Chen Ke-ji, Shi Da-zhuo, Xu Hao, Lü Shu-zheng, Li Tian-chang, Ke Yuan-nan, Zhang Min-zhou, Lu Xiao-yan, Sun Rui-yuan, You Shi-jie
Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.
Chin Med J (Engl). 2006 Jan 5;119(1):6-13.
XS0601, consisting of active ingredients (Chuangxiongol and paeoniflorin), has been shown to inhibit arterial neointimal hyperplasia in animal models and in preliminary human studies. The objective of this study was to evaluate the safety and efficacy of XS0601 in preventing restenosis following percutaneous coronary intervention (PCI).
A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 patients were randomized into treatment with the oral administration of XS0601, or a placebo for 6 months after successful PCI. Angiographic follow-up was scheduled at 6 months, and clinical follow-ups performed at 1, 3 and 6 months after PCI. The primary end point was angiographic restenosis. The secondary end points were the combined incidence of death, target lesion nonfatal myocardial infarction, repeat angioplasty, and coronary artery bypass graft surgery.
A total of 308 patients (91.9%) completed the study and 145 cases (47.1%) received angiographic follow-up. The restenosis rates were significantly reduced in the XS0601 group as compared with the placebo group (26.0% vs. 47.2%, P < 0.05), and the minimum lumen diameter (MLD) was greater [(2.08 +/- 0.89) mm for XS0601 vs. (1.73 +/- 0.94) mm for placebo, P < 0.05]. XS0601 also significantly reduced the combined incidence of major adverse cardiac event (10.4% in the XS0601 group vs. 22.7% in the placebo group, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in XS0601 group (7.1% and 11.0%) as compared with those in placebo group (19.5% and 42.9%) (P < 0.05). No significant side effects occurred within the 6-month follow-up period in the XS0601 group.
Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients.
XS0601由活性成分（川芎哚和芍药苷）组成，已在动物模型和初步人体研究中显示可抑制动脉内膜增生。本研究的目的是评估XS0601预防经皮冠状动脉介入治疗（PCI）后再狭窄的安全性和有效性。
进行了一项多中心、随机、双盲、安慰剂对照试验。总共335例患者在成功PCI后被随机分为口服XS0601治疗组或安慰剂组，治疗6个月。计划在6个月时进行血管造影随访，并在PCI后1、3和6个月进行临床随访。主要终点是血管造影再狭窄。次要终点是死亡、靶病变非致命性心肌梗死、再次血管成形术和冠状动脉旁路移植术的联合发生率。
共有308例患者（91.9%）完成了研究，145例（47.1%）接受了血管造影随访。与安慰剂组相比，XS0601组的再狭窄率显著降低（26.0%对47.2%，P<0.05），最小管腔直径（MLD）更大[XS0601组为（2.08±0.89）mm，安慰剂组为（1.73±0.94）mm，P<0.05]。XS0601还显著降低了主要不良心脏事件的联合发生率（XS0601组为10.4%，安慰剂组为22.7%，P<0.05）。与安慰剂组（19.5%和42.9%）相比，XS0601组在PCI后3个月和6个月时复发性心绞痛的发生率也显著降低（7.1%和11.0%）（P<0.05）。在XS0601组6个月的随访期内未发生明显副作用。
证明服用XS0601 6个月对降低PCI术后患者的再狭窄是安全有效的。
