我们在科学上已经准备好采用氨甲环酸作为常规的关节置换术了吗?

E. A. Sezgin, O. Atik
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引用次数: 6

摘要

骨科文献中有大量关于氨甲环酸(TXA)使用的研究;大多数显示其在减少失血量和输血需求方面的有效性,导致更好的结果,缩短住院时间并降低成本。[1,2] TXA的历史可以追溯到20世纪60年代,TXA是一种相对便宜的药物。然而,在过去十年的骨科实践中,旧的和便宜的并没有限制TXA革新围手术期血液管理,特别是在占选择性手术很大一部分的关节成形术中。[3-5]然而,尽管人们对这种药物有着极大的兴趣和热情,但其药代动力学特性、给药剂量和不同临床情况的最佳给药方式在很大程度上仍然未知。氨甲环酸是一种纤维蛋白凝块稳定剂,实际上不是促凝剂,但它仍然通常与静脉血栓栓塞事件(vte)(如中风、深静脉血栓栓塞、肺栓塞)、心肌梗死的风险增加有关,并且在较小程度上与视网膜损伤、癫痫发作和恶心有关。虽然这种增加的风险还没有得到证实,但在关节置换术中也没有完全排除这种可能性。考虑到即使是荟萃分析,包括来自最高质量的随机对照试验的数据,也难以提供有关TXA使用安全性的具体证据,并且对于前瞻性研究,即使在80%的功率下检测到1%的差异,每组至少需要5,000名患者,TXA的广泛采用似乎仍然缺乏强有力的科学背景。[6,7]美国食品和药物管理局也没有批准它用于血友病和月经过多患者的牙齿出血预防以外的用途。[8,9]
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Are we scientifically ready to adopt tranexamic acid as a routine in arthroplasty?
The orthopedic literature is abundant in studies on use of tranexamic acid (TXA); most showing its effectiveness in reducing blood loss and transfusion requirement leading to better outcome, shorter length of hospital stay and reduced costs.[1,2] History of TXA dates back to 1960s and TXA is a relatively cheap agent. However, being old and cheap have not restrained TXA to revolutionize the perioperative blood management in the last decade of orthopedic practice, particularly in arthroplasty procedures which make up for a big portion of elective surgeries.[3-5] However, despite the great interest in and the enthusiasm surrounding this agent, its pharmacokinetic characteristics, dosing and optimal modality of administration for different clinical scenarios still remain largely unknown. Tranexamic acid is a fibrin clot stabilizer and not actually a pro-coagulant agent, but it is still commonly associated with increased risk of venous thromboembolic events (VTEs) (e.g. stroke, deep venous thromboembolism, pulmonary embolism), myocardial infarction and to a lesser extent, retinal injury, seizures and nausea. Although this increased risk profile has not been demonstrated, neither it has been totally ruled out in arthroplasty procedures. Considering that even the meta-analyses including data from highest quality randomized controlled trials struggle to provide concrete evidence on safety of TXA use and, for prospective studies, there is need for at least 5,000 patients in each group even to detect a 1% difference with an 80% power, TXA’s widespread adoption seems to continue lacking strong scientific background.[6,7] It has also not been approved by the U.S. Food and Drug Administration for uses other than dental bleeding prophylaxis in hemophilic patients and menorrhagia.[8,9]
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来源期刊
CiteScore
1.90
自引率
43.80%
发文量
0
审稿时长
>12 weeks
期刊介绍: Joint Diseases and Related Surgery (formerly published as Eklem Hastalıkları ve Cerrahisi) is the official publication of the Turkish Joint Diseases Foundation. Joint Diseases and Related Surgery is open access journal. The full text of the articles of the Journal is freely available without embargo since 1990. Joint Diseases and Related Surgery is international, double-blind peer-reviewed periodical journal bringing the latest developments in all aspects of joint diseases and related surgey.
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