心血管復方制劑對冠心病相關危險因素干預效果與安全性的系統評價_《中國循證醫學雜志》

作者：

邢冬梅 ¹ ,  張俊華 ¹ , 李玲 ² , 朱明軍 ³ , 商洪才 ¹

1. 天津中醫藥大學循證醫學中心（天津 300193）；2. 天津中醫藥大學第一附屬醫院（天津 300193）；3. 河南中醫學院第一附屬醫院心臟中心（鄭州 450000）;

關鍵詞：

復方制劑冠心病相關危險因素系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20130077

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目的　系統評價心血管復方制劑（Polypill）對冠心病相關危險因素的干預效果和安全性。
方法　計算機檢索PubMed、CENTRAL、ICTRP、CBM、CNKI、WanFang Data和VIP，查找有關心血管Polypill對冠心病相關危險因素的干預效果與安全性的隨機對照試驗，檢索時限均為從建庫至2012年9月。由2位研究者根據納入和排除標準獨立篩選文獻、提取資料和評價質量，然后進行分析。
結果　最終納入5個隨機對照試驗，均來自國外。描述性分析結果顯示：① 在血壓方面，Polypill在降低收縮壓和舒張壓方面明顯優于安慰劑，其差異有統計學意義，但Polypill與單用降壓藥比較無明顯差異。② 在血脂方面，Polypill在降低TC、TG和LDL-C水平方面明顯優于安慰劑，其差異有統計學意義，但Polypill與標準藥物治療無明顯差異。③ 在血糖方面，Polypill在降低血糖方面明顯優于安慰劑，其差異有統計學意義。④ 在不良反應方面，納入研究中報告Polypill的不良事件有干咳、出血傾向或胃炎、肝腎功能異常等。⑤ 在藥物依從性方面，Polypill組與標準治療或安慰劑組比較無明顯差異。
結論　Polypill對高血壓、血脂等冠心病相關因素有干預作用。受納入研究的數量限制，上述結論尚待開展更多大規模、高質量的研究來進一步驗證。心血管Polypill對冠心病一級預防作用的證據尚不充分，尚不推薦臨床應用。

引用本文： 邢冬梅,張俊華,李玲,朱明軍,商洪才. 心血管復方制劑對冠心病相關危險因素干預效果與安全性的系統評價. 中國循證醫學雜志, 2013, 13(4): 446-451. doi: 10.7507/1672-2531.20130077 復制

1.	World Health Organization. The global burden of disease: 2004 update. Geneva: World Health Organization. 2008.
2.	Murray CJL, Lauer JA, Hutubessy RCW, et al. Effectiveness and costs of interventions to lower systolic blood pressure and cholesterol: a global and regional analysis on reduction of cardiovascular-disease risk. Lancet, 2003, 361(9359): 717-725.
3.	Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ, 2003, 326(7404): 1419-1424.
4.	Yusuf S. Two decades of progress in preventing vascular disease. Lancet, 2002, 360(9326): 2-3.
5.	New Zealand Guidelines Group. Evidence-based best practice guideline. The assessment and management of cardiovascular risk. 2003.
6.	Heeley EL, Peiris DP, Patel AA, et al. Cardiovascular risk perception and evidence-practice gaps in Australian general practice (the Aus HEART study). Med J, 2010, 192(5): 254-259.
7.	Burkhart PV, Sabaté E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh, 2003, 35(3): 207.
8.	Wald NJ, Law MR. Formulation for the Prevention of Cardiovascular Disease. UK Patents GB008791 and GB0100548. 2000.
9.	Frishman WH, Zuckerman AL. Amlodipine ? atorvastatin: the first cross risk factor for polypill for the prevention and treatment of cardiovascular disease. Expert Rev Cardiovasc Ther, 2004, 2(5): 675-681.
10.	Clinical Trials Research Unit. The University of Auckland (online 2008) PILL Pilot: Programme to Improve Life and Longevity [http://www.ctru.auckland.ac.nz/content/view/37/35/]. (Last accessed 5th February 2009).
11.	Xavier D, Pais P, Sigamani A, et al. The need to test the theories behind the Polypill: rationale behind the Indian Poly-cap Study. Nat Clin Pract Cardiovasc Med, 2009, 6(2): 96-97.
12.	Higgins JTP, Green S. Cochrane handbook for systematic reviews of interventions. Wiley Online Library, 2008.
13.	The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomized trial. Lancet, 2009, 373(9672): 134-151.
14.	Malekzadeh F, Marshall T, Pourshams A, et al. A pilot double-blind randomized placebo-controlled trial of the effects of fixed-dose combination therapy (“polypill”) on cardiovascular risk factors. Int J Clin Pract, 2010, 64(9): 1220-1227.
15.	PILL Collaborative Group. An international randomized placebo-controlled trial of a four-component combination pill (‘‘Polypill’’) in people with raised cardiovascular risk. PloS One, 2011, 6(5): e19857.
16.	Soliman ES, Mendis S, Dissanayake WP, et al. A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization. Trials, 2011,12: 3.
17.	Wald DS, Morris JK, Wald NJ. Randomized polypill crossover trial in people aged 50 and over. PLoS One, 2012, 7(7): e41297.
18.	Strong K, Mathers C, Leeder S, et al. Preventing chronic diseases: how many lives can we save? Lancet, 2005, 366(9496): 1578-1582.
19.	Lim SS, Gaziano TA, Gakidou E, et al. Prevention of cardiovascular disease in high-risk individuals in low-income and middle-income countries: health effects and costs. Lancet, 2007, 370(9604): 2054-2062.
20.	Zimmerli LU, Schiffer E, Zürbig P, et al. Urinary proteomics biomarkers in coronary artery disease. Mol Cell Proteomics, 2008, 7(2): 290-298.
21.	Sanz G, Fuster V. Polypill and global cardiovascular health strategies. Semin Thorac Cardiovasc Surg, 2011, 23(1): 24-29.
22.	Wise J. Polypill holds promise for people with chronic disease. Bull World Health Organ, 2005, 83(12): 885-887.

1. World Health Organization. The global burden of disease: 2004 update. Geneva: World Health Organization. 2008.
2. Murray CJL, Lauer JA, Hutubessy RCW, et al. Effectiveness and costs of interventions to lower systolic blood pressure and cholesterol: a global and regional analysis on reduction of cardiovascular-disease risk. Lancet, 2003, 361(9359): 717-725.
3. Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ, 2003, 326(7404): 1419-1424.
4. Yusuf S. Two decades of progress in preventing vascular disease. Lancet, 2002, 360(9326): 2-3.
5. New Zealand Guidelines Group. Evidence-based best practice guideline. The assessment and management of cardiovascular risk. 2003.
6. Heeley EL, Peiris DP, Patel AA, et al. Cardiovascular risk perception and evidence-practice gaps in Australian general practice (the Aus HEART study). Med J, 2010, 192(5): 254-259.
7. Burkhart PV, Sabaté E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh, 2003, 35(3): 207.
8. Wald NJ, Law MR. Formulation for the Prevention of Cardiovascular Disease. UK Patents GB008791 and GB0100548. 2000.
9. Frishman WH, Zuckerman AL. Amlodipine ? atorvastatin: the first cross risk factor for polypill for the prevention and treatment of cardiovascular disease. Expert Rev Cardiovasc Ther, 2004, 2(5): 675-681.
10. Clinical Trials Research Unit. The University of Auckland (online 2008) PILL Pilot: Programme to Improve Life and Longevity [http://www.ctru.auckland.ac.nz/content/view/37/35/]. (Last accessed 5th February 2009).
11. Xavier D, Pais P, Sigamani A, et al. The need to test the theories behind the Polypill: rationale behind the Indian Poly-cap Study. Nat Clin Pract Cardiovasc Med, 2009, 6(2): 96-97.
12. Higgins JTP, Green S. Cochrane handbook for systematic reviews of interventions. Wiley Online Library, 2008.
13. The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomized trial. Lancet, 2009, 373(9672): 134-151.
14. Malekzadeh F, Marshall T, Pourshams A, et al. A pilot double-blind randomized placebo-controlled trial of the effects of fixed-dose combination therapy (“polypill”) on cardiovascular risk factors. Int J Clin Pract, 2010, 64(9): 1220-1227.
15. PILL Collaborative Group. An international randomized placebo-controlled trial of a four-component combination pill (‘‘Polypill’’) in people with raised cardiovascular risk. PloS One, 2011, 6(5): e19857.
16. Soliman ES, Mendis S, Dissanayake WP, et al. A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization. Trials, 2011,12: 3.
17. Wald DS, Morris JK, Wald NJ. Randomized polypill crossover trial in people aged 50 and over. PLoS One, 2012, 7(7): e41297.
18. Strong K, Mathers C, Leeder S, et al. Preventing chronic diseases: how many lives can we save? Lancet, 2005, 366(9496): 1578-1582.
19. Lim SS, Gaziano TA, Gakidou E, et al. Prevention of cardiovascular disease in high-risk individuals in low-income and middle-income countries: health effects and costs. Lancet, 2007, 370(9604): 2054-2062.
20. Zimmerli LU, Schiffer E, Zürbig P, et al. Urinary proteomics biomarkers in coronary artery disease. Mol Cell Proteomics, 2008, 7(2): 290-298.
21. Sanz G, Fuster V. Polypill and global cardiovascular health strategies. Semin Thorac Cardiovasc Surg, 2011, 23(1): 24-29.
22. Wise J. Polypill holds promise for people with chronic disease. Bull World Health Organ, 2005, 83(12): 885-887.

《中國循證醫學雜志》

心血管復方制劑對冠心病相關危險因素干預效果與安全性的系統評價

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《中國循證醫學雜志》

心血管復方制劑對冠心病相關危險因素干預效果與安全性的系統評價

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