超早期氨甲環酸治療蛛網膜下腔出血不能改善臨床結局
作者：
小柯機器人發布時間：2020/12/22 21:52:20
荷蘭阿姆斯特丹大學René Post團隊研究了超早期氨甲環酸治療蛛網膜下腔出血對臨床結局的影響。2020年12月21日，該研究發表在《柳葉刀》雜誌上。
在患有動脈瘤性蛛網膜下腔出血的患者中，使用氨甲環酸短期抗纖溶治療已被證明可降低再次出血的風險。但這種治療能否改善臨床結局尚不清楚。研究組調查了氨甲環酸超早期短期治療是否可改善6個月的臨床結局。
研究組在荷蘭的8個治療中心和16個轉診醫院中進行了一項掩蓋結果評估的多中心、前瞻性、隨機、對照、開放標籤試驗，2013年7月24日至2019年7月29日，研究組共招募了955位經CT證實為自發性蛛網膜下腔出血的成年患者，將其隨機分配，其中475名接受常規治療，480名在常規治療的基礎上加用氨甲環酸治療。主要終點為改良Rankin量表評估的6個月臨床結局，分為良好（0–3）或較差（4–6）。
在意向治療分析中，氨甲環酸組475例患者中有287例（60％）觀察到良好的臨床結局，對照組470例中有300例（64％），校正後的優勢比為0.86。氨甲環酸組中有49例（10％）患者在隨機分組後和動脈瘤治療前發生再出血，對照組中有66例（14％），優勢比為0.71。其他嚴重不良事件在兩組之間也具有可比性。
研究結果表明，經改良Rankin量表評估，超早期短期氨甲環酸治療經CT證實的蛛網膜下腔出血（可能由動脈瘤破裂引起）在6個月時並未改善臨床結局。
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