氨甲环酸预防阴道分娩后失血
Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery.
机构信息
From the Department of Obstetrics and Gynecology, Bordeaux University Hospital, Bordeaux (L.S.), the Departments of Obstetrics and Gynecology (L.S.), Pharmacy (A.D., V.D.), and Clinical Research (J.-M.C.), Angers University Hospital, Angers, the Department of Obstetrics and Gynecology, University Medical Center of Nantes and the Centre d'Investigation Clinique Mère Enfant, University Hospital, the National Institute of Agricultural Research, Physiology of Nutritional Adaptations, University of Nantes, the Institute of Digestive Disease and Centre de Recherche en Nutrition Humaine Ouest, Nantes (N.W.), the Maternity Unit, Paris Saint Joseph Hospital (E.A.), INSERM Unité 1153, Obstetrical, Perinatal, and Pediatric Epidemiology Research Team, the Center for Epidemiology and Statistics, Sorbonne Paris Cité, University Hospital Department of Risks in Pregnancy (E.A., C.L.R., G.K., A.S., C.D.-T.), the Port Royal Maternity Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), University Hospital Department of Risks in Pregnancy (C.L.R.), Paris Descartes University, the Department of Obstetrics and Gynecology, Bicêtre University Hospital, AP-HP (M.-V.S.), and the Department of Obstetrics and Gynecology, Trousseau Hospital, AP-HP (G.K.), Paris, the Department of Obstetrics and Gynecology, Caen University Hospital, Caen (D.V.), the Department of Obstetrics and Gynecology, Tours University Hospital, Tours (F.P.), the Department of Obstetrics and Gynecology, Saint Joseph Hospital, Marseille (R.D.), the Department of Obstetrics and Gynecology, Montpellier University Hospital, Montpellier (F.F.), the Center for Research in Epidemiology and Population Health, INSERM Unité 1018, Reproduction and Child Development, Villejuif (F.F.), the Department of Obstetrics and Gynecology, Centre Hospitalier Departemental, La Roche-sur-Yon (G.D.), the Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Department of Obstetrics and Gynecology, University Lyon 1 (M.D.-D.), and the Department of Obstetrics and Gynecology, Croix Rousse University Hospital (C.H.), Lyon, the Department of Obstetrics and Gynecology, François Mitterrand Hospital, Pau (C.B.), the Department of Obstetrics and Gynecology, Jeanne de Flandre University Hospital, Lille (P.D.), and the Production Pharmaceutique pour la Recherche Institutionnelle du Grand Ouest, Brest University Hospital, Brest (A.D., V.D.) - all in France.
出版信息
N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.
BACKGROUND
The use of tranexamic acid reduces mortality due to postpartum hemorrhage. We investigated whether the prophylactic administration of tranexamic acid in addition to prophylactic oxytocin in women with vaginal delivery would decrease the incidence of postpartum hemorrhage.
METHODS
In a multicenter, double-blind, randomized, controlled trial, we randomly assigned women in labor who had a planned vaginal delivery of a singleton live fetus at 35 or more weeks of gestation to receive 1 g of tranexamic acid or placebo, administered intravenously, in addition to prophylactic oxytocin after delivery. The primary outcome was postpartum hemorrhage, defined as blood loss of at least 500 ml, measured with a collector bag.
RESULTS
Of the 4079 women who underwent randomization, 3891 had a vaginal delivery. The primary outcome occurred in 156 of 1921 women (8.1%) in the tranexamic acid group and in 188 of 1918 (9.8%) in the placebo group (relative risk, 0.83; 95% confidence interval [CI], 0.68 to 1.01; P=0.07). Women in the tranexamic acid group had a lower rate of provider-assessed clinically significant postpartum hemorrhage than those in the placebo group (7.8% vs. 10.4%; relative risk, 0.74; 95% CI, 0.61 to 0.91; P=0.004; P=0.04 after adjustment for multiple comparisons post hoc) and also received additional uterotonic agents less often (7.2% vs. 9.7%; relative risk, 0.75; 95% CI, 0.61 to 0.92; P=0.006; adjusted P=0.04). Other secondary outcomes did not differ significantly between the two groups. The incidence of thromboembolic events in the 3 months after delivery did not differ significantly between the tranexamic acid group and the placebo group (0.1% and 0.2%, respectively; relative risk, 0.25; 95% CI, 0.03 to 2.24).
CONCLUSIONS
Among women with vaginal delivery who received prophylactic oxytocin, the use of tranexamic acid did not result in a rate of postpartum hemorrhage of at least 500 ml that was significantly lower than the rate with placebo. (Funded by the French Ministry of Health; TRAAP ClinicalTrials.gov number, NCT02302456 .).
背景
氨甲环酸的使用可降低产后出血导致的死亡率。我们研究了在阴道分娩的妇女中，除了预防性催产素之外，预防性给予氨甲环酸是否会降低产后出血的发生率。
方法
在一项多中心、双盲、随机、对照试验中，我们将妊娠 35 周或以上、计划阴道分娩单胎活胎的产妇随机分为两组，分别接受静脉注射 1 g 氨甲环酸或安慰剂，此外还在分娩后给予预防性催产素。主要结局是产后出血量至少 500 ml，用集液袋测量。
结果
在 4079 名接受随机分组的产妇中，3891 人进行了阴道分娩。在氨甲环酸组 1921 名产妇中有 156 人（8.1%）发生主要结局，安慰剂组 1918 名产妇中有 188 人（9.8%）发生主要结局（相对风险，0.83；95%置信区间[CI]，0.68 至 1.01；P=0.07）。与安慰剂组相比，氨甲环酸组的提供者评估的临床显著产后出血发生率较低（7.8%比 10.4%；相对风险，0.74；95%CI，0.61 至 0.91；P=0.004；经事后多重比较调整后 P=0.04），也较少使用额外的子宫收缩剂（7.2%比 9.7%；相对风险，0.75；95%CI，0.61 至 0.92；P=0.006；经调整后 P=0.04）。两组的其他次要结局没有显著差异。产后 3 个月内血栓栓塞事件的发生率在氨甲环酸组和安慰剂组之间没有显著差异（分别为 0.1%和 0.2%；相对风险，0.25；95%CI，0.03 至 2.24）。
结论
在接受预防性催产素的阴道分娩产妇中，使用氨甲环酸并未使产后出血量至少 500 ml 的发生率显著低于安慰剂组。（由法国卫生部资助；TRAAP ClinicalTrials.gov 编号，NCT02302456）。
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