目的 探討國(guó)人經(jīng)皮冠狀動(dòng)脈介入治療(PCI)術(shù)后20 mg/d阿托伐他汀(立普妥)強(qiáng)化降脂的效果,以及對(duì)心臟事件的影響。
方法 采用雙盲1∶1分層隨機(jī)對(duì)照的試驗(yàn)設(shè)計(jì),納入2005年7月~2006年6月上海胸科醫(yī)院120例冠心病介入治療病人,隨機(jī)分為強(qiáng)化調(diào)脂組(A組,60例,阿托伐他汀20 mg/d)和普通調(diào)脂組(B組,60例,阿托伐他汀10 mg/d)。用藥時(shí)間自PCI術(shù)后當(dāng)日至術(shù)后3月,而后兩組均采用阿托伐他汀10 mg/d至術(shù)后1年。于術(shù)前、術(shù)后1月、3月、6月進(jìn)行血液生化檢查,隨訪心臟事件,觀察藥物不良反應(yīng)。
結(jié)果 該120例病人中,剔除5例,脫落4例,115例病人進(jìn)入意向治療(ITT)分析,符合方案(PP)分析111例,兩組基線特征具有可比性(P gt;0.05);兩組血脂水平比較,TG下降幅度和HDL-C升高幅度差異無(wú)統(tǒng)計(jì)學(xué)意義(P gt;0.05),而LDL-C和TC下降幅度差異有統(tǒng)計(jì)學(xué)意義(P lt;0.05),這種差異從隨訪到術(shù)后3個(gè)月時(shí)開(kāi)始出現(xiàn);PP分析中,術(shù)后3個(gè)月時(shí)兩組LDL-C的達(dá)標(biāo)率分別為87.03%和70.17%,其差異有統(tǒng)計(jì)學(xué)意義(P=0.031),ITT分析與PP分析結(jié)果一致(P=0.044);兩組比較,術(shù)后1個(gè)月及3個(gè)月時(shí)CRP變化差異有統(tǒng)計(jì)學(xué)意義(P lt;0.05),術(shù)后6個(gè)月時(shí)CRP變化趨于穩(wěn)定(P gt;0.05);A組隨訪6.5±3.0個(gè)月,復(fù)發(fā)心絞痛1例,血運(yùn)重建1例;B組隨訪7.2±3.6個(gè)月,復(fù)發(fā)心絞痛3例,致死性/非致死性心梗1例,血運(yùn)重建2例,心源性猝死1例,Kaplan-Meier事件曲線從術(shù)后4個(gè)月時(shí)開(kāi)始分離,并且差異有統(tǒng)計(jì)學(xué)意義(P=0.048);兩組藥物不良反應(yīng)輕微,均未有橫紋肌溶解現(xiàn)象發(fā)生。
結(jié)論 PCI術(shù)后應(yīng)用阿托伐他汀20 mg/d強(qiáng)化降脂安全有效。
引用本文: 王承,潘欣,陳暉,袁方,徐蕾,方唯一. 阿托伐他汀強(qiáng)化降脂治療對(duì)PCI術(shù)后心臟事件的影響. 中國(guó)循證醫(yī)學(xué)雜志, 2007, 07(4): 244-250. doi: 復(fù)制
版權(quán)信息: ?四川大學(xué)華西醫(yī)院華西期刊社《中國(guó)循證醫(yī)學(xué)雜志》版權(quán)所有,未經(jīng)授權(quán)不得轉(zhuǎn)載、改編
1. | The blood lipids disorders prevention and cure special topic group of Chinese journal cardiology editorial committee. Prevention and cure recommendation to blood lipids disorders. Chin J Cardiol, 1997, 25(3): 169-175. |
2. | The Current Status in Clinical Control of Hypercholesterolemia in China Collaborative Research Group. A multi-center study of current status on clinical control of hypercholesterolemia in China. Chin J Cardiol, 2002, 30(2): 109-114. |
3. | Status of Treatment of Blood Lipids Study Group. A survey of treatment status of blood lipids disorders in China. Chin J Cardiol, 2001, 29(1): 15-17. |
4. | Grundy SM, Cleeman J I, Stone NJ, et al. The Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel Ⅲ Guidelines. Circulation, 2004, 44(33): 720-732. |
5. | Takemoto M, Liao JK. Pleiotropic effects of 3-hydroxy-3-met hylglutaryl coenzyme a reductase inhibitors. Arterioscler Thromb Vasc Biol, 2001, 21(11): 1712-1719. |
6. | 中華心血管病雜志編輯委員會(huì)血脂異常防治對(duì)策專題組. 血脂異常防治建議. 中華心血管病雜志, 1997, 25(3): 169~175. |
7. | ACC/AHA Task Force. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures. J Am Coll Cardiol, 1988, 12(2): 529-545. |
8. | Cannon CP, Braunwald E, Mccabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med, 2004, 350(15): 1495-1504. |
9. | Larosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in ptients with stable coronary disease. N Engl J Med, 2005, 352(14): 1425-1435. |
10. | Pedersen TR, Faergeman O, Kastelein JJP, et al. High-Dose Atorvastatin vs Usual-Dose Simvastatin for Secondary Prevention After Myocardial Infarction. JAMA, 2005, 294(19): 2437-2445. |
11. | Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary at artherosclerosis: a randomized controlled trial. JAMA, 2004, 291(9): 1071-1080. |
12. | Jones PH, McKenney JM, Karalis DG, et al. Comparison of the efficacy and safety of atorvastatin initiated at different starting doses in patients with dyslipidenia. Am Heart J, 2005, 149(1): e1. |
13. | 全國(guó)高膽固醇血癥控制狀況多中心研究協(xié)作組. 高膽固醇血癥臨床控制狀況多中心協(xié)作研究——達(dá)標(biāo)率及影響因素. 中華心血管病雜志, 2002, 30(2): 109~114. |
14. | Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ, 2003, 326(7404): 1423. |
15. | Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation, 2003, 107(3): 363-369. |
16. | Almagor M, Keren A, Banai S. Increased C-reactive protein level after coronary stent implantation in patients with stable coronary artery disease. Am Heart J, 2003, 145(2): 248-253. |
17. | 血脂治療現(xiàn)狀調(diào)查協(xié)作組. 我國(guó)血脂異常治療現(xiàn)狀的調(diào)查. 中華心血管病雜志, 2001, 29(1): 15~17. |
18. | Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol, 2006, 97(8A): 52C-60C. |
19. | Ucar M, Mjorndal T, Dahlqvist R. HMG-CoA reductase inhibitors and myotoxicity. Drug Saf, 2000, 22(6): 441-457. |
- 1. The blood lipids disorders prevention and cure special topic group of Chinese journal cardiology editorial committee. Prevention and cure recommendation to blood lipids disorders. Chin J Cardiol, 1997, 25(3): 169-175.
- 2. The Current Status in Clinical Control of Hypercholesterolemia in China Collaborative Research Group. A multi-center study of current status on clinical control of hypercholesterolemia in China. Chin J Cardiol, 2002, 30(2): 109-114.
- 3. Status of Treatment of Blood Lipids Study Group. A survey of treatment status of blood lipids disorders in China. Chin J Cardiol, 2001, 29(1): 15-17.
- 4. Grundy SM, Cleeman J I, Stone NJ, et al. The Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel Ⅲ Guidelines. Circulation, 2004, 44(33): 720-732.
- 5. Takemoto M, Liao JK. Pleiotropic effects of 3-hydroxy-3-met hylglutaryl coenzyme a reductase inhibitors. Arterioscler Thromb Vasc Biol, 2001, 21(11): 1712-1719.
- 6. 中華心血管病雜志編輯委員會(huì)血脂異常防治對(duì)策專題組. 血脂異常防治建議. 中華心血管病雜志, 1997, 25(3): 169~175.
- 7. ACC/AHA Task Force. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures. J Am Coll Cardiol, 1988, 12(2): 529-545.
- 8. Cannon CP, Braunwald E, Mccabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med, 2004, 350(15): 1495-1504.
- 9. Larosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in ptients with stable coronary disease. N Engl J Med, 2005, 352(14): 1425-1435.
- 10. Pedersen TR, Faergeman O, Kastelein JJP, et al. High-Dose Atorvastatin vs Usual-Dose Simvastatin for Secondary Prevention After Myocardial Infarction. JAMA, 2005, 294(19): 2437-2445.
- 11. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary at artherosclerosis: a randomized controlled trial. JAMA, 2004, 291(9): 1071-1080.
- 12. Jones PH, McKenney JM, Karalis DG, et al. Comparison of the efficacy and safety of atorvastatin initiated at different starting doses in patients with dyslipidenia. Am Heart J, 2005, 149(1): e1.
- 13. 全國(guó)高膽固醇血癥控制狀況多中心研究協(xié)作組. 高膽固醇血癥臨床控制狀況多中心協(xié)作研究——達(dá)標(biāo)率及影響因素. 中華心血管病雜志, 2002, 30(2): 109~114.
- 14. Law MR, Wald NJ, Rudnicka AR. Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ, 2003, 326(7404): 1423.
- 15. Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation, 2003, 107(3): 363-369.
- 16. Almagor M, Keren A, Banai S. Increased C-reactive protein level after coronary stent implantation in patients with stable coronary artery disease. Am Heart J, 2003, 145(2): 248-253.
- 17. 血脂治療現(xiàn)狀調(diào)查協(xié)作組. 我國(guó)血脂異常治療現(xiàn)狀的調(diào)查. 中華心血管病雜志, 2001, 29(1): 15~17.
- 18. Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol, 2006, 97(8A): 52C-60C.
- 19. Ucar M, Mjorndal T, Dahlqvist R. HMG-CoA reductase inhibitors and myotoxicity. Drug Saf, 2000, 22(6): 441-457.