药涂球囊成形术治疗下肢动脉闭塞性疾病的疗效及安全性的meta分析  

Efficacy and safety of drug-coated balloon angioplasty in treatment of lower extremity arterial occlusive disease: a meta-analysis of 11 trials

作　　者：冉坤[1] 王超[1] 赵渝[1] 向志[1] 

机构地区：[1]重庆医科大学附属第一医院血管外科,重庆400016

出　　处：《南方医科大学学报》2016年第11期1566-1572,共7页Journal of Southern Medical University

摘　　要：目的采用Meta分析方法评价药涂球囊(DCB)对比非药涂球囊(UCB)成形术治疗下肢动脉闭塞性疾病的疗效及安全性。方法计算机检索国内外数据库中关于DCB和UCB成形术治疗下肢动脉闭塞性疾病的相关随机对照试验,按照纳入标准和排除标准进行文献筛选和质量评价后,采用Rev Man5.3软件进行Meta分析。比较两组患者术后6个月再狭窄率、晚期管径丢失、术后1年靶病变血运重建率、术后1年通畅率、术后1年的死亡率及截肢率。结果共纳入11个试验,1853名患者共有2150处动脉病变,其中DCB组有1110名患者,1288处动脉病变;UCB组有743名患者,862处动脉病变。Meta分析结果显示:与UCB组相比,DCB成形术明显降低了术后6个月的再狭窄率(15.2%vs 39.0%;OR:0.28;95%CI:0.17~0.48;P<0.000 01)、晚期管径丢失(-0.05~0.56 vs 0.54~1.7;WMD:-0.57;95%CI:-0.93^-0.21)和术后1年靶病变血运重建率(13.0%vs 28.1%;OR:0.39;95%CI:0.23~0.64;P=0.0002),提高了术后1年的通畅率(71.8%vs 52.9%;OR:2.32;95%CI:1.21~4.43;P=0.001),而两组的死亡率(4.8%vs 5.0%;OR:1.00;95%CI:0.62~1.63;P=0.99)及截肢率(3.4%vs 2.9%;OR:1.41;95%CI:0.74~2.70;P=0.30)比较差异均无统计学意义。结论与UCB成形术治疗下肢动脉闭塞性疾病相比,DCB成形术是一种疗效更显著,安全性无明显差异的腔内治疗方法。Objective To evaluate the efficacy and safety of drug-coated balloon（DCB） angioplasty versus uncoated balloon（UCB） angioplasty in treatment of lower extremity arterial occlusive disease（LEAOD）. Methods Randomized controlled trial comparing DCB and UCB angioplasty for treatment of LEAOD were searched in online databases. Literature screening and quality assessment was carried out according to the established inclusion criteria and exclusion criteria. Restenosis rate at 6months after surgery, late lumen loss, target lesion revascularization rate, patency rate, mortality rate, and amputation rate at 1year after operation were compared between DCB group and UCB group using Rev Man 5.3 software. Results Eleven trials involving a total of 1853 patients with 2150 lesions were included, with 1110 patients（1288 lesions） in DCB group and 743patients（862 lesions） in UCB group. Meta-analysis showed that the restenosis rate at 6 months after the operation（15.2% vs39.0%; OR： 0.28; 95%CI： 0.17 to 0.48; P〈0.00001）, late lumen loss（range-0.05 to 0.56 vs 0.54 to 1.7; WMD：-0.57; 95%CI：-0.93 to-0.21）, and target lesion revascularization rate at 1 year after operation（13.0% vs 28.1%; OR： 0.39; 95%CI： 0.23 to 0.64; P=0.0002）were significantly lower in DCB group than in UCB group. The patency rate at 1 year after the operation was significantly higher in DCB group than in UCB group（71.8% vs 52.9%; OR： 2.32; 95%CI： 1.21 to 4.43; P=0.001）. The mortality rate（4.8% vs5.0%; OR： 1.00; 95% CI： 0.62 to 1.63; P=0.99） and amputation rate at 1 year after the operation（3.4% vs 2.9%; OR：1.41; 95% CI：0.74 to 2.70; P=0.30） did not differ significantly between DCB and UCB group. Conclusion DCB angioplasty is more effective than UCB angioplasty in endovascular treatment of LEAOD with similar treatment safety.

关 键 词：经皮腔内成形术 下肢动脉闭塞性疾病 药涂球囊 非药涂球囊 随机对照试验 META分析 

分 类 号：R654.4[医药卫生—外科学]