性腎病發生的危險；使用木通或防己超過60g 將會增加腎臟衰竭的危險性，使用關木通超過60 克或馬兜鈴酸超過150 毫克中藥產品，增加泌尿道癌發生風險，並且有線性劑量反應關係。 其他中藥不良反應若依此健保資料庫平台來分析則亦可檢驗各種中藥的安全性，進而研究因應之道。培訓具分辨藥材真偽、抽檢能力之專業人員並成立符合國際中藥高品質管理之認證實驗室，分別在各處做層層檢驗，如海關人員、衛生署、醫院、藥商、中藥局等以確保民眾健康。The incidence of end-stage renal disease (ESRD) in Taiwan is the highest in the world. The prevalence of clinically recognized chronic kidney disease (CKD) increased from 1.99% in 1996 to 9.83% in 2003. The prevalence of CKD in Taiwan are relatively high compared with other countries. Though many explanations exist, aristolochic acid (AA) content in Chinese herbal medicines remains one of the possible causes. Each Chinese herb usually includes various medicinal and toxic ingredients, and herbs of Aristolochia species contain aristolochic acid, which can cause severe damage of human bodies. Several developed countries have prohibited the import of Aristolochia species due to its serious adverse reactions in recent decades. Improper use of aristolochic acid-containing Chinese herbs may lead to rapid interstitial fibrosis, tubular atrophy, and even urothelial carcinoma. To ensure the quality, efficacy and safety, it should avoid misusing Chinese herbal medicine. Implement the reporting system of adverse reactions of Chinese herbs can prove useful for improving drug safety. According to recent studies, aristolochic acid nephropathy and urinary tract carcinoma were found to be associated with increasing dose of AA. These studies were able to estimate risk dosages to renal disease or cancer by analyzing the database of National Health Insurance (NHI). The research revealed that the risk of chronic kidney disease was increased if someone had taken more than 30g of Mu Tong or over 60 g of Fang Chi, and the risk of renal failure was increased in patients who had taken 60 g of Mu Tong and Fang Chi. In addition, people having taken more than 60 g of Mu Tong or more than 150 mg of AA were associated with an increased risk of urinary tract cancer with dose-dependent relationships. We can now examine the safety of every kind of Chinese herbs through the NHI database to determine proper usage and take necessary action to meet safety guidelines. In order to guarantee public health and safety, we must have a trained professional staff and well-established laboratories in the Taiwan government, hospitals and Chinese medicine pharmacies that meet international criteria.