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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个月重复血管造影在缬沙坦组有1例发生支架内再狭窄。⑤6个月复查运动试验缬沙坦组阳性(25.7%)的比例低于对照组(36.4%),但未达到统计学差异。结论:成功介入治疗后的冠心病患者口服6个月缬沙坦有降低复发心肌缺血事件和运动试验阳性率的趋势。
BACKGROUND: Valsartan, an angiotensin II receptor antagonist, has been tested in a considerable number of settings for its protective effect on the heart. Val-PREST study confirmed that long-term oral valsartan stent restenosis rate was significantly reduced, but the current lack of valsartan Chinese stent implantation restenosis rate study reports. PURPOSE: To evaluate the effect of valsartan on clinical events in patients with coronary atherosclerotic heart disease (CAD) after successful intervention. Design: Multi-center, randomized, double-blind assessment, prospective design. SETTING: Beijing Friendship Hospital affiliated to Capital Medical University, Beijing Anzhen Hospital affiliated to Capital Medical University, Peking Union Medical College Hospital, Peking University People’s Hospital, Beijing Tongren Hospital affiliated to Capital Medical University, Beijing Shijingshan Hospital, Beijing Fuxing Hospital affiliated to Capital Medical University, Beijing City vertical willow hospital. PARTICIPANTS: A total of 200 patients with coronary heart disease (CAD) were enrolled in 8 Grade 3 Class Hospitals of Beijing after successful interventional treatment of bare metal stents. They were randomly divided into valsartan group and control group of 100 patients according to a uniform random number, and selected for 2002-12 / 2003-10 completed. The actual number of cases selected 196 cases (100 cases of valsartan, 96 cases of control group). Interventions: The two groups of the same basic drugs (including aspirin, clopidogrel, nitrates, statins, β-blockers or calcium antagonists, etc.), valsartan group based on the addition of valsalon Tan 80mg (Beijing Novartis Pharmaceutical Co., Ltd., batch number: SD34004), 1 / d orally. All patients were followed up for 6 months. MAIN OUTCOME MEASURES: ① Six-month clinical cardiovascular adverse events (death, non-fatal myocardial infarction, recurrent myocardial ischemia, target revascularization). ② 6 months, some patients completed repeat coronary angiography or exercise test, the observation results. Results: ① Two patients (2%) in the valsartan group were withdrawn from the trial due to poor drug resistance. A total of 194 patients were followed up. ② There was no difference in the basic conditions between the two groups. There was no significant difference in the types of lesions, cardiac function and vascular vessel count (P> 0.05). At 6 months of follow-up, there was 1 death in the control group, 1 in each group, and 1 in the valsartan group. The target vessel remodeling was performed in the valsartan group. The valsartan group with recurrent myocardial ischemia was slightly lower than the control group 11.2% vs. 15.6%), but did not reach statistical significance. ④ 6-month repeat angiography in the valsartan group, 1 case of stent restenosis occurred. ⑤ After 6 months of review, the proportion of patients with valsartan-positive (25.7%) was lower than that of the control group (36.4%), but did not reach statistical significance. CONCLUSION: Valsartan, administered orally for 6 months after successful intervention, has the tendency to reduce the incidence of recurrent myocardial ischemia and exercise test.