XS0601 reduces the incidence of restenosis:: a prospective study of 335 patients undergoing percutaneous coronary intervention in China
XS0601 reduces the incidence of restenosis:: a prospective study of 335 patients undergoing percutaneous coronary intervention in China
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DOI：
10.1097/00029330-200601010-00002
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发表时间：
2006-01-05
影响因子：
6.1
通讯作者：
You, SJ
中科院分区：
文献类型：
--
作者：
Chen, KJ;Shi, DZ;You, SJ
背景 XS0601由活性成分（川芎醇和芍药苷）组成，在动物模型和初步人体研究中已被证明可以抑制动脉内膜增生。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。方法进行多中心、随机、双盲、安慰剂对照试验。共有 335 名患者在成功 PCI 后被随机分配接受口服 XS0601 或安慰剂治疗 6 个月。血管造影随访安排在 PCI 后 6 个月进行，临床随访则在 PCI 后 1、3 和 6 个月进行。主要终点是血管造影再狭窄。次要终点为死亡、目标病变非致命性心肌梗死、重复血管成形术和冠状动脉搭桥手术的综合发生率。 结果 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组的再狭窄率显着降低（26.0% vs. 47.2%，P < 0.05），并且最小管腔直径（MLD）更大[XS0601组为（2.08 +/- 0.89）min，安慰剂组为（1.73 +/- 0.94）min，P < 0.05]。 XS0601 还显着降低了主要不良心脏事件的综合发生率（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PCI术后3个月和6个月复发心绞痛的发生率（7.1%和11.0%）也显着降低（P < 0.05）。 XS0601组在6个月的随访期内未出现明显副作用。 结论 服用XS0601 6个月对于减少PCI术后患者的再狭窄是安全有效的。
Background 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).Methods 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.Results 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) min for XS0601 vs. (1.73 +/- 0.94) min 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.Conclusion Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients.