在黎巴嫩长期人道主义危机中用于心血管疾病的固定剂量复方药物：一项实施研究。

Fixed dose combination drugs for cardiovascular disease in a prolonged humanitarian crisis in Lebanon: an implementation study.

机构信息

Centre for Global Chronic Conditions, London School of Hygiene and Tropical Medicine, London, UK

Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Faculty of Epidemiology & Population Health, London, UK.

出版信息

BMJ Open. 2023 Jan 25;13(1):e063668. doi: 10.1136/bmjopen-2022-063668.

DOI:10.1136/bmjopen-2022-063668

PMID:36697043

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9884866/

Abstract

OBJECTIVES

This pre-post implementation study evaluated the introduction of fixed dose combination (FDC) medications for atherosclerotic cardiovascular disease (ASCVD) secondary prevention into routine care in a humanitarian setting.

SETTING

Two Médecins sans Frontières (MSF) primary care clinics serving Syrian refugee and host populations in north Lebanon.

PARTICIPANTS

Consenting patients ≥18 years with existing ASCVD requiring secondary prevention medication were eligible for study enrolment. Those with FDC contraindication(s) or planning to move were excluded. Of 521 enrolled patients, 460 (88.3%) were retained at 6 months, and 418 (80.2%) switched to FDC. Of these, 84% remained on FDC (n=351), 8.1% (n=34) discontinued and 7.9% (n=33) were lost to follow-up by month 12.

INTERVENTIONS

Eligible patients, enrolled February-May 2019, were switched to Trinomia FDC (atorvastatin 20 mg, aspirin 100 mg, ramipril 2.5/5/10 mg) after 6 months' usual care. During the study, the COVID-19 pandemic, an economic crisis and clinic closures occurred.

OUTCOME MEASURES

Descriptive and regression analyses compared key outcomes at 6 and 12 months: medication adherence, non-high density lipoprotein cholesterol (non-HDL-C) and systolic blood pressure (SBP) control. We performed per-protocol, intention-to-treat and secondary analyses of non-switchers.

RESULTS

Among 385 switchers remaining at 12 months, total adherence improved 23%, from 63% (95% CI 58 to 68) at month 6, to 86% (95% CI 82 to 90) at month 12; mean non-HDL-C levels dropped 0.28 mmol/L (95% CI -0.38 to -0.18; p<0.0001), from 2.39 (95% CI 2.26 to 2.51) to 2.11 mmol/L (95% CI 2.00 to 2.22); mean SBP dropped 2.89 mm Hg (95% CI -4.49 to -1.28; p=0.0005) from 132.7 (95% CI 130.8 to 134.6) to 129.7 mm Hg (95% CI 127.9 to 131.5). Non-switchers had smaller improvements in adherence and clinical outcomes.

CONCLUSION

Implementing an ASCVD secondary prevention FDC improved adherence and CVD risk factors in MSF clinics in Lebanon, with potential for wider implementation by humanitarian actors and host health systems.

摘要

目的

本项实施前后研究评估了固定剂量复方药物（FDC）在人道主义环境下用于动脉粥样硬化性心血管疾病（ASCVD）二级预防的常规治疗中的应用。

背景

在黎巴嫩北部为叙利亚难民和当地居民服务的 2 家无国界医生组织（MSF）初级保健诊所。

参与者

年龄≥18 岁且存在 ASCVD 需接受二级预防药物治疗的符合条件的患者，若存在 FDC 禁忌证或计划搬迁则被排除在外。在纳入的 521 例患者中，460 例（88.3%）在 6 个月时保留，418 例（80.2%）转为 FDC。其中，84%（n=351）仍在使用 FDC，8.1%（n=34）停药，7.9%（n=33）在 12 个月时失访。

干预措施

在 2019 年 2 月至 5 月期间纳入符合条件的患者，在接受 6 个月的常规治疗后，转换为 Trinomia FDC（阿托伐他汀 20mg、阿司匹林 100mg、雷米普利 2.5/5/10mg）。在研究期间，发生了 COVID-19 大流行、经济危机和诊所关闭。

结果

在 385 名仍在 12 个月时的转换者中，药物依从性提高了 23%，从第 6 个月的 63%（95%CI 58 至 68）提高到第 12 个月的 86%（95%CI 82 至 90）；非高密度脂蛋白胆固醇（non-HDL-C）水平平均下降 0.28mmol/L（95%CI -0.38 至 -0.18；p<0.0001），从 2.39mmol/L（95%CI 2.26 至 2.51）降至 2.11mmol/L（95%CI 2.00 至 2.22）；平均收缩压下降 2.89mmHg（95%CI -4.49 至 -1.28；p=0.0005），从 132.7mmHg（95%CI 130.8 至 134.6）降至 129.7mmHg（95%CI 127.9 至 131.5）。非转换者在依从性和临床结局方面的改善较小。