氨氯地平單用及其與ACEI聯用治療成人原發性高血壓有效性與安全性的Meta分析_《中國循證醫學雜志》

作者：

 呂硯 ¹ , 鄒最 ² , 賈懷信 ³ , 鐘京 ¹ , 方偉武 ¹

1. 解放軍306醫院麻醉科（北京 100101）；2. 上海市長征醫院麻醉科（上海 200003）；3. 北京673醫院麻醉科（北京 100000）;

關鍵詞：

氨氯地平血管緊張素轉換酶抑制劑抗高血壓藥 Meta 分析

DOI：

10.7507/1672-2531.20100452

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目的　評價氨氯地平單用及其與ACEI 聯用治療成人原發性高血壓的有效性與安全性。
方法　電子檢索Cochrane 對照試驗注冊數據庫（2009 年第2 期）、PubMed、EMbase、CBM、CNKI（從建庫至2009 年8 月）。由兩名評價者按納入與排除標準和Cochrane 協作網推薦的簡單評價法選擇文獻、評價質量，而后對同質研究采用Stata10.0 軟件進行Meta 分析。
結果　共納入17 個RCT，包括3 291 例病人。Meta 分析結果顯示：與單用氨氯地平相比，氨氯地平與ACEI 聯用能進一步降低收縮壓［WMD=5.72，95%CI（4.10，7.33），P=0.016］和舒張壓［WMD=3.62，95%CI（4.85，2.39），P=0.000］，總不良反應率下降［RR 0.86，95%CI（0.75，0.99），P=0.034］，其差異有統計學意義。
結論　現有證據表明，氨氯地平與ACEI 聯用能進一步降低成人原發性高血壓患者血壓和不良反應發生率，其有效性和安全性均優于氨氯地平單用。而氨氯地平與ACEI 聯用能否降低遠期聯合心血管事件風險，且組織型ACEI 是否更有優勢，則尚需大樣本、高質量的隨機對照試驗來進一步研究。

引用本文： 呂硯,鄒最,賈懷信,鐘京,方偉武. 氨氯地平單用及其與ACEI聯用治療成人原發性高血壓有效性與安全性的Meta分析. 中國循證醫學雜志, 2010, 10(5): 578-584. doi: 10.7507/1672-2531.20100452 復制

1.	陳少萍, 秦永文, 鄭興. 聯合用藥——高血壓病人血壓控制達標的基本策略. 藥學服務與研究, 2006, 6(6): 401-405.
2.	Wu Y, Huxley R, Li L, et al. Prevalence, awareness, treatment, and control of hypertension in China: data from the China National Nutrition and Health Survey 2002. Circulation, 2008, 118(25): 2679-2686.
3.	Kostis JB, Lacy CR, Cosgrove NM, et al. Association of calcium channel blocker use with increased rate of acute myocardial infarction in patients with left ventricular dysfunction. Am Heart J, 1997, 133(5): 550-557.
4.	Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA, 2003, 289(19): 2560-2572.
5.	Chalmers J, MacMahon S, Mancia G, et al. 1999 World Health Organization-International Society of Hypertension Guidelines for the management of hypertension. Guidelines sub-committee. J Hypertens, 1999, 17(2): 151-183.
6.	Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
7.	DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials, 1986, 7(3): 177-188.
8.	Follmann D, Elliott P, Suh I, et al. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol, 1992, 45(7): 769-773.
9.	Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4): 1088-1101.
10.	Duval S, Tweedie R. Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics, 2000, 56(2): 455-463.
11.	Neutel JM, Smith DH, Weber MA. Effect of antihypertensive monotherapy and combination therapy on arterial distensibility and left ventricular mass. Am J Hypertens, 2004, 17(1): 37-42.
12.	Brown MJ, Dickerson JE. Alpha-blockade and calcium antagonism: an effective and well-tolerated combination for the treatment of resistant hypertension. J Hypertens, 1995, 13(6): 701-707.
13.	Cappuccio FP, Markandu ND, Singer DR, et al. Amlodipine and lisinopril in combination for the treatment of essential hypertension: efficacy and predictors of response. J Hypertens, 1993, 11(8): 839-847.
14.	Fogari R, Malamani GD, Zoppi A, et al. Effect of benazepril addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. J Hum Hypertens, 2003, 17(3): 207-212.
15.	Fogari R, Preti P, Zoppi A, et al. Effects of amlodipine fosinopril combination on microalbuminuria in hypertensive type 2 diabetic patients. Am J Hypertens, 2002, 15(12): 1042-1049.
16.	Fogari R, Preti P, Lazzari P, et al. Effect of benazepril amlodipine combination on fibrinolysis in hypertensive diabetic patients. Eur J Clin Pharmacol, 2003, 59(4): 271-275.
17.	Jamerson KA, Nwose O, Jean-Louis L, et al. Initial angiotensinconverting enzyme inhibitor/calcium channel blocker combination therapy achieves superior blood pressure control compared with calcium channel blocker monotherapy in patients with stage 2 hypertension. Am J Hypertens, 2004, 17(6): 495-501.
18.	Kuschnir E, Acuna E, Sevilla D, et al. Treatment of patients with essential hypertension: amlodipine 5 mg/benazepril 20 mg compared with amlodipine 5 mg, benazepril 20 mg, and placebo. Clin Ther, 1996, 18(6): 1213-1224.
19.	MacGregor MS, Deighan CJ, Rodger RS, et al. A prospective openlabel randomised trial of quinapril and/or amlodipine in progressive non-diabetic renal failure. Nephron, 2005, 101(3): c139-149.
20.	Messerli FH, Oparil S, Feng Z. Comparison of efficacy and side effects of combination therapy of angiotensin-converting enzyme inhibitor (benazepril) with calcium antagonist (either nifedipine or amlodipine) versus high-dose calcium antagonist monotherapy for systemic hypertension. Am J Cardiol, 2000, 86(11): 1182-1187.
21.	Miranda RD, Mion D, Rocha JC, et al. An 18-week, prospective, randomized, double-blind, multicenter study of amlodipine/ramipril combination versus amlodipine monotherapy in the treatment of hypertension: the assessment of combination therapy of amlodipine/ ramipril (ATAR) study. Clin Ther, 2008, 30(9): 1618-1628.
22.	Naidu MU, Usha PR, Rao TR, et al. Evaluation of amlodipine, lisinopril, and a combination in the treatment of essential hypertension. Postgrad Med J, 2000, 76(896): 350-353.
23.	Neutel JM, Smith DH, Weber MA, et al. Efficacy of combination therapy with amlodipine besylate/benazepril hydrochloride for lowering systolic blood pressure in stage 2 hypertension. Am J Geriatr Cardiol, 2006, 15(3): 142-150.
24.	Pool J, Kaihlanen P, Lewis G, et al. Once-daily treatment of patients with hypertension: a placebo-controlled study of amlodipine and benazepril vs amlodipine or benazepril alone. J Hum Hypertens, 2001, 15(7): 495-498.
25.	Chrysant SG, Sugimoto DH, Lefkowitz M, et al. The effects of high-dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy. Blood Pressure, 2007, 1: 10-17.
26.	Mohler ER, Herrington D, Ouyang P, et al. A randomized, doubleblind trial comparing the effects of amlodipine besylate/benazepril HCl vs amlodipine on endothelial function and blood pressure. J Clin Hypertens (Greenwich), 2006, 8(10): 692-698.
27.	Ueng KC, Lin LC, Voon WC, et al. An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension. Blood pressure, 2008, 1: 24-31.

1. 陳少萍, 秦永文, 鄭興. 聯合用藥——高血壓病人血壓控制達標的基本策略. 藥學服務與研究, 2006, 6(6): 401-405.
2. Wu Y, Huxley R, Li L, et al. Prevalence, awareness, treatment, and control of hypertension in China: data from the China National Nutrition and Health Survey 2002. Circulation, 2008, 118(25): 2679-2686.
3. Kostis JB, Lacy CR, Cosgrove NM, et al. Association of calcium channel blocker use with increased rate of acute myocardial infarction in patients with left ventricular dysfunction. Am Heart J, 1997, 133(5): 550-557.
4. Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA, 2003, 289(19): 2560-2572.
5. Chalmers J, MacMahon S, Mancia G, et al. 1999 World Health Organization-International Society of Hypertension Guidelines for the management of hypertension. Guidelines sub-committee. J Hypertens, 1999, 17(2): 151-183.
6. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
7. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials, 1986, 7(3): 177-188.
8. Follmann D, Elliott P, Suh I, et al. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol, 1992, 45(7): 769-773.
9. Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics, 1994, 50(4): 1088-1101.
10. Duval S, Tweedie R. Trim and fill: A simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis. Biometrics, 2000, 56(2): 455-463.
11. Neutel JM, Smith DH, Weber MA. Effect of antihypertensive monotherapy and combination therapy on arterial distensibility and left ventricular mass. Am J Hypertens, 2004, 17(1): 37-42.
12. Brown MJ, Dickerson JE. Alpha-blockade and calcium antagonism: an effective and well-tolerated combination for the treatment of resistant hypertension. J Hypertens, 1995, 13(6): 701-707.
13. Cappuccio FP, Markandu ND, Singer DR, et al. Amlodipine and lisinopril in combination for the treatment of essential hypertension: efficacy and predictors of response. J Hypertens, 1993, 11(8): 839-847.
14. Fogari R, Malamani GD, Zoppi A, et al. Effect of benazepril addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. J Hum Hypertens, 2003, 17(3): 207-212.
15. Fogari R, Preti P, Zoppi A, et al. Effects of amlodipine fosinopril combination on microalbuminuria in hypertensive type 2 diabetic patients. Am J Hypertens, 2002, 15(12): 1042-1049.
16. Fogari R, Preti P, Lazzari P, et al. Effect of benazepril amlodipine combination on fibrinolysis in hypertensive diabetic patients. Eur J Clin Pharmacol, 2003, 59(4): 271-275.
17. Jamerson KA, Nwose O, Jean-Louis L, et al. Initial angiotensinconverting enzyme inhibitor/calcium channel blocker combination therapy achieves superior blood pressure control compared with calcium channel blocker monotherapy in patients with stage 2 hypertension. Am J Hypertens, 2004, 17(6): 495-501.
18. Kuschnir E, Acuna E, Sevilla D, et al. Treatment of patients with essential hypertension: amlodipine 5 mg/benazepril 20 mg compared with amlodipine 5 mg, benazepril 20 mg, and placebo. Clin Ther, 1996, 18(6): 1213-1224.
19. MacGregor MS, Deighan CJ, Rodger RS, et al. A prospective openlabel randomised trial of quinapril and/or amlodipine in progressive non-diabetic renal failure. Nephron, 2005, 101(3): c139-149.
20. Messerli FH, Oparil S, Feng Z. Comparison of efficacy and side effects of combination therapy of angiotensin-converting enzyme inhibitor (benazepril) with calcium antagonist (either nifedipine or amlodipine) versus high-dose calcium antagonist monotherapy for systemic hypertension. Am J Cardiol, 2000, 86(11): 1182-1187.
21. Miranda RD, Mion D, Rocha JC, et al. An 18-week, prospective, randomized, double-blind, multicenter study of amlodipine/ramipril combination versus amlodipine monotherapy in the treatment of hypertension: the assessment of combination therapy of amlodipine/ ramipril (ATAR) study. Clin Ther, 2008, 30(9): 1618-1628.
22. Naidu MU, Usha PR, Rao TR, et al. Evaluation of amlodipine, lisinopril, and a combination in the treatment of essential hypertension. Postgrad Med J, 2000, 76(896): 350-353.
23. Neutel JM, Smith DH, Weber MA, et al. Efficacy of combination therapy with amlodipine besylate/benazepril hydrochloride for lowering systolic blood pressure in stage 2 hypertension. Am J Geriatr Cardiol, 2006, 15(3): 142-150.
24. Pool J, Kaihlanen P, Lewis G, et al. Once-daily treatment of patients with hypertension: a placebo-controlled study of amlodipine and benazepril vs amlodipine or benazepril alone. J Hum Hypertens, 2001, 15(7): 495-498.
25. Chrysant SG, Sugimoto DH, Lefkowitz M, et al. The effects of high-dose amlodipine/benazepril combination therapies on blood pressure reduction in patients not adequately controlled with amlodipine monotherapy. Blood Pressure, 2007, 1: 10-17.
26. Mohler ER, Herrington D, Ouyang P, et al. A randomized, doubleblind trial comparing the effects of amlodipine besylate/benazepril HCl vs amlodipine on endothelial function and blood pressure. J Clin Hypertens (Greenwich), 2006, 8(10): 692-698.
27. Ueng KC, Lin LC, Voon WC, et al. An eight-week, multicenter, randomized, double-blind study to evaluate the efficacy and tolerability of fixed-dose amlodipine/benazepril combination in comparison with amlodipine as first-line therapy in chinese patients with mild to moderate hypertension. Blood pressure, 2008, 1: 24-31.

《中國循證醫學雜志》

氨氯地平單用及其與ACEI聯用治療成人原發性高血壓有效性與安全性的Meta分析

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《中國循證醫學雜志》

氨氯地平單用及其與ACEI聯用治療成人原發性高血壓有效性與安全性的Meta分析

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