中西藥交互作用型態分析及醫令警示系統建置之成效

Implementation and outcome of herb-drug interaction alert system at one teaching hospital in Taiwan

王爾瑩(Er-Ying Wang)

指導教授 ： 簡淑真

臺北醫學大學/藥學院/藥學研究所/碩士(2010年)

https://doi.org/10.6831/TMU.2010.00179

摘要

研究目的：藉由院內中西藥交互作用自動警示系統之建置，評估院內中西藥交互作用發生情形及自動警示系統建置之成效。

研究方法：本研究主要分三階段；第一階段為建置院內中西藥交互作用資料庫，及設定30天內跨處方檢核中西藥交互作用自動警示系統。第二階段進行回溯性研究，研究對象為自2009年1月1日至2009年12月31日期間，有同時併用本院開立之中西藥且發生中西藥交互作用的門診病人，主要研究內容為中西藥交互作用發生率、中西藥交互作用型態及不良反應發生率。第三階段研究期間為自動警示系統執行後之三個月，評估自動警示系統執行後之中西藥交互作用發生率變化情形、不良反應發生率、醫師處方改變率及生理指標監測率。

研究結果：本研究依據參考文獻共建立1,891筆中西藥交互作用組合，其中61筆(3.2%)曾有臨床案例報告。2009年1月1日至12月31日期間，中西藥併用發生率為1.7%，其中，中西藥交互作用發生率為13.7%；中西藥交互作用發生率最高的三個西醫科別為心臟外科(41.8%)、心臟內科(38.7%)、內分泌科(34.2%)。

2009年期間共有563位發生中西藥交互作用病人，平均年齡為52.2歲，女性佔72.3%，有4人(0.7%)發生不良反應事件。563位病人共產生3,868筆中西藥交互作用資料，其中藥物藥效學交互作用佔72.1%，藥物動力學交互作用佔27.9%。依病人就診西醫科別分析，最常發生的科別依序為心臟內科(24.6%)、血液腫瘤科(21.1%)、內分泌科(11.7%)及神經內科(11.5%)；出現最多的西藥為抗高血壓藥物(25.5%)、抗糖尿病藥物(22.3%)、抗胃酸藥(17.4%)及抗血栓劑(17.3%)。

中西藥交互作用自動警示系統執行後之三個月，中西藥交互作用發生率與去年同時期相比，由15.1%降至11.2% (p = 0.014)；有36.2%的醫師會因警示改變藥物處方，27.7%的醫師會監測可監測指標；沒有不良反應事件發生。

結論：在同時設有傳統醫學科與西醫科別門診之教學醫院，中西藥交互作用發生率為13.7%，其中使用中西藥交互作用藥物的病人，不良反應發生率為0.7%。建立院內中西藥交互作用自動警示系統，可協助醫師處方時的判斷，自動警示系統執行後，中西藥交互作用發生率有顯著下降。目前國內尚缺乏實證性的中西藥交互作用資料，未來需要更多實證經驗以增加資料庫的實用性。

關鍵字

中西藥交互作用 ； 中西藥交互作用警示系統 ； 中西藥交互作用發生率 ； 型態分析

並列摘要

Background: The widely use of herbal products among the public has raised some concerns regarding issues of herb-drug interactions. In Taiwan, traditional medicine (TM) continues to be widely used. However, current information about herb-drug interactions, including the incidence of herb-drug interactions and the risk of related adverse drug events (ADEs) in Taiwan are still limited.

Objectives: The purpose of this study is to (1) establish a herb-drug interaction alert system; (2) estimate the incidence of herb-drug interactions and the risk of ADEs related to herb-drug interaction; (3) evaluate the outcomes of implementation of the herb-drug interaction alert system.

Method: (1) The potential herb-drug interactions in the alert system were established based on case reports, clinical trials, or theoretical interactions. (2) Outpatients who had also visited traditional medicine clinics and had potential herb-drug interaction(s) in 2009 and 3 months after implementation of alert system were enrolled. Patient’s demographic information, the information on the prescriptions and laboratory data were collected from health information system to evaluate the incidence and the patterns of herb-drug interactions, and the risk of ADEs. (3) Information from alert system was collected to evaluate the doctors’ reply after receiving the alerts.

Results: There were 1,891 potential herb-drug interactions documented in the herb-drug interaction alert system, 61 (3.2%) interactions were based on case reports. In 2009, the incidence of herb-drug interactions was 13.7%. There were 563 patients had potential herb-drug interactions, 72.3% were female, the most common western medicines were antihypertensive agents (25.5%), hypoglycemics (22.3%), antacids (17.4%) and anticoagulants (17.3%). Among these patients, 4 (0.7%) patients experienced an adverse drug event related to herb-drug interaction(s). The incidence of herb-drug interactions after implementation of alert system was decreased from 15.1% to 11.2% (p = 0.014), and approximately 36.2% of doctors changed prescription medicine after receiving the alarm information and and 27.7% monitored available parameters.

Conclusion: The incidence of herb-drug interactions among outpatients was 13.7%, and the risk of ADEs was 0.7%. The incidence of herb-drug interactions significantly decreased to 11.2% (p = 0.014) after implementation of the herb-drug interaction alert system. The information of evidence-based herb-drug interactions is still limited, more studies are needed in the future.

並列關鍵字

Herb-drug Interaction ； Herb-drug Interaction Alert System ； Incidence Rate of Herb-drug Interaction

參考文獻

6. 黃慧嫻. 從美歐植物藥管理之法制趨勢探討我國中草藥產業發展之機會與挑戰. 科技法律透析 2007;19:24-46.

13. 賴永昌, 陳玉蘭, 賴婕瑄. Toxicity of Chinese Herbal Medicine and drug-herb Interactions. 中山醫學雜誌 2007;18:343-57.

1. World Health Organization. WHO Traditional Medicine Strategy 2002-2005. In; 2002.

8. Tatro DS. Drug interaction facts 2010: Wolters Kluwer Health, Inc.; 2010.

10. Brazier NC, Levine MA. Drug-herb interaction among commonly used conventional medicines: a compendium for health care professionals. American Journal of Therapeutics 2003;10:163-9.