局部应用与静脉应用氨甲环酸在初次全膝关节置换术中的疗效与安全性：一项随机对照试验的系统评价与荟萃分析。
完整摘要 · 中文译文
背景：全膝关节置换术（TKA）常导致大量围手术期失血和术后血红蛋白下降，经常需要异体输血。氨甲环酸（TXA）可有效减少出血，但关于局部给药还是静脉（IV）给药能带来更优的临床结局仍存在争议。本系统评价和荟萃分析利用随机对照试验（RCT）的汇总数据，评估了局部给药与静脉给药TXA在初次全膝关节置换术中的疗效和安全性。 方法：检索PubMed中比较局部给药与静脉给药TXA的平行组RCT。采用随机效应模型，通过标准化均数差（SMD）分析连续变量结局，通过相对危险度（RR）及95%置信区间（CI）分析二分类变量结局。 结果：共纳入11项RCT。汇总分析显示，局部给药与静脉给药TXA在所有指标上均无统计学显著差异。术后血红蛋白下降（9项研究，815例患者；SMD = -0.292，95% CI：-0.748至0.163，P = 0.208）、总失血量（5项研究，418例患者；SMD = 0.356，95% CI：-0.297至1.009，P = 0.284）、引流量（5项研究，357例患者；SMD = 0.721，95% CI：-0.394至1.836，P = 0.204）和输血率（10项研究，914例患者；RR = 0.644，95% CI：0.343至1.209，P = 0.171）。安全性数据有限，因为仅有七项研究报告了可用的深静脉血栓（DVT）数据（四项研究未报告或未说明血栓栓塞/不良事件），且仅静脉给药组报告了一例DVT事件。 结论：在初次全膝关节置换术中，未发 在局部与静脉（IV）氨甲环酸（TXA）之间，就血液保护、引流量和输血率而言，检测到耳差异，并存在相当大的不确定性，尤其在安全性和血栓栓塞结局方面。
完整摘要 · 英文原文
BACKGROUND: Total knee arthroplasty (TKA) often leads to substantial perioperative blood loss and postoperative hemoglobin decline, frequently requiring allogeneic transfusions. Tranexamic acid (TXA) effectively reduces bleeding, but debate persists regarding whether topical or intravenous (IV) administration provides superior clinical outcomes.This systematic review and meta-analysis evaluated the efficacy and safety of topical versus IV TXA in primary TKA using pooled data from randomized controlled trials (RCTs). METHODS: PubMed was searched for parallel-group RCTs comparing topical and IV TXA. Random-effects models analyzed continuous outcomes via standardized mean differences (SMDs) and dichotomous outcomes via relative risks (RRs) with 95% confidence intervals (CIs). RESULTS: Eleven RCTs were included. Pooled analysis demonstrated no statistically significant differences between topical and IV TXA across all metrics. Postoperative hemoglobin drop (9 studies, 815 patients; SMD = -0.292, 95% CI: -0.748 to 0.163, P = 0.208), total blood loss (5 studies, 418 patients; SMD = 0.356, 95% CI: -0.297 to 1.009, P = 0.284), drainage volume (5 studies, 357 patients; SMD = 0.721, 95% CI: -0.394 to 1.836, P = 0.204), and transfusion rate (10 studies, 914 patients; RR = 0.644, 95% CI: 0.343 to 1.209, P = 0.171). Safety data were limited, as usable deep vein thrombosis (DVT) data were reported in only seven studies (with four studies not reporting or not stating thromboembolic/adverse event), and only a single DVT event was reported in the IV group. CONCLUSIONS: In primary TKA, no clear difference was detected between topical and IV TXA for blood conservation, drainage volumes, and transfusion rates, with substantial uncertainty, especially for safety and thromboembolic outcomes.