Kirsten R, Heintz B, Nelson K, Oremek G
Department of Clinical Pharmacology, University of Frankfurt, FRG.
Int J Clin Pharmacol Ther Toxicol. 1989 Mar;27(3):129-34.
Hyperlipidemia is of particular concern in dialysis patients due to the high incidence of ischemic cardiovascular complications. Two groups of 10 patients with at least one year of dialysis and a residual glomerular filtration rate less than 1 ml/min, serum cholesterol greater than 260 mg/dl, LDL cholesterol greater than 180 mg/dl and triglycerides greater than 200 mg/dl were admitted to the study. The patients received either 3 x 450 mg 3-sn-polyenyl-phosphatidylcholine (PPC) mornings and evenings (2.7 g daily, 6 capsules) or placebo during the double-blind, randomized study. Six weeks treatment was followed by a two-week wash-out phase. Lipid parameters including total cholesterol, triglycerides, HDL and LDL cholesterol were determined 14 days before treatment, at treatment begin, at 2, 4 and 6 weeks during treatment and 14 days after treatment cessation. PPC caused a significant decrease in total cholesterol (-37.8 mg/dl) two weeks after treatment begin (2 p less than 0.001). This decrease remained constant during the duration of treatment. Two weeks after PPC application a decrease in LDL-cholesterol had occurred (-32.0 mg/dl) (2 p less than 0.01) as compared to stable placebo values. Significant PPC induced decreases in triglycerides occurred four (-58.2 mg/dl; 2 p less than 0.001) and six weeks (-43.3 mg/dl; 2 p less than 0.01) after initiation of treatment, as compared to the placebo group (four weeks: +5.7 mg/dl and six weeks: -11.4 mg/dl). Side effects in the PPC group were equivalent to those reported in the placebo group. This study shows that PPC is an effective antihyperlipidemic agent in dialysis patients.
由于缺血性心血管并发症的高发生率,高脂血症在透析患者中尤为令人关注。两组各10名透析至少一年且残余肾小球滤过率低于1 ml/分钟、血清胆固醇大于260 mg/dl、低密度脂蛋白胆固醇大于180 mg/dl以及甘油三酯大于200 mg/dl的患者被纳入该研究。在这项双盲、随机研究中,患者早晚分别服用3×450 mg的3-sn-多烯磷脂酰胆碱(PPC)(每日2.7 g,6粒胶囊)或安慰剂。六周治疗后是为期两周的洗脱期。在治疗前14天、治疗开始时、治疗期间的第2、4和6周以及治疗停止后14天测定包括总胆固醇、甘油三酯、高密度脂蛋白和低密度脂蛋白胆固醇在内的血脂参数。治疗开始两周后,PPC使总胆固醇显著降低(-37.8 mg/dl)(P<0.001)。在治疗期间,这种降低保持稳定。与稳定的安慰剂值相比,应用PPC两周后低密度脂蛋白胆固醇降低(-32.0 mg/dl)(P<0.01)。与安慰剂组相比(四周:+5.7 mg/dl,六周:-11.4 mg/dl),治疗开始后四周(-58.2 mg/dl;P<0.001)和六周(-43.3 mg/dl;P<0.01)PPC使甘油三酯显著降低。PPC组的副作用与安慰剂组报告的副作用相当。这项研究表明,PPC是一种治疗透析患者高脂血症的有效药物。