Berridge David C, Kessel David O, Robertson Iain
Leeds Vascular Institute, Leeds General Infirmary, Leeds, UK.
Cochrane Database Syst Rev. 2013 Jun 6(6):CD002784. doi: 10.1002/14651858.CD002784.pub2.
Peripheral arterial thrombolysis is technique used in the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of thrombolysis. However, it is not known whether thrombolysis works better than surgery in the initial treatment of acute limb ischaemia.
To determine the preferred initial treatment, surgery or thrombolysis, for acute limb ischaemia.
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched March 2013) and CENTRAL (2013, Issue 2).
All randomised studies comparing thrombolysis and surgery for the initial treatment of acute limb ischaemia.
Each author independently assessed trial quality and extracted data. Agreement was reached by consensus.
Five trials with a total of 1283 participants were included. There was no significant difference in limb salvage or death at 30 days, six months or one year between initial surgery and initial thrombolysis. However, stroke was significantly more frequent at 30 days in thrombolysis participants (1.3%) compared to surgery participants (0%) (Odds ratio (OR) 6.41; 95% confidence interval (CI) 1.57 to 26.22). Major haemorrhage was more likely at 30 days in thrombolysis participants (8.8%) compared to surgery participants (3.3%) (OR 2.80; 95% CI 1.70 to 4.60); and distal embolization was more likely at 30 days in thrombolysis participants (12.4%) compared to surgery participants (0%) (OR 8.35; 95% CI 4.47 to 15.58).Participants treated by initial thrombolysis underwent a less severe degree of intervention (OR 5.37; 95% CI 3.99 to 7.22) and displayed equivalent overall survival compared to initial surgery (OR 0.87; 95% CI 0.61 to 1.25).
AUTHORS' CONCLUSIONS: 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 be associated with a higher risk of ongoing limb ischaemia and haemorrhagic complications including stroke. The higher risk of complications must be balanced against risks of surgery in each person.
外周动脉溶栓是用于治疗外周动脉缺血的一项技术。关于溶栓的适应症、风险和益处,人们已了解很多。然而,在急性肢体缺血的初始治疗中,溶栓是否比手术效果更好尚不清楚。
确定急性肢体缺血的首选初始治疗方法是手术还是溶栓。
本次更新中,Cochrane外周血管疾病组试验搜索协调员检索了专业注册库(最后检索时间为2013年3月)和CENTRAL(2013年第2期)。
所有比较溶栓和手术用于急性肢体缺血初始治疗的随机研究。
每位作者独立评估试验质量并提取数据。通过共识达成一致意见。
纳入了5项试验,共1283名参与者。初始手术和初始溶栓在30天、6个月或1年时的肢体挽救率或死亡率无显著差异。然而,溶栓组参与者在30天时发生中风的频率(1.3%)显著高于手术组参与者(0%)(比值比(OR)6.41;95%置信区间(CI)1.57至26.22)。溶栓组参与者在30天时发生大出血的可能性(8.8%)高于手术组参与者(3.3%)(OR 2.80;95%CI 1.70至4.60);溶栓组参与者在30天时发生远端栓塞的可能性(12.4%)高于手术组参与者(0%)(OR 8.35;95%CI 4.47至15.58)。与初始手术相比,初始接受溶栓治疗的参与者所接受的干预程度较轻(OR 5.37;95%CI 3.99至7.22),且总体生存率相当(OR 0.87;95%CI 0.61至1.25)。
根据现有证据,不能提倡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无总体差异。溶栓可能与持续肢体缺血和包括中风在内的出血性并发症的较高风险相关。并发症的较高风险必须与每个人的手术风险相权衡。