Zeman M, Zák A, Vecka M, Romaniv S
IV. interní klinika 1. LF UK a VFN, Praha.
Cas Lek Cesk. 2003 Aug;142(8):500-4.
It is difficult to achieve satisfactory decreases of both plasma LDL-cholesterol (LDL-C) and triglycerides (TG) and increase of HDL-C with only single statin or fibrate treatment of patients with mixed hyperlipoproteinaemias (HLP). Combination treatment with both statin and fibrate has been shown to enhance achieving of recommended targets in these patients with high-risk of coronary heart disease. On the other hand unpleasant side effects including myopathy and rhabdomyolysis were described in some cases after statin-fibrate combination therapy. Aim of the study was to evaluate efficacy and safety of long-term treatment of pravastatin + fenofibrate or simvastatin + ciprofibrate therapy in the high-risk group of patients with severe mixed hyperlipoproteinemia.
A set of 86 patients (55 M/31 F) was followed for a period at least one year (median 3 years). These patients were randomly assigned to combination of pravastatin 20 mg + fenofibrate 200 mg (n = 46) (group A), or simvastatin 20 mg + ciprofibrate 100 mg (n = 40) (group B). We have observed significant reduction in plasma TC (22% in group A, 20% in group B), in LDL-C (36%, resp. 33%), reduction of TG (44%, resp. 46%), apo-B (35%, resp. 33%) whilst HDL-C significantly increased (18%, resp. 16%). Concomitantly we have seen significant decreases in uricaemia (14%, resp. 18%). No patient needed to stop treatment due to abnormalities in liver function tests. Levels of creatinkinase became non-significantly elevated (by 16%, resp. 13%). No patient exhibited myopathy or rhabdomyolysis.
The long-term combined therapy with statin-fibrate (pravastatin 20 mg + fenofirbrate 200 mg, or simvastatin 20 mg + ciprofibrate 100 mg) in severe mixed HLP was safe and effectively improved plasma lipid and apolipoprotein levels. Both combinations seemed to be similarly efficient and safe.
对于混合型高脂血症（HLP）患者，仅使用单一的他汀类药物或贝特类药物治疗，很难同时使血浆低密度脂蛋白胆固醇（LDL-C）和甘油三酯（TG）令人满意地降低，以及使高密度脂蛋白胆固醇（HDL-C）升高。已证明，他汀类药物和贝特类药物联合治疗可提高这些冠心病高危患者达到推荐目标的几率。另一方面，在一些他汀类药物与贝特类药物联合治疗的病例中，出现了包括肌病和横纹肌溶解在内的不良副作用。本研究的目的是评估普伐他汀+非诺贝特或辛伐他汀+环丙贝特长期治疗重度混合型高脂血症高危患者的疗效和安全性。
一组86例患者（55例男性/31例女性）接受了至少一年（中位时间为3年）的随访。这些患者被随机分配至普伐他汀20mg+非诺贝特200mg联合治疗组（n = 46）（A组），或辛伐他汀20mg+环丙贝特100mg联合治疗组（n = 40）（B组）。我们观察到血浆总胆固醇（TC）显著降低（A组降低22%，B组降低20%），低密度脂蛋白胆固醇（LDL-C）降低（分别为36%和33%），甘油三酯（TG）降低（分别为44%和46%），载脂蛋白B（apo-B）降低（分别为35%和33%），而高密度脂蛋白胆固醇（HDL-C）显著升高（分别为18%和16%）。同时，我们还观察到血尿酸水平显著降低（分别为14%和18%）。没有患者因肝功能检查异常而需要停止治疗。肌酸激酶水平有非显著性升高（分别升高16%和13%）。没有患者出现肌病或横纹肌溶解。
在重度混合型HLP患者中，他汀类药物与贝特类药物（普伐他汀20mg+非诺贝特200mg，或辛伐他汀20mg+环丙贝特100mg）的长期联合治疗是安全的，并且能有效改善血脂和载脂蛋白水平。两种联合治疗方案似乎同样有效且安全。
