目的明确早期心脏康复训练对急性心肌梗死(AMI)经皮冠状动脉介入治疗(PCI)术后患者的临床价值,进一步探索不同心脏康复模式对AMI患者预后的效果。方法选取2014年1月—2016年5月绍兴市人民医院接受PCI的AMI患者90例,采用随机数字表法分为...目的明确早期心脏康复训练对急性心肌梗死(AMI)经皮冠状动脉介入治疗(PCI)术后患者的临床价值,进一步探索不同心脏康复模式对AMI患者预后的效果。方法选取2014年1月—2016年5月绍兴市人民医院接受PCI的AMI患者90例,采用随机数字表法分为3组,传统常规组(30例)、传统强化组(30例)和新型优化组(30例)。传统常规组根据2006年颁布的中国PCI术后心脏康复程序中急症PCI术后1周康复程序制定,以步行等简单的方式作为主要运动形式;传统强化组根据2006年颁布的中国PCI术后心脏康复程序中择期PCI术后康复程序制定,基础活动量和总活动量强于传统常规组;新型优化组在传统常规康复模式基础上,综合荷兰Avans大学、UMC St RAdboud医学院及香港伊利沙伯医院接受的最新心脏康复理念,为患者提供早期、个体化和精确定量的新型心脏康复方案。3组均为期6个月。各组患者分别于PCI术后即刻(康复前)和心脏康复干预6个月后(康复后)行心脏彩色多普勒检查,测量左心室射血分数(LVEF)、左心室收缩末期容积(LVESV)、左心室舒张末期容积(LVEDV)、室壁运动积分指数(WMSI)。测定血清中肿瘤坏死因子α(TNF-α)、一氧化氮(NO)、内皮素1(ET-1)、可溶性血管细胞黏附分子1(sVCAM-1)水平。观察患者心脏康复干预期间恶性心律失常、心绞痛、心力衰竭、猝死发生情况。结果康复前3组患者LVEF、LVESV、LVEDV、WMSI、TNF-α、NO、ET-1、sVCAM-1水平比较,差异均无统计学意义(P>0.05)。康复后传统强化组WMSI低于传统常规组,新型优化组LVEF高于传统常规组和传统强化组、WMSI低于传统常规组和传统强化组(P<0.05)。3组康复后LVEF较康复前升高(P<0.05)。康复后传统强化组TNF-α、ET-1、sVCAM-1水平低于传统常规组,NO水平高于传统常规组;新型优化组TNF-α、ET-1、sVCAM-1水平低于传统常规组和传统强化组、NO水平高于传统常规组和�展开更多
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 thi...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） 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.Conclusion Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients.展开更多
文摘目的明确早期心脏康复训练对急性心肌梗死(AMI)经皮冠状动脉介入治疗(PCI)术后患者的临床价值,进一步探索不同心脏康复模式对AMI患者预后的效果。方法选取2014年1月—2016年5月绍兴市人民医院接受PCI的AMI患者90例,采用随机数字表法分为3组,传统常规组(30例)、传统强化组(30例)和新型优化组(30例)。传统常规组根据2006年颁布的中国PCI术后心脏康复程序中急症PCI术后1周康复程序制定,以步行等简单的方式作为主要运动形式;传统强化组根据2006年颁布的中国PCI术后心脏康复程序中择期PCI术后康复程序制定,基础活动量和总活动量强于传统常规组;新型优化组在传统常规康复模式基础上,综合荷兰Avans大学、UMC St RAdboud医学院及香港伊利沙伯医院接受的最新心脏康复理念,为患者提供早期、个体化和精确定量的新型心脏康复方案。3组均为期6个月。各组患者分别于PCI术后即刻(康复前)和心脏康复干预6个月后(康复后)行心脏彩色多普勒检查,测量左心室射血分数(LVEF)、左心室收缩末期容积(LVESV)、左心室舒张末期容积(LVEDV)、室壁运动积分指数(WMSI)。测定血清中肿瘤坏死因子α(TNF-α)、一氧化氮(NO)、内皮素1(ET-1)、可溶性血管细胞黏附分子1(sVCAM-1)水平。观察患者心脏康复干预期间恶性心律失常、心绞痛、心力衰竭、猝死发生情况。结果康复前3组患者LVEF、LVESV、LVEDV、WMSI、TNF-α、NO、ET-1、sVCAM-1水平比较,差异均无统计学意义(P>0.05)。康复后传统强化组WMSI低于传统常规组,新型优化组LVEF高于传统常规组和传统强化组、WMSI低于传统常规组和传统强化组(P<0.05)。3组康复后LVEF较康复前升高(P<0.05)。康复后传统强化组TNF-α、ET-1、sVCAM-1水平低于传统常规组,NO水平高于传统常规组;新型优化组TNF-α、ET-1、sVCAM-1水平低于传统常规组和传统强化组、NO水平高于传统常规组和�
基金THIS STUDY WAS SUPPORTED BY GRANTS FROM NATIONAL TENTH FIVE-YEAR PROJECTS PLAN (NO. 2001BA701A20)
文摘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） 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.Conclusion Administration of XS0601 for 6 months is demonstrated to be safe and effective in reducing restenosis in post-PCI patients.
