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氨甲环酸预防阴道分娩后失血
Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery


Loïc Sentilhes ... 妇产科和儿科 • 2018.08.23
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• 产后出血预防的进展 • 热稳定型卡贝缩宫素与催产素预防阴道分娩后出血的比较 • 氨甲环酸真的是产科救命药吗

摘要


背景

使用氨甲环酸可降低产后出血导致的死亡率。我们研究了在阴道分娩产妇中,除预防性给予催产素外预防性施用氨甲环酸是否会降低产后出血发生率。

 

方法

在一项多中心、双盲、随机、对照试验中,我们将在妊娠≥35周,接受计划的单活胎阴道分娩的产妇随机分组,在产后,除接受预防性催产素给药之外,还接受1 g氨甲环酸或安慰剂静脉给药。主要结局为产后出血,定义为失血≥500 mL(用收集袋测定失血量)。

 

结果

在4,079名被随机分组的产妇中,3,891名采用了阴道分娩。氨甲环酸组1,921名产妇中的156名(8.1%)和安慰剂组1,918名产妇中的188名(9.8%)发生了主要结局(相对危险度,0.83;95%置信区间[CI],0.68~1.01;P=0.07)。在医师评估的临床上显著的产后出血发生率方面,氨甲环酸组低于安慰剂组(7.8% vs. 10.4%;相对危险度,0.74;95% CI,0.61~0.91;P=0.004;事后多重比较校正后,P=0.04),并且前者也较少接受额外的子宫收缩剂治疗(7.2% vs. 9.7%;相对危险度,0.75;95% CI,0.61~0.92;P=0.006;校正的P=0.04)。两组的其他次要结局无显著差异。在氨甲环酸组和安慰剂组中,分娩后3个月内的血栓栓塞事件发生率无显著差异(分别为0.1%和0.2%;相对危险度,0.25;95% CI,0.03~2.24)。

 

结论

在接受预防性催产素给药的阴道分娩产妇中,使用氨甲环酸时产后出血≥500 mL的发生率未显著低于使用安慰剂时的发生率(由法国卫生部[French Ministry of Health]资助;TRAAP在ClinicalTrials.gov注册号为NCT02302456)。





作者信息

Loïc Sentilhes, M.D., Ph.D., Norbert Winer, M.D., Ph.D., Elie Azria, M.D., Ph.D., Marie-Victoire Sénat, M.D., Ph.D., Camille Le Ray, M.D., Ph.D., Delphine Vardon, M.D., Franck Perrotin, M.D., Ph.D., Raoul Desbrière, M.D., Florent Fuchs, M.D., Ph.D., Gilles Kayem, M.D., Ph.D., Guillaume Ducarme, M.D., Ph.D., Muriel Doret-Dion, M.D., Ph.D., Cyril Huissoud, M.D., Ph.D., Caroline Bohec, M.D., Philippe Deruelle, M.D., Ph.D., Astrid Darsonval, Pharm.D., Jean-Marie Chrétien, M.Sc., Aurélien Seco, M.Sc., Valérie Daniel, Pharm.D., and Catherine Deneux-Tharaux, M.D., Ph.D. for the Groupe de Recherche en Obstétrique et Gynécologie*
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. Address reprint requests to Dr. Sentilhes at the Department of Obstetrics and Gynecology, Bordeaux University Hospital, Place Amélie Raba Léon, 33000 Bordeaux, France, or at loicsentilhes@hotmail.com. *A complete list of the members of the Groupe de Recherche en Obstétrique et Gynécologie is provided in the Supplementary Appendix, available at NEJM.org.

 

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