【作者】 赵宇红；

【导师】 许丹焰；

【作者基本信息】 中南大学 ， 心血管内科学， 2011， 硕士

【摘要】 目的：通过对脂必泰和阿托伐他汀10mg联用与单独使用阿托伐他汀20mg、阿托伐他汀40mg进行对比研究,观察各组的降脂疗效、对冠心病患者炎症因子促心肌素(CT-1)、高敏C反应蛋白(hs-CRP)的影响及不良反应,评价脂必泰和阿托伐他汀10mg联用对冠心病患者的临床降脂、抗炎疗效及其临床应用安全性。为脂必泰和阿托伐他汀联合应用提供临床参考依据,为冠心病的治疗提供新的思路和策略。方法：选取150例符合临床诊断标准的冠心病患者,所有患者均在基本药物治疗下进行随机分组,平均分为3组。1组予以脂必泰胶囊480mg,每日分两次口服+阿托伐他汀钙10mg,每晚睡前半小时服用1次,连用8周；2组予以阿托伐他汀钙20mg口服,每晚睡前半小时服用1次,连用8周；3组予以阿托伐他汀钙40mg口服,每晚睡前半小时服用1次,连用8周。基本药物治疗指：所有入组的冠心病患者依据病情给予下列药物：血管紧张素转换酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗剂(ARB)、钙离子拮抗剂(CCB)、氯吡格雷、拜阿司匹林、β受体阻滞剂、欣康片(单硝酸异山梨酯片)以及其它相应的降压、降糖等治疗。所有患者分别于治疗前、治疗后4周、8周清晨空腹抽取外周静脉血,分离血清检测CT-1 hs-CRP浓度。所有患者均于治疗前、治疗后4周、8周清晨空腹抽取外周静脉血,分离血清检测血脂谱：甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白A1(ApoA1)、载脂蛋白B100 (ApoB100)。同时检测肝功能指标：谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆红素(TBIL)、直接胆红素(DBIL)；肾功能指标：尿素氮(BUN)、肌酐(Cr)；肌酶谱：肌酸激酶(CK)、肌酸激酶同工酶MB(CK-MB)、肌钙蛋白(aTn-I)、肌红蛋白(MYO)。所有患者入院后行常规12导联心电图(ECG)检查。结果：1、与治疗前相比,三组患者经治疗4周、8周后,血清TC、LDL-C、ApoB100浓度均显著下降,均具有统计学差异(所有P<0.01)。其中脂必泰+阿托伐他汀10mg组与阿托伐他汀40mg组疗效近似,二者较阿托伐他汀20mg组略有优势,但组间比较无统计学差异(P>0.05)。2、与治疗前相比,三组患者经治疗4周、8周后TG均下降,脂必泰+阿托伐他汀10mg组与阿托伐他汀40mg组治疗4周、8周后TG明显下降(所有P<0.01),脂必泰+阿托伐他汀10mg组TG下降更明显；阿托伐他汀20mg组治疗4周后TG无明显下降(P>0.05),治疗8周后TG显著下降(P<0.01),治疗8周后三组间比较无统计学差异(P>0.05)。3、与治疗前相比,三组患者经治疗4周、8周后HDL-C.ApOA1水平有所升高,但无统计学差异(所有P>0.05),组间比较亦无差异(P>0.05)。4、与治疗前相比,三组患者治疗4周、8周后炎症因子CT-1、hs-CRP均显著下降(P<0.01),脂必泰+阿托伐他汀10mg组与阿托伐他汀40mg组较阿托伐他汀20mg组下降更为明显,但组问比较无统计学差异(P>0.05)。5、与治疗前相比,三组患者治疗4周、8周后肝功能、肾功能、肌病发生率、肌酶升高发生率、消化道不良反应发生率均无统计学差异(P>0.05),组间比较无统计学差异(P>0.05)。结论：脂必泰与阿托伐他汀10mg联用可以明显降低冠心病患者TG、TC、LDL-C、ApoB100水平,轻度升高HDL-C、ApoA1水平,并显著降低炎症因子CT-1、hs-CRP水平,疗效与阿托伐他汀40mg相仿,较阿托伐他汀20mg具有优势,而且副作用小,临床应用安全,可望成为今后降脂治疗的新趋势。更多还原

【Abstract】 Objective:By discuss zhibitai combined with atorvastatin 10mg and only use atorvastatin 20mg or atorvastatin 40mg, we well evaluate the clinical lipid-lowering, anti-inflammatory effect and clinical app-lication security of zhibitai combined with atorvastatin 10mg by comparing the lipid-lowering effects of observed in each group myo-cardial inflammatory factors of carditrophin-1 (CT-1),high sen-sitivity creactive protein (hs-CRP) and adverse effects in patients with coronary heart disease.The result will provide clinical reference applications and provide new ideas and strategies for zhibitai combined with atorvastatin in coronary heart diseaseMethods:150 patients with clinical diagnostic criteria for coronary heart disease patients, all patients were divided into 3 groups under medical treatment in the basic randomized. Group 1 to zhibitai 480 mg, orally twice daily+atorvastatin calcium 10mg, taken a half an hour before going to bed every night, once every 8 weeks, once every 8 weeks; 2 groups to atorvastatin calcium 20mg taken a half an hour before going to bed every night, once every 8 weeks, once every 8 weeks; 3 groups to atorvastatin calcium 40mg orally, taken a half an hour before going to bed every night, once every 8 weeks.Basic medical treatment means:all entry groups to give patients with coronary heart disease based on the following drugs:angioten-sin converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB), calcium channel blockers (CCB), Clopidogrel, Aspirin,βblockers, Zhixinkang tablets (isosorbide mononitrate tablets) and other appropriate blood pressure, glucose and other treat ment.All patients test the concentration of CT-1 and hs-CRP in the serum separating from venous blood in before treatment, after 4 weeks and after 8 weeks.All patients test the lipoprotein profile:triglyceride (TG), total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low-density lipoprotein choles-terol (LDL-C), apolipoprotein A1 (ApoA1) and apolipoprotein B100(ApoB100).Simultaneous test liver function:alanine aminotransferase (ALT), aspartate amino trans-ferase (AST), total bilirubin (TBIL), direct bilirubin (DBIL); renal function:urea ni-trogen (BUN), creatinine (Cr); muscle enzymes: creatine kinase (CK), creatine kinase isoenzyme MB (CK-MB), troponin (aTn-I), myoglobin (MYO) in the serum separating from venous blood in before treatment, after 4 weeks and after 8 weeks.All patients test 12-lead electrocardio-gram (ECG) examina-tion after hospitalization.Results:1、compared with before treatment, the levels of TC, LDL-C, ApoB100 in three groups were significantly decreased after 4 weeks and 8 weeks (all P<0.01). Zhibitai+atorvastatin 100mg group and atorvastatin 40mg group have similar efficacy, both groups had slight advantage than atorvastatin 20mg group,but no significant difference between the two groups (P> 0.05).2、compared with before treatment, the levels of TG in three groups of patients were decreased, zhibitai+ atorvastatin 10mg group and atorvastatin 40mg group decreased more significantly than atorvas-tatin 20mg group, atorvastatin 20mg group had no significant decrease after treatment 4 weeks (P> 0.05), after 8 weeks treatment decreased significantly (P<0.01), no significant difference between the three groups after treatmeat for 8 weeks. (P> 0.05)3、compared with before treatment, the levels of HDL-C and ApoA1 in three groups of patients were increased after 4 weeks and 8 weeks, but no significant differences (all P> 0.05), no difference between the three groups (P> 0.05).4、compared with before treatment, the levels of CT-1 and hs-CRP were significantly decreased in three groups of patients treated for after 4 weeks and 8 weeks (P<0.01), zhibitai+ atorvastatin 10mg group and atorvastatin 40mg group decreased more significantly than atorvastatin 20mg group, no significant difference between the three groups (P> 0.05).5、compared with before treatment, the levels of liver function, kidney function, the incidence of myopathy, muscle enzyme increased incidence and gastrointestinal adverse reactions in three groups of patients was no significant difference in the incidence rate after treated 4 weeks and 8 weeks (P> 0.05), no significant differen-ce between the three groups (P> 0.05).Conclusion:Zhibitai combined with atorvastatin lOmg in patients with coronary heart disease can be significantly reduced TG, TC, LDL-C, ApoB100 level, slightly elevated HDL-C, ApoA1 levels and significantly reduce the inflammatory cytokines CT-1, hs-CRP levels, efficacy and similar atorvastatin 40mg, atorvastatin 20mg compared with more advantages and fewer side effects, clinical application security, is expected to become the new trend for future lipid-lowering therapy.更多还原