多发伤肋骨骨折内固定多中心前瞻性对照临床研究（胸壁损伤协会非连枷型）
A multicenter, prospective, controlled clinical trial of surgical stabilization of rib fractures in patients with severe, nonflail fracture patterns (Chest Wall Injury Society NONFLAIL).
机构信息
From the Department of Surgery, Division of Trauma, Denver Health Medical Center (F.M.P., K.L.), Denver Colorado; Department of Surgery, Division of Trauma, University of Nebraska Medical Center (Z.B.), Omaha, Nebraska; Department of Surgery, Division of Trauma, Medical University of South Carolina (E.A.E.), Charleston, South Carolina; Department of Surgery, Division of Trauma, St. Mary's Medical Center (L.L.), West Palm Beach, Florida; Department of Surgery, Division of Trauma, Intermountain Medical Center (S.M.), Murray, Utah; Department of Surgery, Division of CT Surgery, St. Joseph Health (L.P.), Mission Hospital, Mission Viejo, California; Department of Surgery, Division of Trauma, George Washington University (B.S.), Washington, District of Columbia; Department of Surgery, Division of Trauma, Wright State University/Miami Valley Hospital (G.S.), Dayton, Ohio; Department of Surgery, Division of Trauma, Carolinas Medical Center (B.T.), Charlotte, North Carolina; Department of Surgery, Division of Trauma, The Queens Medical Center (F.Z.), Honolulu, Hawaii; Department of Surgery, Division of Trauma, Sanford Health (C.D.), Fargo, North Dakota; Department of Surgery, Division of Trauma, Baystate Medical Center (A.R.D.), Springfield, Massachusetts.
出版信息
J Trauma Acute Care Surg. 2020 Feb;88(2):249-257. doi: 10.1097/TA.0000000000002559.
BACKGROUND
The efficacy of surgical stabilization of rib fracture (SSRF) in patients without flail chest has not been studied specifically. We hypothesized that SSRF improves outcomes among patients with displaced rib fractures in the absence of flail chest.
METHODS
Multicenter, prospective, controlled, clinical trial (12 centers) comparing SSRF within 72 hours to medical management. Inclusion criteria were three or more ipsilateral, severely displaced rib fractures without flail chest. The trial involved both randomized and observational arms at patient discretion. The primary outcome was the numeric pain score (NPS) at 2-week follow-up. Narcotic consumption, spirometry, pulmonary function tests, pleural space complications (tube thoracostomy or surgery for retained hemothorax or empyema >24 hours from admission) and both overall and respiratory disability-related quality of life (RD-QoL) were also compared.
RESULTS
One hundred ten subjects were enrolled. There were no significant differences between subjects who selected randomization (n = 23) versus observation (n = 87); these groups were combined for all analyses. Of the 110 subjects, 51 (46.4%) underwent SSRF. There were no significant baseline differences between the operative and nonoperative groups. At 2-week follow-up, the NPS was significantly lower in the operative, as compared with the nonoperative group (2.9 vs. 4.5, p < 0.01), and RD-QoL was significantly improved (disability score, 21 vs. 25, p = 0.03). Narcotic consumption also trended toward being lower in the operative, as compared with the nonoperative group (0.5 vs. 1.2 narcotic equivalents, p = 0.05). During the index admission, pleural space complications were significantly lower in the operative, as compared with the nonoperative group (0% vs. 10.2%, p = 0.02).
CONCLUSION
In this clinical trial, SSRF performed within 72 hours improved the primary outcome of NPS at 2-week follow-up among patients with three or more displaced fractures in the absence of flail chest. These data support the role of SSRF in patients without flail chest.
LEVEL OF EVIDENCE
Therapeutic, level II.
背景
尚未专门研究外科固定肋骨骨折（SSRF）在无连枷胸患者中的疗效。我们假设 SSRF 可改善无连枷胸的移位性肋骨骨折患者的预后。
方法
多中心、前瞻性、对照、临床试验（12 个中心）比较了 72 小时内 SSRF 与药物治疗。纳入标准为同侧三个或更多严重移位的肋骨骨折，无连枷胸。该试验既有随机分组，也有患者自主选择的观察分组。主要结局是 2 周随访时的数字疼痛评分（NPS）。比较了阿片类药物消耗、肺活量测定、肺功能检查、胸膜腔并发症（胸管引流或手术治疗入院后 24 小时以上的血胸或脓胸）以及整体和与呼吸功能障碍相关的生活质量（RD-QoL）。
结果
共纳入 110 例患者。选择随机分组（n = 23）与观察（n = 87）的患者之间无显著差异；这些组在所有分析中合并。110 例患者中，51 例（46.4%）行 SSRF。手术组和非手术组在基线时无显著差异。2 周随访时，手术组的 NPS 明显低于非手术组（2.9 比 4.5，p < 0.01），RD-QoL 明显改善（残疾评分，21 比 25，p = 0.03）。与非手术组相比，手术组的阿片类药物消耗也呈下降趋势（0.5 比 1.2 麻醉当量，p = 0.05）。在住院期间，手术组胸膜腔并发症明显低于非手术组（0%比 10.2%，p = 0.02）。
结论
在这项临床试验中，72 小时内进行的 SSRF 改善了无连枷胸的 3 处或更多移位性骨折患者的主要结局，即 2 周随访时的 NPS。这些数据支持 SSRF 在无连枷胸患者中的作用。
证据水平
治疗性，二级。
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