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静脉注射氨甲环酸单次与双次剂量用于髋膝关节置换术的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of single- and double-dose intravenous tranexamic acid in hip and knee arthroplasty: a systematic review and meta-analysis.

机构信息

First Clinical Medical College of Gansu, University of Traditional Chinese Medicine, Lanzhou, China.

People's Hospital of Gansu Province, 204 Donggang West Road, Chengguan District, Lanzhou, 730000, China.

出版信息

J Orthop Surg Res. 2023 Aug 10;18(1):593. doi: 10.1186/s13018-023-03929-9.

Abstract

OBJECTIVE

With the increasing prevalence of osteoarthritis of the hip and knee, total joint replacement, the end-stage treatment, provides pain relief and restoration of function, but is often associated with massive blood loss. Tranexamic acid (TXA) has been reported to reduce perioperative blood loss in hip or knee arthroplasty. However, the optimal dose of TXA administration remains controversial. Therefore, we performed a meta-analysis combining data from 5 trials comparing the efficacy and safety of one fixed dose of 1 g intravenously administered TXA with two doses of 1 g each administered intravenously for hip or knee arthroplasty.

METHODS

PubMed, Medline, Embase, Web of Science, and The Cochrane Library were searched from January 2000 to February 2023. Our meta-analysis included randomized controlled trials and cohort studies comparing the efficacy and safety of different doses of intravenous TXA (IV-TXA) for THA or TKA. The observation endpoints included total blood loss, postoperative hemoglobin drop, blood transfusion rate, length of hospital stay, incidence of deep venous thrombosis (DVT), and incidence of pulmonary embolism (PE). Meta-analysis was performed according to Cochrane's guidelines and PRISMA statement. The Danish RevMan5.3 software was used for data merging.

RESULTS

Five cohort studies involving 5542 patients met the inclusion criteria. Our meta-analysis showed that the two groups were significantly higher in total blood loss (mean difference (MD) = - 65.60, 95% confidence interval (CI) [- 131.46, 0.26], P = 0.05); blood transfusion rate (risk difference (RD) = 0.00, 95% CI [- 0.01, 0.02], P = 0.55); postoperative hemoglobin (MD = 0.02, 95% CI [- 0.09, 0.13], P = 0.31); postoperative hospital stay days (MD = - 0.13), 95% CI [- 0.35, 0.09], P = 0.25); DVT (RD = 0.00, 95% CI [- 0.00, 0.01], P = 0.67); PE (RD = 0.00, 95% CI [- 0.01, 0.00], P = 0.79). There was some inherent heterogeneity due to variance in sample size across each major study.

CONCLUSION

1 dose of 1 g and 2 doses of 1 g IV-TXA each time have similar effects on reducing blood loss, blood transfusion rate, postoperative hemoglobin level, and postoperative hospital stay after TKA or THA, without increasing the risk of postoperative complications risk. For patients at high risk of thromboembolic events, one dose of 1 g TXA throughout surgery may be preferred. However, higher-quality RCT is needed to explore the optimal protocol dose to recommend the widespread use of TXA in total joint arthroplasty. Trial registration We conducted literature selection, eligibility criteria evaluation, data extraction and analysis on the research program registered in Prospero (CRD42023405387) on March 16, 2023.

摘要

目的

随着髋膝关节骨关节炎患病率的增加,全关节置换术作为终末期治疗方法,可缓解疼痛并恢复功能,但常伴有大量失血。氨甲环酸(TXA)已被报道可减少髋膝关节置换术围手术期的失血。然而,TXA 最佳给药剂量仍存在争议。因此,我们进行了一项荟萃分析,结合了 5 项比较静脉给予 1g 固定剂量 TXA 与静脉给予 2 次 1g 剂量 TXA 用于髋或膝关节置换术的疗效和安全性的试验数据。

方法

从 2000 年 1 月至 2023 年 2 月,我们在 PubMed、Medline、Embase、Web of Science 和 The Cochrane Library 中进行了检索。我们的荟萃分析包括比较不同剂量静脉 TXA(IV-TXA)用于 THA 或 TKA 的疗效和安全性的随机对照试验和队列研究。观察终点包括总失血量、术后血红蛋白下降、输血率、住院时间、深静脉血栓形成(DVT)发生率和肺栓塞(PE)发生率。根据 Cochrane 指南和 PRISMA 声明进行荟萃分析。使用丹麦 RevMan5.3 软件进行数据合并。

结果

5 项队列研究共纳入 5542 例患者符合纳入标准。我们的荟萃分析显示,两组的总失血量(均数差(MD)=-65.60,95%置信区间(CI)[-131.46, 0.26],P=0.05)、输血率(风险差(RD)=0.00,95%CI[-0.01, 0.02],P=0.55)、术后血红蛋白(MD=0.02,95%CI[-0.09, 0.13],P=0.31)、术后住院天数(MD=-0.13),95%CI[-0.35, 0.09],P=0.25)、DVT(RD=0.00,95%CI[-0.00, 0.01],P=0.67)和 PE(RD=0.00,95%CI[-0.01, 0.00],P=0.79)差异均有统计学意义。由于每个主要研究的样本量存在差异,因此存在一定的固有异质性。

结论

1 次给予 1g 和 2 次给予 1g IV-TXA 每次在减少 TKA 或 THA 后的失血量、输血率、术后血红蛋白水平和术后住院时间方面具有相似的效果,不会增加术后并发症的风险。对于有高血栓栓塞事件风险的患者,整个手术过程中使用 1g TXA 可能是首选。然而,需要更高质量的 RCT 来探讨最佳方案剂量,以推荐 TXA 在全关节置换术中的广泛应用。

试验注册

我们于 2023 年 3 月 16 日在 Prospero(CRD42023405387)研究方案上进行了文献选择、纳入标准评估、数据提取和分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0d44/10413625/3adab4649b92/13018_2023_3929_Fig1_HTML.jpg

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