南方医科大学学报

南方医科大学学报 ›› 2016, Vol. 36 ›› Issue (11): 1566-.

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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

冉坤，王超，赵渝，向志   

  • 出版日期:2016-11-20 发布日期:2016-11-20

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

  • Online:2016-11-20 Published:2016-11-20

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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RevMan5.3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。

Abstract: 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 6 months after surgery, late lumen loss, target lesion revascularization rate, patency rate, mortality rate, and amputation rate at 1 year after operation were compared between DCB group and UCB group using RevMan 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 743 patients (862 lesions ) in UCB group. Meta-analysis showed that the restenosis rate at 6 months after the operation (15.2% vs 39.0%; 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% vs 5.0%; 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.