Yang Li, Yi Li, Zhijie Zhang, Jian Zhang, Hong Chen, Haichu Yu, Xiaoping Meng, Haitao Yuan, Lili Shao, Yan Lu, Bin Liu, Jiayao Xu, Yi Zhang, Jing Li, Yaling Han
{"title":"养心氏与曲美他嗪对冠心病患者经皮冠状动脉介入治疗后运动耐量的有效性和安全性：多中心双盲临床试验。","authors":"Yang Li, Yi Li, Zhijie Zhang, Jian Zhang, Hong Chen, Haichu Yu, Xiaoping Meng, Haitao Yuan, Lili Shao, Yan Lu, Bin Liu, Jiayao Xu, Yi Zhang, Jing Li, Yaling Han","doi":"10.1016/j.phymed.2024.156198","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Optimizing medication to improve exercise tolerance in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) is limited. Yangxinshi tablets, an herbal-based oral medicine, relieve symptoms of angina might be that they can improve energy metabolism of the ischemic myocardium. We conducted a randomized trial to assess the efficacy and safety of Yangxinshi vs. trimetazidine in improving exercise tolerance in patients with CHD after PCI.</p><p><strong>Methods: </strong>This prospective, randomized, double-blind, double-dummy, multicenter, non-inferiority study enrolled patients aged 18-75 years with CHD who underwent their first PCI within 2 months of diagnosis. Patients were randomized to Yangxinshi plus trimetazidine-placebo or trimetazidine plus Yangxinshi-placebo for 24 weeks. The primary endpoint was the change in metabolic equivalents (METs) assessed by cardiopulmonary exercise test (CPET) between 0 and 24 weeks. Secondary endpoints were comprehensive variables of the CPET, health status and adverse events. This study has been registered at ClinicalTrials. gov (NCT03809273).</p><p><strong>Results: </strong>Between August 1, 2019, and March 31, 2022, a total of 681 patients were randomized to Yangxinshi (n = 341) or trimetazidine (n = 340). After 24 weeks, the exercise tolerance of patients increased by 0.77±1.25 METs in the Yangxinshi group and 0.76±1.00 METs in the trimetazidine group (difference, 0.01; 95 % confidence interval [CI], -0.17 to 0.19), meeting the predefined non-inferiority threshold. Better outcomes were observed in the Yangxinshi group compared with the trimetazidine group for patient-reported depression (PHQ-9; -1.88±3.32 vs. -0.93±3.68; p < 0.001) and anxiety (GAD-7; -1.70±3.26 vs. -0.39±3.29; p < 0.001). Adverse events were similar in both groups.</p><p><strong>Conclusions: </strong>In patients with CHD after PCI, Yangxinshi was non-inferior to trimetazidine in improving exercise tolerance during the 24-week treatment period. Notably, patients in the Yangxinshi group showed a better mental health profile compared with trimetazidine recipients.</p>","PeriodicalId":20212,"journal":{"name":"Phytomedicine","volume":"135 ","pages":"156198"},"PeriodicalIF":6.7000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial.\",\"authors\":\"Yang Li, Yi Li, Zhijie Zhang, Jian Zhang, Hong Chen, Haichu Yu, Xiaoping Meng, Haitao Yuan, Lili Shao, Yan Lu, Bin Liu, Jiayao Xu, Yi Zhang, Jing Li, Yaling Han\",\"doi\":\"10.1016/j.phymed.2024.156198\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Optimizing medication to improve exercise tolerance in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) is limited. Yangxinshi tablets, an herbal-based oral medicine, relieve symptoms of angina might be that they can improve energy metabolism of the ischemic myocardium. We conducted a randomized trial to assess the efficacy and safety of Yangxinshi vs. trimetazidine in improving exercise tolerance in patients with CHD after PCI.</p><p><strong>Methods: </strong>This prospective, randomized, double-blind, double-dummy, multicenter, non-inferiority study enrolled patients aged 18-75 years with CHD who underwent their first PCI within 2 months of diagnosis. Patients were randomized to Yangxinshi plus trimetazidine-placebo or trimetazidine plus Yangxinshi-placebo for 24 weeks. The primary endpoint was the change in metabolic equivalents (METs) assessed by cardiopulmonary exercise test (CPET) between 0 and 24 weeks. Secondary endpoints were comprehensive variables of the CPET, health status and adverse events. This study has been registered at ClinicalTrials. gov (NCT03809273).</p><p><strong>Results: </strong>Between August 1, 2019, and March 31, 2022, a total of 681 patients were randomized to Yangxinshi (n = 341) or trimetazidine (n = 340). After 24 weeks, the exercise tolerance of patients increased by 0.77±1.25 METs in the Yangxinshi group and 0.76±1.00 METs in the trimetazidine group (difference, 0.01; 95 % confidence interval [CI], -0.17 to 0.19), meeting the predefined non-inferiority threshold. Better outcomes were observed in the Yangxinshi group compared with the trimetazidine group for patient-reported depression (PHQ-9; -1.88±3.32 vs. -0.93±3.68; p < 0.001) and anxiety (GAD-7; -1.70±3.26 vs. -0.39±3.29; p < 0.001). Adverse events were similar in both groups.</p><p><strong>Conclusions: </strong>In patients with CHD after PCI, Yangxinshi was non-inferior to trimetazidine in improving exercise tolerance during the 24-week treatment period. Notably, patients in the Yangxinshi group showed a better mental health profile compared with trimetazidine recipients.</p>\",\"PeriodicalId\":20212,\"journal\":{\"name\":\"Phytomedicine\",\"volume\":\"135 \",\"pages\":\"156198\"},\"PeriodicalIF\":6.7000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phytomedicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.phymed.2024.156198\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phytomedicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.phymed.2024.156198","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
Efficacy and safety of yangxinshi versus trimetazidine on exercise tolerance in patients with coronary heart disease after percutaneous coronary intervention: Multicenter, double-blind clinical trial.
Background: Optimizing medication to improve exercise tolerance in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) is limited. Yangxinshi tablets, an herbal-based oral medicine, relieve symptoms of angina might be that they can improve energy metabolism of the ischemic myocardium. We conducted a randomized trial to assess the efficacy and safety of Yangxinshi vs. trimetazidine in improving exercise tolerance in patients with CHD after PCI.
Methods: This prospective, randomized, double-blind, double-dummy, multicenter, non-inferiority study enrolled patients aged 18-75 years with CHD who underwent their first PCI within 2 months of diagnosis. Patients were randomized to Yangxinshi plus trimetazidine-placebo or trimetazidine plus Yangxinshi-placebo for 24 weeks. The primary endpoint was the change in metabolic equivalents (METs) assessed by cardiopulmonary exercise test (CPET) between 0 and 24 weeks. Secondary endpoints were comprehensive variables of the CPET, health status and adverse events. This study has been registered at ClinicalTrials. gov (NCT03809273).
Results: Between August 1, 2019, and March 31, 2022, a total of 681 patients were randomized to Yangxinshi (n = 341) or trimetazidine (n = 340). After 24 weeks, the exercise tolerance of patients increased by 0.77±1.25 METs in the Yangxinshi group and 0.76±1.00 METs in the trimetazidine group (difference, 0.01; 95 % confidence interval [CI], -0.17 to 0.19), meeting the predefined non-inferiority threshold. Better outcomes were observed in the Yangxinshi group compared with the trimetazidine group for patient-reported depression (PHQ-9; -1.88±3.32 vs. -0.93±3.68; p < 0.001) and anxiety (GAD-7; -1.70±3.26 vs. -0.39±3.29; p < 0.001). Adverse events were similar in both groups.
Conclusions: In patients with CHD after PCI, Yangxinshi was non-inferior to trimetazidine in improving exercise tolerance during the 24-week treatment period. Notably, patients in the Yangxinshi group showed a better mental health profile compared with trimetazidine recipients.
期刊介绍：
Phytomedicine is a therapy-oriented journal that publishes innovative studies on the efficacy, safety, quality, and mechanisms of action of specified plant extracts, phytopharmaceuticals, and their isolated constituents. This includes clinical, pharmacological, pharmacokinetic, and toxicological studies of herbal medicinal products, preparations, and purified compounds with defined and consistent quality, ensuring reproducible pharmacological activity. Founded in 1994, Phytomedicine aims to focus and stimulate research in this field and establish internationally accepted scientific standards for pharmacological studies, proof of clinical efficacy, and safety of phytomedicines.
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