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通过常规治疗中添加抗动脉粥样硬化药物实现卒中最小化(SMAART):改善撒哈拉以南非洲地区卒中结局的一项试点试验概念

Stroke minimization through additive anti-atherosclerotic agents in routine treatment (SMAART): A pilot trial concept for improving stroke outcomes in sub-Saharan Africa.

作者信息

Sarfo Fred Stephen, Ovbiagele Bruce

机构信息

Kwame Nkrumah University of Science and Technology, Kumasi, Ghana; Komfo Anokye Teaching Hospital, Kumasi, Ghana.

Department of Neurology and Neurosurgery, Medical University of South Carolina, Charleston, SC, USA.

出版信息

J Neurol Sci. 2017 Jun 15;377:167-173. doi: 10.1016/j.jns.2017.04.012. Epub 2017 Apr 12.


DOI:10.1016/j.jns.2017.04.012
PMID:28477689
Abstract

There has been an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA), which when compared to stroke profiles in high-income countries (HIC) is characterized by a younger age of onset, higher case fatality rates, and more severe disability among survivors. Stroke survivors in SSA (vs. HIC) are especially at high risk for recurrent vascular events or death due to undiagnosed or under-controlled vascular risk factors, logistical challenges, low health literacy, and lack of care affordability. While international expert consensus secondary prevention guidelines recommend that antihypertensive, statin and anti-platelet therapy, be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular risk reduction, these goals are seldom realized in routine clinical care settings in SSA. A relatively simple, low-cost, evidence-based strategy that could be largely applied in a uniform manner to stroke survivors in low-to-middle income countries (LMICs), including the nations of SSA, is sorely needed. Fixed-dose combination pills, also known "polypills", containing generic drugs, i.e. Aspirin, a statin, and blood pressure (BP) lowering medication(s) may be a viable avenue to improve medication adherence and consequently reduce risk of further disability or death on a large scale among stroke survivors encountered in resource-constrained regions. In this conceptual article, we review the data supporting the rationale for a polypill to improve stroke outcomes in SSA and propose the conduct of a Stroke Minimization through Additive Anti-atherosclerotic Agent in Routine Treatment (SMAART) pilot study to determine the impact of a polypill such as the Polycap DS® in reducing future vascular risk compared to usual care in recent stroke in SSA. A preliminarily feasible and efficacy-suggesting SMAART trial could inform the future design of a multi-center, double-blinded, placebo-controlled, randomized trial comparing the clinical efficacy of the polypill strategy for vascular risk moderation among stroke survivors in LMICs.

摘要

撒哈拉以南非洲(SSA)地区中风的患病率出现了前所未有的上升,与高收入国家(HIC)的中风情况相比,其特点是发病年龄较轻、病死率较高,且幸存者中的残疾情况更为严重。SSA地区(与HIC地区相比)的中风幸存者尤其面临着因血管危险因素未被诊断或控制不佳、后勤挑战、健康素养低下以及缺乏医疗可及性而导致的复发性血管事件或死亡的高风险。虽然国际专家共识二级预防指南建议在缺血性中风后立即开始使用抗高血压、他汀类和抗血小板治疗,并持续坚持以实现最佳的血管风险降低,但这些目标在SSA地区的常规临床护理环境中很少能够实现。迫切需要一种相对简单、低成本、基于证据的策略,该策略可以在包括SSA国家在内的低收入和中等收入国家(LMICs)以统一的方式广泛应用于中风幸存者。固定剂量复方药丸,也称为“多效药丸”,包含通用药物,即阿司匹林、一种他汀类药物和降血压药物,可能是一种可行的途径,以提高药物依从性,从而在资源有限地区遇到的中风幸存者中大规模降低进一步残疾或死亡的风险。在这篇概念性文章中,我们回顾了支持使用多效药丸改善SSA地区中风结局的理论依据的数据,并提议开展一项通过常规治疗中添加抗动脉粥样硬化药物实现中风最小化(SMAART)的试点研究,以确定与SSA地区近期中风的常规护理相比,Polycap DS®等多效药丸在降低未来血管风险方面的影响。一项初步可行且提示疗效的SMAART试验可以为未来设计一项多中心、双盲、安慰剂对照、随机试验提供信息,该试验将比较多效药丸策略对LMICs中风幸存者血管风险调节效果的临床疗效。

相似文献

[1]
Stroke minimization through additive anti-atherosclerotic agents in routine treatment (SMAART): A pilot trial concept for improving stroke outcomes in sub-Saharan Africa.

J Neurol Sci. 2017-6-15

[2]
Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial.

Trials. 2018-3-14

[3]
Polypill Programs to Prevent Stroke and Cut Costs in Low Income Countries: Moving From Clinical Efficacy to Pragmatic Implementation.

Stroke. 2023-2

[4]
Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE): rationale and design of a randomised controlled trial of a cardiovascular preventive polypill-based strategy in India and Europe.

Eur J Prev Cardiol. 2014-2

[5]
Cost-effectiveness of a fixed dose combination (polypill) in secondary prevention of cardiovascular diseases in India: Within-trial cost-effectiveness analysis of the UMPIRE trial.

Int J Cardiol. 2018-3-21

[6]
Risk Factor Control in Stroke Survivors with Diagnosed and Undiagnosed Diabetes: A Ghanaian Registry Analysis.

J Stroke Cerebrovasc Dis. 2020-9-22

[7]
A pragmatic randomized trial of a polypill-based strategy to improve use of indicated preventive treatments in people at high cardiovascular disease risk.

Eur J Prev Cardiol. 2014-3-27

[8]
The combined use of aspirin, a statin, and blood pressure-lowering agents (polypill components) in clinical practice in patients with vascular diseases or type 2 diabetes mellitus.

Eur J Prev Cardiol. 2012-5-30

[9]
The concept of the polypill in the prevention of cardiovascular disease.

Ann Glob Health. 2013-12-25

[10]
Implementation of a structured guideline-based program for the secondary prevention of ischemic stroke in China.

Stroke. 2014-1-2

引用本文的文献

[1]
Long-term determinants of death after stroke in Ghana: Analysis by stroke types & subtypes.

J Stroke Cerebrovasc Dis. 2022-9

[2]
Non-pharmacological interventions to achieve blood pressure control in African patients: a systematic review.

BMJ Open. 2022-2-28

[3]
Stroke in Africa: profile, progress, prospects and priorities.

Nat Rev Neurol. 2021-10

[4]
Reducing stroke burden through a targeted self-management intervention for reducing stroke risk factors in high-risk Ugandans: A protocol for a randomized controlled trial.

PLoS One. 2021

[5]
Low blood pressure levels & incident stroke risk among elderly Ghanaians with hypertension.

J Neurol Sci. 2020-6-15

[6]
The Sub-Saharan Africa Conference on Stroke (SSACS): An idea whose time has come.

J Neurol Sci. 2019-3-29

[7]
Incident stroke among Ghanaians with hypertension and diabetes: A multicenter, prospective cohort study.

J Neurol Sci. 2018-9-13

[8]
Long-Term Outcomes of Stroke in a Ghanaian Outpatient Clinic.

J Stroke Cerebrovasc Dis. 2018-4

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