Polypill对心血管疾病预防效果和安全性的Meta分析
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摘要
目的系统评价Polypill对心血管疾病(CVD)的预防效果和安全性。方法检索自建库至2017年5月以来相关文献,从Cochrane Library、PubMed、Web of Science、中国知网、万方、维普以及中国生物医学数据库中查找临床上有关Polypill在CVD预防效果和安全性方面的随机对照试验,采用RevMan5.3软件分别对结局指标进行Meta分析。结果最终纳入15篇外文文献,显示:整体Meta分析中Polypill组的血压、血脂下降水平显著大于对照组[收缩压、舒张压和血清总胆固醇(TC)(P<0.000 1)和低密度脂蛋白胆固醇(LDL-C)(P=0.000 3)],依从性和全因死亡率与对照组差异无统计学意义,而安全性Polypill组不良反应发生率略高于对照组,差异有统计学意义(P=0.000 6)。分组分析中与安慰剂组相比,Polypill组可显著降低SBP(P=0.002)、DBP(P=0.01)、TC(P<0.000 01)和LDL-C(P<0.000 1)且依从性和安全性差异有统计学意义;与标准治疗组比较,Polypill组降低SBP、DBP与之相当,但能显著降低TC水平(P=0.04),依从性方面差异无统计学意义(P=0.85);与正常护理组比较,Polypill组在降低DBP和不良反应发生率方面有显著差异(P=0.04),而在SBP、TC、LDL-C、依从性和全因死亡率方面差异无统计学意义;与其他组对比,Polypill组中SBP、TC下降幅度具有统计学意义。结论 Polypill在心血管疾病预防方面具有较好的效果,但Polypill组发生不良反应的情况多于对照组且研究存在异质性,故今后需开展更多的临床试验加以证明。
AIM To systematically evaluate the efficacy and safety of polypill on cardiovascular disease(CVD) prevention. METHODS The relevant literature had been retrieved and collected from the website of the Cochrane Library,PubMed,Web of Science,CNKI,Wanfang database,VIP database and Chinese Biomedical database to search randomized controlled trials on the efficacy and safety of polypill in the prevention of CVD since the establishment of databases to May 2017. RESULTS Fifteen foreign references were included.In the overall meta-analysis,the reduction levels of blood pressure and lipid in the polypill group were significantly greater than those in the control group [SBP,DBP,TC(P<0.000 1), LDL-C(P=0.000 3)],adherence and all-cause mortality were not significantly different,but the incidence of adverse reactions in the polypill group was slightly higher than that in the control group(P=0.000 6). In the subgroup analysis,polypill significantly reduced SBP(P=0.002),DBP(P=0.01),TC(P<0.000 01) and LDL-C(P<0.000 1),and there were significant differences between adherence and safety.The SBP and DBP of polypill group were equivalent to those of standard treatment group,but the level of TC was significantly lower than that of standard treatment group(P=0.04). There was no significant difference in adherence(P=0.85).Compared with the usual care group,the polypill group had significant difference in reducing the DBP and the incidence of adverse reactions(P=0.04),but there was no significant difference in SBP,TC,LDL-C,adherence and all-cause mortality. Compared with other groups,the reduction of SBP and TC in polypill group had significant difference. CONCLUSION Polypill has a good effect in the prevention of CVD.However,the adverse drug reactions in the polypill group are more than those in the control group and there is heterogeneity between the study.Therefore,more clinical trials are needed to prove this in the future.
AIM To systematically evaluate the efficacy and safety of polypill on cardiovascular disease(CVD) prevention. METHODS The relevant literature had been retrieved and collected from the website of the Cochrane Library,PubMed,Web of Science,CNKI,Wanfang database,VIP database and Chinese Biomedical database to search randomized controlled trials on the efficacy and safety of polypill in the prevention of CVD since the establishment of databases to May 2017. RESULTS Fifteen foreign references were included.In the overall meta-analysis,the reduction levels of blood pressure and lipid in the polypill group were significantly greater than those in the control group [SBP,DBP,TC(P<0.000 1), LDL-C(P=0.000 3)],adherence and all-cause mortality were not significantly different,but the incidence of adverse reactions in the polypill group was slightly higher than that in the control group(P=0.000 6). In the subgroup analysis,polypill significantly reduced SBP(P=0.002),DBP(P=0.01),TC(P<0.000 01) and LDL-C(P<0.000 1),and there were significant differences between adherence and safety.The SBP and DBP of polypill group were equivalent to those of standard treatment group,but the level of TC was significantly lower than that of standard treatment group(P=0.04). There was no significant difference in adherence(P=0.85).Compared with the usual care group,the polypill group had significant difference in reducing the DBP and the incidence of adverse reactions(P=0.04),but there was no significant difference in SBP,TC,LDL-C,adherence and all-cause mortality. Compared with other groups,the reduction of SBP and TC in polypill group had significant difference. CONCLUSION Polypill has a good effect in the prevention of CVD.However,the adverse drug reactions in the polypill group are more than those in the control group and there is heterogeneity between the study.Therefore,more clinical trials are needed to prove this in the future.
引文
[1] 龚海荣,李向平.“polypill”用于心血管疾病防治的利与弊[J].医学与哲学(临床决策论坛版),2010,31(05):31.
[2] WALD N J,LAW M R.A strategy to reduce cardiovascular disease by more than 80%[J].BMJ,2003,326(7404):1419.
[3] 向丽,姜鹏,胡耀华,等.“Polypill”的发展及前景[J].药学实践杂志,2012,30(03):161.
[4] 方冬,万静,方奇,等.Polypill对心血管疾病危险因素的干预效果和安全性的Meta分析[J].华西医学,2015,(06):1054.
[5] HUFFMAN M D,De CATES A N,EBRAHIM S.Fixed-dose combination therapy (polypill) for the prevention of cardiovascular disease[J].J AMA,2014,312(19):2030.
[6] 邢冬梅,张俊华,李玲,等.心血管复方制剂对冠心病相关危险因素干预效果与安全性的系统评价[J].中国循证医学杂志,2013,13,(4):446.
[7] INDIAN POLYCAP STUDY(TIPS),YUSUF S, PAIS P,et al.Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease(TIPS):a phase Ⅱ,double-blind,randomised trial[J].Lancet,2009,373(9672):1341.
[8] MALEKZADEH F,MARSHALL T,POURSHAMS A,et al.A pilotdouble-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy(“Polypill”) on cardiovascular risk factors[J]. Int J Clin Pract,2010,64(9):1220.
[9] GRIMM R,MALIK M,YUNIS C,et al. Simultaneous treatment to attain blood pressure and lipid goals and reduced CV risk burden using amlodipine/atorvastatin single-pill therapy in treated hypertensive participants in a randomized controlled trial[J]. Vasc Health Risk Manag,2010,6:261.
[10] SOLIMAN E Z,MENDIS S,DISSANAYAKE W P,et al.A polypill for primary prevention of cardiovascular disease:a feasibility study of the World Health Organization[J].Trials,2011,12(1):1.
[11] GROUP P C.An international randomised placebo-controlled trial of a fourcomponent combination pill (“Polypill”) in people with raised cardiovascular risk[J].PLoS One,2011,6(5):e19857.
[12] ZAMORANO J,ERDINE S,PAVIA A,et al.Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors:The CRUCIAL trial[J]. Curr Med Res Opin,2011,27(4):821.
[13] WALD D S,MORRIS J K,WALD N J.Randomized Polypill crossover trial in people aged 50 and over[J]. PLoS One,2012,7(7):e41297.
[14] NEUTEL J M,BESTERMANN W H,DYESS E M,et al.The use of a single-pill calcium channel blocker/statin combination in the management of hypertension and dyslipidemia:a randomized,placebo-controlled, multicenter study[J]. J Clin Hypertens,2009,11(1):22.
[15] THOM S,POULTER N,FIELD J,et al.Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD:the UMPIRE randomized clinical trial[J].JAMA,2013,310(9):918.
[16] SELAK V,ELLEY C R,BULLEN C,et al.Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomised controlled trial in primary care[J]. BMJ,2014,348(May 27 11): g3318.
[17] PATEL A,CASS A,PEIRIS D,et al.A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk.[J].Eur J Prev Cardiol,2015,22(7):920.
[18]CASTELLANOJ M,SANZ G,PEALV O,et al.A polypill strategy to improve adherence:results from FOCUS(Fixed-dose Combination Drug for Secondary Cardiovascular Prevention)Project[J]. J Am Coll Cardiol,2014,64(20):2071.
[19] KIM S H,LEE H L,LIM W H,etal.Efficacy and safety of fixed-dose combination of olmesartan medoxomil and rosuvastatin in Korean patients with hypertension and dyslipidemia[J].Atherosclerosis,2016,252:e57.
[20] MARAZZI G,PELLICCIA F,CAMPOLONGO G,et al.Greater cardiovascular risk reduction with once-daily fixed combination of three antihypert-ensive agents and statin versus free-drug combination:The ALL-IN-ONE trial.[J].Int J Cardiol,2016,222:885.
[21] KIM S H,JO S H,LEE S C,et al.Blood pressure and cholesterol-lowering efficacy of a fixed-dose combination with irbesartan and atorvastatin in patients with hypertension and hypercholesterolemia:a randomized, double-blind,factorial,multicenter phase Ⅲ study[J].Clin Ther,2016,38(10):2171.
[2] WALD N J,LAW M R.A strategy to reduce cardiovascular disease by more than 80%[J].BMJ,2003,326(7404):1419.
[3] 向丽,姜鹏,胡耀华,等.“Polypill”的发展及前景[J].药学实践杂志,2012,30(03):161.
[4] 方冬,万静,方奇,等.Polypill对心血管疾病危险因素的干预效果和安全性的Meta分析[J].华西医学,2015,(06):1054.
[5] HUFFMAN M D,De CATES A N,EBRAHIM S.Fixed-dose combination therapy (polypill) for the prevention of cardiovascular disease[J].J AMA,2014,312(19):2030.
[6] 邢冬梅,张俊华,李玲,等.心血管复方制剂对冠心病相关危险因素干预效果与安全性的系统评价[J].中国循证医学杂志,2013,13,(4):446.
[7] INDIAN POLYCAP STUDY(TIPS),YUSUF S, PAIS P,et al.Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease(TIPS):a phase Ⅱ,double-blind,randomised trial[J].Lancet,2009,373(9672):1341.
[8] MALEKZADEH F,MARSHALL T,POURSHAMS A,et al.A pilotdouble-blind randomised placebo-controlled trial of the effects of fixed-dose combination therapy(“Polypill”) on cardiovascular risk factors[J]. Int J Clin Pract,2010,64(9):1220.
[9] GRIMM R,MALIK M,YUNIS C,et al. Simultaneous treatment to attain blood pressure and lipid goals and reduced CV risk burden using amlodipine/atorvastatin single-pill therapy in treated hypertensive participants in a randomized controlled trial[J]. Vasc Health Risk Manag,2010,6:261.
[10] SOLIMAN E Z,MENDIS S,DISSANAYAKE W P,et al.A polypill for primary prevention of cardiovascular disease:a feasibility study of the World Health Organization[J].Trials,2011,12(1):1.
[11] GROUP P C.An international randomised placebo-controlled trial of a fourcomponent combination pill (“Polypill”) in people with raised cardiovascular risk[J].PLoS One,2011,6(5):e19857.
[12] ZAMORANO J,ERDINE S,PAVIA A,et al.Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors:The CRUCIAL trial[J]. Curr Med Res Opin,2011,27(4):821.
[13] WALD D S,MORRIS J K,WALD N J.Randomized Polypill crossover trial in people aged 50 and over[J]. PLoS One,2012,7(7):e41297.
[14] NEUTEL J M,BESTERMANN W H,DYESS E M,et al.The use of a single-pill calcium channel blocker/statin combination in the management of hypertension and dyslipidemia:a randomized,placebo-controlled, multicenter study[J]. J Clin Hypertens,2009,11(1):22.
[15] THOM S,POULTER N,FIELD J,et al.Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD:the UMPIRE randomized clinical trial[J].JAMA,2013,310(9):918.
[16] SELAK V,ELLEY C R,BULLEN C,et al.Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomised controlled trial in primary care[J]. BMJ,2014,348(May 27 11): g3318.
[17] PATEL A,CASS A,PEIRIS D,et al.A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk.[J].Eur J Prev Cardiol,2015,22(7):920.
[18]CASTELLANOJ M,SANZ G,PEALV O,et al.A polypill strategy to improve adherence:results from FOCUS(Fixed-dose Combination Drug for Secondary Cardiovascular Prevention)Project[J]. J Am Coll Cardiol,2014,64(20):2071.
[19] KIM S H,LEE H L,LIM W H,etal.Efficacy and safety of fixed-dose combination of olmesartan medoxomil and rosuvastatin in Korean patients with hypertension and dyslipidemia[J].Atherosclerosis,2016,252:e57.
[20] MARAZZI G,PELLICCIA F,CAMPOLONGO G,et al.Greater cardiovascular risk reduction with once-daily fixed combination of three antihypert-ensive agents and statin versus free-drug combination:The ALL-IN-ONE trial.[J].Int J Cardiol,2016,222:885.
[21] KIM S H,JO S H,LEE S C,et al.Blood pressure and cholesterol-lowering efficacy of a fixed-dose combination with irbesartan and atorvastatin in patients with hypertension and hypercholesterolemia:a randomized, double-blind,factorial,multicenter phase Ⅲ study[J].Clin Ther,2016,38(10):2171.