中西藥交互作用臨床監測與評估

楊榮季
長庚醫療財團法人
藥物因其起源、演繹過程及醫藥理論不同，導致我國有中藥、西藥之別。台灣現今醫療環境，中醫、西醫的體系各自運行，民眾中藥及西藥併用治療疾病在多元化醫療中是普遍性的，但醫師看診時未能事先得知。中西藥併用所產生的藥物交互作用可能影響療效，甚至對人體產生不良反應，在此情況下不僅影響病人用藥安全，相對的也會造成醫療資源浪費，是臨床用藥安全極需注重的焦點。中西藥交互作用藥理成分結構複雜，國內外相關文獻明顯不足，目前所知道的知識還是很有限；因此，必須儘速蒐集本土中西藥交互作用臨床案例，有規劃、有系統的研究分析中西藥併用在臨床上所發生之不良反應案例與風險評估，累積充分的臨床經驗實為當務之急。
本研究之先導性試行的對象為醫院內門診中西藥併用病患，在藥物方面初期先以廣泛被使用的Warfarin併用中藥之病患為主，一方面進行中西藥併用病患之藥物回溯研究；另一方面根據藥物安全監視（Pharmacovigilance）的概念，採用主動式監視(active surveillance)的方法，運用資訊技術建置中西藥併用集中監測系統（Intensive Monitoring Syetem），此系統除了可提供醫師中西藥交互作用訊息外，藥師也能即時服務中西藥併用病患藥物諮詢及衛教，更重要的是可以長期觀察病患用藥紀錄及生化檢驗值是否異常，監測病患中西藥併用之用藥安全，並評估分析中西藥併用所產生不良反應（Adverse Drug Reactions）案件及可能發生的交互作用，以期建立治療範圍(Therapeutic index)狹小西藥併用中藥之藥物安全監視模型，達到早期發現、警告及預測中西藥交互作用之不良反應，以提昇病人用藥安全。
關鍵字：中藥、西藥、交互作用

Monitoring and Evaluation of Between Traditional Chinese Medicine and Western Medicine Interactions

Due to our special cultural background, a parallel use of Traditional Chinese Medicine(TCM) and western medicines by the general public is a common scenario in our society. However, little is known by most attending physicians about their patients’ concurrent TCM or western medications. Such a problem not only poses a big threat to patients’ health given the potential hazardous herb-drug interactions but causes unnecessary wastes to precious medical resources and therefore deserves much attention. Indeed, the much complicated cross-interactions of TCM and western medicines is a field of knowledge that is still underdeveloped and lacking relevant researches. Owing to this, a well-organized, systematic study collecting cases of herb-drug interactions in Taiwan is urgently needed to analyze and assess the incidence of adverse drug reactions in combined Chinese and western medication uses.
To start a pilot study, we have selected our study subjects from patients in our outpatient services taking warfarin and Traditional Chinese medicines simultaneously. In addition to performing a retrospective study about patients using combined medication, we’re also doing prospectively pharmacovigilance, i.e. a continued, active surveillance of any adverse drug reactions, exploiting modern information technologies to set up an Intensive Monitoring System for herb-drug interactions. This system provides a platform for doctors from both sides to exchange herb-drug interaction information and for pharmacists to educate and offer consultation to patients. Most important of all, a database of long-term follow-up of patients’ medication histories and blood tests is made possible for analysis to elucidate herb-drug interactions and for the safety of combined Chinese western medicine uses. Finally, a sound safety monitoring system be born for Chinese medicines and the narrow-ranged therapeutic western drugs for early warning and predicting of possible adverse reactions of combined medicine uses.
關鍵字：Traditional Chinese Medicine,Western medicine, Interaction