他汀联合依折麦布与双倍剂量他汀对冠心病患者MACE影响的Meta分析
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摘要
目的系统评价他汀联合依折麦布与双倍剂量他汀对冠心病患者主要不良心血管事件(MACE)的影响,为临床治疗提供参考。方法计算机检索The Cochrane Library、PubMed、Embase、CNKI、CSTJ、CBMdisc以及万方医学网,收集他汀联合依折麦布(联合组)对比双倍剂量他汀(他汀组)治疗冠心病患者的随机对照研究,提取相关资料并按照修改后的Jadad评分量表评价纳入研究质量,采用Rev Man 5.3软件进行Meta分析。结果共纳入29篇30项随机对照研究,合计4 757例患者。Meta分析结果显示,与他汀组比较,联合组MACE(P=0.03)、再发心绞痛(P<0.001)和再发心肌梗死(P<0.001)明显降低;而两组心源性死亡、血运重建、心力衰竭及卒中发生率差异无显著性。与他汀组比较,联合组转氨酶升高(P<0.001)、肌酸激酶升高(P=0.02)和肌损伤发生率(P<0.001)等显著降低。根据他汀种类和剂量进行亚组分析,结果显示,10 mg依折麦布+20 mg阿托伐他汀组降低MACE(P=0.02)、心肌梗死发生率(P=0.003)较阿托伐他汀40 mg组更具优势。随访时间长短对研究结果未见影响。结论对于冠心病患者,联合组治疗较他汀组在心绞痛、心肌梗死方面获益明显,心源性死亡和卒中方面差异无显著性,且不良反应发生率显著减少。
Aim To evaluate the effects of ezetimibe co-administered with statins vs statins dose-doubling on major adverse cardiovascular events in patients with coronary heart disease systematically,in order to provide evidence-based reference for clinical use.Methods The pertinent randomized controlled trials(RCTs) about ezetimibe co-administered with statins trail group and statins dose-doubling control group in the treatment of coronary heart disease were retrieved from The Cochrane Library,PubMed,Embase,CNKI,CSTJ,CBMdisc and Wan fang Database.The quality of included studies were evaluated according to modified Jadad quality scale after extracting data.Meta-analysis was performed by using Rev Man 5.3 statistical software.Results A total of 30 RCTs were included,involving 4 757 patients.The results of Meta-analysis showed that compared with double-dose statins,ezetimibe-plus-statins markedly decrease major adverse cardiovascular events(P=0.03),angina(P<0.001) and myocardial infarction(P<0.001);the incidence of cardiac death,revascularization,heart failure and stroke had no significant difference in two groups;ezetimibe-plus-statins significantly decrease adverse reactions,such as transaminase elevation(P<0.001),creatine kinase elevation(P=0.02),and muscle pain,muscle weakness and other muscle injuries(P<0.001).Meta-analysis in subgroup was studied according to the kinds and dosage of statins and follow-up time,compared with atorvastatin 40 mg,ezetimibe 10 mg plus atorvastatin 20 mg showed more advantages in reducing the incidence of major adverse cardiovascular events and myocardial infarction than other subgroups.However,no effect was found on the results between a long follow-up time(≥6 months) with a short follow-up time(≤3 months).Conclusions For patients with coronary heart disease,statins combined with ezetimibe has a significant benefit in myocardial infarction and angina compared with double dose statins,but the benefit of cardiac death and stroke were not found.The incidence of adverse reactions is significantly reduced.
Aim To evaluate the effects of ezetimibe co-administered with statins vs statins dose-doubling on major adverse cardiovascular events in patients with coronary heart disease systematically,in order to provide evidence-based reference for clinical use.Methods The pertinent randomized controlled trials(RCTs) about ezetimibe co-administered with statins trail group and statins dose-doubling control group in the treatment of coronary heart disease were retrieved from The Cochrane Library,PubMed,Embase,CNKI,CSTJ,CBMdisc and Wan fang Database.The quality of included studies were evaluated according to modified Jadad quality scale after extracting data.Meta-analysis was performed by using Rev Man 5.3 statistical software.Results A total of 30 RCTs were included,involving 4 757 patients.The results of Meta-analysis showed that compared with double-dose statins,ezetimibe-plus-statins markedly decrease major adverse cardiovascular events(P=0.03),angina(P<0.001) and myocardial infarction(P<0.001);the incidence of cardiac death,revascularization,heart failure and stroke had no significant difference in two groups;ezetimibe-plus-statins significantly decrease adverse reactions,such as transaminase elevation(P<0.001),creatine kinase elevation(P=0.02),and muscle pain,muscle weakness and other muscle injuries(P<0.001).Meta-analysis in subgroup was studied according to the kinds and dosage of statins and follow-up time,compared with atorvastatin 40 mg,ezetimibe 10 mg plus atorvastatin 20 mg showed more advantages in reducing the incidence of major adverse cardiovascular events and myocardial infarction than other subgroups.However,no effect was found on the results between a long follow-up time(≥6 months) with a short follow-up time(≤3 months).Conclusions For patients with coronary heart disease,statins combined with ezetimibe has a significant benefit in myocardial infarction and angina compared with double dose statins,but the benefit of cardiac death and stroke were not found.The incidence of adverse reactions is significantly reduced.
引文
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[4]Hunt D,Young P,Simes J,et al.Benefits of pravastatin on cardiovascular events and mortality in older patients with coronary heart disease are equal to or exceed those seen in younger patients:results from the LIPID trial[J].Ann Intem Med,2001,134(10):931-940.
[5]Wenger NK,Lewis SJ,Herrington DM,et al.Outcomes of using high or low dose atorvastatin in patients 65 years of age or older with stable coronary heart disease[J].Ann Intem Med,2007,147(1):1-9.
[6]Lloyd SM,Stott DJ,De Craen AJ,et al.Long-term effects of statin treatment in elderly people:extended follow-up of the PRO spective study of pravastatin in the eldedy at risk(PROSPER)[J].PLos One,2013,8(9):e72642.
[7]Teng M,Lin L,Zhao YJ,et al.Statins for primary prevention of cardiovascular disease in elderly patients:systematic review and meta-analysis[J].Drugs Aging,2015,32(8):649-661.
[8]Savarese G,Gotto AM Jr,Paolillo S,et al.Benefits of statins in elderly subjects without established cardiovascular disease:a metaanalysis[J].J Am Coll Cardiol,2013,62(22):2090-2099.
[9]Pauriah M,Elder DH,Ogston S,et al.High-potency statin and ezetimibe use and mortality in survivors of an acute myocardial infarction:a population-based study[J].Heart,2014,100(11):867-872.
[10]Zhao SP,Yu BL,Peng DQ,et al.The effect of moderate-dose versus double-dose statins on patients with acute coronary syndrome in China:results of the CHILLAS trial[J].Atherosclerosis,2014,233(2):707-712.
[11]Pandey AS,Bissonnette S,Boukas S,et al.Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia:the EZE(STAT)2 trial[J].Arch Med Sci,2011,7(5):767-775.
[12]Okada K,Kimura K,Iwahashi N,et al.Long-term effect of ezetimibe-plus-statin vs double-dose statin on low-density lipoprotein cholesterol lowering in coronary artery disease patients pre-treated with a statin focus on cholesterol absorption and synthesis[J].Circulation,2011,124(s21):A12204.
[13]张宁,李芳芳,唐其柱,等.低剂量他汀联合依折麦布与高剂量他汀对老年高血脂患者降脂效果meta分析[J].医学研究杂志,2014,43(12):70-74.
[14]El-Tamalawy MM,Ibrahim OM,Hassan TM,et al.Effect of combination therapy of ezetimibe and atorvastatin on remnant lipoprotein versus double atorvastatin dose in Egyptian diabetic patients[J].J Clin Pharmacol,2018,58(1):34-41.
[15]Lin Wu FL,Wang J,Ho W,et al.Effectiveness of a combination of ezetimibe and statins in patients with acute coronary syndrome and multiple comorbidities:a 6-year population-based cohort study[J].Int J Cardiol,2017,233:43-51.
[16]Lee YH,Hong NK,Kim G,et al.Impact of adding ezetimibe to statin therapy on cardiovascular events between diabetes and nondiabetes:a propensity score matched study and meta-analysis[J].Diabetes,2016,65(S1):109.
[17]Hong N,Lee YH,Tsujita K,et al.Comparison of the effects of ezetimibe-statin combination therapy on major adverse cardiovascular events in patients with and without diabetes:a meta-analysis[J].Endocrinol Metab(Seoul),2018,33(2):219-227.
[18]刘志,李静,高敬,等.老年急性冠状动脉综合征患者阿托伐他汀联合依折麦布对比双倍剂量阿托伐他汀疗效研究[J].中华老年心脑血管病杂志,2017,19(1):5-8.
[19]高瑞迁.阿托伐他汀联合依折麦布治疗急性冠状动脉综合征患者的临床疗效[J].中国药物经济学,2017,12(4):75-77.
[20]温涛,贾永平,张巧玲,等.阿托伐他汀联用依折麦布对冠心病的治疗效果评价[J].中西医结合心脑血管病杂志,2013,11(11):1317-1318.
[21]李飞.依折麦布联合小剂量阿托伐他汀钙对急性冠状动脉综合征患者糖代谢水平的影响[D].延安:延安大学,2015:1-32.
[22]Liu Z,Hao H,Yin CL,et al.Therapeutic effects of atorvastatin and ezetimibe compared with double-dose atorvastatin in very elderly patients with acute coronary syndrome[J].Oncotarget,2017,8(25):41582-41589.
[23]刘富群.依折麦布联合阿托伐他汀治疗老年不稳定型心绞痛疗效观察[J].中国现代药物应用,2013,7(22):82-84.
[24]林波.依折麦布联合阿托伐他汀治疗高脂血症疗效观察[J].中外健康文摘,2011,8(36):72-73.
[25]郑士玉.探讨阿托伐他汀联用依折麦布对冠心病的治疗效果[J].中国中药杂志,2016,41(3):1511-1512.
[26]杨栋,苏慧.依折麦布联合阿托伐他汀治疗老年冠心病患者的降脂疗效[J].心脏杂志,2013,25(5):566-568.
[27]刘青.阿托伐他汀联合依折麦布对冠心病患者降脂疗效观察[D].延安:延安大学,2016:1-32.
[28]李朝晖,田峰,刘新民.依折麦布联合阿托伐他汀对LDLC未达标急性冠状动脉综合征患者易损斑块的影响[J].中国急救医学,2017,37(11):1024-1028.
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