专题研究(Monographic Study)

药物涂层球囊治疗下肢动脉硬化闭塞症的疗效

Published at: 2016年第25卷第12期

张天华 1 , 迟德财 1 , 姜维良 1
1 哈尔滨医科大学附属第二医院 血管外科,黑龙江 哈尔滨 150086
通讯作者 天华 张 Email: hunterzth@163.com
DOI: 10.3978/j.issn.1005-6947.10.3978/j.issn.1005-6947.2016.12.009
基金:

摘要

目的:探讨紫杉醇药物涂层球囊(DCB)治疗下肢动脉硬化闭塞症的疗效。方法:将28例符合条件的股腘动脉病变患者纳入研究。患者均有中度至重度的间歇性跛行或缺血性静息痛(Rutherford 2~4级),狭窄程度为70%~99%,同时满足病变长度为4~20 cm,或者为累及股浅动脉至腘动脉近端的≤10 cm的闭塞性病变。其中17例采用DCB治疗(DCB组),11例采用金属裸支架(BMS)治疗(BMS组)。主要疗效终点指标为随访12个月后的一期通畅率,靶病变处血运重建和再狭窄的发生等情况。结果:两组患者术前临床资料差异均无统计学意义(均P>0.05);12个月后随访,DCB组与BMS组一期通畅率无统计学差异(88.2% vs. 72.7%,P=0.35),但DCB组靶病变处血运重建率优于较BMS组(5.9% vs. 45.5%,P=0.02);两组均未出现术中死亡或手术相关死亡,均未出现主要肢体的截肢,DCB组与BMS组靶病变处血栓形成率分别为5.9% vs. 9.1%;12个月随访显示两组在功能改善效果相似。结论:DCB在治疗下肢动脉硬化闭塞症有良好的临床疗效,无论通畅率或者预防再狭窄以及安全性方面均不劣于BMS。对于股腘动脉病变的患者,DCB可能是重要的治疗选择。


Efficacy of drug-coated balloon in treatment of lower limb atherosclerosis obliterans

Abstract

Objective: To investigate the efficacy of paclitaxel-eluting drug-coated balloon (DCB) in treatment of atherosclerosis obliterans (ASO) of the lower extremities. Methods: Twenty-eight eligible patients with femoropopliteal disease were enrolled to study. All patients had moderate or severe intermittent claudication or ischemic rest pain (Rutherford grade 2–4), the degree of stenosis ranging from 70% to 99%, and simultaneously with length of lesion between 4 and 20 cm or occlusive lesion ≤10 cm involving the superficial femoral artery to proximal popliteal artery. Of the patients, 17 cases received DCB treatment (DCB group), and 11 cases received bare metal stent (BMS) implantation (BMS group). The end-point measurements of the main efficacy were the patency rates, and revascularization and restenosis in the region of the target lesion at 12 months after operation. Results: There was no statistical difference in all clinical variables between the two groups before operation (all P>0.05). At follow-up 12 months after operation, the primary patency rates between DCB group and BMS group showed no significant difference (88.2% vs. 72.7%, P=0.35), but the revascularization rate in the region of the target lesion in DCB group was significantly better than that in BMS group (5.9% vs. 45.5%, P=0.02). In both groups, no intraoperative or procedure-related death occurred and no major amputation was required. The thrombosis formation rate in the region of the target lesion in DCB group and BMS group was 5.9% and 9.1%, respectively. The functional improvements of the two groups were similar at follow-up 12 months later. Conclusion: DCB has a good clinical efficacy in treatment of ASO of the lower limbs, and is not inferior to BMS in terms of patency rate and restenosis prevention as well as safety. DCB may be an important therapeutic alternative for patients with femoropopliteal lesions.


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引用

引用本文: 天华 张, 德财 迟, 维良 姜. 药物涂层球囊治疗下肢动脉硬化闭塞症的疗效 [J]. 中国普通外科杂志, 2016, 25(12): 1719-1724.
Cite this article as: ZHANG Tianhua, CHI Decai, JIANG Weiliang . Efficacy of drug-coated balloon in treatment of lower limb atherosclerosis obliterans [J]. Chin J Gen Surg, 2016, 25(12): 1719-1724.