中国实用外科杂志

中国实用外科杂志

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涂药球囊治疗膝下动脉病变安全性和有效性Meta分析

刘    杰，容    丹，张敏宏，栾绍亮，贾    鑫，刘小平，郭    伟   

  1. 中国人民解放军总医院血管外科，北京100853
  • 出版日期:2018-12-01 发布日期:2018-12-06

  • Online:2018-12-01 Published:2018-12-06

摘要：

目的    比较涂药球囊（DCB）和普通球囊（UCB）治疗膝下动脉病变的安全性和有效性。方法    中国人民解放军总医院全面检索PubMed、EMBASE、Cochrane Library和Clinicaltrials.gov数据库, 检索时限均为自建库起至2018-06-30。纳入DCB与UCB治疗膝下动脉病变的随机对照研究。对1年随访的主要截肢率、全因病死率、晚期管腔丢失、靶病变血运重建进行Meta分析。采用Revman 5.3和R软件进行分析，效应值采用均差或相对危险度表示。结果    纳入4项随机对照研究，590例受试者和841处病变。Meta分析结果显示：在1年主要截肢率和1年全因病死率的安全性指标方面两组未见显著性差异（P＞0.05）。在1年晚期管腔丢失和1年靶病变血运重建的有效性指标方面显著优于UCB组（P＜0.05）。结论    DCB组在治疗有效性方面显著优于UCB组，两者在安全性上差异无统计学意义。尚需更多长期随访的随机对照试验予以印证。

关键词: 涂药球囊, 膝下动脉闭塞, Meta分析

Abstract:

Safety and efficacy of drug-coated balloon angioplasty versus uncoated balloon angioplasty for infrapopliteal arterial occlusive disease: A system review and meta-analysis        LIU Jie, RONG Dan，ZHANG Min-hong, et al. Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital, Beijing 100853, China
Corresponding author： GUO Wei，E-mail：pla301dml@vip.sina.com
Abstract    Objective    To assess the safety and efficacy of drug-coated balloons (DCBs) compared with uncoated balloons (UCBs) for infrapopliteal arterial occlusive disease. Methods    The electronic databases of Medline, Embase, Cochrane library, and ClinicalTrials.gov to compare DCBs vs. UCBs for infrapopliteal arterial occlusive disease were searched. All data were pooled with relative risk or mean difference, and Meta-analysis was performed on late lumen loss (LLL， twelve months), target lesion revascularization (TLR，twelve months), major amputation（twelve months）, and all caused-mortality（twelve months）. Meta-analysis was carried out using Revman version 5.3 and R statics package. Results    Four random controlled trials were included. The analysis found a significant reduction of LLL at 12 months  and TLR at 1 years in DCB groups compared with UCB groups（P＜0.05）. No significant difference was found in amputation rate at 1 year and all caused mortality at 1 year（P＞0.05）. Conclusion    DCBs improve the treatment efficacy of infrapopliteal arterial occlusive disease by significantly decreasing LLL and TLR. More RCTs with long-time follow up were warranted.

Key words: drug-coated balloon, infrapopliteal arterial occlusive disease, Meta-analysis