Gabriel González Villa Monte, Juan Bacigalupe, Maximiliano De Abreu, Laura Antonietti, Gloria Luna, Carlos Tajer, Javier Mariani
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引用次数: 0
Abstract
Introduction: Patients discharged with a diagnosis of acute coronary syndrome (ACS) are at increased risk for recurrent cardiovascular events. Improved adherence to treatment has been associated with better outcomes. The objective of this study was to evaluate the effect of an educational intervention on medication adherence in patients following ACS.
Materials and methods: A single-center, randomized, open-label, controlled clinical trial with parallel groups and a six-month follow-up.
Results: Sixty-three patients were randomized to the mixed educational intervention group and sixty-nine to the control group. Baseline characteristics were similar between groups: 82.6% were male, with a median age of 56 years (IQR 51-61), 73.5% had completed primary education. Mean ejection fraction (EF) was 47.7% (SD 12.33). Most patients were discharged with more than four medications, with a median of seven (IQR 6.0-8.0) tablets per day. At one month, adherence was 80.0% in the intervention group and 66.2% in the control group (RR 1.21; 95% CI 0.97-1.50; p = 0.12). At three months, adherence was 79.7% vs. 77.4% (RR 1.03; 95% CI 0.85-1.24; p = 0.94), and at six months -the primary endpoint- 73.3% vs. 71.9% (RR 1.02; 95% CI 0.82-1.27; p = 1.00). No significant differences were observed between groups in the occurrence of clinical events.
Conclusion: The educational intervention was well accepted and feasible to implement, but it did not result in improved medication adherence or a reduction in clinical events over the medium term.
诊断为急性冠脉综合征(ACS)的患者出院后心血管事件复发的风险增加。改善对治疗的坚持与更好的结果相关。本研究的目的是评估教育干预对ACS患者服药依从性的影响。材料和方法:单中心,随机,开放标签,对照临床试验,平行组和六个月随访。结果:63例患者随机分为混合教育干预组,69例为对照组。各组之间的基线特征相似:82.6%为男性,中位年龄为56岁(IQR 51-61), 73.5%完成了小学教育。平均射血分数(EF)为47.7% (SD 12.33)。大多数患者出院时服用了4种以上的药物,平均每天服用7片(IQR 6.0-8.0)。1个月时,干预组的依从性为80.0%,对照组为66.2% (RR 1.21; 95% CI 0.97-1.50; p = 0.12)。3个月时,依从性为79.7% vs. 77.4% (RR 1.03; 95% CI 0.85-1.24; p = 0.94), 6个月时,主要终点为73.3% vs. 71.9% (RR 1.02; 95% CI 0.82-1.27; p = 1.00)。两组间临床事件发生无显著差异。结论:教育干预是被广泛接受和可行的,但在中期并没有提高药物依从性或减少临床事件。