Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Evid Based Complement Alternat Med. 2013;2013:741518. doi: 10.1155/2013/741518. Epub 2013 Jul 2.
Aims. To evaluate the efficacy of Chinese herbal medicines (CHMs) plus conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI). Methods and Results. Participants (n = 808) with ACS who underwent PCI from thirteen hospitals of mainland China were randomized into two groups: CHMs plus conventional treatment group (treatment group) or conventional treatment alone group (control group). All participants received conventional treatment, and participants in treatment group additionally received CHMs for six months. The primary endpoint was the composite of cardiac death, nonfatal recurrent MI, and ischemia-driven revascularization. Secondary endpoint was the composite of readmission for ACS, stroke, or congestive heart failure. The safety endpoint involved occurrence of major bleeding events. The incidence of primary endpoint was 2.7% in treatment group versus 6.2% in control group (HR, 0.43; 95% CI, 0.21 to 0.87; P = 0.015). The incidence of secondary endpoint was 3.5% in treatment group versus 8.7% in control group (HR, 0.39; 95% CI, 0.21 to 0.72; P = 0.002). No major bleeding events were observed in any participant. Conclusion. Treatment with CHMs plus conventional treatment further reduced the occurrence of cardiovascular events in patients with ACS after PCI without increasing risk of major bleeding.
目的。评价中药（CHMs）联合常规治疗对经皮冠状动脉介入治疗（PCI）后急性冠状动脉综合征（ACS）患者的疗效。
方法和结果。中国大陆 13 家医院的 808 名接受 PCI 的 ACS 患者被随机分为两组：中药联合常规治疗组（治疗组）或单纯常规治疗组（对照组）。所有参与者均接受常规治疗，治疗组参与者另外接受 CHMs 治疗六个月。主要终点是心脏死亡、非致死性复发性 MI 和缺血驱动的血运重建的复合终点。次要终点是 ACS、中风或充血性心力衰竭再入院的复合终点。安全性终点包括主要出血事件的发生。治疗组的主要终点发生率为 2.7%，对照组为 6.2%（HR，0.43；95%CI，0.21 至 0.87；P = 0.015）。治疗组的次要终点发生率为 3.5%，对照组为 8.7%（HR，0.39；95%CI，0.21 至 0.72；P = 0.002）。任何参与者均未发生主要出血事件。
结论。在 PCI 后 ACS 患者中，与单纯常规治疗相比，加用 CHMs 治疗可进一步降低心血管事件的发生，而不增加大出血的风险。
