辛伐他汀和非诺贝特联合应用于混合型高脂血症的近期疗效和安全性观察

目的评价联合应用辛伐他汀和非诺贝特对混合型高脂血症病人的调脂作用和安全性。方法60例原发混合型高脂血症病人,随机分为两组,辛伐他汀治疗组(单药组)30例,睡前服用辛伐他汀10mg;辛伐他汀联合非诺贝特治疗组(联合组)30例,睡前服用10mg辛伐他汀和早午各100mg非诺贝特。两组均治疗8周,观察调脂疗效和不良反应。结果治疗后两组各项血脂指标与治疗前比,除单药组三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)与治疗前相近外,其余各指标均有显著改善(P<0.01),且以联合组改善最明显,总胆固醇(TC)从(7.01±0.33)mmol/L降至(4.91±0.32)mmol/L,LDL-C从(4.32±0.39)mmol/L,降至(2.63±0.32)mmol/L;TG从(3.62±0.36)mmol/L降至(1.52±0.22)mmol/L;HDL-C从(0.89±0.03)mmol/L升至(1.14±0.04)mmol/L。联合组TC、LDL-C、TG的达标率分别为50.0%、53.3%、56.7%,三项全部达标者占46.7%,明显高于单药组(P<0.05)。其治疗总有效率明显高于单药组。两组不良反应轻微。结论辛伐他汀(10mg/d)联合非诺贝特(200mg/d)对混合型高脂血症病人的调脂作用优于辛伐他汀(10mg/d)单药治疗,且具有良好的安全性。     

小剂量普伐他汀与非诺贝特联合治疗混合型高血脂症临床疗效及安全性

目的 探讨小剂量普伐他汀与非诺贝特联合应用治疗混合型高血脂症的临床疗效及安全性.方法 混合型高血脂症患者189例,随机分为3组,即普伐他汀组(10 mg/d, n=64)、非诺贝特组(200 mg/d, n=63)、联合治疗组(普伐他汀10 mg/d 非诺贝特200 mg/d, n=62),治疗12周;12周时单药治疗血脂水平未全部达标者再随机分为3组,即联合治疗组、普伐他汀20 mg治疗组及非诺贝特组,再治疗12周.观察治疗前后主要血脂水平的变化率、达标率及不良反应.结果 (1)12周时联合治疗组血清总胆固醇(TC)、低密度脂蛋白胆固醇LDL-C、三酰甘油(TG)下降的幅度及血清高密度脂蛋白胆固醇(HDL-C)升高的幅度均高于单独用药组(P值均＜0.01);TC、LDL-C、TG 3项全部达标率也高于单独用药组(P均＜0.01).(2)单独用药血脂参数未全部达标者(n=35)改为联合治疗组治疗12周后TC及LDL-C下降的幅度与普伐他汀20 mg组比较,差异无统计学意义,而降低TG及升高HDL-C幅度高于普伐他汀20 mg组(P值均＜0.01);联合治疗组与单用非诺贝特组比较, 降低TC、LDL-C、TG及升高HDL-C的幅度高于非诺贝特组(P值＜0.01或＜0.05);联合用药组3项全部达标率为44%,而普伐他汀20 mg组及非诺贝特组全部达标为21%、17%(P值均＜0.01).(3)联合治疗的不良反应与单独用药相比没有明显增加.结论 小剂量普伐他汀(10 mg/d)与非诺贝特(200 mg/d)联合治疗混合型高血脂症,较单独用药更有效、更全面地改善各项血脂水平,具有良好的安全性和耐受性.     

小剂量普伐他汀与非诺贝特联合治疗混合型高血脂症临床疗效及安全性

目的探讨小剂量普伐他汀与非诺贝特联合应用治疗混合型高血脂症的临床疗效及安全性。方法混合型高血脂症患者189例,随机分为3组,即普伐他汀组(10mg/d,n=64)、非诺贝特组(200mg/d,n=63)、联合治疗组(普伐他汀10mg/d+非诺贝特200mg/d,n=62),治疗12周;12周时单药治疗血脂水平未全部达标者再随机分为3组,即联合治疗组、普伐他汀20mg治疗组及非诺贝特组,再治疗12周。观察治疗前后主要血脂水平的变化率、达标率及不良反应。结果(1)12周时联合治疗组血清总胆固醇(TC)、低密度脂蛋白胆固醇LDL-C、三酰甘油(TG)下降的幅度及血清高密度脂蛋白胆固醇(HDL-C)升高的幅度均高于单独用药组(P值均<0.01);TC、LDL-C、TG3项全部达标率也高于单独用药组(P均<0.01)。(2)单独用药血脂参数未全部达标者(n=35)改为联合治疗组治疗12周后TC及LDL-C下降的幅度与普伐他汀20mg组比较,差异无统计学意义,而降低TG及升高HDL-C幅度高于普伐他汀20mg组(P值均<0.01);联合治疗组与单用非诺贝特组比较,降低TC、LDL-C、TG及升高HDL-C的幅度高于非诺贝特组(P值<0.01或<0.05);联合用药组3项全部达标率为44%,而普伐他汀20mg组及非诺贝特组全部达标为21%、17%(P值均<0.01)。(3)联合治疗的不良反应与单独用药相比没有明显增加。结论小剂量普伐他汀(10mg/d)与非诺贝特(200mg/d)联合治疗混合型高血脂症,较单独用药更有效、更全面地改善各项血脂水平,具有良好的安全性和耐受性。     

辛伐他汀联合非诺贝特治疗混合型高脂血症的疗效和安全性探讨

目的 评价辛伐他汀联合非诺贝特治疗混合型高脂血症的疗效和安全性.方法 选择冠心病合并混合型高脂血症患者46例,治疗前2周停服调脂药,随机分为辛伐他汀+非诺贝特联合组(A组n=23)和辛伐他汀单药组(B组n=23)两组.A组患者中男16例,女7例,年龄(60.01±8.25)岁,给予辛伐他汀20 mg,每晚睡前口服,非诺贝特0.1 g,每日2次,连续24周.B组患者中男15例,女8例,年龄(60.00±7.8)岁,给予辛伐他汀20 mg,每晚睡前口服,连续24周,服药前和服药24周后各测定TC、TG、LDL-C、HDL-C、GPT、CK一次.结果 治疗24周后,A组血清总胆固醇降低27.8%,TG下降56%,LDL-C下降41.4%,HDL-C升高22%.B组TC下降15.4%,TG下降11.6%,LDL-C下降24.7%,HDL-C上升11.5%(P<0.05),24周内A组有3例发生不稳定性心绞痛,B组有6例发生不稳定性心绞痛(P<0.05).两组没有患者因为严重不良反应事件而退出.结论 联合应用辛伐他汀和非诺贝特治疗混合型高脂血症与单药相比能更有效地降低高血脂水平,显著降低冠心病发病率,改善预后.     

非诺贝特微粒化胶囊联合辛伐他汀对混合型高脂血症的治疗

目的:观察非诺贝特微粒化胶囊联合辛伐他汀治疗混合型高脂血症的疗效和安全性。方法:冠心病及有高危因素的混合型高脂血症患者72例,分为两组:辛伐他汀组36例,口服辛伐他汀20mg,每日1次;非诺贝特微粒化胶囊加辛伐他汀组(联合治疗组)36例,在辛伐他汀基础上加服非诺贝特微粒化胶囊200mg,每日1次;两组疗程均为8周。观察治疗前后血脂变化和相关不良反应。结果:①两组治疗后血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)均有改善(P0.05～0.01),但联合治疗组治疗后LDL-C和TG改善情况优于辛伐他汀组(P0.05)。②联合治疗组TC、LDL-C、TG的达标率分别为58.3%、44.4%、50.0%,三项达标率为36.1%,明显高于辛伐他汀组的13.9%(P0.01)。③两组均没有出现严重不良反应。结论:非诺贝特微粒化胶囊联合辛伐他汀对混合型高脂血症的冠心病及有高危因素患者有较好调脂作用,值得在临床推广应用。     

ω-3脂肪酸增强辛伐他汀降脂的效果

美国心血管病杂志2008年8月15日报道:辛伐他汀与ω-3酸性乙醛酯(P-OM3)联合治疗对混合型高脂血症患者的血脂和脂蛋白水平有协同改善作用(Am J Cardiol,2008,102:429-433)。辛伐他汀与ω-3联合治疗与辛伐他汀与非诺贝特的联合疗的效果相似。因此,这种联合治疗是混合性高血脂患者的可选择的治疗方案之一。该研究入选39例三酰甘油水平和非高密度脂蛋白胆固醇(non-HDL-C)水平升高的患者,随机分为辛伐他汀组(20 mg/d)+P-OM3(4 g/d)治疗与辛伐他汀+安慰剂(单药治疗组),疗程6周。结果发现:联合治疗组 non-HDL-C 水平下降幅度明显高于单药治疗组(40%比34%)。与单药治疗组相比,联合治疗组的极低密度脂蛋白胆固醇(VLDL-C)和三酰甘油水平明显降低,高密度脂蛋白(HDL)水平明显升高。同样,     

联合应用阿托伐他汀和烟酸缓释片治疗混合性高脂血症的疗效及安全性观察

目的:探讨联合应用阿托伐他汀和烟酸缓释片治疗混合性高脂血症的临床疗效及安全性。方法:入选混合性高脂血症患者121例,随机分入阿托伐他汀组(10 mg／d,n=64)、联合治疗组(阿托伐他汀10 mg／d+烟酸缓释片500 mg／d,n=57),疗程3个月。观察治疗前后主要血脂参数的变化率、达标率以及不良反应。结果:①2组血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)和甘油三酯(TG)水平均有不同程度的改善,但联合治疗组血脂参数的变化幅度更大,明显优于阿托伐他汀组(P均<0．01～0．05)。②联合治疗组TC、LDL-C和TG的达标率分别为75．44％、64．91％和61．40％,三项全部达标者占45．61％,明显高于阿托伐他汀组(P均<0．01)。③联合治疗组不良反应的发生率和阿托伐他汀组相比差异无统计学意义(P均>0．05)。结论:研究结果提示,烟酸缓释片(500 mg/d)与阿托伐他汀(10 mg／d)联合治疗可以更全面地改善混合性高脂血症患者的血脂异常,具有良好的安全性和耐受性。     

辛伐他汀并非诺贝特治疗急性冠脉综合征的疗效

目的：探讨联合应用辛伐他汀和非诺贝特对急性冠脉综合征（ACS）患者血脂参数及炎症因子的影响。方法：共人选58例ACS患者．随机分为：辛伐他汀组（20mg／d，18例）；非诺贝特组（200mg／d，18例）；联合治疗组（辛伐他汀20rag／d＋非诺贝特200mg／d，22例），疗程均为6个月。观察治疗前、后血清总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、甘油三酯（TG）、高密度脂蛋白胆固醇（HDL—C）、一氧化氮（NO）、内皮素（ET）和C反应蛋白（CRP）含量的变化，以及药物不良反应。结果：各组治疗后血清TC、LDL-C、TG水平显著降低（P均〈0.05），血清HDL—C水平有不同程度增高。其中以联合治疗组最为明显（P均〈0．05）。和辛伐他汀组相比，非诺贝特组TC和LDL-C水平无明显差异（P〉0．05），而TG水平显著降低，HDL—C水平明显增高（P〈0．05），与治疗前相比，各组治疗后血清NO水平增高，CRP和ET水平降低（P〈0．05），联合治疗组较辛伐他汀组、非诺贝特组更显著（P均〈0.05），三组均无不良反应。结论：联合辛伐他汀和非诺贝特治疗可以更全面地改善ACS患者的血脂异常，其改善内皮功能和降低炎症因子的作用较单药治疗更有效。     

小剂量氟伐他汀联合非诺贝特治疗老年混合型高脂血症的临床研究

目的观察小剂量氟伐他汀联合非诺贝特治疗老年混合型高脂血症的疗效及安全性。方法将入选的70例老年混合型高脂血症患者，随机分为氟伐他汀单药治疗组（12=35，20mg／d），氟伐他汀（20mg／d）、非诺贝特（200mg，隔日1次）联合治疗组（12=35），疗程均为12周。结果联合治疗组血脂参数变化最显著，降低低密度脂蛋白胆固醇、三酰甘油和升高高密度脂蛋白胆固醇的能力明显优于单药组（P〈0．01或P〈0．05），且未发现明显不良反应。结论小荆量氟伐他汀与非诺贝特联合治疗可以更有效地改善老年混合型高脂血症患者的血脂异常，具有良好的安全性和耐受性。     

辛伐他汀和非诺贝特对高脂血症患者血脂水平的影响

目的观察辛伐他汀和非诺贝特治疗高脂血症的临床疗效,对比分析二者对血清血脂水平的影响。方法将150例混合型高脂血症患者随机分为他汀组、贝特组、联合组三组,每组各50例,他汀组予以辛伐他汀10 mg/d治疗,贝特组予以非诺贝特200 mg/d治疗,联合组予以辛伐他汀10 mg/d和非诺贝特200 mg/d联合治疗,监测治疗前、治疗后12周的总胆固醇(TC)、低密度脂蛋白(LDL-C)、三酰甘油(TG)及高密度脂蛋白(HDL-C)的变化,同时监测谷丙转氨酶(ALT)、血尿素氮(BUN)、血肌酐(Cr)及肌酸激酶(CK)的变化。结果治疗12周后,三组TC、LDL-C、TG及HDL-C的变化均有所改善,差异具有统计学意义(P0.05)。他汀组(TC:4.21±0.62 mmol/L,LDL-C:3.21±0.61mmol/L)与贝特组(TC:4.91±0.53 mmol/L,LDL-C:3.52±0.52 mmol/L)比较,差异有统计学意义(P0.05),他汀组与联合组(TC:4.31±0.63 mmol/L,LDL-C:3.22±0.61 mmol/L)比较,差异无统计学意义(P0.05)。贝特组与联合组比较,差异有统计学意义(P0.05)。他汀组(HDL-C:1.21±0.22 mmol/L,TG:2.91±0.62 mmol/L)与贝特组(HDL-C:1.32±0.11mmol/L,TG:1.52±0.51 mmol/L)比较,差异无统计学意义(P0.05),他汀组与联合组(HDL-C:1.41±0.21 mmol/L,TG:1.21±0.62mmol/L)比较,差异有统计学意义(P0.05)贝特组与联合组比较,差异有统计学意义(P0.05)。三组不良反应比较,差异无显著性(P0.05)。结论联合应用辛伐他汀与非诺贝特对混合型高脂血症患者的总有效率要优于单独使用辛伐他汀或非诺贝特,且不良反应没有增高,具有良好的安全性。     

Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial)

Patients with combined hyperlipidemia (elevated triglyceride [TG] levels, elevated low-density lipoprotein [LDL] cholesterol, and multiple lipoprotein abnormalities) are at increased risk for coronary heart disease. We conducted a multicenter (in the United States), randomized, double-blind, active-controlled, 18-week study to determine if combination therapy with simvastatin plus fenofibrate is more effective in reducing elevated TG levels, thus improving the lipoprotein pattern in patients with combined hyperlipidemia compared with simvastatin monotherapy, and to evaluate safety and tolerability. Patients (aged 21 to 68 years) with a diagnosis of combined hyperlipidemia (fasting TG levels >/=150 and 130 mg/dl) received simvastatin monotherapy (20 mg/day, n = 207) or simvastatin 20 mg plus fenofibrate (160 mg/day) combination therapy (n = 411) for 12 weeks following a 6-week diet and placebo run-in period. From baseline to week 12, median TG levels decreased 43.0% (combination therapy) and 20.1% (simvastatin monotherapy [treatment difference -23.6%, p <0.001]). Mean LDL cholesterol levels decreased 31.2% and 25.8% (treatment difference -5.4%, p <0.001), and high-density lipoprotein cholesterol levels increased 18.6% and 9.7% (treatment difference 8.8%, p <0.001) in the combination therapy versus monotherapy groups, respectively. No drug-related serious adverse experiences were observed. No patient experienced clinical myopathy or severe abnormalities in liver function. Combination therapy with simvastatin 20 mg and fenofibrate 160 mg in patients with combined hyperlipidemia resulted in additional improvement in all lipoprotein parameters measured compared with simvastatin 20 mg monotherapy and was well tolerated. Thus, this combination therapy is a beneficial therapeutic option for managing combined hyperlipidemia.     

Combination therapy with fluvastatin and fenofibrate in ischemic heart disease patients with combined hyperlipidemia and type 2 diabetes

AIM: To assess efficacy of combination therapy with fluvastatin and fenofibrate in ischemic heart disease (IHD) patients with combined hyperlipidemia and type 2 diabetes. MATERIAL: Patients with IHD and combined hyperlipidemia with (n=56)) or without type 2 diabetes (n=30). METHODS: After 8-week diet period the patients were randomized to 4 weeks monotherapy with either fluvastatin (40 mg/day) or micronized fenofibrate (200 mg/day). In patients whose low-density lipoprotein cholesterol (LDL CH) remained > 2,6 mmol/1 and triglycerides (TG) > 2.3 mmol/1 combination of fluvastatin 40 mg/day and fenofibrate 200 mg/day was used for the next 12 weeks. RESULTS: Target levels of LDL CH and TG were achieved in 75 and 88%, respectively, of diabetics, and in 73 and 88%, respectively, of non-diabetics. CONCLUSION: The use of combination of fluvastatin and fenofibrate was more effective then monotherapy for correction of lipid abnormalities in combined hyperlipidemia both in diabetics and non-diabetics with IHD.     

Effects of adding fenofibrate (200 mg/day) to simvastatin (10 mg/day) in patients with combined hyperlipidemia and metabolic syndrome

Combined hyperlipidemia predisposes subjects to coronary heart disease. Two lipid abnormalities--increased cholesterol and atherogenic dyslipidemia--are potential targets of lipid-lowering therapy. Successful management of both may require combined drug therapy. Statins are effective low-density lipoprotein (LDL) cholesterol-lowering drugs. For atherogenic dyslipidemia (high triglycerides, small LDL, and low high-density lipoprotein [HDL]), fibrates are potentially beneficial. The present study was designed to examine the safety and efficacy of a combination of low-dose simvastatin and fenofibrate in the treatment of combined hyperlipidemia. It was a randomized, placebo-controlled trial with a crossover design. Three randomized phases were employed (double placebo, simvastatin 10 mg/day and placebo, and simvastatin 10 mg/day plus fenofibrate 200 mg/day). Each phase lasted 3 months, and in the last week of each phase, measurements were made of plasma lipids, lipoprotein cholesterol, plasma apolipoproteins B, C-II, and C-III and LDL speciation on 3 consecutive days. Simvastatin therapy decreased total cholesterol by 27%, non-HDL cholesterol by 30%, total apolipoprotein B by 31%, very low-density lipoprotein (VLDL) + intermediate-density lipoprotein (IDL) cholesterol by 37%, VLDL + IDL apolipoprotein B by 14%, LDL cholesterol by 28%, and LDL apolipoprotein B by 21%. The addition of fenofibrate caused an additional decrease in VLDL + IDL cholesterol and VLDL + IDL apolipoprotein B by 36% and 32%, respectively. Simvastatin alone caused a small increase in the ratio of large-to-small LDL, whereas the addition of fenofibrate to simvastatin therapy caused a marked increase in the ratio of large-to-small LDL species. Simvastatin alone produced a small (6%) and insignificant increase in HDL cholesterol concentrations. When fenofibrate was added to simvastatin therapy, HDL cholesterol increased significantly by 23%. No significant side effects were observed with either simvastatin alone or with combined drug therapy. Therefore, a combination of simvastatin 10 mg/day and fenofibrate 200 mg/day appears to be effective and safe for the treatment of atherogenic dyslipidemia in combined hyperlipidemia.     

Comparison of combined statin-fibrate treatment to monotherapy in patients with mixed hyperlipidemia

BACKGROUND: Statins are the preferred drugs for the treatment of hypercholesterolemia, and fibrates for hypertriglyceridemia. In patients with mixed hyperlipidemia, monotherapy with one of these agents may not be effective and combined treatment may be preferable. AIM: To compare retrospectively the efficacy and safety of combined statin-fibrate treatment in patients with mixed hyperlipidemia in whom previous monotherapy with one of these agents occurred ineffective. METHODS AND RESULTS: The initial study group consisted of 327 patients who received micronised fenofibrate and 93 patients who received simvastatin for 12 months. Both agents caused significant changes in lipid profile. Following fibrate therapy, total cholesterol (TC), LDL-cholesterol (LDL-C) and triglyceride (TG) levels decreased by 27.9%, 28.2% and 58%, respectively, and following simvastatin therapy by 33.6%, 42.8% and 37.5%, respectively. The HDL-cholesterol (HDL-C) level increased after fenofibrate by 14.8% and remained unchanged following simvastatin therapy. The TC/HDL-C ratio decreased following fenofibrate by 35.6%, and following simvastatin by 35.3%. In some patients the required reduction in lipid parameters was not achieved fenofibrate or simvastatin. Subsequently, 93 patients underwent combined therapy by adding a second agent (simvastatin in a dose of 20 mg/day or fenofibrate in a dose of 200 mg per day) which was continued for another 12 months. The addition of simvastatin to fenofibrate decreased TC, LDL-C and TG levels by 35.5%, 42.1% and 59.6%, respectively in comparison to before treatment volumes. HDL-C level was increased by 11.1%, and TC/HDL-C ratio decreased by 45.3%. The addition of fenofibrate to simvastatin decreased TC, LDL-C and TG levels by 39.3%, 48.9% and 51,6%, respectively. HDL-C level was increased by 13.4%, and TC/HDL-C ratio decreased by 49.3%. No clinical side effects nor an increase in the transaminase levels, requiring termination of the treatment, were observed. CONCLUSIONS: Combined therapy with 20 mg of simvastatin and 200 mg of micronised fenofibrate is highly effective and safe in patients with mixed hyperlipidemia.     

烟酸缓释片联用辛伐他汀对混合型高脂血症的疗效

目的探讨联合应用炯酸缓释片与辛伐他汀对混合型高脂血症的疗效、安全性及对C反应蛋白的影响。方法有冠心病及高危因素的混合型高脂血症80例，辛伐他汀组39例．口服辛伐他汀剂量20mg／d；烟酸加辛伐他汀组（联合治疗组）41例，口服炯酸缓释片500mg／d，辛伐他汀20mg／d。，疗程均12周。观察治疗前、后血脂变化，不良反应及高敏C反应蛋白的变化。结果①两组治疗后血清总胆固醇、低密度脂蛋白胆固醇、甘油三酯均有所改善，但联合治疗组的改变幅度，分别达54％、47％、47％，高密度脂蛋白胆固醇升高37．5％；②联合治疗组总胆固醇、低密度脂蛋白胆固醇、甘油三酯的达标率分别为63％、49％和56％，三项全达标占44％，高于辛伐他汀组（P〈0．01）；③联合治疗组治疗前后高敏C反应蛋白变化较辛伐他汀组明显（P〈0．05）；④两组均没出现严重不良反应。结论烟酸缓释片联用辛伐他汀可改善混合型高脂血症的冠心病及高危患者的血脂异常．使高敏C反应蛋白降低。     

阿托伐他汀治疗混合型高脂血症的疗效和安全性

目的　评估红惠医药发展公司生产的阿托伐他汀 (Atorvastatin)治疗高脂血症 ,特别是混合型高脂血症的疗效和安全性。方法　试验组 (阿托伐他汀 10mg d) 5 2例和对照组 (舒降之 10mg d) 5 3例 ,进行随机单盲平行对照试验 ,观察两组降脂疗效和不良反应发生情况。结果　经过 8周治疗 ,阿托伐他汀组TC、LDL C、TG和 (TC HDL C) HDL C分别下降 30 % ,40 % ,30 %和 36 % (P <0 .0 1) ,HDL C虽有升高 (5 % ) ,但差异无显著性意义 (P >0 .0 5 )。组间比较 ,阿托伐他汀降LDL C和TG作用明显优于辛伐他汀 (P <0 .0 5 ) ,降TC作用则两组相似。两组不良反应均很轻微和少见。结论　阿托伐他汀 10mg d治疗混合型高脂血症可以明显降低TC、LDL C ,TG和 (TC HDL C) HDL C ;阿托伐他汀降低LDL C和TG的作用大于同剂量辛伐他汀 ;阿托伐他汀的不良反应轻微 ,耐受性好。