强化脂必泰治疗对血脂异常的冠心病中、高危患者炎症因子的影响及其安全性评估
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摘要
目的:评价强化脂必泰治疗对血脂异常的冠心病中高危患者炎症因子的影响并评估其临床安全性。
     方法:选择我院2007年6月至2008年5月住院及门诊的冠心病中、高危患者240例,其中男性157例,女性83例,年龄在55-72岁;随机分为试验组120例(男79例,女41例)对照组120例(男78例,女42例)。试验组予以基本治疗十脂必泰胶囊480mg口服每日两次,对照组予基本治疗十阿托伐他汀10mg口服每日1次。(基本治疗:除降脂治疗以外,根据患者病情给予降压/降糖/其他治疗)。所有患者于治疗前及治疗后4周、8周分别检测血脂、心肌酶学、肝肾功能一次。所有患者于治疗前及治疗后8周分别检测hs-CRP、P-选择素、MMP-9、SICAM-1一次。
     结果:两组治疗4周、8周后与治疗前比较TC、LDL-C显著下降(p<0.05),HDL-C显著升高(p<0.05);脂必泰组治疗4周、8周后与治疗前比较TG显著下降(P<0.05),而阿托伐他汀组治疗4周与治疗前比较TG无显著下降(P>0.05),治疗8周后TG显著下降(P<0.05);两组治疗8周后hs-CRP、P-选择素、MMP-9、SICAM-1各炎症因子较治疗前均明显降低(p<0.01),两组间比较差异无显著性(p>0.05)。两组治疗前后肝肾功能、肌酶变化、肌病发生率,消化道反应发生率无统计学差异(p>0.05)。
     结论:强化脂必泰治疗除能有效调脂外,还能有效降低血脂异常的冠心病中、高危患者的炎症因子,且临床应用安全。
Objective: To evaluate the lipid lowing effects and the clinical safety of intensive therapy of Chinese medicine Zhibitai in patients with moderate and high risk of atherosclerosis.
     Methods: 240 patients who were 55-72 year-old with moderate and high risk of atherosclerosis in our hospital from June 2007 to May 2008 were recruited. There were 157 male and 83 female among them. All the patients were randomly divided in to test group which was 120 people (79 male, 41 female) or control group which was 120 people (78 male, 42 female). Test group was received basic treatment plus 480mg of Zhibitai orally twice a day, whereas the control group was received basic treatment plus 10mg atorvastatin orally once daily (basic treatment means that conventional drug treatment: anti-platelet drug、nitrates agents、antihypertensive drugs and hypoglycemic agents in addition to lipid-lowering drugs). Blood lipoproteins, myocardial enzyme、liver and renal function were measured before treatment and at the fourth and eighth weeks after therapy , whereas hs-CRP、P-selectin、MMP-9、SIC AM-1 were detected before treatment and eighth week after therapy in all patients.
     Results: TC、TG and LDL-C were significantly decreased but HDL was increased in both group individually after 4 and 8 weeks treatment(p<0.01). Inflammatory factors such as hs- CRP、P-selectin、MMP-9、SICAM-1 were decreased significantly. However there was no significant difference between the two groups. There were no difference in liver and kidney function, myocardial enzyme, incidence of muscle-ache and digestive system reaction.
     Conclusion: Besides the lipoprotein disorder, the inflammatory factors in patients with moderate and high risk of atherosclerosis could be regulated by intensive therapy of Zhibitai. Most importantly, it is safe to use Zhibitai in clinic.
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