脂必泰胶囊与阿托伐他汀治疗心血管高危患者的对比研究
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摘要
目的:以阿托伐他汀为阳性对照,观察脂必泰胶囊对心血管高危患者的调脂疗效及安全性,同时比较二者对部分血管内皮功能指标的影响。
方法:选取2007年7月至2008年12月在我院心内科就诊的具有≥2个心血管疾病危险因素的患者为研究对象,共计83例。随机分为脂必泰组(n=44)和阿托伐他汀组(n=39),分别于治疗前、治疗第4周和第8周观察血脂(TG、TC、LDL-C和HDL-C)水平变化。同时,于治疗前以及治疗第8周,超声测定肱动脉内皮依赖性舒张功能(FMD)及颈动脉内-中膜厚度(IMT),且采用酶联免疫吸附法测定血浆血管假性血友病因子(vWF)浓度,并评价用药安全性。
结果:
1.脂必泰胶囊治疗4周及8周后,心血管高危患者的血清TG、TC、LDL-C水平均显著降低(P＜0.05),而HDL-C水平较治疗前无统计学差异(P＞0.05)。阿托伐他汀治疗4周后,患者TG、LDL-C水平显著降低(P＜0.05),而TC和HDL-C水平与治疗前比较无统计学差异(P＞0.05)。他汀治疗8周后,患者TG、TC、LDL-C及HDL-C水平均显著降低(P＜0.05)。治疗8周后,两种药物在降低TC、TG及LDL-C水平的程度上无显著性差异(P＞0.05)。
2.治疗8周后,脂必泰胶囊和阿托伐他汀均显著改善患者的FMD(P＜0.05),且两组间FMD改善程度无显著性差异(P＞0.05)。
3.治疗8周后,脂必泰胶囊和阿托伐他汀均可显著降低患者的血浆vWF水平(P＜0.05),且两组间血浆vWF水平降低程度无显著性差异(P＞0.05)。
4.治疗8周后,与治疗前比较,脂必泰胶囊和阿托伐他汀均未显著减少患者的IMT(P＞0.05)。
5.FMD、vWF、IMT与血脂各成分之间无显著相关性(P＞0.05),且FMD、vWF及IMT各自之间无未见显著相关(P＞0.05)。
6.脂必泰胶囊治疗8周后,患者谷丙转氨酶(ALT)及总胆红素(TBIL)明显降低(P＜0.05),而阿托伐他汀组ALT及TBIL无显著变化(P＞0.05)。脂必泰胶囊对血常规、肾功能等影响甚微,不良反应少,患者耐受性好。
结论:与阿托伐他汀比较,脂必泰胶囊同样能有效降低心血管高危患者的血清TC、TG及LDL-C水平,且二者疗效相当。与阿托伐他汀不同的是,脂必泰胶囊不造成HDL-C水平降低,且降低TC作用较阿托伐他汀更快。除调脂作用外,脂必泰胶囊还能有效改善FMD,降低血浆vWF水平,从而改善血管内皮功能。脂必泰胶囊对部分转氨酶及胆红素升高的肝功能异常患者有益,不良反应少,患者耐受性好。
Objectives:The aim of this study was to to evaluate the effects of Zhibitai capsule on blood lipids and endothelial function in patients with high cardiovascular risk,compared with Atorvastatin.
Methods:Eighty three subjects with high risk factors of cardiovascular disease were randomizedly devided into Zhibitai group (n=44) and Atorvastatin group(n=39),and the course of treatment was eight weeks.The levels of blood lipids were assayed by clinical chemistry method.With Doppler ultrasound technique,the flow-mediated dialation (FMD) and intima media thickness(IMT) were measured.Plasma von Willebrand factor(vWF) levels were measured with enzyme linked immunosorbent assay before and after treatment,respectively.
Results:
1.The levels of triglyeride(TG),total cholesterol(TC) and low density lipoprotein cholesterol(LDL-C) were decreased markedly after therapy with Zhibitai and atorvastatin for 8 weeks(P＜0.05),but high density lipoprotein cholesterol(HDL-C) had no significant changes with Zhibitai(P＞0.05 ),whereas HDL-C were decreased markly after therapy with atorvastatin for 8 weeks(P＜0.05 ).The variation of the TC,TG and LDL-C levels had no difference between two group(P＞0.05).
2.The FMD was improved significantly in two groups after therapy (P＜0.05).
3.Plama vWF levels were reduced markly in two groups after therapy(P＜0.05).
4.There was no significant alteration of IMT in two groups(P＞ 0.05).
5.There was no correlation between absolute FMD,plasma vWF levels,IMT and blood lipids.There was no correlation between the variation of them.
6.The adverse effects of Zhibitai was very mild,and the compliance of patients was very well.
Conclusions:Zhibitai has the same good effects on reducing blood levels of TG,TC and LDL-C as Atorvastatin,but no significant negative effect on HDL-C.Besides,It can improve FMD and reduce plama vWF levels to improve vascular endothelial function.The adverse effects of Zhibitai was very mild,and the compliance of patients was very well.
方法:选取2007年7月至2008年12月在我院心内科就诊的具有≥2个心血管疾病危险因素的患者为研究对象,共计83例。随机分为脂必泰组(n=44)和阿托伐他汀组(n=39),分别于治疗前、治疗第4周和第8周观察血脂(TG、TC、LDL-C和HDL-C)水平变化。同时,于治疗前以及治疗第8周,超声测定肱动脉内皮依赖性舒张功能(FMD)及颈动脉内-中膜厚度(IMT),且采用酶联免疫吸附法测定血浆血管假性血友病因子(vWF)浓度,并评价用药安全性。
结果:
1.脂必泰胶囊治疗4周及8周后,心血管高危患者的血清TG、TC、LDL-C水平均显著降低(P＜0.05),而HDL-C水平较治疗前无统计学差异(P＞0.05)。阿托伐他汀治疗4周后,患者TG、LDL-C水平显著降低(P＜0.05),而TC和HDL-C水平与治疗前比较无统计学差异(P＞0.05)。他汀治疗8周后,患者TG、TC、LDL-C及HDL-C水平均显著降低(P＜0.05)。治疗8周后,两种药物在降低TC、TG及LDL-C水平的程度上无显著性差异(P＞0.05)。
2.治疗8周后,脂必泰胶囊和阿托伐他汀均显著改善患者的FMD(P＜0.05),且两组间FMD改善程度无显著性差异(P＞0.05)。
3.治疗8周后,脂必泰胶囊和阿托伐他汀均可显著降低患者的血浆vWF水平(P＜0.05),且两组间血浆vWF水平降低程度无显著性差异(P＞0.05)。
4.治疗8周后,与治疗前比较,脂必泰胶囊和阿托伐他汀均未显著减少患者的IMT(P＞0.05)。
5.FMD、vWF、IMT与血脂各成分之间无显著相关性(P＞0.05),且FMD、vWF及IMT各自之间无未见显著相关(P＞0.05)。
6.脂必泰胶囊治疗8周后,患者谷丙转氨酶(ALT)及总胆红素(TBIL)明显降低(P＜0.05),而阿托伐他汀组ALT及TBIL无显著变化(P＞0.05)。脂必泰胶囊对血常规、肾功能等影响甚微,不良反应少,患者耐受性好。
结论:与阿托伐他汀比较,脂必泰胶囊同样能有效降低心血管高危患者的血清TC、TG及LDL-C水平,且二者疗效相当。与阿托伐他汀不同的是,脂必泰胶囊不造成HDL-C水平降低,且降低TC作用较阿托伐他汀更快。除调脂作用外,脂必泰胶囊还能有效改善FMD,降低血浆vWF水平,从而改善血管内皮功能。脂必泰胶囊对部分转氨酶及胆红素升高的肝功能异常患者有益,不良反应少,患者耐受性好。
Objectives:The aim of this study was to to evaluate the effects of Zhibitai capsule on blood lipids and endothelial function in patients with high cardiovascular risk,compared with Atorvastatin.
Methods:Eighty three subjects with high risk factors of cardiovascular disease were randomizedly devided into Zhibitai group (n=44) and Atorvastatin group(n=39),and the course of treatment was eight weeks.The levels of blood lipids were assayed by clinical chemistry method.With Doppler ultrasound technique,the flow-mediated dialation (FMD) and intima media thickness(IMT) were measured.Plasma von Willebrand factor(vWF) levels were measured with enzyme linked immunosorbent assay before and after treatment,respectively.
Results:
1.The levels of triglyeride(TG),total cholesterol(TC) and low density lipoprotein cholesterol(LDL-C) were decreased markedly after therapy with Zhibitai and atorvastatin for 8 weeks(P＜0.05),but high density lipoprotein cholesterol(HDL-C) had no significant changes with Zhibitai(P＞0.05 ),whereas HDL-C were decreased markly after therapy with atorvastatin for 8 weeks(P＜0.05 ).The variation of the TC,TG and LDL-C levels had no difference between two group(P＞0.05).
2.The FMD was improved significantly in two groups after therapy (P＜0.05).
3.Plama vWF levels were reduced markly in two groups after therapy(P＜0.05).
4.There was no significant alteration of IMT in two groups(P＞ 0.05).
5.There was no correlation between absolute FMD,plasma vWF levels,IMT and blood lipids.There was no correlation between the variation of them.
6.The adverse effects of Zhibitai was very mild,and the compliance of patients was very well.
Conclusions:Zhibitai has the same good effects on reducing blood levels of TG,TC and LDL-C as Atorvastatin,but no significant negative effect on HDL-C.Besides,It can improve FMD and reduce plama vWF levels to improve vascular endothelial function.The adverse effects of Zhibitai was very mild,and the compliance of patients was very well.
引文
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[20] Lin SJ, Chen YH, Lin FY, et al. Pravastatin induces thrombomodulin expression in TNFalpha-treated human aortic endothelial cells by inhibiting Rac1 and Cdc42 translocation and activity. J Cell Biochem, 2007,101(3):642-653
[21] Tousoulis D, Antoniades C, Bosinakou E,et al. Effects of atorvastatin on reactive hyperaemia and the thrombosis - fibrinolysis system in patients with heart failure. Heart, 2005, 91(1):27 - 31
[22] Sacks FM, Pfeffer MA, Moye LA, et al. The effect of Pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med, 1996, 335:1001 - 1009
[23] Ray KK, Cannon CP. The Potential Relevance of the Multiple Lipid-Independent (Pleiotropic) Effects of Statins in the Management of Acute Coronary Syndromes. J Am Coll Cardiol, 2005,46:1425-1433
[24] Dietzen DJ, Page KL, Tetzloff TA. Lipid rafts are necessary for tonic inhibition of cellular tissue factor procoagulant activity. Blood, 2004, 103: 3038-3044
[25] Dietzen DJ, Page, KL, Tetzloff TA, et al. Inhibition of 3-Hydroxy-3-Methylglutaryl Coenzyme A (HMG CoA) Reductase Blunts Factor Vila/Tissue Factor and Prothrombinase Activities via Effects on Membrane Phosphatidylserine. Arterioscler Thromb Vasc Biol, 2007,27(3):690-696
[1]Calabro P,Yeh ET.Multitasking of the 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor:beyond cardiovascular diseases.Curr Atheroscler Rep,2004,6:36-41
[2]Jean D.Beneficial Cardiovascular Pleiotropic Effects of Statins.Circulation,2004,109:Ⅲ-39-Ⅲ-43
[3]史旭波,胡大一.他汀类药物的非降脂作用.中国民康医学杂志,2006,18(5):334-335
[4]Mo Al-Qaisi,Rajesh K Kharbanda,Tarun K Mittal,et al.Measurement of endothelial function and its clinical utility for cardiovascular risk.Vasc Health Risk Manag,2008,4(3):647- 652
[5]Todd J.Anderson.Prognostic Significance of Brachial Flow-Mediated Vasodilation Circulation,2007,115:2373-2375
[6]Karatzis EN,Ikonomidis I,Vamvakou GD,et al.Long-term prognostic role of flow-mediated dilatation of the brachial artery after acute coronary syndromes without ST elevation.Am J Card,2006,98:1424- 1428
[7]Matsushima,V,Takase,B,Uehata A,et al.Comparative predictive and diagnostic value of flow-mediated vasodilation in the brachial artery and intima media thickness of the carotid artery for assessment of coronary artery disease severity.Int J Cardiol,2007,117:165- 172
[8]Pretnar-Oblak J,Sebestjen M,Sabovic M.Statin treatment improves cerebral more than systemic endothelial dysfunction in patients with arterial hypertension.Am J Hypertens,2008,21(6):674-678
[9]Koh KK,Quon MJ,Han SH,et al.Simvastatin improves flow-mediated dilation but reduces adiponectin levels and insulin sensitivity in hypercholesterolemic patients.Diabetes Care,2008,31(4):776-782
[10]Leu HB,Wu CC,Wu TC,et al.Fluvastatin reduces oxidative stress,decreases serum monocyte chemotactic protein-1 level and improves endothelial function in patients with hypercholesterolemia.J Formos Med Assoc,2004,103(12):914-920
[11]Ferreira WP,Bertolami MC,Santos SN,et al.One-month therapy with simvastatin restores endothelial function in hypercholesterolemic children and adolescents。 Pediatr Cardiol,2007,28(1):8-13
[12]Vlachopoulos C,Aznaouridis K,Dagre A,et al.Protective effect of atorvastatin on acute systemic inflammation-induced endothelial dysfunction in hypercholesterolaemic subjects.Eur Heart J,2007 28(17):2102-2109
[13]Girma JP.Biology of von Willebrand factor.Nephrol Ther,2006,2(2):S143-148
[14]Lip GY,Blann Avon Willebrand factor:a marker of endothelial dysfunction in vascular disorders?.Cardiovasc Res,1997,34(2):255-265
[15]陈雅玲,董强.他汀类药物对血管内皮功能检测的研究进展.中国脑血管病杂志,2008,5(7):332-336
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[17]Felmeden DC,Blann AD,Spencer CG,et al.A comparison of flow-mediated dilatation and yon Willebrand factor as markers of endothelial cell function in health and in hypertension:relationship to cardiovascular risk and effects of treatment:a substudy of the Anglo-Scandinavian Cardiac Outcomes Trial.Blood Coagul Fibrinolysis,2003,14(5):425-431
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[1]Calabro P,Yeh ET.Multitasking of the 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor:beyond cardiovascular diseases.Curr Atheroscler Rep,2004,6:36-41
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[20] Lin SJ, Chen YH, Lin FY, et al. Pravastatin induces thrombomodulin expression in TNFalpha-treated human aortic endothelial cells by inhibiting Rac1 and Cdc42 translocation and activity. J Cell Biochem, 2007,101(3):642-653
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[23] Ray KK, Cannon CP. The Potential Relevance of the Multiple Lipid-Independent (Pleiotropic) Effects of Statins in the Management of Acute Coronary Syndromes. J Am Coll Cardiol, 2005,46:1425-1433
[24] Dietzen DJ, Page KL, Tetzloff TA. Lipid rafts are necessary for tonic inhibition of cellular tissue factor procoagulant activity. Blood, 2004, 103: 3038-3044
[25] Dietzen DJ, Page, KL, Tetzloff TA, et al. Inhibition of 3-Hydroxy-3-Methylglutaryl Coenzyme A (HMG CoA) Reductase Blunts Factor Vila/Tissue Factor and Prothrombinase Activities via Effects on Membrane Phosphatidylserine. Arterioscler Thromb Vasc Biol, 2007,27(3):690-696
[1]Calabro P,Yeh ET.Multitasking of the 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor:beyond cardiovascular diseases.Curr Atheroscler Rep,2004,6:36-41
[2]Jean D.Beneficial Cardiovascular Pleiotropic Effects of Statins.Circulation,2004,109:Ⅲ-39-Ⅲ-43
[3]史旭波,胡大一.他汀类药物的非降脂作用.中国民康医学杂志,2006,18(5):334-335
[4]Mo Al-Qaisi,Rajesh K Kharbanda,Tarun K Mittal,et al.Measurement of endothelial function and its clinical utility for cardiovascular risk.Vasc Health Risk Manag,2008,4(3):647- 652
[5]Todd J.Anderson.Prognostic Significance of Brachial Flow-Mediated Vasodilation Circulation,2007,115:2373-2375
[6]Karatzis EN,Ikonomidis I,Vamvakou GD,et al.Long-term prognostic role of flow-mediated dilatation of the brachial artery after acute coronary syndromes without ST elevation.Am J Card,2006,98:1424- 1428
[7]Matsushima,V,Takase,B,Uehata A,et al.Comparative predictive and diagnostic value of flow-mediated vasodilation in the brachial artery and intima media thickness of the carotid artery for assessment of coronary artery disease severity.Int J Cardiol,2007,117:165- 172
[8]Pretnar-Oblak J,Sebestjen M,Sabovic M.Statin treatment improves cerebral more than systemic endothelial dysfunction in patients with arterial hypertension.Am J Hypertens,2008,21(6):674-678
[9]Koh KK,Quon MJ,Han SH,et al.Simvastatin improves flow-mediated dilation but reduces adiponectin levels and insulin sensitivity in hypercholesterolemic patients.Diabetes Care,2008,31(4):776-782
[10]Leu HB,Wu CC,Wu TC,et al.Fluvastatin reduces oxidative stress,decreases serum monocyte chemotactic protein-1 level and improves endothelial function in patients with hypercholesterolemia.J Formos Med Assoc,2004,103(12):914-920
[11]Ferreira WP,Bertolami MC,Santos SN,et al.One-month therapy with simvastatin restores endothelial function in hypercholesterolemic children and adolescents。 Pediatr Cardiol,2007,28(1):8-13
[12]Vlachopoulos C,Aznaouridis K,Dagre A,et al.Protective effect of atorvastatin on acute systemic inflammation-induced endothelial dysfunction in hypercholesterolaemic subjects.Eur Heart J,2007 28(17):2102-2109
[13]Girma JP.Biology of von Willebrand factor.Nephrol Ther,2006,2(2):S143-148
[14]Lip GY,Blann Avon Willebrand factor:a marker of endothelial dysfunction in vascular disorders?.Cardiovasc Res,1997,34(2):255-265
[15]陈雅玲,董强.他汀类药物对血管内皮功能检测的研究进展.中国脑血管病杂志,2008,5(7):332-336
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