A Prospective Randomized Trial of Catheter-Directed Thrombolysis With Additional Balloon Dilatation for Iliofemoral Deep Venous Thrombosis: A Single-Center Experience
A Prospective Randomized Trial of Catheter-Directed Thrombolysis With Additional Balloon Dilatation for Iliofemoral Deep Venous Thrombosis: A Single-Center Experience
复制标题
导管定向溶栓联合球囊扩张治疗髂股深静脉血栓的前瞻性随机试验：单中心经验
DOI：
10.1007/s00270-013-0747-3
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发表时间：
2014-08
影响因子：
2.9
通讯作者：
Chen YK
中科院分区：
文献类型：
--
作者：
Zhang Xiaoqin;Ren Qingshuai;Sun Jianming;Tang Bo;Chen Yikuan;Jiang Xuemei;Gong Jianping;Chen YK
目的导管溶栓（CDT）对急性髂股深静脉血栓形成（DVT）有效，但对亚急性DVT仍有部分疗效。本研究的目的是进行一项前瞻性随机对照单中心临床试验，比较CDT单独与CDT与额外的球囊扩张治疗髂股DVT。MethodsThe试验是在2007年2月和2011年1月之间进行的。入选前缺乏有效治疗的髂股DVT患者被随机分配到CDT组（对照组）或CDT+额外球囊扩张组（干预组）。不足的流行病学和经济学研究，生活质量（VEINES-QOL），静脉下肢症状的严重程度（VEINES-Sym），36项健康调查简表（SF-36），并获得Villalta评分在预定的follow-up.ResultsSeven 22例患者进行了筛选，386名符合条件的患者进行了随机分组。Villalta评分干预组为4.20 ± 3.05，对照组为4.89 ± 3.45，两组比较差异无统计学意义。亚急性期患者术后1个月（6.79 ± 4.23，8.28 ± 5.03，P = 0.02）~ 24个月（4.21 ± 3.08，5.67 ± 3.71，P = 0.006），干预组与对照组比较差异有统计学意义。在随访结束时，亚急性患者的VEINES-QOL/Sym也观察到显著差异（52.87 ± 6.52，50.31 ± 6.07，P = 0.009; 51.87 ± 6.37，49.72 ± 5.96，P = 0.02）和SF-36 PCS/MCS（45.02 ± 12.07，41.13 ± 11.68，P = 0.03; 53.26 ± 11.43，49.50 ± 11.06，P = 0.03）。然而，单独使用CDT对急性患者非常有效。
PurposeCatheter-directed thrombolysis (CDT) is effective for acute iliofemoral deep venous thrombosis (DVT), but CDT remains partially effective for subacute DVT. The aim of this study was to conduct a prospective randomized controlled single-centre clinical trial to compare CDT alone with CDT with additional balloon dilatation for the treatment of iliofemoral DVT.MethodsThe trial was performed between February 2007 and January 2011. Iliofemoral DVT patients lacking effective therapy before enrollment were randomly assigned either to CDT (control group) or to CDT with additional balloon dilatation (intervention group). Insufficiency Epidemiological and Economic Study-Quality of Life (VEINES-QOL), Severity of Venous Lower Limb Symptoms (VEINES-Sym), 36-Item Short-Form Health Survey (SF-36), and Villalta scores were obtained at scheduled follow-up.ResultsSeven hundred twenty-two patients were screened, and 386 eligible patients were randomized. No significant difference for mean total Villalta score was observed between the intervention group (4.20 ± 3.05) and the control group (4.89 ± 3.45). However, post hoc analysis of the scores in subacute patients showed significant differences between the intervention group and the control group from 1 month (6.79 ± 4.23, 8.28 ± 5.03,P= 0.02) to 24 months (4.21 ± 3.08, 5.67 ± 3.71,P= 0.006). A significant difference was also observed in subacute patients at the end of follow-up for VEINES-QOL/Sym (52.87 ± 6.52, 50.31 ± 6.07,P= 0.009; 51.87 ± 6.37, 49.72 ± 5.96,P= 0.02) and SF-36 PCS/MCS (45.02 ± 12.07, 41.13 ± 11.68,P= 0.03; 53.26 ± 11.43, 49.50 ± 11.06,P= 0.03).ConclusionSubacute iliofemoral DVT patients lacking effective therapy during acute phase, might receive more benefits from CDT with additional balloon dilatation. However, CDT alone is highly effective for acute patients.
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DOI：
10.1161/atvbaha.110.213413
发表时间：
2011-03
期刊：
Arteriosclerosis, thrombosis, and vascular biology
影响因子：
--
作者：
Popuri RK;Vedantham S
通讯作者：
Vedantham S
影响因子：
10.4
作者：
Arnaud Perrier;Henri Bounameaux
通讯作者：
Arnaud Perrier;Henri Bounameaux
影响因子：
9
作者：
Delis, KT;Bountouroglou, D;Mansfield, AO
通讯作者：
Mansfield, AO
DOI：
10.1097/01.rvi.0000197359.26571.c2
发表时间：
2006-03-01
影响因子：
2.9
作者：
Vedantham, S;Grassi, CJ;Sacks, D
通讯作者：
Sacks, D
影响因子：
19.7
作者：
Mewissen, MW;Seabrook, GR;Haughton, SH
通讯作者：
Haughton, SH