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氨甲环酸的使用并不影响门诊足部和踝关节手术的围手术期结果——一项前瞻性、三盲、随机对照试验。

Use of tranexamic acid does not influence perioperative outcomes in ambulatory foot and ankle surgery-a prospective triple blinded randomized controlled trial.

机构信息

Mount Sinai Health System, New York, NY, USA.

NYU Langone Health, New York, NY, USA.

出版信息

Int Orthop. 2021 Sep;45(9):2277-2284. doi: 10.1007/s00264-021-05131-0. Epub 2021 Jul 29.

Abstract

STUDY OBJECTIVE

TXA is an antifibrinolytic medication widely used to reduce perioperative blood loss, but it has been seldom used during foot and ankle surgery. Our study evaluates the impact of TXA use on blood loss, post-operative pain, peri-operative opioid consumption, and wound healing in ambulatory outpatient foot and ankle procedures.

DESIGN

Prospective, triple-blinded, randomized controlled trial.

SETTING

Peri-operative environment of a major academic health centre in New York City.

PATIENTS

A total of 100 participants who were scheduled for ambulatory foot and ankle surgery with a single surgeon.

INTERVENTIONS

Patients receive either 10 mg/kg TXA (TXA group) or 10 ml/kg of normal saline (placebo group) intravenously prior to skin incision.

MEASUREMENTS

Primary outcome was intra-operative blood loss. Secondary outcomes were peri-operative opioid consumption and wound complications between post-operative days 14 and 21.

MAIN RESULTS

We found no difference between TXA and placebo groups in terms of intra-operative blood loss, p value 0.71, 95% CI (63.13-19.80). There was no difference between the two groups in terms of post-operative morphine milliequivalents (MME). The incidence of wound complications was 16.3% in the TXA group compared to 15.7% in the placebo group with OR 1.04, p value 0.93, 95% CI (0.32-2.77). No adverse events associated with TXA were reported.

CONCLUSIONS

The use of TXA during foot and ankle surgery was not associated with any benefits in perioperative outcomes in our outpatient ambulatory surgical population. Considering potential risks, we do not support the routine use of TXA in this surgical model.

摘要

研究目的

TXA 是一种抗纤维蛋白溶解药物,广泛用于减少围手术期失血,但在足踝手术中很少使用。我们的研究评估了 TXA 在门诊足踝手术中对失血量、术后疼痛、围手术期阿片类药物消耗和伤口愈合的影响。

设计

前瞻性、三盲、随机对照试验。

设置

纽约市一家主要学术医疗中心的围手术期环境。

患者

共 100 名计划接受单外科医生门诊足踝手术的患者。

干预措施

患者在皮肤切开前分别静脉注射 10mg/kg TXA(TXA 组)或 10ml/kg 生理盐水(安慰剂组)。

测量

主要结果为术中失血量。次要结果为术后第 14 至 21 天的围手术期阿片类药物消耗和伤口并发症。

主要结果

TXA 组与安慰剂组在术中失血量方面无差异,p 值为 0.71,95%CI(63.13-19.80)。两组术后吗啡毫克当量(MME)无差异。TXA 组的伤口并发症发生率为 16.3%,安慰剂组为 15.7%,OR 为 1.04,p 值为 0.93,95%CI(0.32-2.77)。未报告与 TXA 相关的不良事件。

结论

在我们的门诊手术人群中,TXA 在足踝手术中使用并未带来围手术期结局的任何益处。考虑到潜在风险,我们不支持在这种手术模式下常规使用 TXA。

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