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氨甲环酸用于前置胎盘孕妇:一项双盲、多中心随机临床试验

Tranexamic Acid in Pregnant Women With Placenta Previa: A Double-Blind, Multicenter Randomized Clinical Trial.

作者信息

Alalaf Shahla, Jawad Ariana K, Al-Tawil Namir G, Dizaye Kawa F, Sileem Sileem A, Elebiary Noor, Mahmood Zanwer S, Khalil Rozhan Y, Amin Khalida M, Ali Nazdaar R

机构信息

Obstetrics and Gynecology, Hawler Medical University, College of Medicine, Erbil, IRQ.

Obstetrics and Gynecology, Kurdistan Higher Council of Medical Specialties, Erbil, IRQ.

出版信息

Cureus. 2024 Dec 7;16(12):e75297. doi: 10.7759/cureus.75297. eCollection 2024 Dec.

DOI:10.7759/cureus.75297
PMID:39776703
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11704449/
Abstract

AIMS

To determine the effectiveness of tranexamic acid (TXA) in reducing vaginal bleeding, extending pregnancy duration, and enhancing perinatal outcomes in pregnant women with placenta previa.

METHODS

A multicenter, randomized, double-blind clinical trial was conducted at three maternity teaching hospitals in Iraq's Kurdistan region, Azadi Hospital in the north of Iraq, and Al-Azhar University Hospital in Egypt on 146 women with placenta previa. Participants were randomly assigned to two interventional groups in a 1:1 ratio to receive either TXA or Dextrose 5% water (D5W). The two groups were compared in terms of the cessation of vaginal bleeding, continuation of pregnancy to term, and the perinatal outcome after repeated use of either method of treatment.

RESULTS

Bleeding stopped in 91.8% of the TXA group; however, the placebo group had more admissions for blood transfusion, received more units of packed red blood cells, and almost all their deliveries were preterm compared with the TXA group. Factors significantly associated with 'stopped bleeding' were TXA (OR = 5.2; 95% CI = 1.7-15.5), BMI of < 25 kg/m (OR = 6.3; 95% CI = 1.2-35.5), and BMI of 25-29 kg/m, late preterm delivery (32-36+6 weeks) [OR = 20.6; 95% CI = 4.6-90.2], and term delivery (39-40+6 weeks) [OR = 4.5; 95% CI = 4.5-776.2] compared with very preterm deliveries (28-32+6 weeks).

CONCLUSIONS

Treatment with TXA during pregnancy in women with placenta previa significantly outperforms in managing vaginal bleeding, prolonging pregnancy to a favorable gestational age and perinatal outcome. Larger studies are needed to confirm its benefits and guide clinical practice.

摘要

目的

确定氨甲环酸(TXA)在减少前置胎盘孕妇阴道出血、延长妊娠时间及改善围产期结局方面的有效性。

方法

在伊拉克库尔德地区的三家妇产教学医院、伊拉克北部的阿扎迪医院以及埃及的爱资哈尔大学医院,对146例前置胎盘孕妇进行了一项多中心、随机、双盲临床试验。参与者按1:1比例随机分为两个干预组,分别接受TXA或5%葡萄糖水(D5W)。比较两组在阴道出血停止情况、妊娠持续至足月情况以及重复使用任一治疗方法后的围产期结局。

结果

TXA组91.8%的患者出血停止;然而,与TXA组相比,安慰剂组输血入院次数更多,接受的浓缩红细胞单位更多,且几乎所有分娩均为早产。与“出血停止”显著相关的因素有TXA(比值比[OR]=5.2;95%置信区间[CI]=1.7 - 15.5)、体重指数(BMI)<25 kg/m²(OR = 6.3;95% CI = 1.2 - 35.5)、BMI为25 - 29 kg/m²、晚期早产(32 - 36⁺⁶周)[OR = 20.6;95% CI = 4.6 - 90.2]以及足月分娩(39 - 40⁺⁶周)[OR = 4.5;95% CI = 4.5 - 776.2],与极早产(28 - 32⁺⁶周)相比。

结论

前置胎盘孕妇孕期使用TXA在控制阴道出血、将妊娠延长至有利孕周及改善围产期结局方面显著优于其他方法。需要开展更大规模的研究以证实其益处并指导临床实践。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c836/11704449/6b967217f40c/cureus-0016-00000075297-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c836/11704449/d29b39fcb075/cureus-0016-00000075297-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c836/11704449/6b967217f40c/cureus-0016-00000075297-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c836/11704449/d29b39fcb075/cureus-0016-00000075297-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c836/11704449/6b967217f40c/cureus-0016-00000075297-i02.jpg

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本文引用的文献

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Maternal and Perinatal Outcomes in Placenta Previa: A Comprehensive Review of Evidence.前置胎盘的母儿结局:证据的全面综述
Cureus. 2024 May 6;16(5):e59737. doi: 10.7759/cureus.59737. eCollection 2024 May.
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Risk factors and perinatal outcomes for persistent placenta previa in nulliparas.初产妇前置胎盘持续存在的危险因素及围产期结局
Am J Obstet Gynecol MFM. 2023 Oct;5(10):101136. doi: 10.1016/j.ajogmf.2023.101136. Epub 2023 Aug 18.
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Tranexamic acid for the prevention of blood loss after cesarean section: an updated systematic review and meta-analysis of randomized controlled trials.
氨甲环酸预防剖宫产术后出血的效果:一项更新的随机对照试验的系统评价和荟萃分析。
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Risk Factors and Pregnancy Outcomes of Antepartum Hemorrhage in Women with Placenta Previa.前置胎盘孕妇产前出血的风险因素和妊娠结局。
Reprod Sci. 2023 Sep;30(9):2728-2735. doi: 10.1007/s43032-023-01191-2. Epub 2023 Mar 20.
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Use of tranexamic acid (TXA) to reduce preterm birth and other adverse obstetrical outcomes among pregnant individuals with placenta previa: a systematic review protocol.氨甲环酸(TXA)在前置胎盘孕妇中减少早产和其他不良产科结局的应用:系统评价方案。
BMJ Open. 2023 Mar 7;13(3):e068892. doi: 10.1136/bmjopen-2022-068892.
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The role of tranexamic acid in the management of postpartum haemorrhage.氨甲环酸在产后出血管理中的作用。
Best Pract Res Clin Anaesthesiol. 2022 Dec;36(3-4):411-426. doi: 10.1016/j.bpa.2022.08.004. Epub 2022 Aug 31.
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