国产可降解雷帕霉素药物洗脱支架置入的疗效评价：与金属裸支架比较

中国组织工程研究与临床康复第15卷第3期2011–01–15出版

Journal of Clinical Rehabilitative Tissue Engineering Research January 15, 2011 Vol.15, No.3 ISSN 1673-8225 CN 21-1539/R CODEN: ZLKHAH

487 Department of Cardiology, Shenzhou Hospital Affiliated to Shenyang Medical College, Shenyang 110002, Liaoning Province, China

Zhao Hong-li★, Master, Associate chief physician, Department of Cardiology, Shenzhou Hospital Affiliated to Shenyang Medical College, Shenyang 110002, Liaoning Province, China

zhao_hongli@ sina.c om.c n Correspondence to: Li Lu, Doctor, Chief physician, Department of Cardiology, Shenzhou Hospital Affiliated to Shenyang Medical College, Shenyang 110002, Liaoning Province, China liluxin5@

Supported by: Science and Technology Program of Shenyang, No. 1081284-9-00*

Received: 2010-07-21 Accepted: 2010-09-26

国产可降解雷帕霉素药物洗脱支架置入的疗效评价：与金属裸支架比较*★赵红丽，李潞，王帅，李纯

Efficacy of homemade biodegradable rapamycin drug-eluting stent implantation: Compared with bare-metal stents

Zhao Hong-li, Li Lu, Wang Shuai, Li Chun

Abstract

BACKGROUND:The drug-eluting stent (DES) can obviously decrease restenosis rate, but permanent polymer coating impedes

the process of vascular endothelial and promotes restenosis, cause many complications such as late thrombosis at the same

time of the inhibition of vascular smooth muscle cells proliferation.

OBJECTIVE: To investigate the long-term outcomes and safety after homemade biodegradable DES implantation for patients

with coronary artery disease and diabetes mellitus, and compare with bare-metal stents.

METHODS: A total of 136 consecutive patients of coronary artery disease and type-2 diabetes mellitus, receiving homemade

biodegradable DES (EXCEL TM) implantation following percutaneous coronary angioplasty were studied as DES group; A total of

87 patients with coronary artery disease and type-2 diabetes mellitus treated with bare-metal stents were included as control

group. All patients were identified and followed up at least 12 months. The differences of major adverse cardiovascular events

were recorded and the patients were rechecked undergoing quantitative coronary angiography.

RESULTS AND CONCLUSION: A total 129 patients in DES group and 83 patients in control group accomplished follow-up at a

mean time of (13.5±3.5) months. There were 8 patients and 12 patients in DES group and control group appeared major adverse

cardiovascular events with significant difference between the two groups (P=0.045), the rate of target vessel revascularization

and repeated angina were higher control group than in BMS group (P < 0.05). The late loss index and restenosis rate with DES

were lower when underwent quantitative coronary angiograph follow-up (P < 0.05). The restenosis and major adverse

cardiovascular events were reduced by homemade biodegradable DES in coronary heart disease patients with diabetic mellitus,

and DES is safe and effective with improved long-termed prognosis.

Zhao HL, Li L, Wang S, Li C.Efficacy of homemade biodegradable rapamycin drug-eluting stent implantation: Compared with

bare-metal stents. Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu. 2011;15(3): 487-490.

[ ]

摘要

背景：药物洗脱支架明显降低了再狭窄率，但永久聚合物涂层在抑制血管平滑肌细胞增生的同时，阻碍血管完全内皮化进

程，促使再狭窄发生，且永久聚合物涂层可引发晚期血栓等并发症。

目的：观察冠心病合并糖尿患者置入国产可降解药物洗脱支架后的远期疗效和安全性，并与置入金属裸支架患者进行比较。

方法：实验组选择冠心病合并2型糖尿病患者136例，首次经皮冠状动脉成形治疗，置入国产可降解药物洗脱支架

(EXCEL TM)，并以同期行金属裸支架置入治疗的冠心病合并2型糖尿病患者87例为对照组，随访12个月以上，记录主要

不良心血管事件发生情况，并复查冠状动脉造影。

结果与结论：实验组129例，对照组83例完成(13.5±3.5)个月随访，实验组及对照组分别有8例及12例患者发生不良心

血管事件，两组间差异有显著性意义(P=0.045)，对照组靶血管血运重建及再发心绞痛多于实验组(P < 0.05)。两组患者随访

冠状动脉造影的定量分析提示实验组最终丢失指数小于对照组(P < 0.05)，再狭窄率低于对照组(P < 0.05)。说明对于冠心病

合并糖尿病患者，应用国产可降解药物洗脱支架可降低不良心血管事件发生率，减少再狭窄，改善患者远期预后，安全性

能良好。

关键词：血管成形；裸支架；可降解药物洗脱支架；经皮冠状动脉；糖尿病

doi:10.3969/j.issn.1673-8225.2011.03.026

赵红丽，李潞，王帅，李纯.国产可降解雷帕霉素药物洗脱支架置入的疗效评价：与金属裸支架比较[J].中国组织工程研究与

临床康复，2011，15(3):487-490. [h ttp:// h ttp://]

0 引言

冠状动脉内支架置入是冠状动脉粥样硬化性心脏病(冠心病)介入治疗的重大发展，裸金属支架再狭窄率可达20%~40%，2003年药物洗脱支架的应用使再狭窄率明显降低，是又一个介入治疗的里程碑，但近年来药物洗脱支架置入后晚发支架内血栓形成，引起广泛关注[1-2]。研究证实药物洗脱支架明显降低再狭窄率的同时，其表面永久聚合物涂层在抑制血管平滑肌细胞增生的同时，阻碍血管完全内皮化进程，可引发支架内血栓形成[3-4]，故新一代药物洗脱支架着重于改善多聚物的生物相容性，通过应用可降解的多聚物来提高支架的安全性能。冠心病是糖尿病的重要并发症，同时糖尿病是支架内再狭窄的最主要危险因素[5]，在接受冠状动脉介入治疗的患者中，糖尿病患者占20%~