通心络胶囊联合吡格列酮对2型糖尿病合并冠心病冠状动脉支架内再狭窄的影响：一项前瞻性随机双盲平行安慰剂对照研究  

Effect of Tongxinluo capsule combined with pioglitazone for treatment of coronary stent restenosis in patients with coronary heart disease and type 2 diabetes： a prospective randomized double-blind placebo-controlled study

作　　者：杨铁骊[1] 潘胜军[1] 张小方[1] 李丽蓉[1] 钱国强[1] 

机构地区：[1]黄淮学院附属医院,河南驻马店463000

出　　处：《中国中西医结合急救杂志》2016年第4期341-347,共7页Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care

基　　金：河南省重点科技攻关项目（122102310473）

摘　　要：目的观察通心络胶囊联合吡格列酮对2型糖尿病合并冠心病接受雷帕霉素药物洗脱支架（DES）介入治疗后支架内再狭窄（ISR）的影响。方法采用前瞻性随机双盲平行安慰剂对照研究方法，将黄淮学院附属医院343例成功实施经皮冠状动脉介入治疗fPCI）植入雷帕霉素DES的2型糖尿病合并冠心病患者按随机数字表法分为观察组（172例）和对照组（171例）。观察组在常规用药基础上服用通心络胶囊和吡格列酮，对照组在常规用药基础上服用与通心络胶囊相同规格等量的安慰剂胶囊和吡格列酮，治疗周期均为12个月。两组于PCI术后随访12个月并于术后12个月复查冠状动脉（冠脉）造影（CAG）。比较两组随访期间主要不良心血管事件（MACE）发生率，1年后1SR率和相关参数，随访期间血小板活化标志物和血管内皮功能指标；比较343例使用Firebird或Cypher支架患者的安全性和有效性。结果观察组复发心绞痛[AP：4．65％（8／172）比9．94％（17／171）]、急性心肌梗死[AMI：1．16％（2／172）比2．92％（5／171）]、心力衰竭[HF：1．74％（3／172）比5．26％（9／171）]和MACE发生率[4．65％（8／172）比10．53％（18／171）]均较对照组显著降低（均P〈0．05）；介入后1年观察组直径狭窄率[（10．21±10．42）％比（25．93±11．74）％]、晚期管腔丢失[LLL（mm）：0．21±0．17比0．45±0．24）和ISR率[2．33％（4／172）比8．19％（14／171）]均较对照组显著降低（均P〈0．05），最小管腔内径（MLD）较对照组显著升高（mm：2．81±0．41比2．46±0．37，P〈0．05）。两组患者介入后当日α颗粒膜糖蛋白（CD62p）、溶酶体膜糖蛋白（CD63p）和血小板膜糖蛋白（GP）Ⅱb／Ⅲa受体复合物、血管性血友病因子（vWF）和内皮素-1（ET-1）均较介入前显著升高，一氧化氮（NO）较介入前显著降低（均P〈0．05）；�Objective To investigate the effect of Tongxinluo capsule combined with pioglitazone for treatment of in-stent restenosis （ISR） after having received rapamycin drug-eluting stent （DES） intervention in patients with type 2 diabetes mellitus complicated with coronary heart disease. Methods A prospective randomized double-blind placebo-controlled study was conducted. 343 cases of successful implementation of percutaneous coronary intervention （PCI） with implantation of rapamycin DES in patients with type 2 diabetes mellitus and coronary heart disease admitted to Affiliated Hospital of Huanghuai University were randomly divided into observation group （172 cases）and control group （171 cases） according to the random number table method. Conventional treatment was given to the observation group and control group. In addition, in the observation group, Tongxinluo capsule and pioglitazone were given to the patients, while in the control group, the patients took placebo capsules （with the same specification and dosage as those of Tongxinluo） and pioglitazone, the treatment cycle being 12 months in both groups. After PCI the patients in the two groups were followed up for 12 months, and in the end, coronary angiography （CAG） was repeated. The incidences of major adverse cardiovascular events （MACE） during follow-up, the incidence of ISR after 1 year and the related parameters including platelet activation markers and vascular endothelial function index during follow-up were compared between the two groups. According to stent types, 343 patients were divided into Firebird and Cypher groups, and their safety and effectiveness were compared. Results The recurrence rate of angina pectoris [AP： 4.65% （8/172） vs. 9.94% （17/171）], the incidences of acute myocardial infarction [AMI： 1.16% （2/172） vs. 2.92% （5/171）], heart failure [HF： 1.74% （3/172） vs. 5.26% （9/171）] and of MACE [4.65% （8/172） vs. 10.53% （18/171）] in the observation group were significantly lower

关 键 词：通心络胶囊 吡格列酮 2型糖尿病 冠心病 支架内再狭窄 主要不良心血管事件 

分 类 号：R587.1[医药卫生—内分泌]