SPINE
Efficacy and safety of using antifibrinolytic agents in spine surgery: a meta-analysis
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(3):23 PLoS One. 2013 Nov 22;8(11):e820639 randomized controlled studies, with a total of 664 patients, were included in this meta-analysis to compare antifibrinolytic agents such as tranexamic acid (TXA) and epsilonaminocaproic acid (EACA), to a placebo in regards to blood loss, transfusion requirements and deep vein thrombosis incidence in patients who underwent spine surgery. The antifibrinolytic agents were effective in reducing total blood loss, total blood transfusion and ratio of blood transfusion; additionally, the incidence of deep vein thrombosis was comparable between the antifibrinolytic agents and the placebos used.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
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はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Spine surgery, particularly multilevel spinal fusion, deformity correction and anterior-posterior spinal fusion, are associated with significant blood loss and transfusion requirements. Transfusions can be the cause of a variety of complications which can be decreased with autologous blood donations, application of cell saver-systems or the use of erythropoietin; however, these solutions are expensive and logistically challenging. Intraoperative administration of antifibrinolytics such as tranexamic acid (TXA), epsilonaminocaproic acid (EACA) and aprotinin are becoming more popular in spine surgery. Recent high-quality evidence provides reason to conduct a current meta-analysis on the topic; therefore, this study was conducted to determine the effects of antifibrinolytic agents on reducing perioperative blood loss in spine surgery.
主な研究課題は何ですか？
What are the effects of antifibrinolytic agents such as tranexamic acid (TXA) and epsilonaminocaproic acic (EACA) on perioperative blood loss and transfusion requirements in patients undergoing spine surgery?
重要な知見は？
- 8 studies reported on total blood loss, the overall effect was significantly different in favour of the intervention (WMD =-288.8, 95 % CI -46.49 to -110.19; p = 0.002).Subgroup analyses of 6 studies that examined TXA and 2 studies evaluating EACA resulted in similar conclusions (WMD =-285.3, 95 % CI -506.99 to -63.65; p = 0.01 and WMD =-338.1, 95 % CI -583.03 to -93.33; p = 0.007, respectively).
- The 9 studies that reported on total blood transfusion and found a significant difference in favour of antifibrinolytic agents(WMD =-242.76, 95 % CI -422.5 to -62.95; p = 0.008). Subgroup analysis of 6 studies involving TXA indicated significant differences in favour of TXA (WMD=-242.76, 95 % CI -422.5 to -62.95; p = 0.008) and 3 studies display improved results with EACA as well compared to a placebo (WMD =-358.1, 95 % CI -608.49 to -107.71; p = 0.005)
- Ratio of blood transfusion was available in 7 studies and overall antifibrinolytic agents proved superior over the placebo (RR = 0.73, 95% CI 0.58 to 0.93; p = 0.010). A subgroup analysis of TXA alone resulted in similar findings (RR =0.71, 95 % CI 0.54 to 0.92; p= 0.01).
- 9 Studies examined the DVT incidence and found no difference between groups (RR 0.25, 95 % CI 0.03 to 2.22; p= 0.21).
最も覚えておくべきことは？
The antifibrinolytic agents tranexamic acid (TXA) and epsilonaminocaproic acid (EACA) were both effective in reducing total blood loss, total blood transfusion and ratio of blood transfusion. The incidence of deep vein thrombosis was comparable between the antifibrinolytic agents and the placebos used.
それが私の患者ケアにどのように影響するか？
Results of this study suggest that patients undergoing spine surgery can benefit from the administration of antifibrinolytic agents such as tranexamic acid and epsilonaminocaproic acid in terms of reducing blood loss and transfusion requirements. This study was limited by the small sample sizes of the included trials and the heterogeneity in variation in drug dose, surgical procedure, operation time, age of patients, protocol for estimating blood loss and transfusion indication. All of the included studies featured intravenous administration of the study drugs; whether there is a role of topical agents in spine surgery remains to be determined.
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