髋部骨折患者应用氨甲环酸的有效性和安全性的Meta分析

Meta-Analysis of the Efficacy and Safety of Tranexamic Acid in Patients with Hip Fracture

摘要: 目的：通过Meta分析比较氨甲环酸和安慰剂治疗髋部骨折患者中的有效性与安全性。方法：通过检索PubMed、Cochrane Library、EMbase、中国知网、万方和维普数据库，根据纳入及排除标准检索出关于氨甲环酸和安慰剂治疗髋部骨折的随机对照研究23篇、回顾性研究4篇，使用Endnote X9软件管理文献，使用Revman 5.3软件对所提取的数据进行Meta分析，主要分析髋部骨折患者接受氨甲环酸和安慰剂治疗后总失血量、术中出血、术后失血量、术后血红蛋白值、输血率、血栓发生率和死亡率等。结果：1) 共纳入23项随机对照研究和4项回顾性研究，其中10篇文献属于中高质量文献，8篇文献属于低质量文献；27项研究共3162例患者，氨甲环酸组患者1507例，对照组患者1655例；2) Meta结果显示：氨甲环酸组总失血量[RR = −197.84, 95% CI (−265.51, −130.18), P < 0.00001]低于对照组，氨甲环酸组输血率[RR: 0.35, 95% CI (0.29, 0.42), P < 0.00001]低于对照组，氨甲环酸组与对照组之间血栓发生率无显著差异[RR = 1.16, 95% CI (0.83, 1.62), P = 0.39]，氨甲环酸组术后血红蛋白值[RR: 5.09, 95% CI (3.36, 6.82), P < 0.00001]高于对照组，氨甲环酸组与对照组之间术中出血量无显著差异[RR = −47.51，95% CI (−124.68, 29.66), P = 0.23]，氨甲环酸组与对照组之间死亡率无显著差异[RR = 1.13, 95% CI (0.67, 1.90), P = 0.64]。结论：Meta分析结果显示，髋部骨折患者应用氨甲环酸能够有效减少患者的总失血量、输血率，且提高术后血红蛋白值，但预防血栓发生率、术中出血量、死亡率等安全性方面氨甲环酸组和对照组基本相似。

Abstract: Objective: Meta-analysis to compare the efficacy and safety of tranexamic acid and placebo in pa-tients with hip fracture. Methods: By searching the PubMed, Cochrane Library, EMbase, CNKI, Wan-fang, and VIP databases, according to the inclusion and exclusion criteria, 23 randomized controlled studies on tranexamic acid and placebo and 4 retrospective studies were retrieved. Managing the literature using the Endnote X9 software, the Meta-analysis of the extracted data was performed using the Revman 5.3 software. The main analysis is the total blood loss, intraoperative bleeding, postoperative blood loss, postoperative hemoglobin value, transfusion rate, thrombosis incidence and mortality of patients with hip fracture receiving tranexamic acid and placebo. Results: 1) A to-tal of 23 randomized controlled studies and 4 retrospective studies were included, Among them, 10 documents belong to medium and high quality documents, 8 articles belong to low-quality litera-ture; 27 studies included 3162 patients. Of 1507 patients in the tranexamic acid group, 1655 pa-tients in the control group; 2) Meta results showed that: the total blood loss in the tranexamic acid group [RR = −197.84, 95% CI (−265.51, −130.18), P < 0.00001] was lower than that in the control group. Transfusion rate in the tranexamic acid group [RR: 0.35, 95% CI (0.29, 0.42), P < 0.00001] was lower than that in the control group. There was no significant difference in thrombosis inci-dence between tranexamic acid group and control group [RR = 1.16, 95% CI (0.83, 1.62), P = 0.39]. Postoperative hemoglobin values in the tranexamic acid group [RR: 5.09, 95% CI (3.36, 6.82), P < 0.00001] was higher than that in the control group. There was no significant difference in in-traoperative bleeding between the tranexamic acid group and the control group [RR = −47.51, 95% CI (−124.68, 29.66), P = 0.23]. There was no significant difference in mortality between the tranexamic acid and control groups [RR = 1.13, 95% CI (0.67, 1.90), P = 0.64]. Conclusion: Me-ta-analysis showed that the application of tranexamic acid in hip fracture patients could effectively reduce the total blood loss, blood transfusion rate, and improve the postoperative hemoglobin val-ue, but the incidence of thrombosis prevention, intraoperative blood loss, mortality and the control group were basically similar.