Service d'accueil des urgences.
Service d'accueil des urgences, Centre hospitalier universitaire de Rouen, Rouen, France.
Am J Respir Crit Care Med. 2023 Jun 1;207(11):1475-1485. doi: 10.1164/rccm.202110-2409OC.
Management of first episodes of primary spontaneous pneumothorax remains the subject of debate. To determine whether first-line simple aspiration is noninferior to first-line chest tube drainage for lung expansion in patients with complete primary spontaneous pneumothorax. We conducted a prospective, open-label, randomized noninferiority trial. Adults aged 18-50 years with complete primary spontaneous pneumothorax (total separation of the lung from the chest wall), recruited at 31 French hospitals from 2009 to 2015, received simple aspiration ( = 200) or chest tube drainage ( = 202) as first-line treatment. The primary outcome was pulmonary expansion 24 hours after the procedure. Secondary outcomes were tolerance of treatment, occurrence of adverse events, and recurrence of pneumothorax within 1 year. Substantial discordance in the numerical inputs used for trial planning and the actual trial rates of the primary outcome resulted in a reevaluation of the trial analysis plan. Treatment failure occurred in 29% in the aspiration group and 18% in the chest tube drainage group (difference in failure rate, 0.113; 95% confidence interval [CI], 0.026-0.200). The aspiration group experienced less pain overall (mean difference, -1.4; 95% CI, -1.89, -0.91), less pain limiting breathing (frequency difference, -0.18; 95% CI, -0.27, -0.09), and less kinking of the device (frequency difference, -0.05; 95% CI, -0.09, -0.01). Recurrence of pneumothorax was 20% in this group versus 27% in the drainage group (frequency difference, -0.07; 95% CI, -0.16, +0.02). First-line management of complete primary spontaneous pneumothorax with simple aspiration had a higher failure rate than chest tube drainage but was better tolerated with fewer adverse events. Clinical trial registered with www.clinicaltrials.gov (NCT01008228).
原发性自发性气胸首次发作的处理仍然存在争议。为了确定初次单纯抽吸是否不如初次胸腔管引流对完全性原发性自发性气胸患者的肺扩张有效。我们进行了一项前瞻性、开放标签、随机非劣效性试验。2009 年至 2015 年期间，在法国 31 家医院招募了年龄在 18-50 岁之间、患有完全性原发性自发性气胸（肺与胸壁完全分离）的成年人，他们接受了单纯抽吸（n=200）或胸腔管引流（n=202）作为一线治疗。主要结局是术后 24 小时的肺扩张。次要结局是治疗的耐受性、不良事件的发生和 1 年内气胸的复发。由于试验计划中使用的数值输入与实际主要结局试验率存在显著差异，因此重新评估了试验分析计划。抽吸组治疗失败的发生率为 29%，胸腔管引流组为 18%（失败率差异为 0.113；95%置信区间[CI]为 0.026-0.200）。总体而言，抽吸组疼痛程度较轻（平均差值，-1.4；95%CI，-1.89，-0.91），呼吸受限的疼痛程度较轻（频率差值，-0.18；95%CI，-0.27，-0.09），且设备扭曲的频率较低（频率差值，-0.05；95%CI，-0.09，-0.01）。该组气胸复发率为 20%，引流组为 27%（频率差值，-0.07；95%CI，-0.16，+0.02）。初次采用单纯抽吸治疗完全性原发性自发性气胸的失败率高于胸腔管引流，但耐受性更好，不良事件更少。该临床试验已在 www.clinicaltrials.gov（NCT01008228）注册。
