氨甲环酸预防剖宫产术后出血。
Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery.
机构信息
From the Department of Obstetrics and Gynecology (L.S., H.M., A.M.), the Department of Clinical Research and Innovation (S.R.), and the Euclid-French Clinical Research Infrastructure Network (F-CRIN) Clinical Trials Platform, Department of Clinical Research and Innovation (C.R.), Bordeaux University Hospital, and the Public Health Department, Clinical Epidemiology Unit, Centre Hospitalier Universitaire (CHU) Bordeaux (A.B., A.G.), Bordeaux, the Department of Obstetrics and Gynecology, Bicêtre University Hospital (M.V.S.), the Department of Obstetrics and Gynecology, Trousseau Hospital (G.K.), the Department of Obstetrics and Gynecology, Robert Debré Hospital (D.K.), Port Royal Maternity Unit, Cochin Hospital (C.L.R.), and the Department of Obstetrics and Gynecology, Necker-Enfants Malades Hospital (L.J.S.), Assistance Publique-Hôpitaux de Paris, Université de Paris, Center of Research in Epidemiology and Statistics Sorbonne, Obstetrical, Perinatal, and Pediatric Epidemiology Research Team (EPOPé), INSERM, Institut National de la Recherche Agronomique (INRA), University Hospital Department-Risks in Pregnancy (G.K., E.A., C.L.R., C.D.-T.), and the Maternity Unit, Paris Saint Joseph Hospital, Paris Descartes University (E.A.), Paris, the Department of Obstetrics and Gynecology, Rennes University Hospital, Rennes (M.L.L.), the Department of Obstetrics and Gynecology, University Medical Center of Nantes, Centre d'Investigation Clinique Mère Enfant, University Hospital, and INRA, Unité Mixte de Recherche (UMR) 1280, Physiology of Nutritional Adaptations, University of Nantes, Institut des Maladie de l'Appareil Digestif, and Centre de Recherche en Nutrition Humaine-Ouest, Nantes (N.W.), the Department of Obstetrics and Gynecology, Poissy/Saint-Germain Hospital, Poissy (P.R.), the Department of Obstetrics and Gynecology, Rouen University Hospital, Rouen (E.V.), the Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier (F.F.), INSERM, Center for Research in Epidemiology and Population Health, Unité 1018, Reproduction and Child Development, Villejuif (F.F.), the Department of Obstetrics and Gynecology, Clermont-Ferrand University Hospital, Clermont-Ferrand (D.G.), the Department of Obstetrics and Gynecology, Saint-Joseph Hospital (R.D.), and the Department of Obstetrics and Gynecology, Assistance Publique-Hôpitaux de Marseille, Aix Marseille Université (F.B.), Marseille, the Department of Obstetrics and Gynecology, Saint-Etienne University Hospital, Saint Etienne (C.C.), the Department of Obstetrics and Gynecology, University Hospital of Strasbourg, Strasbourg (F.M.), the Department of Obstetrics and Gynecology, Tours University Hospital, Tours (F.P.), the Department of Obstetrics and Gynecology, Toulouse University Hospital, Toulouse (O.P.), the Department of Obstetrics and Gynecology, Nancy University Hospital, Nancy (E.G.), the Department of Obstetrics and Gynecology, Centre Médico-chirurgical et Obstétrical, Schiltigheim (N.S.), the Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau (C.B.), the Department of Obstetrics and Gynecology, Besançon University Hospital, Besançon (N.M.), the Departments of Obstetrics and Gynecology (G.L.) and Pharmacy (V.D., A.D.), Angers University Hospital, Angers, the Department of Obstetrics and Gynecology, Carémeau University Hospital, Nîmes (V.L.), the Department of Obstetrics and Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, Créteil (B.H.), the Department of Obstetrics and Gynecology, Caen University Hospital, Caen (D.V.), and PPRIGO (Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest), Brest University Hospital, Brest (V.D., A.D.) - all in France.
出版信息
N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.
BACKGROUND
Prophylactic administration of tranexamic acid has been associated with reduced postpartum blood loss after cesarean delivery in several small trials, but evidence of its benefit in this clinical context remains inconclusive.
METHODS
In a multicenter, double-blind, randomized, controlled trial, we assigned women undergoing cesarean delivery before or during labor at 34 or more gestational weeks to receive an intravenously administered prophylactic uterotonic agent and either tranexamic acid (1 g) or placebo. The primary outcome was postpartum hemorrhage, defined as a calculated estimated blood loss greater than 1000 ml or receipt of a red-cell transfusion within 2 days after delivery. Secondary outcomes included gravimetrically estimated blood loss, provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, and postpartum blood transfusion.
RESULTS
Of the 4551 women who underwent randomization, 4431 underwent cesarean delivery, 4153 (93.7%) of whom had primary outcome data available. The primary outcome occurred in 556 of 2086 women (26.7%) in the tranexamic acid group and in 653 of 2067 (31.6%) in the placebo group (adjusted risk ratio, 0.84; 95% confidence interval [CI], 0.75 to 0.94; P = 0.003). There were no significant between-group differences in mean gravimetrically estimated blood loss or in the percentage of women with provider-assessed clinically significant postpartum hemorrhage, use of additional uterotonic agents, or postpartum blood transfusion. Thromboembolic events in the 3 months after delivery occurred in 0.4% of women (8 of 2049) who received tranexamic acid and in 0.1% of women (2 of 2056) who received placebo (adjusted risk ratio, 4.01; 95% CI, 0.85 to 18.92; P = 0.08).
CONCLUSIONS
Among women who underwent cesarean delivery and received prophylactic uterotonic agents, tranexamic acid treatment resulted in a significantly lower incidence of calculated estimated blood loss greater than 1000 ml or red-cell transfusion by day 2 than placebo, but it did not result in a lower incidence of hemorrhage-related secondary clinical outcomes. (Funded by the French Ministry of Health; TRAAP2 ClinicalTrials.gov number, NCT03431805.).
背景
几项小型试验表明，剖宫产术中预防性应用氨甲环酸可减少产后出血量，但在这种临床情况下，其益处的证据仍不确定。
方法
在一项多中心、双盲、随机、对照试验中，我们将在 34 周或以上妊娠时进行剖宫产的女性随机分为接受静脉给予预防性子宫收缩剂和氨甲环酸（1 克）或安慰剂的两组。主要结局是产后出血，定义为计算的失血量大于 1000ml 或产后 2 天内接受红细胞输血。次要结局包括称重估计的出血量、提供者评估的临床显著产后出血、额外使用子宫收缩剂和产后输血。
结果
在 4551 名接受随机分组的女性中，有 4431 名进行了剖宫产，其中 4153 名（93.7%）有主要结局数据。在氨甲环酸组的 2086 名女性中有 556 名（26.7%）发生主要结局，在安慰剂组的 2067 名女性中有 653 名（31.6%）发生主要结局（调整风险比，0.84；95%置信区间[CI]，0.75 至 0.94；P=0.003）。两组间平均称重估计出血量或提供者评估的临床显著产后出血、额外使用子宫收缩剂或产后输血的女性比例无显著差异。产后 3 个月内发生血栓栓塞事件的女性在氨甲环酸组中占 0.4%（8 例/2049 例），在安慰剂组中占 0.1%（2 例/2056 例）（调整风险比，4.01；95%CI，0.85 至 18.92；P=0.08）。
结论
在接受预防性子宫收缩剂的剖宫产女性中，氨甲环酸治疗组的计算失血量大于 1000ml 或红细胞输血的发生率明显低于安慰剂组，但与出血相关的次要临床结局发生率没有降低。（由法国卫生部资助；TRAAP2 ClinicalTrials.gov 编号，NCT03431805）。
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