腔内修复术治疗腹主动脉瘤疗效及安全性系统评价

Effectiveness and safety of endovascular repair versus open repair for abdominal aortic aneurysms:a systematic review and meta-analyses of randomized controlled trials

目的系统评价血管腔内修复术(edovascular repair ER)与传统开腹术(open repair OR)治疗肾动脉下非破裂型腹主动脉瘤(abdominal aortic aneurysms AAA)的有效性与安全性。方法计算机检索Cochrane Library(2008年第3期)、PubMed(1990-2008)、MEDLINE(OVID,1990-2008)、EMBASE.com(1990-2008)、中国生物医学文献数据库、中文科技期刊全文数据库及中国期刊全文数据库等数据库,并辅以手工检索。对纳入随机对照试验采用RevMan5.0.18软件进行Meta分析。结果纳入4个随机对照试验共6篇文献。Meta分析结果显示:与OR比较,ER能明显降低术后30d全因死亡率[OR=0.32,95%CI(0.16,0.62),P=0.0008]和中期动脉瘤相关死亡率[OR=0.50,95%CI(0.30,0.85),P=0.010],ER术后中期再次手术率高于OR[OR=2.43,95%CI(1.69,3.50),P<0.00001]。中期全因死亡率及中期总并发症发生率差异无统计学意义(P>0.2)。结论ER是一种短期疗效肯定的治疗肾动脉下非破裂型AAA的微创治疗方式,ER发生再次手术危险性较高导致ER总体获益不确定,意味着合理筛选病例很重要。

Objective To evaluate the efficacy and safety of ER compared with OR for AAA. Methods We searched MEDLINE （OVID, 1990 to 2008）, EMBASE.com （1990 to 2008）, Coehrane Central Register of Controlled Trials （1991 to October 2008）, PubMed （ 1990 to 2008）, Chinese Biomedical Literature Database （CBM）, Chinese Scientific Journal Full-text Database （CSJD）, and Chinese Journal Full-text Database （CJFD）, added with handsearching and other retrievals.The Cochrane Collaboration＇s RevMan 5.0.18 was used for meta-analyses. Results Four RCTs including 6 literatures reporting data on safety and efficacy of ER versus OR were included. Meta-analyses showed that ER was superior to OR as measured by the 30-day all cause mortality （OR 0.32; 95%CI 0.16 to 0.62; P=0.0008） and mid-term AAA-cause mortality （OR 0.50, 95%CI 0.30 to 0.85; P=0.010）. Midterm all-cause mortality： ER was similar with open repair （OR 0.91, 95%CI 0.69 to 1.19; P=0.48）. About mid-term all-complication, no significant difference was observed between ER and OR （OR 2.51, 95%CI 0.48 to 13.04; P=0.27）. OR was superior to ER as measured by the reintervation rate （OR 2.2; 95%CI 1.67 to 2.88; P〈0.00001）. DREAM and EVAR-1 showed that OR was superior to ER as measured by the one-month and nine-month reintervation rate （OR 1.76; 95%CI 1.10 to 2.80; P=0.02） and （OR 2.59; 95%CI 1.10 to 6.10 P=0.03）. Conclusions The short-term efficacy of ER is better than OR on the treatment of infrarenal and unruptured aortic aneurysms. Although the mid-term all-cause mortality is similar： the risk of reintervation rate is higher than ER. Those mean that the reasonable selection is very important.