Montroy Joshua, Hutton Brian, Moodley Preveshen, Fergusson Nicholas A, Cheng Wei, Tinmouth Alan, Lavallée Luke T, Fergusson Dean A, Breau Rodney H
Clinical Epidemiology Program, Centre for Practice Changing Research, Ottawa Hospital Research Institute, Ottawa, ON, Canada; University of Ottawa, School of Epidemiology, Community Medicine and Preventive Medicine, Ottawa, ON, Canada.
Division of Urology, Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.
Transfus Med Rev. 2018 Feb 19. doi: 10.1016/j.tmrv.2018.02.003.
Tranexamic acid (TXA) is an effective hemostatic agent used for the reduction of blood loss and transfusion. However, the safety profile of TXA remains in question due to a potential increased risk of venous thromboembolism. By applying TXA topically as opposed to intravenously, systemic absorption may be reduced and unwanted side-effects mitigated. The objective of our review is to investigate the efficacy and safety of topically applied tranexamic acid compared to both placebo, and the intravenous administration. Cochrane Central Register of Controlled Trials, MEDLINE, Embase, ISI Web of Science, PubMed, and Clinicaltrials.gov were searched from inception to November, 2016. We included randomized controlled trials that compared topical tranexamic acid to either placebo (or standard care) or intravenous administration, in adult patients. Surgical and non-surgical trials were included. Abstract, full-text selection, data extraction and risk of bias assessment were all performed in duplicate. In total, 67 studies involving 6,034 patients met inclusion criteria. The majority of trials evaluated orthopedic procedures. Compared to placebo, the administration of topical TXA significantly reduced the odds of receiving a blood transfusion (pooled OR 0.28, 95% CI 0.20 to 0.38; P < 0.001) and significantly reduced mean blood loss (WMD -276.6, 95% CI -327.8 to -225.4; P < 0.0001). When compared to the intravenous administration, there was no difference between the two groups in terms of transfusion requirements (pooled OR 1.03, 95% CI 0.72 to 1.46; P=0.88) or blood loss (WMD -21.95, 95% CI -66.61 to 27.71; P=0.34). There was no difference in the odds of developing a venous thromboembolic complication between the topical TXA and control groups (pooled OR=0.78, 95% CI 0.47 to 1.29; P=0.33) or the topical and intravenous groups (pooled OR=0.75, 95% CI 0.39 to 1.46; P=0.40). The topical application of TXA effectively reduces both transfusion risk and blood loss compared to placebo, without increasing thromboembolic risks. There were no major differences between topical and intravenous tranexamic acid with respect to safety and efficacy, and both were superior to placebo with regards to blood loss and transfusion requirements. Further study of the topical application is required outside of the field of orthopedics.
氨甲环酸（TXA）是一种有效的止血剂，用于减少失血和输血。然而，由于静脉血栓栓塞风险可能增加，TXA的安全性仍存在疑问。与静脉注射相比，局部应用TXA可减少全身吸收并减轻不良副作用。我们综述的目的是研究局部应用氨甲环酸与安慰剂及静脉给药相比的疗效和安全性。检索了Cochrane对照试验中央注册库、MEDLINE、Embase、ISI科学网、PubMed和Clinicaltrials.gov，检索时间从创建至2016年11月。我们纳入了比较局部应用氨甲环酸与安慰剂（或标准治疗）或静脉给药的成年患者随机对照试验。纳入了外科和非外科试验。摘要筛选、全文筛选、数据提取和偏倚风险评估均重复进行。总共67项研究涉及6034例患者符合纳入标准。大多数试验评估了骨科手术。与安慰剂相比，局部应用TXA显著降低了接受输血的几率（合并OR 0.28，95%CI 0.20至0.38；P<0.001），并显著减少了平均失血量（WMD -276.6，95%CI -327.8至-225.4；P<0.0001）。与静脉给药相比，两组在输血需求（合并OR 1.03，95%CI 0.72至1.46；P=0.88）或失血量（WMD -21.95，95%CI -66.61至27.71；P=0.34）方面没有差异。局部应用TXA组与对照组之间发生静脉血栓栓塞并发症的几率没有差异（合并OR=0.78，95%CI 0.47至1.29；P=0.33），局部应用组与静脉给药组之间也没有差异（合并OR=0.75，95%CI 0.39至1.46；P=0.40）。与安慰剂相比，局部应用TXA可有效降低输血风险和失血量，且不增加血栓栓塞风险。局部应用和静脉应用氨甲环酸在安全性和疗效方面没有重大差异，在失血量和输血需求方面均优于安慰剂。骨科领域之外需要对局部应用进行进一步研究。
