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静脉注射与局部应用氨甲环酸联合用于初次全膝关节置换术的疗效与安全性:一项随机对照试验的荟萃分析

The efficacy and safety of combined administration of intravenous and topical tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled trials.

作者信息

Xiong Huazhang, Liu Yi, Zeng Yi, Wu Yuangang, Shen Bin

机构信息

Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, Chengdu, Sichuan Province, 610041, People's Republic of China.

Department of Orthopedic Surgery, The First Affiliated Hospital of Zunyi Medical College, Zunyi, 563003, Guizhou Province, China.

出版信息

BMC Musculoskelet Disord. 2018 Sep 7;19(1):321. doi: 10.1186/s12891-018-2181-9.

Abstract

BACKGROUND

The combined administration of intravenous (IV) and topical tranexamic acid (TXA) in primary total knee (TKA) knee remains controversial. The purpose of this meta-analysis was to assess the efficacy and safety of combined administration of IV and topical TXA in primary TKA.

METHODS

PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Google Search Engine and China National Knowledge Infrastructure databases were searched for randomized controlled trials (RCTs) were comparing the combined administration of IV and topical TXA following primary TKA. The primary outcomes were total blood loss, maximum hemoglobin drop, and deep venous thrombosis (DVT) and/or pulmonary embolism (PE). The second outcomes were drainage volume and transfusion requirements. Data were analyzed using RevMan 5.3.

RESULTS

A total of 6 RCTs involving 701 patients were included in the meta-analysis. The combined group provided lower total blood loss (MD - 156.34 mL, 95% CI, - 241.51 to - 71.18; P = 0.0003), drainage volume (MD - 43.54 mL, 95% CI, - 67.59 to - 19.48; P = 0.0004), maximum hemoglobin drop (MD - 0.56 g/dl, 95% CI, - 0.93 to - 0.19; P = 0.003) than IV TXA alone. No significant difference were found in terms of transfusion requirements (RR 0.48, 95% CI, 0.16 to 1.44; P = 0.19), DVT (RR 1.01, 95% CI, 0.14 to 7.12; P = 0.99) and PE (RR 0.33, 95% CI, 0.01 to 7.91; P = 0.49) between the two group. Subgroup analyses shows that the combined group was less total blood loss in non-tourniquet (P = 0.0008), topical TXA dose > 1.5 g (P <  0.00001) and number of IV TXA ≥ 2 doses (P = 0.005) of TXA compared with the IV group alone.

CONCLUSIONS

The available evidence indicates combined group were associated with lower total blood loss, drainage volume, and maximum hemoglobin drop. A similar transfusion requirement was found in both groups. Subgroup analyses demonstrates that total blood loss was less in patients with non-tourniquet, topical TXA dose > 1.5 g and number of IV TXA ≥ 2 doses of TXA. There was no increase the rates of DVT and PE.

摘要

背景

在初次全膝关节置换术(TKA)中,静脉注射(IV)与局部应用氨甲环酸(TXA)联合使用仍存在争议。本荟萃分析的目的是评估IV与局部应用TXA联合使用在初次TKA中的疗效和安全性。

方法

检索了PubMed、EMBASE、Cochrane对照试验中央注册库、科学网、谷歌搜索引擎和中国知网数据库,查找比较初次TKA后IV与局部应用TXA联合使用的随机对照试验(RCT)。主要结局为总失血量、最大血红蛋白下降以及深静脉血栓形成(DVT)和/或肺栓塞(PE)。次要结局为引流量和输血需求。使用RevMan 5.3软件进行数据分析。

结果

本荟萃分析共纳入6项RCT,涉及701例患者。联合用药组的总失血量(MD -156.34 mL,95%CI,-241.51至-71.18;P = 0.0003)、引流量(MD -43.54 mL,95%CI,-67.59至-19.48;P = 0.0004)、最大血红蛋白下降(MD -0.56 g/dl,95%CI,-0.93至-0.19;P = 0.003)均低于单纯静脉注射TXA组。两组在输血需求(RR 0.48,95%CI,0.16至1.44;P = 0.19)、DVT(RR 1.01,95%CI,0.14至7.12;P = 0.99)和PE(RR 0.33,95%CI,0.01至7.91;P = 0.49)方面无显著差异。亚组分析显示,与单纯静脉注射组相比,联合用药组在非止血带情况下(P = 0.0008)、局部TXA剂量>1.5 g(P < 0.00001)以及静脉注射TXA剂量≥2剂(P = 0.005)时总失血量更少。

结论

现有证据表明联合用药组总失血量、引流量和最大血红蛋白下降更低。两组输血需求相似。亚组分析表明,非止血带患者、局部TXA剂量>1.5 g以及静脉注射TXA剂量≥2剂时总失血量更少。DVT和PE发生率未增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a22c/6129000/504197f216df/12891_2018_2181_Fig1_HTML.jpg

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