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别嘌醇与曲美他嗪治疗心绞痛的随机临床试验。

Allopurinol versus Trimetazidine for the Treatment of Angina: A Randomized Clinical Trial.

机构信息

Universidade Federal da Bahia, Salvador, BA - Brasil.

Ana Nery Hospital, Salvador, BA - Brasil.

出版信息

Arq Bras Cardiol. 2024 Jul;121(8):e20230659. doi: 10.36660/abc.20230659.

Abstract

BACKGROUND

Recently, it was demonstrated that allopurinol, a xanthine oxidase inhibitor, has cardiovascular and anti-ischaemic properties and may be a metabolic antianginal agent option.Objective: The objective of this study was to evaluate the antianginal effect of allopurinol as a third drug for patients with stable coronary artery disease (CAD).

METHODS

This was a randomized clinical trial between 2018 and 2020 including patients with CAD who maintained angina despite initial optimization with beta-blockers and calcium channel blockers. The individuals were randomized 1:1 to 300 mg of allopurinol twice daily or 35 mg of trimetazidine twice daily. The main outcome was the difference in the angina frequency domain of the Seattle Angina Questionnaire (SAQ-AF). A probability (p) value < 0.05 was considered statistically significant.

RESULTS

A hundred and eight patients were included in the randomization phase, with 54 (50%) in the allopurinol group and 54 (50%) in the trimetazidine group. Six (5.6%) individuals, 3 from each group, were lost to follow-up for the primary outcome. In the allopurinol and trimetazidine groups, the median SAQ-AF scores were 50 (30.0 to 70.0) and 50 (21.3 to 78.3), respectively. In both groups, the SAQ-AF score improved, but the median of the difference compared to baseline was lower in the allopurinol group (10 [0 to 30] versus 20 [10 to 40]; p < 0.001), as was the mean of the difference in the total SAQ score (12.8 ± 17.8 versus 21.2 ± 15.9; p = 0.014).

CONCLUSION

Both allopurinol and trimetazidine improved the control of angina symptoms; however, trimetazidine presented a greater gain compared to baseline. Brazilian Registry of Clinical Trials - Registration Number RBR-5kh98y.

摘要

背景

最近有研究表明,黄嘌呤氧化酶抑制剂别嘌醇具有心血管和抗缺血作用,可能成为代谢性抗心绞痛药物的选择。

目的

本研究旨在评估别嘌醇作为稳定型冠状动脉疾病(CAD)患者的第三种药物的抗心绞痛作用。

方法

这是一项 2018 年至 2020 年期间的随机临床试验,纳入了在初始接受β受体阻滞剂和钙通道阻滞剂优化治疗后仍有稳定型 CAD 患者心绞痛的患者。这些患者被随机分为 1:1 组,分别接受每天两次 300mg 别嘌醇或每天两次 35mg 曲美他嗪治疗。主要结局为西雅图心绞痛问卷(SAQ-AF)的心绞痛频率域差异。p 值<0.05 被认为具有统计学意义。

结果

108 例患者被纳入随机分组阶段,其中 54 例(50%)患者分入别嘌醇组,54 例(50%)患者分入曲美他嗪组。有 6 例(5.6%)患者,每组各 3 例,因主要结局失访。在别嘌醇组和曲美他嗪组中,SAQ-AF 评分的中位数分别为 50(30.0 至 70.0)和 50(21.3 至 78.3)。在两组中,SAQ-AF 评分均有所改善,但别嘌醇组的改善程度低于曲美他嗪组(差值中位数:10[0 至 30]对 20[10 至 40];p<0.001),SAQ 总评分差值的均值也低于曲美他嗪组(12.8±17.8 对 21.2±15.9;p=0.014)。

结论

别嘌醇和曲美他嗪均改善了心绞痛症状的控制;然而,与基线相比,曲美他嗪的改善程度更大。巴西临床试验注册编号 RBR-5kh98y。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d9b7/11463339/9b005f182dcf/0066-782X-abc-121-8-e20230659-gf01.jpg

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