尼可地尔在心绞痛患者中的应用及健康状况结局：一项前瞻性、多中心、队列研究（GREAT）

Nicorandil Use and Health Status Outcomes in Patients with Angina Pectoris: A Prospective, Multicenter, Cohort Study (GREAT).

作者信息

Zhao Xiliang, Cheng Guojie, Sun Liling, Liu Yajuan, Du Xin, Xu Su'e, Wu Litao, Wei Ying, Liu Wei, Miao Lifu, Zhang Qihua, Ma Changsheng, Zeng Yong

机构信息

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.

Department of Cardiology, Beijing Daxing District People's Hospital, Beijing, People's Republic of China.

出版信息

Drug Des Devel Ther. 2025 Sep 15;19:8295-8308. doi: 10.2147/DDDT.S506108. eCollection 2025.

DOI:10.2147/DDDT.S506108

PMID:40980423

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12447962/

Abstract

PURPOSE

Coronary artery disease represents a major clinical burden, and angina pectoris is the most frequent manifestation of coronary artery disease. Nicorandil is commonly used for the management of angina pectoris; however, its effects on health status outcomes are unclear.

PATIENTS AND METHODS

This multicenter, prospective, cohort study (GREAT) enrolled 1556 adult coronary artery disease patients with angina pectoris from nine hospitals in China. Patients were classified into nicorandil and control groups. The primary outcome was the change in the Seattle Angina Questionnaire summary score (SAQ-SS) from baseline to 12 months. Secondary outcomes included changes in SAQ-SS at 3, 6, and 9 months. Propensity score matching (PSM) was used to reduce bias and control for confounding factors.

RESULTS

We analyzed 1528 patients with baseline and 12-month health status data. After PSM, 450 matched pairs of patients were identified. A difference of ≥5 points for SAQ-SS is considered clinically significant. Patients in the nicorandil group reported greater mean improvement in SAQ-SS (17.6 ± 14.0, difference: 2.50, 95% CI: 0.74-4.27; P=0.003) at 12 months compared with the control group (15.1 ± 13.0; =0.003). Similar trends were noted in SAQ-SS at 3, 6, and 9 months. Additionally, nicorandil users exhibited significantly greater improvements in the SAQ physical limitation (11.7 ± 16.9 vs 8.4 ± 16.9; difference: 3.27, 95% CI, 1.05-5.48; P =0.001) and SAQ-QoL domain (18.9 ± 21.4 vs 16.3 ± 20.4; difference: 2.62, 95% CI, -0.12 to 5.35; P=0.042) at 12 months. Most patients in the entire cohort (78.4%) reported a clinical improvement in SAQ-SS. The nicorandil group had a higher proportion of patients with at least large improvements (≥20 points) in SAQ-SS (42.5% vs 32.9%; difference: 9.7%, 95% CI: 3.3-16.0; P= 0.004).

CONCLUSION

Among patients with angina pectoris, anti-angina treatment improved the majority of patients' health status. Nicorandil-based regimens were associated with a greater health status outcome improvement compared to those not using nicorandil in coronary artery disease patients with angina pectoris. A substantial proportion of patients using nicorandil exhibited noteworthy improvements in health status outcomes at one year.

REGISTRATION

ClinicalTrials.gov, NCT05050773.

摘要

目的

冠状动脉疾病是一项重大的临床负担，而心绞痛是冠状动脉疾病最常见的表现形式。尼可地尔常用于治疗心绞痛；然而，其对健康状况结局的影响尚不清楚。

患者与方法

这项多中心、前瞻性队列研究（GREAT）纳入了来自中国9家医院的1556例患有心绞痛的成年冠状动脉疾病患者。患者被分为尼可地尔组和对照组。主要结局是西雅图心绞痛问卷总结评分（SAQ-SS）从基线到12个月的变化。次要结局包括3、6和9个月时SAQ-SS的变化。采用倾向评分匹配（PSM）来减少偏倚并控制混杂因素。

结果

我们分析了1528例有基线和12个月健康状况数据的患者。经过PSM后，识别出450对匹配的患者。SAQ-SS相差≥5分被认为具有临床意义。与对照组（15.1±13.0）相比，尼可地尔组患者在12个月时SAQ-SS的平均改善更大（17.6±14.0，差值：2.50，95%CI：0.74 - 4.27；P = 0.003）。在3、6和9个月时的SAQ-SS也观察到类似趋势。此外，尼可地尔使用者在12个月时SAQ身体限制方面（11.7±16.9对8.4±16.9；差值：3.27，95%CI，1.05 - 5.48；P = 0.001）和SAQ生活质量领域（18.9±21.4对16.3±20.4；差值：2.62，95%CI， - 0.12至5.35；P = 0.042）有显著更大的改善。整个队列中的大多数患者（78.4%）报告SAQ-SS有临床改善。尼可地尔组中SAQ-SS至少有大幅改善（≥20分）的患者比例更高（42.5%对32.9%；差值：9.7%，95%CI：3.3 - 16.0；P = 0.004）。