中国循证医学杂志

中国循证医学杂志

创伤骨折手术应用氨甲环酸疗效和安全性的 meta 分析

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目的 系统评价氨甲环酸(tranexamic acid,TXA)减少创伤骨折患者输血率和总出血量的有效性和安全性。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、CNKI、WanFang Data 和 VIP 数据库,并检索 American Academy of Orthopaedic Surgeons(AAOS)和 Orthopaedic Trauma Association(OTA)网站以获取更多相关文献,检索时限均从建库至 2018 年 6 月 30 日。由 2 位研究员独立进行文献筛选、数据提取和偏倚风险评价后,采用 RevMan 5.3 和 Stata 14.0 软件行 meta 分析。 结果 共纳入 10 个 RCT,共计 936 例患者。meta 分析结果显示,与对照组比,TXA 组可明显降低输血率[RR=0.75,95%CI(0.63,0.89),P=0.001]、总失血量[MD=–157.61,95%CI(–250.09,–65.13),P=0.000 8]和伤口并发症发生率[RR=0.24,95%CI(0.10,0.58),P=0.002];但 TXA 组和对照组的血栓事件发生率[RR=1.25,95%CI(0.78,2.00),P=0.36]和术后死亡率[RR=0.81,95%CI(0.40,1.66),P=0.57]差异无统计学意义。 结论 TXA 可有效降低创伤骨折手术患者的输血率和术中、术后总失血量和伤口并发症发生率,不会明显增加血栓事件的发生率和死亡率。受纳入研究数量和质量限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of tranexamic acid (TXA) in reducing blood transfusion and total blood loss in patients undergoing orthopaedic trauma surgery. Methods A systematic literature search was performed using PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, VIP database, and a search for grey literature was also performed in American Academy of Orthopaedic Surgeons (AAOS) and Orthopaedic Trauma Association (OTA). The time was up to June 2018. Two reviewers independently screened literature, extracted data and assessed risk of bias, then meta-analysis was performed by using RevMan 5.3 and Stata 14.0 softwares. Results A total of 10 studies were included, including 936 patients. The pooled results indicated that TXA group was superior to the control group in blood transfusion (RR=0.75, 95%CI 0.63 to 0.89, P=0.001), the total blood loss (MD=–157.61, 95%CI –250.09 to –65.13, P=0.000 8) and the wound complications (RR=0.24, 95%CI 0.10 to 0.58, P=0.002). There was no significant difference in risk of thromboembolic events (RR=1.25, 95%CI 0.78 to 2.00, P=0.36) and the mortality (RR=0.81, 95%CI 0.40 to 1.66, P=0.57) between TXA and control group. Conclusions TXA can effectively reduce the blood transfusion, total blood loss and wound complications in patients undergoing orthopedic trauma surgery. Furthermore, TXA does not significantly increase the incidence of thromboembolic events and mortality. Due to the limited quality of included studies, more high quality studies are needed to verify the above conclusion.

关键词: 氨甲环酸; 创伤骨折; 失血; 输血; Meta 分析; 随机对照试验

Key words: Tranexamic acid; Traumatic fracture; Blood loss; Blood transfusion; Meta-analysis; RCT

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