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全髋关节置换术中是否真的需要使用氨甲环酸?一项十九项随机对照试验的荟萃分析。

Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials.

机构信息

Department of Orthopedics Surgery, The Second Affiliated Hospital of Medical College, Zhejiang University, Hangzhou, China.

出版信息

Arch Orthop Trauma Surg. 2013 Jul;133(7):1017-27. doi: 10.1007/s00402-013-1761-2. Epub 2013 Apr 25.

Abstract

BACKGROUND

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. We examined whether intravenous tranexamic acid, when compared with placebo, was safe and effective in total hip arthroplasty.

METHODS

The literature search was conducted using the PubMed, Cochrane Library, MEDLINE, EMBASE, and China National Knowledge Infrastructure (CNKI) databases. Data were evaluated using the generic evaluation tool designed by the Cochrane Bone, Joint and Muscle Trauma Group. Ultimately, 19 randomized controlled trials involving 1,030 patients were included.

RESULTS

The use of tranexamic acid significantly reduced total blood loss by a mean of 305.27 mL [95 % confidence interval (CI) -397.66 to -212.89, p < 0.001], intraoperative blood loss by a mean of 86.33 mL(95 % CI -152.29 to -20.37, p = 0.01), postoperative blood loss by a mean of 176.79 mL (95 % CI -236.78 to -116.39, p < 0.001), and "hidden" blood loss by a mean of 152.70 mL (95 % CI -187.98 to -117.42, p < 0.001), resulting in a meaningful reduction in the proportion of patients requiring blood transfusion (odds ratio 0.28, 95 % CI 0.19 to 0.42, p < 0.001). There was no significant difference in occurrence of deep vein thrombosis, pulmonary embolism, or other complications among the study groups, or cost or hospitalization duration.

CONCLUSIONS

The data from this meta-analysis indicate that intravenous tranexamic acid may reduce blood loss and transfusion need in patients undergoing total hip arthroplasty without increasing the risk of complications. However, high-quality randomized controlled trials are required to validate the results.

摘要

背景

研究表明,氨甲环酸可减少全髋关节置换术患者的失血量和输血需求。然而,迄今为止,还没有足够大的研究能够明确确定该药物是否安全有效。我们研究了静脉注射氨甲环酸与安慰剂相比,在全髋关节置换术中是否安全有效。

方法

使用 PubMed、Cochrane 图书馆、MEDLINE、EMBASE 和中国国家知识基础设施(CNKI)数据库进行文献检索。使用 Cochrane 骨科、关节和肌肉创伤组设计的通用评价工具评估数据。最终,纳入了 19 项涉及 1030 例患者的随机对照试验。

结果

使用氨甲环酸可使总失血量平均减少 305.27 mL[95%置信区间(CI)-397.66 至-212.89,p<0.001]、术中失血量平均减少 86.33 mL[95%CI-152.29 至-20.37,p=0.01]、术后失血量平均减少 176.79 mL[95%CI-236.78 至-116.39,p<0.001]和“隐性”失血平均减少 152.70 mL[95%CI-187.98 至-117.42,p<0.001],从而显著降低需要输血的患者比例(比值比 0.28,95%CI 0.19 至 0.42,p<0.001)。研究组之间在深静脉血栓形成、肺栓塞或其他并发症的发生率、成本或住院时间方面无显著差异。

结论

本荟萃分析数据表明,静脉注射氨甲环酸可能减少全髋关节置换术患者的失血量和输血需求,而不增加并发症风险。然而,需要高质量的随机对照试验来验证这些结果。

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