臨床使用Atorvastatin需加強適當性及安全性評估

Appropriateness and Safety of Atorvastatin Use Need to be Improved

黃婉綾(Wan-Ling Huang) ； 蘇富敏(Fu-Min Su) ； 李冠廷(Kuan-Ting Lee) ； 黃耀斌(Yaw-Bin Huang) ； 張榮叁(Jung-San Chang)

《臺灣臨床藥學雜誌》 21卷4期 (2013/12) Pp. 299-312

https://doi.org/10.6168/FJCP.2013.2104.03

摘要

背景：Atorvastatin為高單價藥物，廣泛用於治療高血脂症，以減少心血管疾病。在臺灣使用atorvastatin需依照中央健保局規定，在服藥後三至六個月需檢驗血脂濃度以評估療效並監測副作用的產生。此外，由於atorvastatin易與其他CYP 3A4抑制劑產生藥物交互作用提高不良反應的風險。因此atorvastatin的用藥評估十分必要。方法：本研究分別以2010年3月份南部某醫學中心病歷資料，及2008年3月份「全民健康保險研究資料庫－2005年承保抽樣歸人」，進行門急診高血脂症病患使用atorvastatin的用藥評估。兩者均記錄為期十個月內病人所有相關就醫資訊。依照中央健保局藥品使用規範進行藥品使用適當性評估，藥品不適當使用的定義為半年內未檢測血脂濃度與肝功能指標；藥品處方安全性則依Micromedex®與Lexi-Interact^(TM) Online交互作用資料庫進行評估；atorvastatin引起的肝毒性與肌肉副作用分別依照國際醫學組織委員會（CIOMS）與醫學文獻定義進行評估。結果：在醫學中心病歷資料及2005年承保抽樣歸人檔中發現，監測期十個月內未曾檢測任一血脂濃度、未曾檢測任一肝功能、未曾檢測CPK者約分別為8%、20%及90%。若以「服用藥品半年內未檢測完整血脂數據與任一肝功能」判定藥品不適當使用時，單一醫學中心及2005年承保抽樣歸人檔不適當使用比率分別為42.5%及63.3%；若依「服用藥品半年內未曾檢測過任一血脂數據與任一肝功能」判定藥品不適當使用，則不適當使用比率皆約23%。研究期間出現肝功能異常並經CIOMS評估可能（possible）為atorvastatin引起者為0.4%。不論在單一醫學中心或2005年承保抽樣歸人檔用藥評估中，約10%病人接受具潛在交互作用的處方，增加橫紋肌溶解症的風險，處方藥物以diltiazem、fenofibrate、amiodarone、colchicine、verapamil和gemfibrozil為主。本次研究並未發現atorvastatin引起的橫紋肌溶解症。結論：Atorvastatin使用安全性高，副作用小，然而在監測藥品的副作用與處方安全性方面，尚有改善空間。此外，中央健保局應提供atorvastat。

關鍵字

適當性 ； 安全性 ； 交互作用

並列摘要

Background: Atorvastatin is of high price and is commonly prescribed to manage dyslipidemia to prevent cardiovascular disease. In Taiwan, prescription of atovastatin should follow the regulation of Bureau of National Health Insurance (NHI) to monitor its effect and side effects. Furthermore, atorvastatin may easily interact with CYP 3A4 inhibitors to cause severe adverse reactions. Therefore, medication use evaluation (MUE) of atovastatin is highly appreciated.Methods: Complete chart review of the hyperlipidemic patients taking atorvastatin in Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) during March, 2010, and related data in the Longitudinal Health Insurance Database 2005 (LHID 2005) during March, 2008, were included for MUE, respectively. The MUE was done to evaluate the atorvastatin use from 3 months before March to 6 months later. The appropriateness of MUE was evaluated by the regulation of NHI. The safety issue regarding the severity of drug-drug interactions (DDIs) with comedications was examined by the database of Micromedex® and Lexi-Interact^(TM) Online. The drug-induced liver injury (DILI) and myopathy caused by atorvastatin was evaluated by CIOMS and clinical definitions published before.Results: Patients who took atorvastatin prescribed by physicians without examination of any lipid profile, any liver function tests, and CPK within 10-month period of the evaluation interval were approximately 8%, 20%, and 90%, respectively, both in KMUH and LHID 2005. The inappropriateness of atorvastatin use was at least 23%. Among the patients evaluated, the rate of atovastastin-associated liver injury was 0.4%. Besides, 10.5% patients had co-medications with potential DDIs which will increase the risk of rhabdomyolysis. However, no rhabdomyolysis was found in this study.Conclusions: Atorvastatin is safe, but the appropriateness and safety of atorvastatin use need to be improved.

並列關鍵字

Atorvastatin ； Appropriateness ； Safety ； Drug-Drug Interactions