Department of Neurosurgery, Trauma Research Center, Shahid Rajaee (Emtiaz) Trauma Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
Department of Surgery, Karolinska University Hospital, Stockholm, Sweden.
World J Surg. 2020 Jun;44(6):1844-1853. doi: 10.1007/s00268-020-05391-8.
Observational studies have demonstrated improved outcomes in TBI patients receiving in-hospital beta-blockers. The aim of this study is to conduct a randomized controlled trial examining the effect of beta-blockers on outcomes in TBI patients.
Adult patients with severe TBI (intracranial AIS ≥ 3) were included in the study. Hemodynamically stable patients at 24 h after injury were randomized to receive either 20 mg propranolol orally every 12 h up to 10 days or until discharge (BB+) or no propranolol (BB-). Outcomes of interest were in-hospital mortality and Glasgow Outcome Scale-Extended (GOS-E) score on discharge and at 6-month follow-up. Subgroup analysis including only isolated severe TBI (intracranial AIS ≥ 3 with extracranial AIS ≤ 2) was carried out. Poisson regression models were used.
Two hundred nineteen randomized patients of whom 45% received BB were analyzed. There were no significant demographic or clinical differences between BB and BB cohorts. No significant difference in in-hospital mortality (adj. IRR 0.6 [95% CI 0.3-1.4], p = 0.2) or long-term functional outcome was measured between the cohorts (p = 0.3). One hundred fifty-four patients suffered isolated severe TBI of whom 44% received BB. The BB group had significantly lower mortality relative to the BB group (18.6% vs. 4.4%, p = 0.012). On regression analysis, propranolol had a significant protective effect on in-hospital mortality (adj. IRR 0.32, p = 0.04) and functional outcome at 6-month follow-up (GOS-E ≥ 5 adj. IRR 1.2, p = 0.02).
Propranolol decreases in-hospital mortality and improves long-term functional outcome in isolated severe TBI. This randomized trial speaks in favor of routine administration of beta-blocker therapy as part of a standardized neurointensive care protocol.
Level II; therapeutic.
Therapeutic study.
观察性研究表明，接受院内使用β受体阻滞剂的 TBI 患者的结局得到改善。本研究旨在开展一项随机对照试验，以检验β受体阻滞剂对 TBI 患者结局的影响。
纳入颅内损伤严重程度评分（AIS）≥3 分的成年 TBI 患者。伤后 24 小时内血流动力学稳定的患者被随机分为接受口服普萘洛尔（20mg，每 12 小时一次，持续 10 天或直至出院）组（BB+）或未接受普萘洛尔（BB-）组。主要结局为院内死亡率和出院时及 6 个月时的格拉斯哥预后量表扩展评分（GOS-E）。进行了仅包括单纯性严重 TBI（颅内 AIS≥3 分伴颅外 AIS≤2 分）的亚组分析。采用泊松回归模型。
对 219 例随机分组患者进行了分析，其中 45%的患者接受了 BB。BB 和 BB 两组间无显著的人口统计学或临床差异。两组间院内死亡率（校正后的发病率比[IRR]0.6[95%CI 0.3-1.4]，p=0.2）或长期功能结局（p=0.3）无显著差异。154 例患者患有单纯性严重 TBI，其中 44%的患者接受了 BB。与 BB 组相比，BB 组的死亡率显著降低（18.6% vs. 4.4%，p=0.012）。回归分析显示，普萘洛尔对院内死亡率（校正后的 IRR 0.32，p=0.04）和 6 个月时的功能结局（GOS-E≥5 分的 IRR 1.2，p=0.02）具有显著的保护作用。
普萘洛尔可降低单纯性严重 TBI 患者的院内死亡率和改善长期功能结局。这项随机试验支持常规使用β受体阻滞剂作为标准化神经重症监护方案的一部分。
Ⅱ级；治疗性。
治疗性研究。
