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GALA试验:它会影响临床实践吗?

The GALA trial: will it influence clinical practice?

作者信息

Paraskevas Kosmas I, Mikhailidis Dimitri P, Bell Peter R F

机构信息

Department of Vascular Surgery, Red Cross Hospital, Athens, Greece.

出版信息

Vasc Endovascular Surg. 2009 Oct-Nov;43(5):429-32. doi: 10.1177/1538574409340589. Epub 2009 Jul 23.

DOI:10.1177/1538574409340589
PMID:19628515
Abstract

The General Anesthesia vs. Local Anesthesia for Carotid Surgery (GALA) trial did not show a difference in 30-day postoperative stroke, myocardial infarction and death rates between patients undergoing carotid endarterectomy (CEA) under local vs. general anesthesia. The present article discusses some limitations of the GALA trial. Firstly, the expected stroke and death rates following CEA is so low, that it was unlikely that the GALA trial would show any significant difference between local and general anesthesia. Secondly, preoperative statin use was not recorded. Thirdly, intraoperative shunt usa ge rates (a possible parameter for the development of stroke) varied considerably between the 2 groups (43% vs. 14%, for general vs. local anesthesia, respectively; P < .0001), as well as between UK and non-UK surgeons who always (73.6% vs. 20.8%, respectively; P < .0001), never (4.2% vs. 26%, respectively; P < .0002), or selectively (22.2% vs. 53.2%, respectively; P < .0001) used a shunt. Furthermore, no information was provided regarding the type of shunts used; for example, atraumatic shunts may be associated with lower perioperative stroke rates. These limitations could influence the interpretation of the results of the GALA trial. Due to lack of differences between the 2 groups and the presence of the above limitations, it seems likely that this trial will have little effect on clinical practice.

摘要

颈动脉手术全身麻醉与局部麻醉比较(GALA)试验表明,接受颈动脉内膜切除术(CEA)的患者在局部麻醉与全身麻醉下术后30天的中风、心肌梗死和死亡率并无差异。本文讨论了GALA试验的一些局限性。首先,CEA术后预期的中风和死亡率很低,因此GALA试验不太可能显示局部麻醉和全身麻醉之间有任何显著差异。其次,术前他汀类药物的使用情况未作记录。第三,两组术中分流使用率(中风发生的一个可能参数)差异很大(全身麻醉组为43%,局部麻醉组为14%;P<0.0001),英国和非英国外科医生之间也存在差异,英国外科医生总是使用分流的比例为73.6%,非英国外科医生为20.8%(P<0.0001);从不使用分流的比例分别为4.2%和26%(P<0.0002);选择性使用分流的比例分别为22.2%和53.2%(P<0.0001)。此外,未提供所使用分流类型的信息;例如,无损伤分流可能与较低的围手术期中风率相关。这些局限性可能会影响对GALA试验结果的解读。由于两组之间没有差异且存在上述局限性,该试验似乎对临床实践影响不大。

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The GALA trial: will it influence clinical practice?GALA试验:它会影响临床实践吗?
Vasc Endovascular Surg. 2009 Oct-Nov;43(5):429-32. doi: 10.1177/1538574409340589. Epub 2009 Jul 23.
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Cost-effectiveness analysis of general anaesthesia versus local anaesthesia for carotid surgery (GALA Trial).颈动脉手术全身麻醉与局部麻醉的成本效果分析(GALA 试验)。
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The hypothesis regarding the benefit of carotid endarterectomy under locoregional anesthesia in prevention of stroke may be unanswered.关于在局部麻醉下进行颈动脉内膜切除术预防中风的益处的假设可能尚未得到解答。
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