McKenney James M, Sica Domenic
Virginia Commonwealth University, Richmond, Virginia, USA.
Am J Health Syst Pharm. 2007 Mar 15;64(6):595-605. doi: 10.2146/ajhp060164.
A review of the key properties and trial results associated with prescription omega-3 fatty acids (P-O3FA) and a description of its place in the treatment of hypertriglyceridemia and coronary heart disease (CHD) risk are presented.
P-O3FA is made from the fish oil extracted from the fish carcass, which is put through a purification process that refines, esterifies, purifies, and concentrates the ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Each 1-g capsule provides 840 mg of EPA and DHA; the remaining 160 mg contains other omega-3 and omega-6 fatty acids, saturated fatty acids, and monounsaturated acids. When used at a daily dose of 4 g in patients with very high triglycerides (> or = 500 mg/dL), P-O3FA reduces triglycerides by an average of 45% and very-low-density-lipoprotein cholesterol by more than 50%. Changes in high-density-lipoprotein (HDL) cholesterol and non-HDL cholesterol are usually modest. P-O3FA has been tested in the GISSI-Prevenzione trial - a large, multicenter, open-label, randomized, controlled trial conducted in 11,324 patients. The results of the trial demonstrated significant reductions in all endpoints with the use of P-O3FA.
P-O3FA has demonstrated an efficacy and safety in adult patients with high and very high triglycerides adjunct to diet, and the reduction in serum triglyceride levels was dependent on the baseline triglyceride levels. A large controlled clinical trial is necessary to determine if P-O3FA can be used to reduce CHD risk, either as combined with hydroxymethylglutaryl-coenzyme A reductase inhibitors or as monotherapy.
综述与处方ω-3脂肪酸(P-O3FA)相关的关键特性和试验结果,并描述其在治疗高甘油三酯血症和冠心病(CHD)风险中的地位。
P-O3FA由从鱼体中提取的鱼油制成,经过纯化过程,对二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)的乙酯进行精炼、酯化、纯化和浓缩。每粒1克胶囊提供840毫克的EPA和DHA;其余160毫克包含其他ω-3和ω-6脂肪酸、饱和脂肪酸和单不饱和酸。在甘油三酯水平非常高(≥500毫克/分升)的患者中,每日服用4克P-O3FA时,甘油三酯平均降低45%,极低密度脂蛋白胆固醇降低超过50%。高密度脂蛋白(HDL)胆固醇和非HDL胆固醇的变化通常较小。P-O3FA已在GISSI-Prevenzione试验中进行了测试——这是一项在11324名患者中进行的大型、多中心、开放标签、随机对照试验。试验结果表明,使用P-O3FA可使所有终点指标显著降低。
P-O3FA在饮食辅助治疗高甘油三酯和极高甘油三酯的成年患者中已证明有效且安全,血清甘油三酯水平的降低取决于基线甘油三酯水平。有必要进行一项大型对照临床试验,以确定P-O3FA是否可用于降低CHD风险,无论是与羟甲基戊二酰辅酶A还原酶抑制剂联合使用还是作为单一疗法。