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手术治疗与常规胸腔引流管治疗原发性自发性气胸的随机对照试验。

Surgical treatment versus conventional chest tube drainage in primary spontaneous pneumothorax: a randomized controlled trial.

机构信息

Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark.

Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark.

出版信息

Eur J Cardiothorac Surg. 2018 Jul 1;54(1):113-121. doi: 10.1093/ejcts/ezy003.

DOI:10.1093/ejcts/ezy003
PMID:29509892
Abstract

OBJECTIVES

Primary spontaneous pneumothorax frequently recurs after chest tube management. Evidence is lacking whether patients may benefit from surgery following their first episode.

METHODS

We performed a multicentre, randomized trial and enrolled young, otherwise healthy patients admitted with their first episode of primary spontaneous pneumothorax and treated using conventional chest tube drainage. Patients underwent high-resolution computed tomography on fully expanded lungs, and using web-based randomization, we assigned patients to continued conservative chest tube treatment or chest tube treatment followed by video-assisted thoracoscopic surgery (VATS) with the resection of bullae/blebs and mechanical pleurodesis. Patients were stratified into 2 groups based on the presence of bullae ≥1 cm on high-resolution computed tomography. The primary end point was readmission with ipsilateral recurrence. Secondary end points were complications and length of hospitalization.

RESULTS

Between 1 August 2009 and 4 November 2016, we screened 457 patients, of whom 373 were eligible for inclusion and 181 were enrolled: male/female ratio = 5.0. We identified 88 patients with blebs <1 cm: 50 were randomly assigned to chest tube treatment and 38 to VATS. Ninety-three patients had bullae ≥1 cm: 43 were randomly assigned to chest tube treatment and 50 to VATS. Forty-three (23.8%) patients experienced recurrence during the follow-up period. Overall, recurrence was significantly lower following VATS when compared with conventional chest tube treatment (P = 0.0012). When stratified by bullae size, VATS proved significantly better for bullae ≥1 cm (P = 0.014). We observed a size-response relationship with increased risk of recurrence for larger bullae (P = 0.013).

CONCLUSIONS

Surgery was an effective treatment to prevent recurrence in patients with their first presentation of primary spontaneous pneumothorax and should be the standard of care when high-resolution computed tomography demonstrates bullae ≥2 cm.

CLINICAL TRIAL REGISTRATION

ClinicalTrial.gov: NCT 02866305.

摘要

目的

原发性自发性气胸在胸腔引流管管理后经常复发。目前尚无证据表明首次发作后患者是否可以从手术中获益。

方法

我们进行了一项多中心、随机试验,纳入了因首次发作原发性自发性气胸而入院且接受常规胸腔引流管治疗的年轻、健康的患者。患者在完全膨胀的肺部进行高分辨率计算机断层扫描,然后通过基于网络的随机化,将患者分配到继续保守胸腔引流管治疗或胸腔引流管治疗后行电视辅助胸腔镜手术(VATS)切除大疱/疱和机械胸膜固定术。根据高分辨率计算机断层扫描上是否存在≥1cm 的大疱,将患者分为 2 组。主要终点是同侧复发再入院。次要终点是并发症和住院时间。

结果

在 2009 年 8 月 1 日至 2016 年 11 月 4 日期间,我们筛查了 457 名患者,其中 373 名符合入选条件,181 名被纳入:男女比例为 5.0。我们发现 88 名患者的疱小于 1cm:50 名随机分配到胸腔引流管治疗,38 名随机分配到 VATS。93 名患者有≥1cm 的大疱:43 名随机分配到胸腔引流管治疗,50 名随机分配到 VATS。43 名(23.8%)患者在随访期间复发。总体而言,与常规胸腔引流管治疗相比,VATS 后复发明显降低(P=0.0012)。按大疱大小分层后,VATS 对≥1cm 的大疱效果显著更好(P=0.014)。我们观察到随着大疱增大,复发风险增加,存在大小反应关系(P=0.013)。

结论

对于首次出现原发性自发性气胸的患者,手术是一种预防复发的有效治疗方法,当高分辨率计算机断层扫描显示大疱≥2cm 时,应作为标准治疗方法。

临床试验注册

ClinicalTrials.gov:NCT 02866305。

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