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吸入性氨甲环酸治疗咯血:一项随机对照试验。

Inhaled Tranexamic Acid for Hemoptysis Treatment: A Randomized Controlled Trial.

机构信息

Pulmonary Department, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Pulmonary Department, Meir Medical Center, Kfar Saba, Israel.

出版信息

Chest. 2018 Dec;154(6):1379-1384. doi: 10.1016/j.chest.2018.09.026. Epub 2018 Oct 12.

Abstract

BACKGROUND

Tranexamic acid (TA) is an antifibrinolytic drug currently used systemically to control bleeding. To date, there have been no prospective studies of the effectiveness of inhaled TA for the treatment of hemoptysis.

OBJECTIVES

The goal of this study was to prospectively assess the effectiveness of TA inhalations (ie, nebulized TA) for hemoptysis treatment.

METHODS

This analysis was a double-blind, randomized controlled trial of treatment with nebulized TA (500 mg tid) vs placebo (normal saline) in patients admitted with hemoptysis of various etiologies. Patients with massive hemoptysis (expectorated blood > 200 mL/24 h) and hemodynamic or respiratory instability were excluded. Mortality and hemoptysis recurrence rate were assessed at 30 days and following 1 year.

RESULTS

Forty-seven patients were randomized to receive TA inhalations (n = 25) or normal saline (n = 22). TA was associated with a significantly reduced expectorated blood volume starting from day 2 of admission. Resolution of hemoptysis within 5 days of admission was observed in more TA-treated patients than in those receiving placebo (96% vs 50%; P < .0005). Mean hospital length of stay was shorter for the TA group (5.7 ± 2.5 days vs 7.8 ± 4.6 days; P = .046), with fewer patients requiring invasive procedures such as interventional bronchoscopy or angiographic embolization to control the bleeding (0% vs 18.2%; P = .041). No side effects were noted in either group throughout the follow-up period. In addition, a reduced recurrence rate was noted at the 1-year follow-up (P = .009).

CONCLUSIONS

TA inhalations can be used safely and effectively to control bleeding in patients with nonmassive hemoptysis.

TRIAL REGISTRY

ClinicalTrials.gov; No.: NCT01496196; URL: www.clinicaltrials.gov.

摘要

背景

氨甲环酸(TA)是一种抗纤维蛋白溶解药物,目前被系统地用于控制出血。迄今为止,尚无前瞻性研究吸入 TA 治疗咯血的有效性。

目的

本研究旨在前瞻性评估 TA 吸入(即雾化 TA)治疗咯血的疗效。

方法

这是一项针对各种病因咯血入院患者的双盲、随机对照试验,接受雾化 TA(500mg tid)或安慰剂(生理盐水)治疗。排除大量咯血(预计 24 小时内咯血>200ml)和血流动力学或呼吸不稳定的患者。在 30 天和 1 年后评估死亡率和咯血复发率。

结果

47 例患者随机分为接受 TA 吸入(n=25)或生理盐水(n=22)治疗。从入院第 2 天开始,TA 组的预计排血量明显减少。与接受安慰剂治疗的患者相比,接受 TA 治疗的患者在入院后 5 天内咯血缓解的比例更高(96% vs 50%;P<.0005)。TA 组的平均住院时间更短(5.7±2.5 天 vs 7.8±4.6 天;P=0.046),需要介入性支气管镜检查或血管造影栓塞等侵入性操作控制出血的患者比例也更低(0% vs 18.2%;P=0.041)。在整个随访期间,两组均未出现任何不良反应。此外,在 1 年随访时复发率降低(P=0.009)。

结论

TA 吸入可安全有效地控制非大量咯血患者的出血。

试验注册

ClinicalTrials.gov;编号:NCT01496196;网址:www.clinicaltrials.gov。

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