前置胎盘剖宫产术前静脉注射氨甲环酸的疗效:一项随机双盲对照试验

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摘要

背景:前置胎盘是产后出血(PPH)的常见原因,是导致产妇发病率和死亡率的重要原因。氨甲环酸是一种抗纤溶药物,可用于治疗PPH。许多指南的建议是,一旦诊断出PPH,就开始给予氨甲环酸,以减少产后失血。此外,一些研究报道了剖宫产术前给予氨甲环酸作为预防措施,以减少术中出血量和预防PPH的有益使用。据作者所知,在高危产科病例中,如前置胎盘,没有足够的数据支持使用氨甲环酸预防PPH的建议。目的:评价剖宫产术前补充静脉氨甲环酸与胎盘娩出后预防性静脉催产素在减少术中出血量和预防前置胎盘PPH方面的疗效。材料与方法:本研究采用双盲安慰剂对照试验,比较剖宫产前切开皮肤前静脉注射1 g氨甲环酸与胎盘娩出后单独预防性静脉注射催产素。该研究招募了60名在2021年7月至2022年7月期间在春武里医院(Chonburi Hospital)被诊断患有前置胎盘(GA)超过28周的妇女,她们因活动性出血接受了紧急剖宫产手术,或计划在37周完成剖宫产手术。主要结局为术中出血量。结果:60名确诊为前置胎盘的女性被招募,每组30名患者。ⅰ组患者在切开皮肤前给予氨甲环酸1 g,ⅱ组患者给予NSS 100 ml安慰剂。两组均在胎盘分娩后静脉注射催产素20单位。主要结果显示,术前静脉注射氨甲环酸与安慰剂相比,术中出血量显著减少,分别为349.5 ml(范围为168 ~ 2200)和619 ml(范围为288 ~ 3243),p<0.001。次要结局显示PPH发生率从4(13.33%)比10(33.33%)显著降低,p=0.030;输血1个单位以上的发生率从5(16.67%)比13(43.33%)显著降低,p=0.047。结论:剖宫产术前预防性补充氨甲环酸1 g,胎盘分娩后预防性静脉注射催产素,可有效减少术中出血量和PPH。关键词:氨甲环酸;术前;前置胎盘;术中出血量;剖腹产
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Efficacy of Preoperative Intravenous Tranexamic Acid Before Cesarean Section in Placenta Previa: A Randomized Double Blind Control Trial
Background: Placenta previa is a common cause of postpartum hemorrhage (PPH) that contributes substantively to maternal morbidity and mortality rates. Tranexamic acid is an antifibrinolytic drug that is useful for the treatment of PPH. The recommendation from many guidelines is to start giving tranexamic acid as soon as PPH is diagnosed to reduce postpartum blood loss. Furthermore, some studies report the beneficial use of tranexamic acid given as a prophylactic before Cesarean section to decrease intraoperative blood loss and prevent PPH. To the authors’ knowledge, in high-risk obstetrics case such as placenta previa, there was insufficient data to support recommendations of the use of tranexamic acid for prevent PPH. Objective: To evaluate the efficacy of supplementary intravenous tranexamic acid before cesarean section versus prophylactic intravenous oxytocin after placenta delivery alone to decrease intraoperative blood loss and prevent PPH in placenta previa. Material and Methods: The present study conducted a double blinded placebo control trial comparing adjunct 1 g tranexamic acid given intravenously before skin incision with prophylactic intravenous oxytocin after placenta delivery alone before cesarean section for placenta previa. The study recruited 60 women who were diagnosed with placenta previa at gestational age (GA) of more than 28 completed weeks undergoing emergency cesarean section due to active bleeding or scheduled for elective cesarean section at 37 completed weeks at Chonburi Hospital between July 2021 and July 2022. The primary outcome was intraoperative blood loss. Results: Sixty diagnosed placenta previa women were recruited, with 30 patients per group. Group I patients were given 1 g tranexamic acid and Group II were given a placebo of 100 ml NSS before skin incision. Both groups received intravenous oxytocin 20 units after placenta delivery. The main outcome showed that preoperative tranexamic acid intravenous reduced intraoperative blood loss significantly compared with the placebo at 349.5 ml (range of 168 to 2,200) versus 619 ml (range of 288 to 3,243), p<0.001. The secondary outcome showed a significant decrease in the incidence of PPH at 4 (13.33%) versus 10 (33.33%), p=0.030 and decreased in the incidence of blood transfusion of more than one unit from 5 (16.67%) versus 13 (43.33%), p=0.047. Conclusion: Prophylactic supplementary 1 g tranexamic acid intravenously before cesarean section to prophylactic intravenous oxytocin after placental delivery was found to effectively reduce intraoperative blood loss and PPH. Keywords: Tranexamic acid; Preoperative; Placenta previa; Intraoperative blood loss; Cesarean section
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