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Objective: This double-blind and randomized placebo-controlled trial evaluated the safety and efficacy of Danhong injection combined with Naoxintong capsule in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI).

目的: 采用随机双盲对照试验评价丹红注射液联合脑心通胶囊在急性冠状动脉综合征 (ACS)PCI术后的疗效及安全性

Methods: ACS patients scheduled to undergo PCI (n = 130) were equally and

randomly apportioned to either a treatment or control group. After PCI, the treatment group received Danhong injection combined with Naoxintong capsule for 12 weeks,while the control group was given placebo. Both groups were otherwise treated with conventional secondary prevention of coronary artery disease. The groups were primarily evaluated for clinical efficacy and cardiovascular events. Evaluative indicators of safety included adverse events, platelet count, and liver, renal, and blood coagulation functions.

方法: 计划接受PCI治疗的ACS患者 (n=130),随机分配给治疗或对照组。PCI后,治疗组给予丹红注射液联合脑心通胶囊12周,对照组给予安慰剂。两组均予冠状动脉疾病的常规二级预防。评估临床疗效和心血管事件发生情况。评价安全指标包括不良事件、血小板计数、肝脏、肾脏和血液凝血功能.

Result: No cardiovascular events or adverse reactions were observed in either group.The treatment group demonstrated better signs of clinical efficacy, including left ventricular ejection fraction, higher nitric oxide levels, and lower levels of endothelin (ET)-1 and von Willebrand factor (VWF).

结果: 两组均无心血管事件或不良反应。丹红注射液联合脑心通胶囊治疗组表现出更好的临床疗效, 包括左心室射血分数、高NO水平、内皮素水平较低(ET)-1和血管性血友病因子较低(VWF)。

Conclusion: ACS patients treated with Danhong injection combined with Naoxintong capsule after PCI demonstrated better improvement with regard to markers associated with atherosclerosis and adverse cardiovascular events, without apparent adverse effects. Thus, Danhong injection combined with Naoxintong capsule was safe and effective for treating ACS patients after PCI.

结论:丹红注射液联合脑心通胶囊治疗ACS患者的PCI术后临床观察显示，对动脉粥样硬化和减少心血管相关不良事件有更好的改善效果,与对照组比较没有明显的不良反应。因此,丹红注射液联合脑心通胶囊治疗是安全的,治疗ACS患者PCI术后疗效良好。