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用于心血管疾病二级预防的复方制剂:在提高依从性方面有效,但它们安全吗?

Polypills for the secondary prevention of cardiovascular disease: effective in improving adherence but are they safe?

作者信息

Selak Vanessa, Webster Ruth

机构信息

University of Auckland, Auckland, New Zealand.

The George Institute for Global Health, Level 5, 1 King Street, Newtown, New South Wales, 2042, Australia.

出版信息

Ther Adv Drug Saf. 2018 Feb;9(2):157-162. doi: 10.1177/2042098617747836. Epub 2017 Dec 20.

DOI:10.1177/2042098617747836
PMID:29387338
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5772523/
Abstract

International guidelines recommend blood pressure-lowering therapy, statins and aspirin for people who have had a cardiovascular event but use of these medications is low, particularly for lower income countries. Clinical trials have demonstrated that combining these medications into a single pill or capsule (a 'polypill') improves adherence, systolic blood pressure and low density lipoprotein cholesterol compared with usual care in secondary prevention. Uptake of polypill-based care has been underwhelming, possibly due to safety concerns. Overall, results from the clinical trials of polypill use among people who have had a cardiovascular event show no immediate safety concerns. Increased use and adherence to medications will always be associated with side effects however use within a combination medication has not been shown to be any less safe than individual component medications. Research investigating the relative consequences of nonadherence to a polypill compared with individual components would be useful.

摘要

国际指南建议,对于发生过心血管事件的人群,应进行降压治疗、使用他汀类药物和阿司匹林,但这些药物的使用率较低,在低收入国家尤其如此。临床试验表明,与二级预防中的常规治疗相比,将这些药物组合成单一药丸或胶囊(“复方制剂”)可提高依从性、降低收缩压并降低低密度脂蛋白胆固醇。基于复方制剂的治疗方法的采用情况并不理想,这可能是由于安全担忧。总体而言,在发生过心血管事件的人群中使用复方制剂的临床试验结果显示,目前不存在直接的安全问题。然而,药物使用的增加和依从性的提高总会伴随着副作用,不过尚未证明复方制剂中的药物使用比单一成分药物的安全性更低。研究不依从复方制剂与不依从单一成分药物的相对后果将很有帮助。

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Trends Cardiovasc Med. 2023 Apr;33(3):182-189. doi: 10.1016/j.tcm.2021.12.013. Epub 2021 Dec 30.
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本文引用的文献

1
Putting polypills into practice: challenges and lessons learned.将多效药丸付诸实践:挑战与经验教训。
Lancet. 2017 Mar 11;389(10073):1066-1074. doi: 10.1016/S0140-6736(17)30558-5.
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An integrated general practice and pharmacy-based intervention to promote the use of appropriate preventive medications among individuals at high cardiovascular disease risk: protocol for a cluster randomized controlled trial.一项基于综合全科医疗和药房的干预措施,以促进心血管疾病高风险个体使用适当的预防性药物:一项整群随机对照试验方案。
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More HOPE for Prevention with Statins.他汀类药物预防带来更多希望。
N Engl J Med. 2016 May 26;374(21):2085-7. doi: 10.1056/NEJMe1603504. Epub 2016 Apr 2.
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Do polypills lead to neglect of lifestyle risk factors? Findings from an individual participant data meta-analysis among 3140 patients at high risk of cardiovascular disease.复方药丸会导致对生活方式风险因素的忽视吗?对3140名心血管疾病高危患者进行的个体参与者数据荟萃分析结果
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Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk: A prospective, individual patient data meta-analysis of 3140 patients in six countries.固定剂量复方药物(“多效药丸”)与常规治疗相比对心血管疾病患者或高危患者的有效性:一项对六个国家3140例患者的前瞻性个体患者数据荟萃分析。
Int J Cardiol. 2016 Feb 15;205:147-156. doi: 10.1016/j.ijcard.2015.12.015. Epub 2015 Dec 14.
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The Effect of a Cardiovascular Polypill Strategy on Pill Burden.心血管复方药策略对用药负担的影响。
Cardiovasc Ther. 2015 Dec;33(6):347-52. doi: 10.1111/1755-5922.12151.
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Patients' and providers' perspectives of a polypill strategy to improve cardiovascular prevention in Australian primary health care: a qualitative study set within a pragmatic randomized, controlled trial.患者与医疗服务提供者对澳大利亚初级卫生保健中采用复方制剂策略改善心血管疾病预防的看法:一项基于实用随机对照试验的定性研究
Circ Cardiovasc Qual Outcomes. 2015 May;8(3):301-8. doi: 10.1161/CIRCOUTCOMES.115.001483. Epub 2015 May 5.
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A polypill strategy to improve adherence: results from the FOCUS project.多药复方片策略提高依从性:FOCUS 项目结果。
J Am Coll Cardiol. 2014;64(20):2071-82. doi: 10.1016/j.jacc.2014.08.021. Epub 2014 Sep 1.
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J Am Coll Cardiol. 2014 Aug 12;64(6):613-21. doi: 10.1016/j.jacc.2014.06.009.
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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.固定剂量联合治疗对心血管疾病高危患者依从性和危险因素控制的影响:初级保健中的随机对照试验。
BMJ. 2014 May 27;348:g3318. doi: 10.1136/bmj.g3318.