A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (eSZeSie∫a⟩S) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients
A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (eSZeSie∫a⟩S) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients
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DOI：
10.1007/s11655-011-0843-7
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发表时间：
2011-09-01
影响因子：
2.9
通讯作者：
Chen Ke-ji
中科院分区：
文献类型：
--
作者：
Shang Qing-hua;Xu Hao;Chen Ke-ji
评价由创雄乐和芍药苷组成的雄芍胶囊（eSZeSie integral a > S， XS）预防老年冠心病（CHD）患者PCI术后再狭窄的安全性和有效性。进行多中心、随机、双盲、安慰剂对照试验。共有335名冠心病患者在PCI成功后被随机分配到口服XS或安慰剂治疗6个月。分别于PCI术后1、3、6个月进行临床随访，6个月进行血管造影随访。主要终点是血管造影再狭窄，随访时定义为管腔狭窄a (c) 3/4 50%。次要终点是死亡率、靶病变非致死性心肌梗死、重复靶血管成形术和冠状动脉搭桥手术（CABG）的综合发生率。以上临床终点事件的随访持续至PCI后1年。对152例老年患者（68例血管造影随访）的亚组分析显示，与安慰剂组相比，XS组再狭窄发生率有降低的趋势（24.32% vs. 38.71%, P < 0.05），最小管腔直径（MLD）在随访期间显著升高（XS组2.15 +/- 0.84比安慰剂组1.73 +/- 0.91,P < 0.05）。与安慰剂组（17.72%和43.04%）相比，XS组在PCI术后3个月和6个月心绞痛复发的发生率也显著降低（4.11%和12.33%），但临床结局的综合发生率无显著差异（XS组为6.85%，安慰剂组为11.39%,P < 0.05）。XS组随访6个月无明显不良反应发生。在标准西药的基础上加用XS治疗6个月，对减少老年冠心病患者PCI术后心绞痛复发和抑制PCI术后管腔再狭窄安全有效。
To evaluate the safety and efficacy of Xiongshao Capsule (eSZeSie integral a > S, XS), consisting of Chuangxiongol and paeoniflorin, in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients.A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS, or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1, 3 and 6 months after PCI and an angiographic follow-up was scheduled at 6 months. The primary endpoint was angiographic restenosis defined as a luminal stenosis a (c) 3/4 50% in follow-up. The secondary endpoints were combined incidence of death, target lesion nonfatal myocardial infarction, repeat target-vessel angioplasty, and coronary artery bypass graft surgery (CABG). The follow-up for the above clinical endpoint events was continued to 1 year after PCI.The subgroup analysis of 152 senile patients (68 cases angiographic follow-up) showed that the restenosis rates tended to reduce in the XS group as compared with that in the placebo group (24.32% vs. 38.71%, P > 0.05), and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 +/- 0.84 for XS vs. 1.73 +/- 0.91 for placebo, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in the XS group (4.11% and 12.33%) as compared with those in the placebo group (17.72% and 43.04%), but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group, P > 0.05). No significant adverse reactions occurred within the 6-month follow-up period in the XS group.Administration of XS in addition to standardized Western medication for 6 months is demonstrated to be safe and effective in reducing post-PCI recurrent angina and inhibiting luminal restenosis after PCI in senile CHD patients.