缬沙坦对冠状动脉粥样硬化性心脏病患者介入治疗后长期预后的影响:多中心双盲评估的随机对照研究(英文)  

Effect of valsartan on the long-term prognosis of patients with coronary atherosclerotic heart disease following successful intervention therapy:Multicenter,double blind,randomized and controlled evaluation

作　　者：王雷[1] 贾三庆[1] 陈方[2] 马长生[2] 张抒扬[3] 赵红[4] 庞文跃[5] 王明生[6] 杨明[7] 李瑞杰[8] 

机构地区：[1]首都医科大学附属北京友谊医院心血管疾病诊治研究中心,北京市100050 [2]首都医科大学附属北京安贞医院,北京市100029 [3]北京协和医院,北京市100730 [4]北京大学人民医院,北京市100044 [5]首都医科大学附属北京同仁医院,北京市100730 [6]北京市石景山医院,北京市100043 [7]首都医科大学附属北京复兴医院,北京市100038 [8]北京市垂杨柳医院,北京市100022

出　　处：《中国组织工程研究与临床康复》2007年第8期1577-1580,共4页Journal of Clinical Rehabilitative Tissue Engineering Research

摘　　要：背景:缬沙坦是一血管紧张素Ⅱ受体拮抗剂,已有相当多的试验证实它对于心脏的保护作用。Val-PREST研究证实长期口服缬沙坦可使支架内的再狭窄率显著降低,但目前缺乏缬沙坦对中国人支架植入术后再狭窄率影响的研究报道。目的:评价成功介入治疗后的冠状动脉粥样硬化心脏病(简称冠心病)患者口服6个月缬沙坦对临床事件的影响。设计:多中心、随机对照、双盲法评估,前瞻性设计。单位:首都医科大学附属北京友谊医院、首都医科大学附属北京安贞医院、北京协和医院、北京大学人民医院、首都医科大学附属北京同仁医院、北京市石景山医院、首都医科大学附属北京复兴医院、北京市垂杨柳医院。对象:在北京8家3级甲等医院入选200例金属裸支架介入治疗成功后的冠心病患者,按照统一的随机号随机分为缬沙坦组和对照组各100例,入选工作2002-12/2003-10完成。实际入选病例数196例(缬沙坦组100例,对照组96例)。干预措施:两组基础用药相同(包括阿司匹林、氯吡格雷、硝酸酯类药物、他汀类药物、β-阻滞剂或钙离子拮抗剂等),缬沙坦组在此基础上加用缬沙坦80mg(北京诺华制药有限公司,批号:SD34004),1次/d口服。所有患者随访6个月。主要观察指标:①6个月临床心血管不良事件(死亡、非致命性心肌梗死、复发心肌缺血、靶血管再次血运重建)。②6个月时部分患者完成重复冠脉造影检查或运动试验,观察结果。结果:①缬沙坦组有2例(2%)因药物耐受不良在随访过程中退出试验,共有194例完成随访。②2组患者基础情况没有差异,病变类型、心功能及病变血管支数均没有统计学差异(P>0.05)。③6个月随访时,对照组死亡1例,两组各有1例急性心肌梗死发生,缬沙坦组1例进行了靶血管重建,复发心肌缺血事件缬沙坦组略低于对照组(11.2%比15.6%),但未达到统计学差异。④6个月BACKGROUND ： Valsartan is an antagonist of angiotensin Ⅱ（Ang Ⅱ） receptor. Many researches have proved that it can protect heart tissue. Val-PREST suggests that valsartan with a long-term administration can decrease restenosis rate in stent; however, effect of valsartan on restenosis rate of Chinese population is still unclear presently. OBJECTIVE： To evaluate the effect of oral valsartan for 6 months on patients with coronary heart disease （CHD） who undertook successful intervention therapy. DESIGN： Multicenter, double blind, randomized, and controlled evaluation and prospective design. SETTING： Beijing Friendship Hospital Affiliated to Capital Medical University; Beijing Anzhen Hospital Affiliated to Capital Medical University; Peking Union Hospital; People＇s Hospital of Peking University; Beijing Tongren Hospital Affiliated to Capital Medical University; Beijing Shijingshan Hospital; Beijing Fuxing Hospital Affiliated to Capital Medical University; Beijing Chuiyangliu Hospital. PARTICIPANTS： Eight three-grade A hospitals in Beijing participated in the study. Since December 2002 to October 2003, a total of 200 patients who underwent bare mental stent implantation were consented, but 196 patients were recruited in the end. All 196 patients were randomized into valsartan group （100 cases） and control group （96 cases）. METHODS： Basic medicines in the two group included aspirin, ciopidogrel, nitrides, statins, β-receptor antagonists, calcium channel antagonists, etc. Additionally, Patients in valsartan group were also given valsartan （Beijing Nuohua Pharmaceutical Co. Ltd., batch number： SD 34004） in a dosage of 80 mg a day. Both groups were followed-up once a month for total 6 months. MAIN OUTCOME MEASURES： ①Major adverse cardiac events within 6 months on clinics （death, non-fatal myocardial infarction, hospitalisation once more due to recurrent myocardial ischemia, and target vessel revascularization）; ②Results of duplicated coronary angiography or exe

关 键 词：缬沙坦 冠心病 运动试验 

分 类 号：R541.4[医药卫生—心血管疾病]