JAMA:早期预防性低温不能改善严重创伤性脑损伤患者的预后

2019-01-10 杨中华 脑血管病及重症文献导读

严重创伤性脑损伤是神经功能残疾的首要病因,大约50%的患者死亡或遗留严重残疾。同时,创伤性脑损伤的社会和经济学花费很高。


严重创伤性脑损伤是神经功能残疾的首要病因,大约50%的患者死亡或遗留严重残疾。同时,创伤性脑损伤的社会和经济学花费很高。

创伤性脑损伤的急性期管理目标为维持生理性参数以最小化继发性脑损伤。损伤后尽早降低体温或预防性低温可能能够改善创伤性脑损伤患者的预后(vs 正常体温)。预防性低温会减轻创伤性脑损伤被早期激活的脑部炎症和生化级联,从而减轻了二级脑损伤。这不同于为了治疗高颅压而采取的延迟性挽救性低温,后者被Eurotherm3235试验证实是有害的。不过,预防性低温也会引起创伤后凝血功能障碍、免疫抑制、出血、感染和心律失常。

2007年一项 meta分析提示严重创伤性脑损伤后采取预防性低温能够降低死亡率,改善长期神经功能预后,这为临床实践提供了低级别的推荐意见。在该 meta 分析中,唯一的大型随机试验(n = 392)显示预防性低温不能获益,不过存在方法学缺陷,包括延迟诱导和低温持续时间较短,以及仅根据时间进行复温而不是根据患者的颅内压。随后提前终止(纳入不足50%)两项试验也发现没有获益。2018年 meta 分析报道显示预防性低温能够降低死亡风险。这些作者发现介于33-35度低温,低温时间超过48h,以及缓慢复温(<0.25℃/h)与改善预后关系最强。早期预防性低温的临床价值还不清楚。

2018年12月来自澳大利亚的D. James Cooper等在 JAMA 上公布了POLAR-RCT试验结果,目的在于比较早期预防性低温和正常体温对严重创伤性脑损伤患者的疗效。

该研究为国际多中心、随机试验,在院外和急诊室共纳入了511例严重创伤性脑损伤患者。其中266例随机分配到预防性低温组,245例分配到正常体温组。预防性低温组:如果颅内压升高,早期诱导性低温(32-35℃)至少72h,一直到7天,随后逐渐复温;正常体温组的目标体温为37℃,如果需要给予体表降温装置(surface-cooling wraps)。两组各管理7天。主要终点为6个月 GOS-Extended 评分5-8分。

511例患者进行了随机,466例完成了主要终点评价。在这个试验中创伤后迅速采取低温治疗(平均1.8h),缓慢复温(平均22.5h)。低温组和正常体温组主要终点发生率分别为48.8%和49.1%(risk difference, 0.4%[95% CI, –9.4%to 8.7%);低温的相对风险,0.99 [95%CI, 0.82-1.19]; P = 0.94。在低温和正常体温组,肺炎发生率分别为55% VS 51.3%,颅内出血增加的比例分别为18.1% vs 15.4%。

最终作者认为对于严重创伤性脑损伤患者,与正常体温相比,早期预防性低温并未改善6个月神经功能结局。该项发现不支持严重创伤性脑损伤的患者使用早期预防性低温。

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