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研究生: 吳珮君
Wu, Pei-chun
論文名稱: 高風險病人Statin 類降血脂藥品順從性與其心血管疾病再發生率之相關性
Association between Adherence of Statins and Cardiovascular Event in High Risk Patients
指導教授: 莊善安
Chuang, Shan-An
高雅慧
Yang, Yea-Huei Kao
學位類別: 碩士
Master
系所名稱: 醫學院 - 臨床藥學研究所
Institute of Clinical Pharmacy
論文出版年: 2008
畢業學年度: 96
語文別: 中文
論文頁數: 109
中文關鍵詞: 缺血性中風冠心病藥品順從性藥品持有率心血管疾病他汀
外文關鍵詞: ischemia stroke, medication possession ratio, statins, coronary heart disease, cardiovascular disease, compliance
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  • 研究背景:
    至今心血管相關疾病仍為死亡的主因之一,因此對於預防此類疾病的發生已成為相當重要的課題。許多研究顯示statins類藥品不僅可有效降低血脂,更可用於預防心血管疾病的發生率。然而越來越多研究指出statins藥品順從性與預防心血管疾病發生之臨床療效具高度相關性,發現到低順從性者相對於高順從性者其死亡率可高出8%。其中影響服藥順從性的因素包含對於statins藥品的認知、其本身收入以及醫療人員與使用者之間的互動等等。就國內來說,statins屬於高價藥品,於健保支出中占有越來越大的比例,因此在國內全民健保制度下,患者使用statins的順從性如何?以及順從性與心血管疾病發生率的關係是值得加以探討的議題。
    研究目的:
    探討statins藥品持有率與預防心血管疾病之相關性
    研究方法:
    本研究之研究設計為回溯性世代研究,資料來源主要以2000~2004年健保資料庫,ATC/DDD system;研究對象針對2001年於醫學中心首次發生心血管相關疾病住院患者(index date),且於出院後90天內處方statins者;以持有率做為順從性代表,持有率定義:持有率=(statins總處方天數/一年追蹤天數)x100%,持有率分為三等級80%:high,79~40%:medium,<40%:low,Endpoint則定義為再次發生心血管疾病而住院。
    研究結果:
    依照病患所發生心血管疾病分為冠心病組,以及缺血性中風組,各自計算病患一年藥品持有率,將病患分為三等級後各組病患依序為:冠心組,藥品持有率高者:1196人,藥品持有率中者:1170人,藥品持有率低者:1414人;中風組:藥品持有率高者:412人,藥品持有率中者:604人,藥品持有率低者:908人;而各組其心血管疾病再發生率依藥品持有率高至低為,冠心病組:22.91%,30.26%,29.68%;中風組:4.48%,14.22%,54.24%。將藥品持有率與心血管疾病再發生率做存活分析後發現,在冠心病組,其藥品持有率之風險比為1.038(P=0.6085),校正後為1.011(P=0.8836);中風組,其藥品持有率之風險比為1.411(P=0.0001),校正後為1.423(P<0.0001),進一步以迴歸分析探討各自不同程度藥品持有率與心血管疾病再住院率的關係。在冠心病組,相對於高藥品持有率病患,藥品持有率中病患其風險比為1.373(P=0.0437),校正後風險比為1.326(P=0.0755),藥品持有率低病患風險比為1.094(P=0.5677),校正後風險比為1.05(P=0.7521);而中風組,相對於高藥品持有率病患,藥品持有率中者其風險比為1.562(P=0.0526),校正後風險比為1.552(P=0.0584),藥品持有率低者風險比為2.130(P=0.0003),校正後風險比2.131(P=0.0004)。
    研究結論:
    Statins類藥品可有效降低心血管疾病再次發生率,而藥品順從性卻又是決定藥品有效與否的關鍵,本研究以藥品持有率代表藥品順從性,進一步證實,在冠心病組中,隨著順從性的增加,心血管再發生率也越低,雖然並未達到統計學上差異;而中風組,藥品順從性對於心血管疾病再發生率有一定的重要性,且藥品順從性低者相對於藥品順從性高者,其風險比例又較高,因此,如何提高藥品順從性,可說是決定病患預後的一項重要關鍵。

    Background:
    Until now, cardiovascular disease is still one of the major causes of death. To prevent cardiovascular disease has become an important issue. Many studies have proved that statins can not only effectively control hyperlipidemia but also help to prevent cardiovascular disease. However more and more studies have shown that the adherence of statins and cardiovascular disease prevention is highly related. The mortality of patient with low compliance is higher by 8 % than that of patients with high compliance. There are a lot of factors which may affect compliance, including the knowledge about statins, income, and the interaction between health care provider and patients. In Taiwan, statins has accouted for large part of National Health Insurance expenditure. Therefore, it is important to investagate the association between adherence of statins and cardiovascular disease.
    Objective:
    To analyze the association between adherence of statins and cardiovascular disease.
    Method:
    Our study design is a retrospective cohort study. The data source is from National Health Insurance in 2000~2004. Our subjective is patients with first cardiovascular disease in medical center used statins in 90 days after discharge.Use medication possession ratio (MPR) to present adherence, the calculation of MPR: MPR= (statins prescribed days) /365 days (365days as followed duration)x100%, define >80% as high MPR, 79~40% as moderate MPR, and <40% as low MPR. The endpoint is the readmission of cardiovascular disease
    Result:
    After calculating the one year MPR, in CHD group, there were 1196 persons in high MPR group, 1170 persons in medium MPR group and 1414 persons in low MPR group. And in ischemia stroke group, there were 412 persons in high MPR group, 604 persons in medium MPR group and 908 persons in low MPR group. The event rate of each group were 22.91%,30.26%,29.68% in CHD group and 4.48%,14.22%,54.24% in ischemia group. Used survival analysis to analyse the relationship between adherence of statins and readmission rate of cardiovascular disease, the hazard ratio of MPR in CHD group was 1.038 (P=0.6085), after ajustment the hazard ratio was 1.011 (P=0.8836), and the hazard ratio of MPR in ischemia stroke group was 1.038 (P=0.6085), after ajustment the hazard ratio was 1.011(P=0.8836). Furthermore our study analysed the readmission risk of different MPR by logistic regression. In CHD group, the odds ratio of moderate MPR group, compared to high MPR group, was 1.373 (P=0.0437), after ajustment the hazzar ratio is 1.326(P=0.0755), and the odds ratio group in low MPR group is 1.094(P=0.5677), after ajustment the hazard ratio was 1.05 (P=0.7521). In ischemia stroke group, the odds ratio of moderate MPR group, compared to high MPR group, was 1.562 (P=0.0526), after ajustment the hazard ratio was 1.552 (P=0.0584), and the odds ratio group in low MPR group was 2.130 (P=0.0003), after ajustment the hazard ratio is 2.131 (P=0.0004).

    Conclusion:
    Statins can effectively prevent readmission of cardiovascular disease. And compliance is the key point of statins’ effect. No matter in CHD group or ischemia group, the worse the compliance, the higher the risk of cardiovascular disease.

    中文摘要 ........................................................................................................................... i Abstract ............................................................................................................................ iii 誌謝 ................................................................................................................................ vi 目錄 ............................................................................................................................... vii 表目錄 .............................................................................................................................. x 圖目錄 ............................................................................................................................. xi 第一篇、高風險病人Statins類降血脂藥品持有率與其心血管疾病再發生率之相關性 1 第一章 、研究緣起 1 第二章 、文獻回顧 3 第一節 心血管流行病學 3 2.1.1心血管疾病與缺血性腦中風盛行率 3 2.1.2心血管疾病及其相關危險因子 3 第二節 高血脂流行病學 5 2.2.1高血脂盛行率 5 2.2.2高血脂與心血管疾病相關性 5 第三節 降血脂治療目標與策略 7 第四節 Statins 類降血脂藥品臨床效果 13 2.4.1降血脂效果 13 2.4.2心血管疾病預防效果 13 第五節 藥品順從性與療效 17 2.5.1影響藥品順從性之相關因子,以statins為例 17 2.5.2 Statins類藥品順從性與心血管疾病療效之關係 18 第三章 、研究目的&重要性 20 第四章 、研究方法 21 第一節 研究型態 21 第二節 研究材料 21 第三節 研究工具 22 第四節 研究對象 22 4.4.1納入對象 22 4.4.2排除條件 22 第五節 研究變項與名詞之操作定義說明 23 4.5.1研究名詞定義 23 4.5.2研究變項定義 24 第六節 研究流程 26 第七節 統計分析 31 3.7.1統計模式設定 31 3.7.2資料分析方法 31 第五章 、研究結果 32 第一節 病患基本資料 32 5.1.1病患分組流程 32 5.1.2病患之基本資料 32 第二節 分組比較基本性質與結果 35 5.2.1冠心病組其各藥品持有率組之基本性質 35 5.2.2中風組其各藥品持有率組之基本性質 36 第三節 各影響因子與心血管疾病再住院率風險比 45 第四節 藥品持有率與心血管疾病再住院率 49 5.4.1一年藥品持有率與心血管疾病再住院率 49 5.4.2敏感性測試 50 第六章 、討論 54 第一節 病患基本資料 54 第二節 Statins類藥品使用時機 57 第三節 Statins類藥品持有率 61 第四節 藥品持有率與心血管疾病及再住院率關係 63 6.4.1心血管疾病再住院率於各組間差異 63 6.4.2持有率與心血管疾病再住院率關係及其影響因子 63 第五節 與其他研究之討論 66 6.5.1藥品持有率與藥品順從性 66 6.5.2類似研究結果之比較 66 6.5.3研究設計之異同 67 第七章 、研究限制 69 第八章 、結語與建議 71 第二篇、 臨床藥事服務-高危險藥品注意事項 73 第一章 、背景 73 第二章 、目的 73 第三章 、方法 74 參考文獻 104

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