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再次评估鼻整形术前使用氨甲环酸对失血量和术野质量的影响:一项随机双盲对照试验。

Re-Evaluating the Effect of Preoperative Tranexamic Acid on Blood Loss and Field Quality During Rhinoplasty: A Randomized Double-Blinded Controlled Trial.

机构信息

Department of Surgery, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran.

Department of Community Medicine, School of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran.

出版信息

Aesthetic Plast Surg. 2022 Jun;46(3):1314-1320. doi: 10.1007/s00266-021-02594-9. Epub 2021 Sep 28.

Abstract

BACKGROUND

Nowadays, minimizing the surgical complications of rhinoplasty has gained more importance. Results from previous trials show that Tranexamic acid (TXA) reduces intraoperative bleeding, one of the major complicating factors during rhinoplasty.

OBJECTIVE

To contribute to previous evidence by re-evaluating the efficacy of TXA, specifically in reducing intraoperative blood loss and increasing surgical field quality in rhinoplasty.

STUDY DESIGN AND METHODS

A randomized placebo-controlled trial was conducted (IRCT20111219008458N2). The outcomes included total intraoperative blood loss, measured by the total volume of fluid collected by suction and gauzes, subtracted by volume of used irrigation fluids, and the quality of surgical field, measured by surgeon's satisfaction on a 5-point Likert scale. Demographics, blood coagulation measures, and clinical data were also collected and were held as covariates in analysis. After blinding, randomization, and group allocations, the intervention group received TXA 10mg/kg and the placebo group normal saline in equal volumes.

RESULTS

Data of a total of 80 patients were gathered and analyzed. The total intraoperative blood loss was insignificantly lower (mean difference [95% CI]:  - 3.6 ( - 19.19, 11.99), P = 0.65) and surgeon's satisfaction was insignificantly higher (mean difference [95% CI]: 0.18 ( - 0.11, 0.46), P = 0.22) in TXA group. Results were confirmed by multivariable analysis.

CONCLUSION

In contrast to most of the previous studies, this study showed only a statistically insignificant decrease in total intraoperative blood loss in patients receiving TXA compared to placebo. Further studies are required to more precisely estimate the efficacy of TXA in reducing blood loss during rhinoplasty.

LEVEL OF EVIDENCE

LEVEL I, RANDOMIZED CONTROLLED TRIAL.: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

摘要

背景

如今,尽量减少鼻整形术的手术并发症变得更为重要。先前试验的结果表明,氨甲环酸(TXA)可减少术中出血,这是鼻整形术过程中的主要并发症之一。

目的

通过重新评估 TXA 的疗效,特别是在减少术中失血量和提高鼻整形术手术视野质量方面,为先前的证据做出贡献。

研究设计和方法

进行了一项随机安慰剂对照试验(IRCT20111219008458N2)。结果包括通过吸引和纱布收集的总术中失血量减去使用冲洗液的体积,以及由外科医生对 5 分制 Likert 量表的满意度测量的手术视野质量。还收集了人口统计学、凝血措施和临床数据,并将其作为分析中的协变量。在盲法、随机分组和分组后,干预组接受 TXA 10mg/kg,安慰剂组接受等量生理盐水。

结果

共收集和分析了 80 名患者的数据。总术中失血量无显著降低(平均差异[95%CI]:-3.6(-19.19,11.99),P=0.65),外科医生的满意度无显著提高(平均差异[95%CI]:0.18(-0.11,0.46),P=0.22)在 TXA 组。多变量分析结果证实了这一结果。

结论

与大多数先前的研究相比,本研究仅显示接受 TXA 的患者与安慰剂相比,总术中失血量统计学上无显著降低。需要进一步研究以更准确地估计 TXA 在减少鼻整形术中失血方面的疗效。

证据水平

I 级,随机对照试验:本杂志要求作者为每篇文章分配一个证据水平。有关这些循证医学评级的完整描述,请参阅目录或在线作者指南 www.springer.com/00266。

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