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氨甲环酸联合应用与单一应用于全膝关节和髋关节置换术:一项随机对照试验的荟萃分析。

Combined versus single application of tranexamic acid in total knee and hip arthroplasty: A meta-analysis of randomized controlled trials.

机构信息

Department of Orthopedics, Huaihe Hospital, Henan University, Henan, China.

Department of Orthopedics, Huaihe Hospital, Henan University, Henan, China.

出版信息

Int J Surg. 2017 Jul;43:171-180. doi: 10.1016/j.ijsu.2017.05.065. Epub 2017 Jun 10.

DOI:10.1016/j.ijsu.2017.05.065
PMID:28602763
Abstract

OBJECTIVE

To compare the efficacy and safety of the combined application of both intravenous and topical tranexamic acid versus the single use of either application in patients with total knee and hip arthroplasty.

METHODS

Potentially relevant studies were identified from electronic databases including Medline, PubMed, Embase, ScienceDirect and the Cochrane Library. Patients undergoing primary total knee and hip arthroplasty were included in our studies, with an experimental group that received combined intravenous and topical application of tranexamic acid and a control group that received a single application of tranexamic acid or normal saline. The primary outcomes were total blood loss, hemoglobin decline and transfusion requirements. The secondary outcomes were length of stay, operation time and tranexamic acid-related adverse effects, such as superficial infection, deep vein thrombosis or pulmonary embolism. Modified Jadad scores were used to assess the quality of the included randomized controlled trials (RCTs). The data was pooled using RevMan 5.3. After testing for heterogeneity across studies, the data were aggregated using random-effects modeling when appropriate. We have registered the trial at http://www.researchregistry.com.

RESULTS

Six RCTs that included 704 patients met the inclusion criteria. The present meta-analysis indicated significant differences existed in the total blood loss (MD = -134.65, 95% CI: -191.66 to -77.64, P < 0.0001), postoperative hemoglobin level (MD = 0.74, 95% CI: 0.39 to 1.10, P < 0.0001), drainage volume (MD = -40.19, 95% CI: -55.95 to -24.43, P < 0.00001) and transfusion rate (RD = -0.07, 95% CI: -0.11 to -0.03, P = 0.0004) between groups.

CONCLUSION

Combined administration of tranexamic acid in total knee and hip arthroplasty was associated with significantly reduced total blood loss, postoperative hemoglobin decline, drainage volume, and transfusion requirements. Based on the limitations of current meta-analysis, well-designed, high-quality RCTs with long-term follow-up are still required.

摘要

目的

比较静脉联合局部应用氨甲环酸与单独应用氨甲环酸治疗全膝关节和髋关节置换术患者的疗效和安全性。

方法

从电子数据库(包括 Medline、PubMed、Embase、ScienceDirect 和 Cochrane 图书馆)中确定潜在相关的研究。研究纳入行初次全膝关节和髋关节置换术的患者,实验组给予氨甲环酸静脉联合局部联合应用,对照组给予氨甲环酸单次应用或生理盐水单次应用。主要结局指标为总失血量、血红蛋白下降和输血需求。次要结局指标为住院时间、手术时间和氨甲环酸相关不良反应,如浅表感染、深静脉血栓形成或肺栓塞。采用改良 Jadad 评分评估纳入的随机对照试验(RCT)的质量。使用 RevMan 5.3 汇总数据。在对研究间异质性进行检验后,当合适时,使用随机效应模型对数据进行汇总。我们已在 http://www.researchregistry.com 上对该试验进行了注册。

结果

纳入的 6 项 RCT 共 704 例患者符合纳入标准。本荟萃分析表明,总失血量(MD=-134.65,95%CI:-191.66 至-77.64,P<0.0001)、术后血红蛋白水平(MD=0.74,95%CI:0.39 至 1.10,P<0.0001)、引流量(MD=-40.19,95%CI:-55.95 至-24.43,P<0.00001)和输血率(RD=-0.07,95%CI:-0.11 至-0.03,P=0.0004)差异均有统计学意义。

结论

在全膝关节和髋关节置换术中联合应用氨甲环酸可显著减少总失血量、术后血红蛋白下降、引流量和输血需求。基于目前荟萃分析的局限性,仍需要设计良好、高质量、长期随访的 RCT。

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