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氨甲环酸在膝关节手术中的研究——一项多中心、随机、对照试验。

Tranexamic Acid in Knee Surgery Study-A Multicentered, Randomized, Controlled Trial.

机构信息

Department of Orthopaedics, Middlemore Hospital, Counties Manukau District Health Board (DHB), Auckland, New Zealand; Ko Awatea, Middlemore Hospital, Auckland, New Zealand.

Department of Orthopaedics, Tauranga Hospital, Bay of Plenty DHB, Tauranga, New Zealand.

出版信息

J Arthroplasty. 2017 Nov;32(11):3379-3384. doi: 10.1016/j.arth.2017.05.058. Epub 2017 Jun 9.

DOI:10.1016/j.arth.2017.05.058
PMID:28662956
Abstract

BACKGROUND

Postoperative anemia following elective arthroplasty can lead to prolonged hospital stay and delays in rehabilitation and is often poorly tolerated in patients with cardiovascular disease. Tranexamic acid (TXA) has been shown to reduce perioperative blood loss in total knee arthroplasty (TKA). However, questions over its optimal route of administration remain.

METHODS

A double-blinded, placebo, multicentered, randomized, controlled trial investigating the efficacy of topical and systemic routes of a single intraoperative dose (1.5 g) of TXA was conducted. Patients undergoing primary, unilateral TKA were screened for eligibility. Eligible patients were consecutively enrolled from 5 New Zealand centers between July 2014 and November 2015. Three prospective groups running in parallel (topical TXA [tTXA], systemic TXA [sTXA], and placebo) were investigated for a primary outcome of estimated perioperative blood loss. An intention-to-treat analysis was used to compare outcomes between the study groups (P value <.05).

RESULTS

One hundred and thirty-four patients across the 5 hospitals were recruited into the study. Estimated blood loss was equivalent in the 2 treatment groups, sTXA (749 mL [95% confidence interval, 637-860]) and tTXA (723 mL [620-826]). Compared to the placebo group (1090 mL [923-1257]), blood loss was significantly lower in both treatment groups (P = .001 and P = .0003, respectively). There were no significant differences in secondary outcomes, including rates of symptomatic deep vein thrombosis and pulmonary embolism (P = .759).

CONCLUSION

In the setting of elective TKA, a single 1.5-g dose of tTXA given intraoperatively either systemically or topically effectively reduces blood loss without an increase in complications.

摘要

背景

择期关节置换术后贫血可导致住院时间延长和康复延迟,且在心血管疾病患者中常难以耐受。氨甲环酸(TXA)已被证明可减少全膝关节置换术(TKA)围手术期失血。然而,关于其最佳给药途径仍存在疑问。

方法

进行了一项双盲、安慰剂、多中心、随机、对照试验,以研究单次术中剂量(1.5 g)局部和全身给药途径的 TXA 的疗效。筛选出接受初次单侧 TKA 的患者是否符合入选标准。2014 年 7 月至 2015 年 11 月,来自新西兰 5 个中心的符合条件的患者连续入组。三个平行运行的前瞻性组(局部 TXA [tTXA]、全身 TXA [sTXA]和安慰剂)被用于评估主要结局估计围手术期失血。采用意向治疗分析比较研究组之间的结局(P 值<.05)。

结果

5 家医院共有 134 例患者入组该研究。2 个治疗组的估计失血量相当,sTXA(749 mL [95%置信区间,637-860])和 tTXA(723 mL [620-826])。与安慰剂组(1090 mL [923-1257])相比,两组的失血量均显著降低(P<.001 和 P<.0003)。次要结局(包括症状性深静脉血栓形成和肺栓塞的发生率)无显著差异(P=.759)。

结论

在择期 TKA 中,单次 1.5 g 剂量的 tTXA 无论全身或局部给予,均可有效减少失血,且不增加并发症。

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