Statin併用fenofibric acid在混合型高血脂病人之安全性探討---統合分析(實證醫學)

Safety of statin in combination with fenofibric acid in patients with mixed dyslipidemia :A meta-analysis (Evidence-Based Medicine)

巫櫻桃(Ying-Tao Wu)

指導教授 ： 蔡崇弘

中山醫學大學/醫學院/醫學研究所/碩士(2012年)

https://doi.org/10.6834/CSMU.2012.00034

摘要

研究背景:研究證實降血脂藥 statins除了可有效降低血中的低密度脂蛋白18~55%之外，還可以減少冠狀動脈心臟病的發生率和死亡率。纖維鹽酸衍生物可降低三酸甘油脂20~50%，提高高密度脂蛋白10~20%。當單一藥物對於混合型高血脂症治療無效時需考慮併用,但對於併用時的安全性需進一步研究。
研究目的:對於statins合併fenofibric acid 135mg在混合型高血脂症治療的安全性探討，以提供臨床用藥的參考。
研究方法:本研究於Cochrane library、Pubmed、Medline資料庫中搜尋所有相關臨床試驗，亦篩選全國碩博士論文及臨床試驗註冊處，利用RevMan軟體進行統合分析。收錄標準為:使用statins及fenofibric acid 135mg對於混合型高血脂症患者之安全性的相關隨機對照試驗。研究設計為: 併用statins及fenofibric acid 135mg為實驗組與單獨使用statins或fenofibric acid 135mg為對照組， 兩組在肌變、肝功能、腎功能異常的比率。
研究結果:共收錄9篇隨機對照試驗，運用RevMan軟體進行統計分析，結果:1.低劑量statins合併fenofibric acid 135mg在肌肉、肝、腎方面之不良反應大於同劑量statins。2.中劑量statins合併fenofibric acid 135mg與同劑量 statin在肌肉方面無明顯差異，但在肝、腎之不良反應大於同劑量statins。3.低劑量statins合併fenofibric acid 135mg在肌肉方面，不良反應大於使用fenofibric acid 135mg；在肝臟方面，單獨使用fenofibric acid 135mg之不良反應大於合併使用；但在腎臟方面則無明顯差異。4.中劑量 statins合併fenofibric acid 135mg與對照組fenofibric acid 135mg在肌肉、肝、腎研究發現，二者無明顯差異。
結論與建議:本研究將所收集之文獻進行統合分析，發現合併治療有潛在性的不良反應增加，且醫療費用因合併治療而增加，希望考慮混合型高血脂病人之利大於弊時才使用。

關鍵字

實證醫學 ； 統合分析 ； 高血脂症 ； 纖維酸鹽衍生物 ； HMG CoA還原酶抑制劑

並列摘要

Background: Many studies have confirmed that statins can effectively lower LDL by 18 to 55 % , can also reduce the incidence and mortality of coronary heart disease. Fibrate can lower TG 20 ~ 50% effect and raise HDL by 10 to 20 % . Combined used be considered when a single drug is ineffective for the treatment of mixed hyperlipidemia , but for safety needs further study.
Objective: The subject of the safety for statins combination with fenofibric acid 135mg in patients with mixed dyslipidemia .
Method and Materials : This study in Cochrane library、PubMed,、Medline database search of all relevant clinical trials , screening of the National Master 's thesis and the Registry of clinical trials , used RevMan statistical analysis. Acceptance criteria : the use of statins and fenofibric acid 135mg for the safety with mixed hyperlipidemia correlated random controlled trials. The study was designed to : statins and fenofibrate for the experimental group and the use of statins alone or fenofibric acid 135mg for the control group , the ratio of the two groups in adverse events , including muscle 、 liver、 kidney of safety.
Result: The relevant research after critical appraisal studies,contains nine randomized controlled trials, use software of RevMan statistical analysis. 1. Low dose statins combined fenofibric acid 135mg in muscle、liver、kidney that adverse reactions is greater than corresponded dose statins. 2.Middle dose statins with fenofibric acid 135mg no significant difference in muscle safety; but in liver, kidney that adverse reactions is greater than corresponded statins. 3.Low dose of statins combined fenofibric acid 135mg in muscle that adverse reactions greater than fenofibric acid 135mg; but fenofibric acid 135mg in the liver is greater than the combined use , in the kidney safety no significant difference .4. Middle dose statins combined fenofibric acid 135mg with fenofibric acid 135mg in muscle、liver、kidney of safety no significant difference.
Conclusion and suggestion: In this study, the collection of the literature conducted meta-analysis found that combination therapy increased potential for adverse reactions , and medical expenses due to the combined treatment and to increase only in consideration of the refractory type of mixed hyperlipidemia of patients .

並列關鍵字

evidence-based medicine ； meta-analysis ； hyperlipidemia ； fibric acid derivatives ； HMG-CoA reductase inhibitor

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