高危險群門診病患Statin類藥物治療型態與費用效益評估

冠心病在台灣是導致死亡的主要原因之一，而低密度脂蛋白膽固醇是引起動脈粥狀硬化的主要脂蛋白，許多臨床試驗顯示以statin 類藥物降低低密度脂蛋白可減少冠心病的發病率與死亡率。雖然以實證醫學為基礎的研究已確立statin 類藥物治療的好處，然而目前在高危險群病人血脂異常的處理上仍不甚理想，對於這些病人的照護品質仍有明顯改善的空間。本研究針對某醫學中心高危險群門診病患statin 類藥物治療型態與費用效益做評估。本研究是一回溯性縱向觀察性研究，自某醫學中心健保行政申報資料庫中擷取初次使用statin 類藥物之高危險群病患。符合參與研究的病人分配成十組。以健康資訊系統和電子病歷檢視系統收集相關研究資料，包括基本資料、診斷、血脂值、肝功能測驗和statin 類用藥。 初次處方statin 類藥物的日期定為基準日，每位病人有一次基準日前和至少有一次基準日後之血脂值，追蹤直到statin 類藥物治療改變或研究結束。以SPSS 11.0 for windows 統計套裝軟體進行研究資料的分析。總共有319 位病人符合研究納入條件，各組間平均年齡相近 （63 至67 歲）。比較各種不同statin 與不同劑量之間基準日前和基準日後血脂值改變情形，僅低密度脂蛋白與總膽固醇的改變達統計顯著差異 （p<0.05）。Rosuvastatin 5 mg 和10 mg 組每減少1%低密度脂蛋白每年所需費用各為新台幣132 元和231 元，這些費用比其它組為低。比較各組間達成NCEP ATP III LDL 目標值 （<100 mg/dL） 每位病人每年所需費用，總體結果以rosuvastatin 組較低 （新台幣8130 至14695 元）。本研究結果建議，無論是服用那種statin，甚至於低劑量statin，只要追蹤時間夠長，減少低密度脂蛋白與總膽固醇值皆可呈現臨床效益。Rosuvastatin 5 mg 可能具有較佳的費用治療效益。低劑量statin 可能適用於血脂基礎值不是很高的國內病人。我們的研究將有助於醫療照護與費用因應對策之擬定。

Coronary heart disease (CHD) is the leading cause of death in Taiwan. The low-density lipoprotein cholesterol (LDL-C) is the major lipoprotein to cause atherosclerosis. Many clinical trials indicated that lowering LDL-C with a statin can reduce the morbidity and mortality of CHD. Although there are well-established benefits of statin therapy from evidence-based medical researches, however current management of dyslipidemia in high risk patients is suboptimal. There remains room to improve the quality of care for these patients. We evaluate the treatment patterns and cost effective of statins in high risk outpatients in a medical center. In this retrospective, longitudinal and observational study, we extracted high risk patients who received newly treatment with statins from administrative claims database in a medical center. The patients eligible for participation were assigned to 10 treatment groups. The following data were obtained by using health information system (HIS) and the electronic medical record system including demographics, diagnoses, lipid levels, liver function tests, and use of statins. The date of the first dispensed prescription of statins was considered as the index date, patients were measured with one pre-index and at least one post-index lipid profile had been followed until their statin therapy was changed or until the end of the study period. A total of 319 patients met the inclusion criteria. The mean age was very similar among groups (63 to 67 years). Comparison of the pre-index and post-index changes of all lipid profiles across statins and dose ranges showed that only low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC) significantly changed (p<0.05). The annual costs for each 1% LDL reduction were New Taiwan Dollar (NTD) 132 and 231 of rosuvastatin 5 mg and 10 mg, respectively. These costs were lower than those of simvastatin, fluvastatin, and atorvastatin. The annual costs for each patient to achieve the NCEP ATP III LDL goals (<100 mg/dL) were lowest in rosuvastatin groups (NTD 8130-14695). Our study suggests that in statin-therapy for hyperlipidemia, even low dose statin can reveal clinical efficacy and the longer the duration of follow up the better. Our results also implied that rosuvastatin 5 mg may be the most cost-effective therapy and low dose statin may be suitable for patients whose baseline lipid profile is not very high in the study population. Our study may contribute to the development of strategy for promoting health and reducing costs of health care.