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局部注射氨甲环酸减少皮肤科手术出血的随机双盲安慰剂对照临床试验。

Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

机构信息

Mohs Unit, Sheba Medical Center, Tel Hashomer, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

The National Hemophilia Center and Thrombosis Institute, Sheba Medical Center, Tel Hashomer, Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

出版信息

Dermatol Surg. 2019 Jun;45(6):759-767. doi: 10.1097/DSS.0000000000001786.

Abstract

BACKGROUND

Topical application, oral, and IV injection of tranexamic acid (TXA) have been used to reduce surgical bleeding.

OBJECTIVE

To evaluate the safety and efficacy of TXA injected subcutaneously to reduce bleeding during dermatologic surgery.

METHODS

In this double-blinded, placebo-controlled, randomized prospective study, 131 patients were randomized to subcutaneous injection of lidocaine 2% diluted 1:1 with either saline (placebo) or TXA 100 mg/1 mL before surgery. Before the second stage or closure, size measurements of bloodstain impregnation on Telfa and surgical wound size were recorded and analyzed using mixed-effects linear regression. Subjective evaluation of hemostasis was performed using 4-point scale grading and analyzed using Fischer's exact test.

RESULTS

One hundred twenty-seven patients completed the study. The bloodstain to surgical wound size ratio was smaller in the TXA group (1.77) compared with the placebo group (2.49) (p < .001). An improved effect of TXA on bleeding was observed in the subgroup of patients receiving anticoagulants (mean difference; 95% confidence interval; -0.83; -1.20 to -0.46 p < .001). The subjective hemostasis assessment was significantly better in the TXA group overall (p = .043) and anticoagulant subgroup (p = .001) compared with the placebo group.

CONCLUSION

Subcutaneous injection of TXA was safe, reduced bleeding during dermatologic surgery, and particularly effective for patients receiving anticoagulation treatment.

摘要

背景

氨甲环酸(TXA)的局部应用、口服和静脉注射已被用于减少手术出血。

目的

评估皮下注射 TXA 以减少皮肤科手术出血的安全性和有效性。

方法

在这项双盲、安慰剂对照、随机前瞻性研究中,131 名患者被随机分为手术前皮下注射 2%利多卡因与生理盐水(安慰剂)或 TXA 100mg/1mL 1:1 稀释。在第二阶段或闭合前,记录 Telfa 上的血渍浸渍和手术伤口大小的尺寸测量值,并使用混合效应线性回归进行分析。使用 4 分制对止血的主观评估进行分级,并使用 Fisher 精确检验进行分析。

结果

127 名患者完成了研究。TXA 组的血渍与手术伤口大小的比值(1.77)小于安慰剂组(2.49)(p <.001)。在接受抗凝治疗的患者亚组中,TXA 对出血的改善效果更为明显(平均差异;95%置信区间;-0.83;-1.20 至-0.46 p <.001)。TXA 组的总体主观止血评估(p =.043)和抗凝亚组(p =.001)均明显优于安慰剂组。

结论

皮下注射 TXA 安全,可减少皮肤科手术中的出血,尤其对接受抗凝治疗的患者有效。

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