保守治疗与介入治疗自发性气胸的比较。
Conservative versus Interventional Treatment for Spontaneous Pneumothorax.
机构信息
From the Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Royal Perth Hospital, and the University of Western Australia (S.G.A.B., E.L.B., C.A.R.), Royal Perth Hospital Imaging (K.V.L.) and the Respiratory Department (E.L.B., Q.A.S.), Royal Perth Hospital, the Department of Respiratory Medicine, Sir Charles Gairdner Hospital (Y.C.G.L.), and the Centre for Respiratory Health, School of Medicine and Pharmacology, University of Western Australia (Y.C.G.L.), Perth, Aeromedical and Retrieval Services, Ambulance Tasmania (S.G.A.B.), and the Department of Respiratory Medicine, Royal Hobart Hospital (E.L.B.), Hobart, the Emergency Department, St. George Hospital, Kogarah, NSW (S.E.A.), St. George Clinical School, Faculty of Medicine, University of New South Wales, Kensington (S.E.A., B.C.H.K.), the Emergency Department, Monash Medical Centre (D.E.-W.), the Departments of Medicine (D.E.-W.) and Surgery (J.A.S.), School of Clinical Sciences at Monash Health, Monash University, and the Department of Cardiothoracic Surgery, Monash Health (J.A.S.), Clayton, VIC, the Emergency Department, Gold Coast Health Service District, the School of Medicine, Bond University, and the School of Medicine, Griffith University, Gold Coast, QLD (G.K.), Emergency Medical and Children's Services, Prince Charles Hospital, Chermside, QLD (F.B.K.), the University of Queensland, Brisbane (F.B.K.), the Department of Respiratory and Sleep Medicine, Sutherland Hospital, Sydney (B.C.H.K.), and the Department of Respiratory Medicine, Cairns Hospital, Cairns, QLD (G.S.) - all in Australia; the Medical Research Institute of New Zealand (K.P., I.B., M.W., R.B.), the Capital and Coast District Health Board (K.P., M.W., R.B.), and Pacific Radiology (M.N.), Wellington, and the Adult Emergency Department, Auckland City Hospital and University of Auckland, Auckland (P.G.J.) - all in New Zealand.
出版信息
N Engl J Med. 2020 Jan 30;382(5):405-415. doi: 10.1056/NEJMoa1910775.
BACKGROUND
Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown.
METHODS
In this open-label, multicenter, noninferiority trial, we recruited patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax. Patients were randomly assigned to immediate interventional management of the pneumothorax (intervention group) or a conservative observational approach (conservative-management group) and were followed for 12 months. The primary outcome was lung reexpansion within 8 weeks.
RESULTS
A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservative-management group, 25 patients (15.4%) underwent interventions to manage the pneumothorax, for reasons prespecified in the protocol, and 137 (84.6%) did not undergo interventions. In a complete-case analysis in which data were not available for 23 patients in the intervention group and 37 in the conservative-management group, reexpansion within 8 weeks occurred in 129 of 131 patients (98.5%) with interventional management and in 118 of 125 (94.4%) with conservative management (risk difference, -4.1 percentage points; 95% confidence interval [CI], -8.6 to 0.5; P = 0.02 for noninferiority); the lower boundary of the 95% confidence interval was within the prespecified noninferiority margin of -9 percentage points. In a sensitivity analysis in which all missing data after 56 days were imputed as treatment failure (with reexpansion in 129 of 138 patients [93.5%] in the intervention group and in 118 of 143 [82.5%] in the conservative-management group), the risk difference of -11.0 percentage points (95% CI, -18.4 to -3.5) was outside the prespecified noninferiority margin. Conservative management resulted in a lower risk of serious adverse events or pneumothorax recurrence than interventional management.
CONCLUSIONS
Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events. (Funded by the Emergency Medicine Foundation and others; PSP Australian New Zealand Clinical Trials Registry number, ACTRN12611000184976.).
背景
对于无并发症的中至大量原发性自发性气胸，保守管理是否是介入管理的可接受替代方案尚不清楚。
方法
在这项开放标签、多中心、非劣效性试验中，我们招募了年龄在 14 至 50 岁之间、首次出现单侧中至大量原发性自发性气胸的患者。患者被随机分配到气胸的即刻介入管理（干预组）或保守观察方法（保守管理组），并随访 12 个月。主要结局是 8 周内肺部复张。
结果
共有 316 名患者接受了随机分组（干预组 154 名，保守管理组 162 名）。在保守管理组中，根据方案预先规定的原因，有 25 名（15.4%）患者接受了干预措施来治疗气胸，而有 137 名（84.6%）患者未接受干预。在一项完全病例分析中，干预组有 23 名患者和保守管理组有 37 名患者的数据不可用，在接受介入治疗的 131 名患者中有 129 名（98.5%）和接受保守管理的 125 名患者中有 118 名（94.4%）在 8 周内复张（风险差异为-4.1 个百分点；95%置信区间[-8.6 至 0.5]；非劣效性检验 P 值=0.02）；95%置信区间的下限在预先规定的-9 个百分点的非劣效性边界内。在一项敏感性分析中，将 56 天后所有缺失的数据均推断为治疗失败（干预组 138 名患者中有 129 名[93.5%]，保守管理组 143 名患者中有 118 名[82.5%]），风险差异为-11.0 个百分点（95%置信区间[-18.4 至-3.5]）超出了预先规定的非劣效性边界。与介入治疗相比，保守治疗气胸的严重不良事件或气胸复发风险较低。
结论
尽管主要结局在对缺失数据的保守假设下不具有统计学稳健性，但该试验提供了适度的证据表明，与介入治疗相比，原发性自发性气胸的保守治疗是非劣效的，且严重不良事件的风险较低。（由急诊医学基金会和其他机构资助；PSP 澳大利亚和新西兰临床试验注册编号，ACTRN12611000184976。）
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