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药物涂层球囊与普通球囊治疗股膕动脉硬化闭塞的疗效比较:前瞻性随机对照试验 预览 被引量:5

Efficacy of drug-coated balloon and common balloon for treatment of superficial femoral artery and popliteal artery arteriosclerosis obliterans:prospective randomized controlled triac
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摘要 目的对比药物涂层球囊与普通球囊治疗股腘动脉硬化闭塞的疗效差异。方法收集2015年9月~2016年12月收治于南京市第一医院介入血管科符合入组标准且完成随访的46例患者的临床资料。入组患者由计算机随机分入药物涂层球囊组(n=23)和普通球囊组(n=23)。入组标准:同侧单个或多个股浅动脉和/或腘动脉病变(3~15 cm之间的狭窄或闭塞)、Rutherford分级2~5级、伴有或不伴有其他伴随疾病。排除标准:支架内再狭窄,动脉瘤,急性血栓形成,妊娠,预期寿命不满1年以及膝下动脉闭塞。比较两组患者治疗后6个月,管腔晚期丢失、踝臂指数改善情况、Rutherford分级改善情况、再狭窄发生率、血栓形成率和截肢率的差异性。结果两组患者一般情况及危险因素、病变血管特征情况相比无统计学差异(P>0.05)。两组患者治疗后6个月,在管腔晚期丢失、踝臂指数改善情况、Rutherford分级改善情况、再狭窄发生率、血栓形成的比较中,药物涂层球囊组均优于普通球囊组(P<0.05),而两组截肢率相比差异无统计学差异(P>0.05)。结论在股腘动脉硬化闭塞的治疗中,药物涂层球囊与普通球囊相比可有效降低股腘动脉6个月管腔晚期丢失、再狭窄发生率和血栓形成率,并可获得更优的踝臂指数、Rutherford分级改善。 Objective To compared the efficacy of drug-coated balloon and common balloon for treatment of superficial femoral artery and popliteal artery occlusive disease. Methods Forty-six patients were admitted for ipsilateral single or multiple superficial femoral artery and/or popliteal artery lesions(between 3 and 15 cm stenosis or occlusion),Rutherford grades 2 to 5,with or without other accompanying diseases in the Department of Interventional Vascular Therapy of the First Hospital of Nanjing between September,2015 and December,2016. The patients were randomly assigned into drug-coated balloon(DCB)group(n=23) and common balloon(CB) group(n=23). None of the patients had stent restenosis,aneurysms,acute thrombosis,pregnancy,life expectancy less than 1 year,or below-the-knee artery occlusion. The late lumen loss(LLL),improvement of the ankle brachial index(ABI),improvement of Rutherford grade,incidence of restenosis,thrombosis rate and amputation rate were compared between the two groups at 6 months after treatment. Results The two groups of patients were comparable for general conditions,risk factors,and characteristics of the compromised vessels(P>0.05). Six months after treatment,the patients in DCB group showed significantly smaller LLL,more obvious improvement of the ABI and Rutherford grade,and lower restenosis rate and thrombosis rate than those in CB group(P<0.05). The amputation rates were similar between the two groups(P>0.05). Conclusions DCB shows obvious advantages over common balloon for treatment of superficial artery and popliteal artery arteriosclerosis obliterans in that it more effectively reduces LLL,restenosis rate and thrombosis rate and improves the ABI and Rutherford grade at 6 months after the treatment.
作者 鲁景元 顾建平 徐文健 楼文胜 汪涛 LU Jingyuan;GU Jianping;XU Wenjian;LOU Wensheng;WANG Tao;Department of Interventional Radiology, Nanjing Hospital Affiliated to Nanjing Medical University;Department of Interventional Radiology, Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
出处 《南方医科大学学报》 CSCD 北大核心 2017年第3期296-300,共5页 Journal of Southern Medical University
基金 国家自然科学基金(81541061)~~
关键词 药物涂层球囊 动脉硬化闭塞 管腔晚期丢失 踝臂指数 外周动脉疾病 drug-coated balloon arteriosclerosis obliterans late lumen loss ankle brachial index peripheral arterial disease
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