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静脉注射与局部应用氨甲环酸减少腹部子宫切除术中失血的双盲随机对照试验

Reducing Blood Loss During Abdominal Hysterectomy with Intravenous Versus Topical Tranexamic Acid: A Double-Blind Randomized Controlled Trial.

作者信息

Sallam Hany F, Shady Nahla W

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Aswan University, Aswan, Egypt.

出版信息

J Obstet Gynaecol India. 2019 Apr;69(2):173-179. doi: 10.1007/s13224-018-1149-x. Epub 2018 Jul 3.

DOI:10.1007/s13224-018-1149-x
PMID:30956473
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6430276/
Abstract

OBJECTIVES

To assess the effect of intravenous versus topical tranexamic acid in reducing intraoperative and postoperative blood loss in women with abdominal hysterectomy.

MATERIALS AND METHODS

The study was a randomized double-blind placebo-controlled trial, carried out in a tertiary university hospital in Egypt, from November 2015 to October 2017. A total of 129 women undergoing abdominal hysterectomy for benign etiology were randomly assigned to three groups: Group I [43 patients received 110 ml normal saline IV just before skin in scion], Group II [43 patients received 1 g tranexamic acid in 100 ml saline IV just before skin in scion], and Group III [43 patients received 2 g topical tranexamic acid applied intra-abdominal after hysterectomy]. The primary outcome was intraoperative, postoperative, and all blood loss estimation.

RESULTS

Both Group II (IV tranexamic acid) and Group III (topical tranexamic acid application) showed great reduction in intraoperative and postoperative blood loss (blood in the intra-abdominal drain) compared with Group I (placebo group), ( = 0.0001, 0.0001, 0.0001, 0.0001), so the overall estimated blood loss in groups II and III showed highly reduction compared with Group I ( = 0.0001, 0.0001).

CONCLUSION

Intravenous and topical tranexamic acid application is a safe and reliable method to help decrease blood loss during and after abdominal hysterectomy.

摘要

目的

评估静脉注射与局部应用氨甲环酸对腹式子宫切除术女性术中及术后失血的影响。

材料与方法

本研究为一项随机双盲安慰剂对照试验,于2015年11月至2017年10月在埃及一所三级大学医院进行。共有129例因良性病因接受腹式子宫切除术的女性被随机分为三组:第一组[43例患者在皮肤切开前静脉输注110毫升生理盐水],第二组[43例患者在皮肤切开前静脉输注100毫升含1克氨甲环酸的生理盐水],第三组[43例患者在子宫切除术后腹腔内应用2克局部氨甲环酸]。主要结局指标为术中、术后及总失血量评估。

结果

与第一组(安慰剂组)相比,第二组(静脉注射氨甲环酸)和第三组(局部应用氨甲环酸)的术中及术后失血量(腹腔引流管中的血液)均显著减少(P = 0.0001, 0.0001, 0.0001, 0.0001),因此第二组和第三组的总体估计失血量与第一组相比显著减少(P = 0.0001, 0.0001)。

结论

静脉注射和局部应用氨甲环酸是一种安全可靠的方法,有助于减少腹式子宫切除术期间及术后的失血量。

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本文引用的文献

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Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.氨甲环酸早期给药对产后出血妇女死亡率、子宫切除术和其他并发症的影响(WOMAN):一项国际、随机、双盲、安慰剂对照试验。
Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
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[Can venous iron and tranexamic acid reduce the transfusion need? Report on a non randomized, case control study].静脉注射铁剂和氨甲环酸能否减少输血需求?一项非随机病例对照研究报告
Transfus Clin Biol. 2017 Jun;24(2):52-55. doi: 10.1016/j.tracli.2017.01.002. Epub 2017 Mar 22.
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Comparison of four methods of blood loss estimation after cesarean delivery.剖宫产术后四种失血估计方法的比较。
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Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial.预防性氨甲环酸在良性子宫切除术中的止血效果:一项双盲随机安慰剂对照试验。
Am J Obstet Gynecol. 2016 Jul;215(1):72.e1-8. doi: 10.1016/j.ajog.2016.01.184. Epub 2016 Jan 30.
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Effect of a single preoperative dose of sublingual misoprostol on intraoperative blood loss during total abdominal hysterectomy.术前单次舌下含服米索前列醇对全子宫切除术术中出血量的影响。
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Complications of hysterectomy.子宫切除术的并发症。
Obstet Gynecol. 2013 Mar;121(3):654-673. doi: 10.1097/AOG.0b013e3182841594.
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Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis.氨甲环酸对手术出血的影响:系统评价和累积荟萃分析。
BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
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Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures.局部使用氨甲环酸或氨基己酸预防大型外科手术后出血。
Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27.
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Body mass and risk of complications after hysterectomy on benign indications.体质量与良性指征子宫切除术术后并发症风险。
Hum Reprod. 2011 Jun;26(6):1512-8. doi: 10.1093/humrep/der060. Epub 2011 Apr 5.
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Gynecologic surgery and the management of hemorrhage.妇科手术与出血处理。
Obstet Gynecol Clin North Am. 2010 Sep;37(3):427-36. doi: 10.1016/j.ogc.2010.05.003.