Berridge D C, Kessel D, Robertson I
Cochrane Database Syst Rev. 2000(4):CD002784. doi: 10.1002/14651858.CD002784.
Peripheral arterial thrombolysis has become established as a useful adjunct in the management of peripheral arterial ischaemia. Much has been learnt about indications, risks and benefits using this technique, although data from randomised controlled studies is not extensive. The optimal initial management of the acutely ischaemic leg needs to be determined.
To determine if surgery or thrombolysis is the preferred option in the initial treatment of acute limb ischaemia.
The search strategy was that adopted by the Cochrane Review Group on Peripheral Vascular Diseases. Additionally, reference lists of papers resulting from this search were reviewed.
All randomised studies comparing thrombolysis and surgery in the management of acute limb ischaemia.
Trial quality was assessed and data were extracted independently by all three reviewers.
Patients with acute lesions of less than seven days duration had a significantly increased survival at one year for patients having thrombolysis, compared to those undergoing initial surgery [84% v 58%, p=0.01; Odds ratio (95% CI) 0.28 (0.13,0.63)] largely associated with a reduced level of in-hospital cardio-pulmonary complications (Ouriel 1994). Lesions less than 14 days duration fared better with initial lysis with a reduced amputation and reduced death rate at six months [15.3% v 37.5%; p=0.001; Odds ratio (95%CI) 0.29 (0.12,0.72)] (STILE 1994), compared to initial surgery. Analysis of the same trial at one year however revealed that native vessel thromboses had a more favourable outcome with initial surgery, largely due to continuing ischaemia in the lytic group [64% v 35%; p<0.0001; Odds ratio (95%CI) 3.26(1.96,5.52)] (Weaver 1996). Bypass graft thromboses less than 14 days old treated with initial thrombolysis were shown to have a reduced amputation rate (15% v 47%; p=0.05). However, overall, one year results revealed that thrombolysis of thrombosed grafts was associated with a higher level of continued ischaemia [73% v 50%; P=0.010; Odds ratio (95%CI) 2.72(1.27,5.80)] (Comerota 1996).
REVIEWER'S CONCLUSIONS: A universal initial treatment with either surgery or thrombolysis cannot be advocated on the available evidence. There is no overall difference in limb salvage or death at one year between initial surgery and initial thrombolysis. Thrombolysis may however be associated with a higher risk of ongoing limb ischaemia, and a higher overall risk of haemorrhagic complications including stroke. The higher risk of complications needs to be balanced against the risks of surgery in the individual patient.
外周动脉溶栓已成为外周动脉缺血治疗中一种有用的辅助手段。尽管来自随机对照研究的数据并不广泛,但使用该技术在适应证、风险和益处方面已有很多了解。急性缺血性肢体的最佳初始治疗方法有待确定。
确定在急性肢体缺血的初始治疗中,手术或溶栓哪种是首选方案。
检索策略采用了Cochrane外周血管疾病综述小组所采用的策略。此外,还对此次检索所得论文的参考文献列表进行了审查。
所有比较溶栓与手术治疗急性肢体缺血的随机研究。
由三位审阅者独立评估试验质量并提取数据。
与接受初始手术的患者相比,病程少于7天的急性病变患者接受溶栓治疗后,1年生存率显著提高[84%对58%,p=0.01;优势比(95%可信区间)0.28(0.13,0.63)],这主要与住院期间心肺并发症水平降低有关(乌里尔,1994年)。病程少于14天的病变,初始溶栓治疗效果更好,截肢率和6个月死亡率降低[15.3%对37.5%;p=0.001;优势比(95%可信区间)0.29(0.有更多精彩内容,请访问 12,0.72)](STILE,1994年),与初始手术相比。然而,对同一试验1年时的分析显示,原发性血管血栓形成患者初始手术的预后更好,这主要是由于溶栓组持续存在缺血[64%对35%;p<0.0001;优势比(95%可信区间)3.26(1.96,5.52)](韦弗,1996年)。初始溶栓治疗小于14天的旁路移植血栓形成,截肢率降低(15%对47%;p=0.05)。然而,总体而言,1年结果显示,血栓形成的移植物溶栓与持续缺血水平较高相关[73%对50%;P=0.010;优势比(95%可信区间)2.72(1.27,5.80)](科梅罗塔,1996年)。
根据现有证据,不能主张普遍采用手术或溶栓作为初始治疗方法。初始手术和初始溶栓在1年时的肢体挽救率或死亡率方面没有总体差异。然而,溶栓可能与持续肢体缺血的较高风险以及包括中风在内的出血性并发症的总体较高风险相关。并发症的较高风险需要与个体患者的手术风险相权衡。