目的 探讨消瘀降脂胶囊对非ST段抬高型急性冠脉综合征（NSTE-ACS）患者经皮冠状动脉介入治疗（PCI）术后心肌损伤和血管内皮功能的保护作用及用药安全性，探索性评估其对主要不良心脑血管事件（MACCE）的影响。方法 选择2018年10月—2019年10月上海交通大学医学院附属第六人民医院收治的拟行PCI治疗的NSTE-ACS患者73例，随机分为对照组和试验组。对照组予PCI术后西医常规治疗，试验组在常规治疗基础上联用消瘀降脂胶囊，疗程8周。所有患者均进行PCI术后4年随访。比较两组治疗前后心肌损伤指标高敏肌钙蛋白（hs-cTnI）、血管内皮功能指标内皮素-1（ET-1）和血管性血友病因子（vWF）水平的变化，PCI术后4年MACCE发生率，以及肝肾功能指标的变化。结果 治疗8周，试验组hs-cTnI、ET-1和vWF水较治疗前显著降低（P＜0.05），且显著低于对照组（P＜0.05）。PCI术后4年随访结果显示，试验组4重复合终点（4P-MACCE：死亡、心肌梗死、卒中或重复血运重建）发生率为10.34%，低于对照组23.33%，风险比（HR）为0.36[95%置信区间（CI）： 0.10～1.25]，相对风险降低55.7%；试验组3P-MACCE（死亡、心肌梗死或卒中）发生率低于对照组（6.90% vs 13.3%； HR=0.42，95% CI： 0.08～2.12），相对风险降低48.2%。与对照组相比，试验组MACCE发生风险呈现良好的降低趋势。两组受试者治疗后均未出现血清丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）与血肌酐（Scr）水平异常。结论 在NSTE-ACS患者PCI术后的综合管理中，联用消瘀降脂胶囊可显著减轻心肌损伤、改善血管内皮功能，并展现降低长期MACCE发生风险的临床获益趋势，且安全性良好，这为其在心血管二级预防中的应用提供了潜在价值。

Objective To investigate the protective effects of Xiaoyujiangzhi Capsules on myocardial injury and vascular endothelium function, and the treatment safety in patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) after percutaneous coronary intervention (PCI), and to exploratively evaluate the potential influence on major adverse cardiac and cerebrovascular events (MACCE). Methods A total of 73 patients with NSTE-ACS who were scheduled to undergo PCI at the Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine between October 2018 and October 2019 were selected and randomly allocated to either a control group or an experimental group. The control group received standard post-PCI western medical treatment, while the experimental group received Xiaoyujiangzhi Capsules combined with standard treatment for 8 weeks. All patients were followed up for 4 years post-PCI. The following parameters were compared between the two groups: changes in myocardial injury markers (high-sensitivity cardiac troponin I, hs-cTnI), vascular endothelial function indicators (endothelin-1, ET-1; von Willebrand factor, vWF), the incidence of major adverse cardiac and cerebrovascular events (MACCE) at 4 years after PCI, as well as changes in liver and kidney function indicators. Results After eight weeks of treatment, levels of hs-cTnI, ET-1, and vWF in the experimental group were significantly lower than those before treatment (P<0.05) and significantly lower than those in the control group (P<0.05). The 4-year follow-up results post-PCI showed that the incidence of the 4-component composite endpoint (4P-MACCE: death, myocardial infarction, stroke, or repeat revascularization) was 10.34% in the experimental group, lower than 23.33% in the control group, with a hazard ratio (HR) of 0.36 (95% CI: 0.10–1.25) and a relative risk reduction (RRR) of 55.7%. The incidence of the 3- component composite endpoint (3P-MACCE: death, myocardial infarction, or stroke) was lower in the experimental group than in the control group (6.90% vs 13.3%, HR = 0.42, 95% CI: 0.08–2.12), with an RRR of 48.2%. Compared with the control group, the experimental group showed a favorable trend towards reducing MACCE risk. Regarding safety, no abnormalities in serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine (Scr) levels were observed in both two groups after treatment. Conclusion In the comprehensive management of NSTE-ACS patients post-PCI, the addition of Xiaoyujiangzhi Capsules to standard therapy significantly alleviates myocardial injury, improves vascular endothelial function, and demonstrates a clinical trend towards reducing the risk of long-term MACCE, with a good safety profile. This provides potential value for its application in cardiovascular secondary prevention.

R965