中草药成分复杂，安全性值得关注，研究中使用心悦胶囊和复方川芎胶囊联合抗血小板药物干预的患者出血事件可能会增加。
研究表明，心悦胶囊和复方川芎胶囊联合抗血小板药物不会增加经皮冠状动脉介入治疗后轻度至中度肾功能不全的急性冠状动脉综合征患者出血事件的风险。药物性肝损伤在中药治疗中也经常受到质疑。本研究主要关注中药的安全性，未发现严重肝功能不全。
两组在基线研究中的性别比较存在显著差异。性别是冠状动脉疾病的危险因素之一，没有证据表明性别是肾功能不全的主要危险因素。多因素逻辑回归分析，表明性别因素对主要终点事件和次要终点事件没有影响。
Objective:To observe the role of Chinese herbal medicines in the cardiovascular outcome among patients with acute coronary syndrome (ACS) and renal insufficiency after percutaneous coronary intervention (PCI).
Methods:The subjects came from the 5C trial (chictr.org number: chictr-trc-07000021), post-PCI patients suffered from ACS with mild-to-moderate renal insufficiency (30 mL•min-1•1.73 m-2< estimated glomerular filtration rate≤89 mL•min-1•1.73 m-2) included. The study population consisted of 215 subjects in the control group who were treated with western medicine standard therapy, and 211 subjects in the treatment group who were treated with Chinese herbal medicines (Fufang Chuanxiong Capsule and Xinyue Capsule) for 6 months on the basis of western medicine standard therapy. All were followed for 1 year. The primary endpoint included the composite of cardiac death, nonfatal recurrent myocardial infarction, and ischemia-driven revascularization. Secondary endpoint included the composite of stroke, congestive heart failure, and readmission for ACS. The serum creatinine and estimated glomerular filtration rate (eGFR) were evaluated.
Results:After 1 year follow-up of two groups, there were 16 cases of primary endpoint in the control group and 6 cases of primary endpoint in the treatment group [absolute risk reduction (ARR): 0.046, 95%CI: 0.004-0.088; relative risk (RR): 0.38, 95%CI: 0.15-0.96, P = 0.040]. There were 15 cases of secondary endpoint in the control group and 5 cases of secondary endpoint in the treatment (ARR: 0.041, 95%CI: 0.006-0.086; RR: 0.34, 95%CI: 0.13-0.92, P = 0.033). The eGFR in the treatment group was significantly higher than that in the control group (75.19 ± 16.74 mL min-1·1.73 m-2VS 72.03 ± 14.96 mL min-1·1.73 m-2, P < 0.05). The eGFR in the treatment group was significantly higher after the intervention with Chinese herbal medicines than that before intervention (72.27 ± 11.83 mL min-1·1.73 m-2VS 75.19 ± 16.74 mL min-1·1.73 m-2, P < 0.05).
Conclusion:Chinese herbal medicines plus western medicine standard therapy improved clinical outcomes in patients with ACS and mild-to-moderate renal insufficiency. Additionally, this study also demonstrated Chinese herbal medicines were useful in deferring decline of renal function.
