Background Prospective randomized trials in severely burned children have shown the positive effects of oxandrolone (OX), beta blockers (BB) and a combination of the two (BBOX) on hypermetabolism, catabolism and hyperinflammation short- and long-term post-burn. Although data on severely burned adults are lacking in comparison, BB, OX and BBOX appear to be commonly employed in this patient population. In this study, we perform a secondary analysis of an international prospective randomized trial dataset to provide descriptive evidence regarding the current utilization patterns and potential treatment effects of OX, BB and BBOX. Methods The RE-ENERGIZE (RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury, NCT00985205) trial included 1200 adult patients with severe burns. We stratified patients according to their receipt of OX, BB, BBOX or none of these drugs (None) during acute hospitalization. Descriptive statistics describe the details of drug therapy and unadjusted analyses identify predisposing factors for drug use per group. Association between OX, BB and BBOX and clinical outcomes such as time to discharge alive and 6-month mortality were modeled using adjusted multivariable Cox regressions. Results More than half of all patients in the trial received either OX (n = 138), BB (n = 293) or BBOX (n = 282), as opposed to None (n = 487, 40.6%). Per study site and geographical region, use of OX, BB and BBOX was highly variable. Predisposing factors for the use of OX, BB and BBOX included larger total body surface area (TBSA) burned, higher acute physiology and chronic health evaluation (APACHE) II scores on admission and younger patient age. After adjustment for multiple covariates, the use of OX was associated with a longer time to discharge alive [hazard ratio (HR) 0.62, confidence interval (CI) (0.47–0.82) per 100% increase, p = 0.001]. A higher proportion of days on BB was associated with lower in-hospital-mortality (HR: 0.5, CI 0.28–0.87, p = 0.015) and 6-month mortality (HR: 0.44, CI 0.24–0.82, p = 0.01). Conclusions The use of OX, BB and BBOX is common within the adult burn patient population, with its use varying considerably across sites worldwide. Our findings found mixed associations between outcomes and the use of BB and OX in adult burn patients, with lower acute and 6-month-mortality with BB and longer times to discharge with OX. Further research into these pharmacological modulators of the pathophysiological response to severe burn injury is indicated.

中文翻译：

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β 受体阻滞剂和氧甲氢龙对严重烧伤成人的给药和效果：RE-ENERGIZE 试验的事后分析


背景 对严重烧伤儿童进行的前瞻性随机试验表明，氧雄龙 (OX)、β 受体阻滞剂 (BB) 和两者的组合 (BBOX) 对烧伤后短期和长期的代谢亢进、分解代谢和过度炎症具有积极作用。尽管缺乏严重烧伤成人的数据进行比较，但 BB、OX 和 BBOX 似乎在该患者群体中常用。在本研究中，我们对国际前瞻性随机试验数据集进行了二次分析，以提供有关 OX、BB 和 BBOX 当前使用模式和潜在治疗效果的描述性证据。方法 RE-ENERGIZE（ENtERal 谷氨酰胺随机试验以尽量减少热损伤，NCT00985205）试验纳入了 1200 名严重烧伤的成年患者。我们根据患者在急性住院期间服用 OX、BB、BBOX 或未服用这些药物（无）对患者进行分层。描述性统计描述了药物治疗的细节，未经调整的分析确定了每组药物使用的诱发因素。使用调整后的多变量 Cox 回归对 OX、BB 和 BBOX 与临床结果（例如存活出院时间和 6 个月死亡率）之间的关联进行建模。结果 试验中超过一半的患者接受了 OX (n = 138)、BB (n = 293) 或 BBOX (n = 282)，而不是没有接受治疗 (n = 487, 40.6%)。根据研究地点和地理区域，OX、BB 和 BBOX 的使用差异很大。使用 OX、BB 和 BBOX 的诱发因素包括烧伤总表面积 (TBSA) 较大、入院时较高的急性生理学和慢性健康评估 (APACHE) II 评分以及患者年龄较小。 调整多个协变量后，使用 OX 与较长的存活出院时间相关[每增加 100% 风险比 (HR) 0.62，置信区间 (CI) (0.47–0.82)，p = 0.001]。 BB天数比例越高，院内死亡率（HR：0.5，CI 0.28-0.87，p = 0.015）和6个月死亡率（HR：0.44，CI 0.24-0.82，p = 0.01）越低。结论 OX、BB 和 BBOX 的使用在成人烧伤患者群体中很常见，但其使用情况在世界各地的不同地点差异很大。我们的研究结果发现，成人烧伤患者的结局与 BB 和 OX 的使用之间存在混合关系，BB 组的急性死亡率和 6 个月死亡率较低，OX 组的出院时间更长。需要进一步研究这些对严重烧伤的病理生理反应的药理学调节剂。