氨甲环酸不能降低胃肠道出血引起的死亡风险

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氨甲环酸不能降低胃肠道出血引起的死亡风险

2020-06-20 10:54

本期文章:《柳叶刀》:Volume 395 Number 10241

英国伦敦卫生与热带医学院临床试验组探讨了大剂量24小时输注氨甲环酸对急性胃肠道出血患者死亡和血栓栓塞事件的影响。2020年6月20日,该研究发表在《柳叶刀》杂志上。

氨甲环酸可减少手术出血,并减少创伤患者因出血而导致的死亡。小型试验的荟萃分析表明,氨甲环酸可减少因胃肠道出血引起的死亡。

为了评估氨甲环酸在胃肠道出血患者中的作用,研究组在15个国家/地区的164家医院进行了一项国际、多中心、随机、安慰剂对照试验,2013年7月4日至2019年6月21日,招募了12009例临床医生不确定是否使用氨甲环酸、已成年、有明显上消化道或下消化道出血(定义为出血致死风险)的患者。将其随机分组,其中5994例接受大剂量24小时输注氨甲环酸治疗,6015例接受安慰剂治疗。

共有11952名(99.5%)患者接受了首剂分配治疗。氨甲环酸组5956例患者中有222例(4%)因随机出血而死亡,安慰剂组5981例患者中有226例(4%),风险比为0.99。氨甲环酸组和安慰剂组中动脉血栓栓塞事件(心肌梗塞或中风)发生率相似,分别为0.7%和0.8%。氨甲环酸组中静脉血栓栓塞事件(深静脉血栓形成或肺栓塞)发生率为0.8%,显著高于安慰剂组(0.4%)。

总之,研究结果发现氨甲环酸并不能减少胃肠道出血引起的死亡。

附:英文原文

Title: Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

Author: Ian Roberts, Haleema Shakur-Still, Adefemi Afolabi, Adegboyega Akere, Monica Arribas, Amy Brenner, Rizwana Chaudhri, Ian Gilmore, Kenneth Halligan, Irshad Hussain, Vipul Jairath, Kiran Javaid, Aasia Kayani, Ton Lisman, Raoul Mansukhani, Muttiullah Mutti, Muhammad Arif Nadeem, Richard Pollok, Jonathan Simmons, Majid Soomro, Simon Stanworth, Andrew Veitch, Christopher Hawkey, Adefemi Afolabi, Jack Cuzick, Kenneth Halligan, David Henry, Chris Metcalfe, Ian Roberts, Richard Gray, Alan Barkun, Suresh David, Philip Devereaux, Tony Brady, Ian Roberts, Haleema Shakur-Still, Timothy Coats, Phil Edwards, Ian Gilmore, Vipul Jairath, Katharine Ker, Daniela Manno, Simon Stanworth, Andrew Veitch, Monica Arribas, Emma Austin, Kiran Bal, Eni Balogun, Collette Barrow, Danielle Beaumont, Myriam Benyahia, Amy Brenner, Imogen Brooks, Madeleine Cargill, Laura Carrington, Phil Edwards, Lauren Frimley, Amber Geer, Daniel Gilbert, Catherine Gilliam, Julio Gil Onandia, Nayia Golfi, Daniel Hetherington, Courtenay Howe, Carolyn Hughes, David Ianson, Rob Jackson, Miland Joshi, Sneha Kansagra, Taemi Kawahara, Katharine Ker, Sergey Kostrov, Daniela Manno, Raoul Mansukhani, Hakim Miah, Bernard Ndungu, Kelly Needham, Aroudra Outtandy, Daniel Pearson, Tracey Pepple, Danielle Prowse, Nigel Quashi, Anna Quinn, Maria Ramos, Laura Ranopa, Mia Reid, Ian Roberts, Chris Roukas, Haleema Shakur-Still, Chelci Squires, Jemma Tanner, Andrew Thayne, Ruhama Uddin, Rizwana Chaudhri, Muttiullah Mutti, Kiran Javaid, Aasia Kayani, Bukola Fawole, Folasade Adenike Bello, Oladapo Olayemi, Adefemi Afolabi, Olujide Okunade, Olusade Adetayo, Rizwana Chaudhri, Muttiullah Mutti, Adefemi Afolabi, Folasade Adenike Bello, Bukola Fawole, Oladapo Olayemi, Hussein Khamis, Mohammad Shukri Bin Jahit, Tamar Gogichaishvili, Radu Bogdan Mateescu, Ajay Adhikaree, Abdelmounem Eltayeib Abdo, Mohammad Zaher, Conor Deasy, Joaquin Alvarez Gregori, Bobby Wellsh, Luke Lawton, Raghavendra Kamath, Adrian Barry, Racquel Carpio, Kay Finney, Holly Maguire, Martin James, Frank Coffey, Chris Gough, Lisa Sawers, Aye-Aye Thi, Jonathan Simmons, Claire Burnett, Nicola Jacques, Victoria Murray, Richard Pollok, Heather Jarman, Christine Lambe, Sarah Rounding, Simon Tucker, Romaih Al-Idari, Samuel Guest, Emma Stoddard, David Yeo, Colin Bergin, Elaine Hardy, Joanne Thunder, Paul Jhalli, Edward Hartley, Catherine Jarvis, Carly Swann

Issue&Volume: 2020/06/20

Abstract: Background

Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.

Methods

We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.

Findings

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