以全民健保資料庫研究中藥方劑與西藥之交互作用

研究目的：建立中藥方劑與西藥間交互作用之資料庫，分析全民健康保險研究資料庫之中西醫處方，探討中藥方劑與西藥間交互作用之現況、盛行率、併用方式等，並藉由此研究作為未來制定中西藥交互作用資料庫的基礎與藥品管控方面的參考。研究方法：本研究分為二階段；第一階段是建立中藥方劑與西藥交互作用之資料庫，並根據衛生福利部中央健康保險署核定之健保碼做比對。第二階段分為二個部分；第一部分採回朔性研究，是以1998年至2011年全民健康保險研究資料庫之門診處方明細檔為樣本，分析民眾使用健保中西醫門診之潛在中西藥交互作用，探討其盛行率，再以人口特質、開立醫院之縣市別、評鑑別等做分析。第二部分為將本研究之中西藥交互作用資料庫放進北區某區域教學醫院之自動警示系統，評估院內中西藥交互作用之現況及分析醫師看到警示後所做的處置。研究結果：本研究依據上述方法找出中藥萃取物含有類似西藥成分的中藥有麻黃(萃取物含有類Ephedrine)共15種，當歸、白芷(萃取物含有類Coumarin)共9種，建立586,318筆中西藥交互作用配對。 1998年至2011年之健保資料庫分析，與麻黃(Ephedrine)相關之中西藥交互作用盛行率為0.18‰，最常發生交互作用之中藥方劑為麻杏甘石湯(23.1%)、小青龍湯(15.5%)、定喘湯(13.2%)。與白芷、當歸(Coumarin)相關之中西藥交互作用盛行率為4.59%，最常發生交互作用之中藥方劑為蒼耳散(32%)、藿香正氣散(31.4%)、四物湯(10.7%)。在區域教學醫院自動警示系統共建立480筆中西藥交互作用，在中西藥交互作用警示系統執行兩個月期間，中西藥交互作用警示共出現24次；醫師因警示改變藥物處方的次數為4次，改變藥物處方率為16.7%。結論：台灣獨特的中西藥健保雙軌制度，中西藥併用的情形非常普遍，不同門診開立的藥品可能會產生藥物交互作用，其潛在的風險是不可忽視的。建立中藥方劑與西藥之交互作用資料庫，提供臨床科醫師查詢使用，協助開立處方時的判斷，避免嚴重藥物不良反應的發生。

關鍵字

中藥方劑；中西藥交互作用；全民健保資料庫；警示系統

並列摘要

Background: In 1995, Taiwan launched National Health Insurance (NHI), and traditional Chinese medicine was covered by NHI at 1996. People taking Chinese and western medicine at the same period increased, it is reasonable to propose that the adverse effects resulted from herb-drug interactions may increase too. It is imperative to build up the database of herb-drug interaction for monitoring the adverse effects from Traditional Chinese medicine compound formula with western medicine. Objective: The aim of this study is to (1): Establish the database for recorded drug interaction between traditional Chinese medicine compound formula and western medicine. (2): Analysis the interaction between traditional Chinese medicine and western drug status by using National Health Insurance Database. Method: The study is designed as 2 phases. Phase 1 is to establish the database of the interactions between traditional Chinese compound formula and western medicine. Phase 2 is divided into 2 parts; part 1 initiate the retrospective study, recruited the data from National Health Insurance Research Database in 1998 to 2011; to analyze the potential interaction between traditional Chinese medicine and western medicine, and investigated the incidence, demographic information and prescription hospital by this study. Part 2 is to set up auto alert system based on the traditional Chinese medicine and western medicine interaction database in a teaching hospital in the north of Taiwan. We analyse the incidence in this hospital and the doctors’ prescription pattern after them receiving the alerts. Result: Based on the above method to find traditional Chinese medicine which ingredients are mostly like western medicine: Ephedrae Herba (its extracts contain ephedrine ingredients) and there are 15 compound formula, Angelicae Sinensis Radix, Angelicae Dahuricae Radix (its extracts contain coumarin ingredients) and there are 9 compound formula. There were 586,318 potential herb-drug interactions documented in the traditional Chinese compound formula and western medicine interaction database. In period of 1998 to 2011, the prevalence of herb-drug interaction related to Ephedrae Herba was 0.18‰. The most common traditional Chinese compound formula were MA SHING GAN SHYR TANG(23.1%), SHEAU CHING LONG TANG(15.5%), DINQ CHUAN TANG(13.2%). The prevalence of herb-drug interaction related to Angelicae Sinensis Radix, Angelicae Dahuricae Radix was 4.59%. The most common traditional Chinese compound formula were TSANG EEL SAAN(32%), HUOH SHIANG JENQ CHIH SAAN(31.4%), SHY WUH TANG(10.7%). There were 480 potential herb-drug interactions documented in the teaching hospital alert system. Approximately 16.7% of doctors changed prescription medicine after receiving the alarm information. Conclusion: After implementation of National Health Insurance in Taiwan, the convenience of the clinic-visit makes the utilization of health care increased for both Chinese and western medicine. Different clinics prescription maybe cause drug interaction, the potential risks cannot be ignored. This herb-drug interaction database provides clinical physicians to determine when prescribing to avoid serious adverse drug reactions.