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全膝关节和髋关节置换术中口服与静脉注射氨甲环酸的比较:GRADE分析和荟萃分析。

Comparison of oral versus intravenous tranexamic acid in total knee and hip arthroplasty: A GRADE analysis and meta-analysis.

作者信息

Sun Changjiao, Zhang Xiaofei, Chen Lianxu, Deng Jiuzheng, Ma Qi, Cai Xu, Yang Huadong

机构信息

Department of Orthopedic.

Department of Clinical Epidemiology and Biostatistics, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Changping District, Beijing, China.

出版信息

Medicine (Baltimore). 2020 Oct 30;99(44):e22999. doi: 10.1097/MD.0000000000022999.

Abstract

BACKGROUND

The efficacy and safety of oral tranexamic acid (TXA) remain controversial because of the small number of clinical studies. The aim of the present study was to compare the efficacy and safety of oral TXA with intravenous TXA in patients undergoing total hip arthroplasty and total knee arthroplasty in a systematic review and meta-analysis.

METHODS

We conducted a meta-analysis to identify randomized controlled trials (RCTs) involving oral and intravenous TXA in total hip arthroplasty and total knee arthroplasty up to December 2019 by searching databases including PubMed, Web of Science, Embase, the Cochrane Controlled Trials Register, the Cochrane Library China Biology Medicine, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang. The mean difference or standard mean difference was used to assess continuous outcomes such as hemoglobin (Hb) drop, total blood loss, drain blood loss, and length of hospital stay, with a 95% confidence interval. Relative risks with a 95% confidence interval were used to assess dichotomous outcomes such as transfusion rate and the incidence of deep venous thrombosis and calf muscular vein thrombosis. Review Manager was used for the meta-analysis.

RESULTS

Ten RCTs containing 1080 participants met the inclusion criteria. We found no significant differences in terms of the average Hb drop (P = .60), total blood loss (P = .60), transfusion rate (P = .99), drain blood loss (P = .91), length of hospital stay (P = .95), and the incidence of deep venous thrombosis (P = .55) and calf muscular vein thrombosis (P = .19) between oral and IV TXA.

CONCLUSIONS

Compared with the IV TXA, oral TXA has similar effects on reducing the Hb drop, total blood loss, transfusion rate, drain blood loss, and length of hospital stay without increasing the risk of calf muscular vein thrombosis and deep venous thrombosis. Furthermore, oral TXA is easy to access and administer, which decreases the workload of nurses and even delivers cost-saving benefits to the health care system. We thus conclude that oral TXA may be an optimal approach in total joint arthroplasty. However, more high-quality and multicenter RCTs are still needed to confirm our conclusions.

REGISTRATION

The current meta-analysis was registered on PROSPERO (International Prospective Register of Systematic Reviews), and the registration number was CRD42018111291.

摘要

背景

由于临床研究数量较少,口服氨甲环酸(TXA)的疗效和安全性仍存在争议。本研究的目的是通过系统评价和荟萃分析,比较口服TXA与静脉注射TXA在接受全髋关节置换术和全膝关节置换术患者中的疗效和安全性。

方法

我们通过检索包括PubMed、科学网、Embase、Cochrane对照试验注册库、Cochrane图书馆、中国生物医学数据库、中国知网、中国科技期刊数据库和万方在内的数据库,进行荟萃分析,以确定截至2019年12月涉及全髋关节置换术和全膝关节置换术中口服和静脉注射TXA的随机对照试验(RCT)。采用均数差或标准化均数差来评估连续结局,如血红蛋白(Hb)下降、总失血量、引流管失血量和住院时间,并给出95%置信区间。采用95%置信区间的相对危险度来评估二分结局,如输血率、深静脉血栓形成和小腿肌静脉血栓形成的发生率。使用Review Manager进行荟萃分析。

结果

10项RCT(共1080名参与者)符合纳入标准。我们发现,口服TXA与静脉注射TXA在平均Hb下降(P = 0.60)、总失血量(P = 0.60)、输血率(P = 0.99)、引流管失血量(P = 0.91)、住院时间(P = 0.95)以及深静脉血栓形成发生率(P = 0.55)和小腿肌静脉血栓形成发生率(P = 0.19)方面均无显著差异。

结论

与静脉注射TXA相比,口服TXA在降低Hb下降、总失血量、输血率、引流管失血量和住院时间方面具有相似的效果,且不会增加小腿肌静脉血栓形成和深静脉血栓形成的风险。此外,口服TXA易于获取和给药,这减少了护士的工作量,甚至为医疗保健系统带来了成本节约效益。因此,我们得出结论,口服TXA可能是全关节置换术中的一种最佳方法。然而,仍需要更多高质量的多中心RCT来证实我们的结论。

注册情况

当前的荟萃分析已在PROSPERO(国际系统评价前瞻性注册库)上注册,注册号为CRD42018111291。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a339/7598783/5fb53c4f152f/medi-99-e22999-g001.jpg

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