荷兰阿姆斯特丹大学René Post团队研究了超早期氨甲环酸治疗蛛网膜下腔出血对临床结局的影响。2020年12月21日，该研究发表在《柳叶刀》杂志上。
在患有动脉瘤性蛛网膜下腔出血的患者中，使用氨甲环酸短期抗纤溶治疗已被证明可降低再次出血的风险。但这种治疗能否改善临床结局尚不清楚。研究组调查了氨甲环酸超早期短期治疗是否可改善6个月的临床结局。
研究组在荷兰的8个治疗中心和16个转诊医院中进行了一项掩盖结果评估的多中心、前瞻性、随机、对照、开放标签试验，2013年7月24日至2019年7月29日，研究组共招募了955位经CT证实为自发性蛛网膜下腔出血的成年患者，将其随机分配，其中475名接受常规治疗，480名在常规治疗的基础上加用氨甲环酸治疗。主要终点为改良Rankin量表评估的6个月临床结局，分为良好（0–3）或较差（4–6）。
在意向治疗分析中，氨甲环酸组475例患者中有287例（60％）观察到良好的临床结局，对照组470例中有300例（64％），校正后的优势比为0.86。氨甲环酸组中有49例（10％）患者在随机分组后和动脉瘤治疗前发生再出血，对照组中有66例（14％），优势比为0.71。其他严重不良事件在两组之间也具有可比性。
研究结果表明，经改良Rankin量表评估，超早期短期氨甲环酸治疗经CT证实的蛛网膜下腔出血（可能由动脉瘤破裂引起）在6个月时并未改善临床结局。
附：英文原文
Title: Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial
Author: René Post, Menno R Germans, Maud A Tjerkstra, Mervyn D I Vergouwen, Korné Jellema, Radboud W Koot, Nyika D Kruyt, Peter W A Willems, Jasper F C Wolfs, Frits C deBeer, Hans Kieft, Dharmin Nanda, Bram van der Pol, Gerwin Roks, Frank de Beer, Patricia H A Halkes, Loes J A Reichman, Paul J A M Brouwers, Renske M van den Berg-Vos, Vincent I H Kwa, Taco C van der Ree, Irene Bronner, Janneke van de Vlekkert, Henri P Bienfait, Hieronymus D Boogaarts, Catharina J M Klijn, René van den Berg, Bert A Coert, Janneke Horn, Charles B L M Majoie, Gabril J E Rinkel, Yvo B W E M Roos, W Peter Vandertop, Dagmar Verbaan, René Post, Menno R. Germans, Maud A. Tjerkstra, Mervyn D.I. Vergouwen, Korné Jellema, Radboud W. Koot, Nyika D. Kruyt, Peter W.A. Willems, Jasper F.C. Wolfs, Frits C. de Beer, Hans Kieft, Dharmin Nanda, Bram van der Pol, Gerwin Roks, Frank de Beer, Patricia H.A. Halkes, Loes J.A. Reichman, Paul J.A.M. Brouwers, Renske M. van den Berg-Vos, Vincent I.H. Kwa, Taco C. van der Ree, Irene Bronner, Henri P. Bienfait, Hieronymus D. Boogaarts, Catharina J.M. Klijn, Martine van Bilzen, H.J.G. Dieks, Koen de Gans, J.B.M. ten Holter, Jelle R. de Kruijk, Charlie T.J.M. Leijzer, Delmar Molenaar, Robbert J. van Oostenbrugge, Jeske van Pamelen, Fianne H.M. Spaander, Sarah E. Vermeer, Janneke van den Vlekkert, J. Manuela Voorend
Issue&Volume: 2020-12-21
Abstract:
Background
In patients with aneurysmal subarachnoid haemorrhage, short-term antifibrinolytic therapy with tranexamic acid has been shown to reduce the risk of rebleeding. However, whether this treatment improves clinical outcome is unclear. We investigated whether ultra-early, short-term treatment with tranexamic acid improves clinical outcome at 6 months.
Methods
In this multicentre prospective, randomised, controlled, open-label trial with masked outcome assessment, adult patients with spontaneous CT-proven subarachnoid haemorrhage in eight treatment centres and 16 referring hospitals in the Netherlands were randomly assigned to treatment with tranexamic acid in addition to care as usual (tranexamic acid group) or care as usual only (control group). Tranexamic acid was started immediately after diagnosis in the presenting hospital (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first). The primary endpoint was clinical outcome at 6 months, assessed by the modified Rankin Scale, dichotomised into a good (0–3) or poor (4–6) clinical outcome. Both primary and safety analyses were according to intention to treat. This trial is registered at ClinicalTrials.gov, NCT02684812.
Findings
Between July 24, 2013, and July 29, 2019, we enrolled 955 patients; 480 patients were randomly assigned to tranexamic acid and 475 patients to the control group. In the intention-to-treat analysis, good clinical outcome was observed in 287 (60%) of 475 patients in the tranexamic acid group, and 300 (64%) of 470 patients in the control group (treatment centre adjusted odds ratio 0·86, 95% CI 0·66–1·12). Rebleeding after randomisation and before aneurysm treatment occurred in 49 (10%) patients in the tranexamic acid and in 66 (14%) patients in the control group (odds ratio 0·71, 95% CI 0·48–1·04). Other serious adverse events were comparable between groups.
Interpretation
In patients with CT-proven subarachnoid haemorrhage, presumably caused by a ruptured aneurysm, ultra-early, short-term tranexamic acid treatment did not improve clinical outcome at 6 months, as measured by the modified Rankin Scale.
DOI: 10.1016/S0140-6736(20)32518-6
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32518-6/fulltext
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