经皮冠状动脉介入治疗后残余血管病变及冠状动脉临界病变患者应用硝酸异山梨酯缓释片与单硝酸异山梨酯片的疗效对比研究
Comparative Analysis on the Efficacy of Sustained-release Isosorbide Dinitrate and Isosorbide Mononitrate in Patients With Residual Ischemia After Percutaneous Coronary Intervention or Borderline Coronary Stenosis
郝一莼 1曾谷雨 1赵立超 1陈艳 1宋莹 1袁德山 1汪沛志 1宋雷 1张茵 1高立建 1陈珏 1刘海波 1袁晋青 1赵雪燕 1许晶晶1
作者信息
- 1. 中国医学科学院 北京协和医学院 国家心血管病中心 阜外医院 冠心病中心,北京 100037
- 折叠
摘要
目的:探讨长效硝酸异山梨酯和单硝酸异山梨酯在经皮冠状动脉介入治疗(PCI)后残余血管病变以及冠状动脉临界病变患者中的疗效与安全性.方法:选取中国医学科学院阜外医院 2022 年 7 月至 2023 年 2 月收治的PCI后残余血管病变以及冠心病临界病变患者 435 例,依据随机数字表法分为硝酸异山梨酯缓释片组(n=217)和单硝酸异山梨酯片组(n=218),分别口服两种药物 20 mg每日两次.比较两组患者治疗前和治疗后 1、2、3 个月西雅图心绞痛问卷(SAQ)评分(包括活动受限程度、心绞痛稳定性、心绞痛发作频率、治疗满意度、疾病认知度)以及治疗后主要不良心脑血管事件(MACCE,包括全因死亡、心肌梗死、再次血运重建、脑卒中)、药物不良反应的发生率等.结果:治疗后两组患者的SAQ五个部分评分以及SAQ总分等均显著增加(Ptrend均＜0.001),非劣效检验结果显示两组患者SAQ评分无明显差异(P＜0.001).3 个月后两组MACCE发生率差异无统计学意义(1.4%vs.4.6%,P=0.067).治疗后两组患者中均有头痛等药物不良反应发生,硝酸异山梨酯缓释片组患者中低血压发生率低于单硝酸异山梨酯片组(0.9%vs.4.1%,P=0.033),两组患者因不良反应所致的停药率差异无统计学意义(3.2%vs.3.7%,P=0.916).结论:硝酸异山梨酯缓释片能有效改善PCI后残余血管病变以及冠状动脉临界病变患者生活质量,治疗效果、MACCE发生率、药物不良反应、停药率等与单硝酸异山梨酯片相似,且低血压的发生率更低.
Abstract
Objectives:To compare the effectiveness and safety of sustained-release isosorbide dinitrate(ISDN)or isosorbide mononitrate(ISMN)in Chinese patients with residual ischemia after percutaneous coronary intervention(PCI)or borderline coronary stenosis.Methods:Patients with residual ischemia after PCI or borderline coronary stenosis were randomized to either ISDN(20 mg,twice daily,n=217)or ISMN(20 mg,twice daily,n=218)groups.The patients were treated for 3 months.Main analysis included changes in the Seattle Angina Questionnaire(SAQ),major adverse cardiac or cerebrovascular events(MACCE,including all causes of death,myocardial infarction,revascularization,stroke),and drug-related adverse effects between baseline and 1,2,and 3 months after therapy.Results:After therapy,there was a significant increase in scores across all five SAQ domains in both groups(both Ptrend＜0.001).The non-inferiority test did not reveal any distinction between the two groups.After three months,there was no statistically significant difference in MACCE between the two groups(1.4%vs.4.6%,P=0.067).Following therapy,both groups had negative medication effects such as headaches,hypotension was less common in the ISDN group than in ISMN group(0.9%vs.4.1%,P=0.033).There was no discernible difference in discontinuation rate between the two patient groups(3.2%vs.3.7%,P=0.916).Conclusions:Patients with residual ischemia after PCI or borderline coronary stenosis can significantly enhance their quality of life by taking sustained-release isosorbide dinitrate.The frequency of hypotension is less common in ISPN group,the therapeutic effectiveness,MACCE,and adverse medication effects are comparable between groups.
关键词
硝酸异山梨酯缓释片/单硝酸异山梨酯/冠状动脉临界病变/经皮冠状动脉介入治疗/心绞痛/西雅图生活质量评分Key words
sustained-release isosorbide dinitrate/isosorbide mononitrate/borderline coronary stenosis/percutaneous coronary intervention/angina pectoris/Seattle Angina Questionnaire Score引用本文复制引用
出版年
2024
NETL
NSTL
万方数据