氨甲环酸在初次全膝关节置换术中的应用：失血量、输血及深静脉血栓的系统综述与荟萃分析。
完整摘要 · 中文译文
背景：氨甲环酸（TXA）已广泛用于初次全膝关节置换术（TKA）以减少围手术期失血量，但关于失血量、输血和深静脉血栓形成（DVT）的汇总证据仍有待进一步明确。本荟萃分析的目的是评价TXA在初次TKA中的有效性和安全性。 方法：检索PubMed、Embase、Web of Science、Cochrane Library及相关补充来源，以识别比较TXA与对照方案在初次单侧TKA中应用的随机对照试验（RCT）。主要结局为失血量、输血和DVT。连续性结局以均数差（MD）及95%置信区间（CI）汇总，二分类结局以风险比（RR）或比值比（OR）及95%置信区间汇总。采用Cochrane RoB 2工具评估偏倚风险。荟萃分析采用随机效应模型。对于失血量结局，鉴于随机效应荟萃分析中的方法学选择在存在显著异质性时可能影响统计学显著性，额外采用经验贝叶斯随机效应模型并结合Knapp-Hartung标准误校正进行稳健性分析，以评估该结果是否对模型假设敏感。 结果：共有17项研究纳入系统评价和荟萃分析。与对照相比，TXA与失血量显著减少相关（MD = -423.28 mL，95% CI -536.90至-309.66；P < 0.001），尽管观察到显著异质性（I² = 93.44%） . 留一法敏感性分析显示，剔除单项研究后合并效应仍显著；剔除一项高影响力研究后异质性降至81.88%。Knapp-Hartung校正稳健性分析得出相似且显著的效应估计。TXA还显著降低输血风险（RR = 0.55，95% CI 0.45至0.68；P < 0.001），无异质性（I² = 0.0%）。TXA组与对照组在深静脉血栓（DVT）发生率上无显著差异（OR = 0.75，95% CI 0.47至1.22；P = 0.25），异质性低（I² = 0.0%）。漏斗图检查提示失血量和输血可能存在不对称性；然而，失血量的Egger检验不显著（P = 0.842），而输血检测到显著的小样本效应（P = 0.002）。 结论：当前证据表明，初次全膝关节置换术（TKA）中使用TXA可显著减少失血量和输血需求，现有随机证据未发现DVT风险增加。失血量分析显示存在 substantial 异质性，而输血和DVT分析在各研究间更为一致。
完整摘要 · 英文原文
BACKGROUND: Tranexamic acid (TXA) has been widely used in primary total knee arthroplasty (TKA) to reduce perioperative blood loss, but the pooled evidence regarding blood loss, transfusion, and deep vein thrombosis (DVT) remains to be further clarified. The purpose of this meta-analysis was to evaluate the efficacy and safety of TXA in primary TKA. METHODS: PubMed, Embase, Web of Science, the Cochrane Library, and relevant additional sources were searched to identify randomized controlled trials (RCTs) comparing TXA with a control regimen in primary unilateral TKA. The primary outcomes were blood loss, transfusion, and DVT. Continuous outcomes were pooled as mean differences (MDs) with 95% confidence intervals (CIs), and dichotomous outcomes were pooled as risk ratios (RRs) or odds ratios (ORs) with 95% CIs. Risk of bias was assessed using the Cochrane RoB 2 tool. Random-effects models were applied for meta-analysis. For the blood-loss outcome, an additional robustness analysis was performed using an empirical Bayes random-effects model with Knapp-Hartung standard error adjustment to evaluate whether the result was sensitive to model assumptions, given that methodological choices in random-effects meta-analysis may influence statistical significance when substantial heterogeneity is present. RESULTS: A total of 17 studies were included in the systematic review and meta-analysis. TXA was associated with significantly reduced blood loss compared with control (MD = -423.28 mL, 95% CI -536.90 to -309.66; P < 0.001), although substantial heterogeneity was observed (I² = 93.44%). Leave-one-out sensitivity analysis showed that the pooled effect remained significant after exclusion of individual studies; exclusion of one influential study reduced heterogeneity to 81.88%. The Knapp-Hartung-adjusted robustness analysis yielded a similar significant effect estimate. TXA also significantly reduced transfusion risk (RR = 0.55, 95% CI 0.45 to 0.68; P < 0.001), with no significant heterogeneity (I² = 0.0%). No significant difference was found between the TXA and control groups in the incidence of DVT (OR = 0.75, 95% CI 0.47 to 1.22; P = 0.25), and heterogeneity was low (I² = 0.0%). Funnel plot inspection suggested possible asymmetry for blood loss and transfusion; however, Egger's test was not significant for blood loss (P = 0.842), whereas significant small-study effects were detected for transfusion (P = 0.002). CONCLUSIONS: The current evidence indicates that TXA in primary TKA significantly reduces blood loss and transfusion requirements with no detected increase in DVT risk in the available randomized evidence. The blood loss analysis showed substantial heterogeneity, whereas the transfusion and DVT analyses were more consistent across studies.