Berridge D C, Kessel D, Robertson I
Department of Vascular and Endovascular Surgery, St James's University Hospital, Beckett Street, Leeds, Yorkshire, UK, LS9 7TF. David
Cochrane Database Syst Rev. 2002(3):CD002784. doi: 10.1002/14651858.CD002784.
Peripheral arterial thrombolysis is a useful technique for the management of peripheral arterial ischaemia. Much is known about the indications, risks and benefits of thrombolysis, although data from randomised controlled studies are not extensive. 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.
The Cochrane Controlled Trials Register (Issue 3, 2001), and the Specialised Trials Register of the Cochrane Peripheral Vascular Diseases Group (September 2001) were searched. Proceedings from all British Vascular Surgical Society, European Vascular Surgical Society and North American Society of Vascular Surgery meetings, Society of Cardiovascular and Interventional Radiology (SCVIR) and Cardiovascular and Interventional Society of Europe (CIRSE), were handsearched. Pharmaceutical firms and trialists were asked for information about unpublished trials.
All randomised studies comparing thrombolysis and surgery in the initial management of acute limb ischaemia.
Assessment of trial quality and data extraction was done independently by all reviewers.
Five trials with a total of 1,283 patients were included. Two trials used a list of procedures of increasing severity of intervention. If lytic treatment were successful, further intervention might prove unnecessary. 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, with initial lysis, stroke was significantly more frequent at 30 days, 8/640 patients compared to 0/540 patients receiving initial surgery [Odds ratio (95% CI) 6.41(1.57, 26.22)]; major haemorrhage was more likely at 30 days, 52/588 versus 16/482 [Odds ratio (95% CI) 2.80 (1.70, 4.60)]; and distal embolisation was more likely at 30 days, 42/340 versus 0/338 [Odds ratio (95% CI) 8.35 (4.47, 15.58)]. Patients treated by initial lysis underwent a less severe degree of intervention [Odds ratio (95% CI) 5.37 (3.99, 7.22)], and displayed equivalent overall survival compared to initial surgery [Odds ratio (95% CI) 0.87(0.61, 1.25)].
REVIEWER'S 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 of haemorrhagic complications, including stroke. The higher risk of complications must be balanced against risks of surgery in each patient.
外周动脉溶栓术是治疗外周动脉缺血的一项有用技术。尽管随机对照研究的数据并不广泛，但关于溶栓的适应证、风险和益处已有很多了解。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，即手术还是溶栓。
检索了Cochrane对照试验注册库（2001年第3期）以及Cochrane外周血管疾病组的专门试验注册库（2001年9月）。对所有英国血管外科学会、欧洲血管外科学会和北美血管外科学会会议、心血管和介入放射学会（SCVIR）以及欧洲心血管和介入学会（CIRSE）的会议记录进行了手工检索。向制药公司和试验研究者询问了未发表试验的相关信息。
所有比较溶栓和手术在急性肢体缺血初始治疗中的随机研究。
所有评价者独立进行试验质量评估和数据提取。
纳入了5项试验，共1283例患者。两项试验使用了一份干预严重程度递增的程序清单。如果溶栓治疗成功，可能无需进一步干预。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，初始溶栓时，30天时中风明显更常见，640例患者中有8例发生中风，而接受初始手术的540例患者中无一例发生中风[比值比（95%可信区间）6.41（1.57，26.22）]；30天时大出血更有可能发生，588例患者中有52例，而482例患者中有16例[比值比（95%可信区间）2.80（1.70，4.60）]；30天时远端栓塞更有可能发生，340例患者中有42例，而338例患者中无一例发生[比值比（95%可信区间）8.35（4.47，15.58）]。初始溶栓治疗的患者接受的干预程度较轻[比值比（95%可信区间）5.37（3.99，7.22）]，与初始手术相比，总体生存率相当[比值比（95%可信区间）0.87（0.61，1.25）]。
根据现有证据，不能提倡普遍将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及包括中风在内的出血并发症风险较高有关。必须将较高的并发症风险与每位患者的手术风险进行权衡。
