Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis.

Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis.
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DOI:
10.1136/bmj.e3054
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发表时间:
2012-05-17
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
Roberts I
Roberts I
中科院分区:
其他
文献类型:
--
作者:
Ker K;Edwards P;Perel P;Shakur H;Roberts I

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目的评价氨甲环酸对外科手术患者输血、血栓栓塞事件和死亡率的影响。设计系统综述和荟萃分析。 数据来源:科克伦对照试验注册中心、Medline和Embase,从成立到2011年9月,世界卫生组织国际临床试验注册平台,以及相关文章的参考文献列表。研究选择比较氨甲环酸与无氨甲环酸或安慰剂在手术患者中的随机对照试验。关注的结局指标是接受输血的患者数量;发生血栓栓塞事件(心肌梗死、卒中、深静脉血栓形成和肺栓塞)的患者数量;以及死亡人数。无论语言或出版状态如何,均纳入试验。结果共纳入1972 - 2011年开展的129项试验,共计10 488例患者。氨甲环酸使接受输血的可能性降低了三分之一(风险比0.62,95%置信区间0.58 - 0.65; P<0.001)。当分析仅限于使用充分分配隐藏的试验时,这种效应仍然存在(0.68,0.62至0.74; P<0.001)。氨甲环酸对心肌梗死(0.68,0.43 - 1.09; P=0.11)、卒中(1.14,0.65 - 2.00; P=0.65)、深静脉血栓形成(0.86,0.53 - 1.39; P=0.54)和肺栓塞(0.61,0.25 - 1.47; P=0.27)的影响尚不确定。氨甲环酸组的死亡率较低(0.61,0.38 - 0.98; P=0.04),尽管当分析仅限于使用充分隐藏的试验时,存在相当大的不确定性(0.67,0.33 - 1.34; P=0.25)。累积荟萃分析显示,氨甲环酸减少输血需求的可靠证据已超过10年。结论氨甲环酸减少手术输血的有力证据已经存在多年。关于氨甲环酸对输血影响的进一步试验不太可能增加有用的新信息。然而,氨甲环酸对血栓栓塞事件和死亡率的影响仍不确定。手术患者应该了解这些证据,以便他们能够做出明智的选择。
Objective To assess the effect of tranexamic acid on blood transfusion, thromboembolic events, and mortality in surgical patients. Design Systematic review and meta-analysis. Data sources Cochrane central register of controlled trials, Medline, and Embase, from inception to September 2011, the World Health Organization International Clinical Trials Registry Platform, and the reference lists of relevant articles. Study selection Randomised controlled trials comparing tranexamic acid with no tranexamic acid or placebo in surgical patients. Outcome measures of interest were the number of patients receiving a blood transfusion; the number of patients with a thromboembolic event (myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism); and the number of deaths. Trials were included irrespective of language or publication status. Results 129 trials, totalling 10 488 patients, carried out between 1972 and 2011 were included. Tranexamic acid reduced the probability of receiving a blood transfusion by a third (risk ratio 0.62, 95% confidence interval 0.58 to 0.65; P<0.001). This effect remained when the analysis was restricted to trials using adequate allocation concealment (0.68, 0.62 to 0.74; P<0.001). The effect of tranexamic acid on myocardial infarction (0.68, 0.43 to 1.09; P=0.11), stroke (1.14, 0.65 to 2.00; P=0.65), deep vein thrombosis (0.86, 0.53 to 1.39; P=0.54), and pulmonary embolism (0.61, 0.25 to 1.47; P=0.27) was uncertain. Fewer deaths occurred in the tranexamic acid group (0.61, 0.38 to 0.98; P=0.04), although when the analysis was restricted to trials using adequate concealment there was considerable uncertainty (0.67, 0.33 to 1.34; P=0.25). Cumulative meta-analysis showed that reliable evidence that tranexamic acid reduces the need for transfusion has been available for over 10 years. Conclusions Strong evidence that tranexamic acid reduces blood transfusion in surgery has been available for many years. Further trials on the effect of tranexamic acid on blood transfusion are unlikely to add useful new information. However, the effect of tranexamic acid on thromboembolic events and mortality remains uncertain. Surgical patients should be made aware of this evidence so that they can make an informed choice.
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作者:
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期刊: ACTA ORTHOPAEDICA SCANDINAVICA
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