USE OF TRANEXAMIC ACID IN TRAUMA PATIENTS: AN ANALYSIS OF COST-EFFECTIVENESS FOR USE IN BRAZIL

ABSTRACT Introduction: Use of tranexamic acid (TXA) in trauma has been the subject of growing interest by researchers and health professionals. However, there are still several open questions regarding its use. In some aspects medical literature is controversial. The points of disagreement among experts include questions such as: Which patients should receive TXA in trauma? Should treatment be performed in the pre-hospital environment? Is there any need for laboratory parameters before starting TXA treatment? What is the drug safety profile? The main issue on which there is still no basis in literature is: What is the indication for treatment within massive transfusion protocols? Objective: Answer the questions proposed based on critical evaluation of the evidence gathered so far and carry out a study of cost-effectiveness of TXA use in trauma adapted to the Brazilian reality. Methods: A literature review was performed through searching Pubmed.com, Embase and Cab Abstract by headings "tranexamic AND trauma", in all languages, yielding 426 articles. Manuscripts reporting on TXA utilization for elective procedures were excluded, remaining 79 articles. Fifty-five articles were selected, and critically evaluated in order to answer study questions. The evaluation of cost effectiveness was performed using CRASH-2 trial data and Brazilian official population data. Results: TXA is effective and efficient, and should be administered to a wide range of patients, including those with indication evaluated in research protocols and current indication criteria for TXA should be expanded. As for the cost-effectiveness, the TXA proved to be cost-effective with an average cost of R$ 61.35 (currently US$16) per year of life saved. Conclusion: The use of TXA in trauma setting seems to be effective, efficient and cost-effective in the various groups of polytrauma patients. Its use in massive transfusion protocols should be the subject of further investigations.

摘要 引言：氨甲环酸（tranexamic acid, TXA）在创伤领域的应用日益受到研究者与医务工作者的关注，但目前其临床使用仍存在诸多未决问题，医学文献中相关观点亦存在争议。专家间的分歧包括：哪些创伤患者应接受TXA治疗？是否应在院前环境中开展给药治疗？启动TXA治疗前是否需要检测实验室指标？药物的安全性表现如何？目前文献尚未形成共识的核心问题是：大量输血方案中TXA治疗的适应证是什么？
研究目的：基于对现有证据的批判性评估，解答上述提出的问题，并结合巴西国情开展创伤患者使用TXA的成本效益分析研究。
研究方法：通过Pubmed、Embase及Cab Abstract数据库，以“tranexamic AND trauma”为主题词进行全语言文献检索，共获得426篇相关文献。排除针对择期手术中TXA应用的研究后，剩余79篇文献。最终筛选出55篇文献并进行批判性评估，以解答本研究的核心问题。成本效益分析采用CRASH-2试验数据及巴西官方人口统计数据完成。
研究结果：TXA的应用具有有效性与经济性，其适用人群范围应予以扩大，涵盖研究方案中评估的适应症人群及符合当前TXA应用指征的患者。就成本效益而言，TXA每挽救1年生命的平均成本为61.35雷亚尔（当前约合16美元）。
结论：创伤场景下使用TXA对各类多发伤患者均表现出有效性、经济性与成本效益性。在大量输血方案中应用TXA的适应证仍需进一步研究探索。