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经支气管自体血封堵联合塞子封堵治疗持续性肺漏气:中国多中心随机对照研究。

Management of Persistent Air Leaks Using Endobronchial Autologous Blood Patch and Spigot Occlusion: A Multicentre Randomized Controlled Trial in China.

机构信息

Department of Respiration, Tangdu Hospital, Air Force Military Medical University, Xi'an, China.

Department of Pulmonary and Critical Care Medicine, Second Affiliated Hospital of Fujian Medical University, Quanzhou, China.

出版信息

Respiration. 2019;97(5):436-443. doi: 10.1159/000495298. Epub 2019 Mar 22.

Abstract

BACKGROUND

Optimal management of persistent air leaks (PALs) in patients with secondary spontaneous pneumothorax (SSP) remains controversial.

OBJECTIVE

To evaluate the efficacy and safety of endobronchial autologous blood plus thrombin patch (ABP) and bronchial occlusion using silicone spigots (BOS) in patients with SSP accompanied by alveolar-pleural fistula (APF) and PALs.

METHODS

This prospective multicentre randomized controlled trial compared chest tube-attached water-seal drainage (CTD), ABP, and BOS that were performed between February 2015 and June 2017 in one of six tertiary care hospitals in China. Patients diagnosed with APF experiencing PALs (despite 7 days of CTD) and inoperable patients were included. Outcome measures included success rate of pneumothorax resolution at the end of the observation period (further 14 days), duration of air leak stop, lung expansion, hospital stay, and complications.

RESULTS

In total, 150 subjects were analysed in three groups (CTD, ABP, BOS) of 50 each. At 14 days, 60, 82, and 84% of CTD, ABP, and BOS subjects, respectively, experienced full resolution of pneumothorax (p = 0.008). All duration outcome measures were significantly better in the ABP and BOS groups than in the CTD group (p < 0.016 for all). The incidence of adverse events, including chest pain, cough, and fever, was not significantly different. All subjects in the ABP and BOS groups experienced temporary haemoptysis. Spigot displacement occurred in 8% of BOS subjects.

CONCLUSION

ABP and BOS resulted in clinically meaningful outcomes, including higher success rate, duration of air leak stop, lung expansion, and hospital stay, with an acceptable safety profile.

摘要

背景

对于继发性自发性气胸(SSP)伴肺泡-胸膜瘘(APF)和持续性肺漏气(PALs)患者,其最佳处理方法仍存在争议。

目的

评估支气管内自体血加凝血酶贴剂(ABP)和硅质塞子支气管阻塞(BOS)在 SSP 伴 PALs 患者中的疗效和安全性。

方法

本前瞻性多中心随机对照试验于 2015 年 2 月至 2017 年 6 月在中国六家三级护理医院之一比较了胸腔引流管附水封引流(CTD)、ABP 和 BOS。纳入 PALs 持续时间超过 7 天且无法手术的 APF 患者。主要观察指标包括观察结束时气胸(进一步 14 天)的缓解成功率、漏气停止时间、肺扩张、住院时间和并发症。

结果

共有 150 例患者分为 CTD、ABP 和 BOS 三组,每组 50 例。在 14 天时,CTD、ABP 和 BOS 组气胸完全缓解率分别为 60%、82%和 84%(p = 0.008)。所有持续时间的结果指标在 ABP 和 BOS 组均明显优于 CTD 组(所有 p < 0.016)。胸痛、咳嗽和发热等不良事件的发生率在各组间无显著差异。ABP 和 BOS 组所有患者均出现一过性咯血。BOS 组 8%的患者出现塞子移位。

结论

ABP 和 BOS 可获得有临床意义的结果,包括气胸缓解率更高、漏气停止时间更长、肺扩张更好和住院时间更短,且具有可接受的安全性。

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