雾化 vs 静脉注射氨甲环酸治疗咯血：一项初步的随机对照试验。
Nebulized vs IV Tranexamic Acid for Hemoptysis: A Pilot Randomized Controlled Trial.
机构信息
Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi, India.
Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi, India.
出版信息
Chest. 2023 May;163(5):1176-1184. doi: 10.1016/j.chest.2022.11.021. Epub 2022 Nov 19.
BACKGROUND
Tranexamic acid (TA) is used to control bleeding in patients with hemoptysis. However, the effectiveness of the different routes of TA administration has not been studied.
RESEARCH QUESTION
Does the nebulized route of TA administration reduce the amount of hemoptysis compared with the IV route in patients presenting to the ED with hemoptysis?
STUDY DESIGN AND METHODS
This was a pragmatic, open-label, randomized, parallel, single-center, pilot trial of nebulized TA (500 mg tid) vs IV TA (500 mg tid) in adult patients presenting to the ED with active hemoptysis. The primary outcome was cessation of bleeding at 30 min. Secondary outcomes included amount of hemoptysis at 6, 12, and 24 h; interventional procedures; and side effects of TA. Patients who were hemodynamically unstable or requiring immediate interventional procedure or mechanical ventilation were excluded from the study.
RESULTS
Of the 55 patients in each arm, hemoptysis cessation at 30 min following TA administration was significantly higher in the nebulization arm (n = 40) compared with the IV arm (n = 28): χ (1, n = 110) = 5.55; P = .0019. Also, hemoptysis amount was reduced significantly in the nebulization arm at all time periods of observation (P value at 30 min = .011, at 6 h = .002, 12 h = .0008, and at 24 h = .005). Fewer patients in the nebulization arm required bronchial artery embolization (13 vs 21; P = .024) and thereby had higher discharge rates from the ED (67.92% vs 39.02%; P = .005). Two patients in the nebulization arm had asymptomatic bronchoconstriction that resolved after short-acting beta-agonist nebulization. No patient discharged from the ED underwent any interventional procedure or revisited the ED with rebleed during the 72 h follow-up period.
INTERPRETATION
Nebulized TA may be more efficacious than IV TA in reducing the amount of hemoptysis and need for ED interventional procedures. Future larger studies are needed to further explore the potential of nebulized TA compared with IV TA in patients with mild hemoptysis.
CLINICAL TRIAL REGISTRATION
Clinical Trials Registry-India; No.: CTRI/2019/05/019337; URL: http://ctri.nic.in/Clinicaltrials/advancesearchmain.php.
背景
氨甲环酸（TA）用于控制咯血患者的出血。然而，TA 不同给药途径的有效性尚未得到研究。
研究问题
与静脉途径相比，雾化 TA 给药途径是否能减少 ED 就诊咯血患者的咯血量？
研究设计和方法
这是一项实用的、开放性标签、随机、平行、单中心、初步试验，比较了雾化 TA（500mg tid）与静脉 TA（500mg tid）在 ED 就诊咯血的成人患者中的效果。主要结局是 30 分钟时止血。次要结局包括 6、12 和 24 小时时的咯血量；介入治疗；以及 TA 的副作用。血流动力学不稳定或需要立即介入治疗或机械通气的患者被排除在研究之外。
结果
在每组 55 例患者中，与 IV 组（n=28）相比，TA 给药后 30 分钟时止血的患者在雾化组（n=40）中明显更高：χ（1，n=110）=5.55；P=0.0019。此外，在所有观察时间点，雾化组的咯血量均显著减少（30 分钟时 P 值=0.011，6 小时时 P 值=0.002，12 小时时 P 值=0.0008，24 小时时 P 值=0.005）。雾化组需要支气管动脉栓塞的患者较少（13 例 vs 21 例；P=0.024），因此 ED 出院率较高（67.92% vs 39.02%；P=0.005）。雾化组有 2 例患者出现无症状支气管痉挛，经短效β受体激动剂雾化后缓解。在 72 小时随访期间，没有从 ED 出院的患者进行任何介入治疗或因再出血重新就诊 ED。
解释
与 IV TA 相比，雾化 TA 可能更能有效减少咯血量和 ED 介入治疗的需要。需要进一步进行更大规模的研究，以进一步探索雾化 TA 与 IV TA 相比在轻度咯血患者中的潜在应用。
临床试验注册
印度临床试验注册处；编号：CTRI/2019/05/019337；网址：http://ctri.nic.in/Clinicaltrials/advancesearchmain.php。
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