尼可地尔和硝酸盐在中国中部冠心病患者中的主要不良心血管事件:一项回顾性队列研究

Ping Li, Juan Chen, Na Li, X. You, Lan Shen, N. Zhou
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摘要

目的:冠心病(CHD)患者的剩余心血管风险在现实生活中仍有待解决。本研究旨在探讨尼可地尔和硝酸盐在冠心病患者最佳治疗之外的临床疗效。方法:本回顾性队列研究纳入了2009年10月至2020年3月来自中国武汉两家三级医院的冠心病患者。根据首次记录的抗心绞痛治疗,将患者分为尼可地尔组和硝酸盐组。从这两家医院的数据库中收集人口统计和临床数据。主要终点是累积18个月无主要不良心血管事件(MACE)生存期,通过Kaplan-Meier分析评估。采用倾向评分匹配(PSM)和多变量Cox回归对混杂因素进行校正。结果:共分析14275例患者,其中尼可地尔组590例,硝酸盐组13685例。中位随访时间为0.88年(Q1, Q3: 0.21, 1.54)年,1:4 PSM后两组累积无mace 18个月生存率相当(80.0% vs. 75.0%,校正风险比(aHR): 1.04, 95%可信区间(CI): 0.42-2.56, P = 0.982,7)。尼可地尔组累积18个月无卒中生存率显著高于硝酸盐组(93.0% vs 84.0%, aHR: 0.56, 95% CI: 0.34-0.92, P = 0.023,5)。结论:本回顾性研究显示,尼可地尔和硝酸盐在冠心病患者18个月的mace发生率相似,但尼可地尔与硝酸盐相比卒中发生率较低。需要进行更多的研究来验证这种关联,并探索尼可地尔在未来对mace发生的长期益处。
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Real-World Major Adverse Cardiovascular Events of Nicorandil and Nitrate in Coronary Heart Disease in Central China: A Retrospective Cohort Study
Objective: Residual cardiovascular risk in patients with coronary heart disease (CHD) still needs to be addressed in real-world practice. This study aimed to examine the clinical effectiveness of nicorandil and nitrate in addition to optimal treatment for CHD patients. Methods: This retrospective cohort study included patients with CHD between October 2009 and March 2020 from 2 tertiary hospitals in Wuhan, China. Patients were grouped into nicorandil and nitrate groups depending on the first recorded antianginal therapy. Demographic and clinical data were collected from databases of the 2 hospitals. The primary outcome was cumulative 18-month major adverse cardiovascular event (MACE)-free survival, which was evaluated by Kaplan-Meier analysis. Propensity score matching (PSM) and multivariate Cox regression were adopted to adjust for confounding factors. Results: A total of 14,275 patients were analyzed, including 590 and 13,685 patients in the nicorandil and nitrate groups, respectively. With a median follow-up of 0.88 (Q1, Q3: 0.21, 1.54) years, the cumulative 18-month MACE-free survival rates were comparable between the 2 groups (80.0% vs. 75.0%, adjusted hazard ratio (aHR): 1.04, 95% confidence interval (CI): 0.42–2.56, P = 0.982,7) after 1:4 PSM. The cumulative 18-month stroke-free survival rate was significantly higher in the nicorandil group compared to the nitrate group (93.0% vs. 84.0%, aHR: 0.56, 95% CI: 0.34–0.92, P = 0.023,5). Conclusion: This retrospective study showed that nicorandil and nitrate have similar 18-month rates of MACEs in CHD patients, but nicorandil is associated with lower incidence of stroke compared to nitrate. More studies need to be conducted to validate this association and explore the long-term benefit of nicorandil use on the occurrence of MACEs in the future.
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