MRC CRASH研究的最终结果，一项针对成年颅脑损伤患者静脉注射皮质类固醇的随机安慰剂对照试验——6个月时的结果

Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months.

作者信息

Edwards Phil, Arango Miguel, Balica Laura, Cottingham Rowland, El-Sayed Hesham, Farrell Barbara, Fernandes Janice, Gogichaisvili Tamar, Golden Nyoman, Hartzenberg Bennie, Husain Mazhar, Ulloa Mario Izurieta, Jerbi Zouheir, Khamis Hussein, Komolafe Edward, Laloë Véronique, Lomas Gabrielle, Ludwig Silke, Mazairac Guy, Muñoz Sanchéz Maria de los Angeles, Nasi Luis, Olldashi Fatos, Plunkett Patrick, Roberts Ian, Sandercock Peter, Shakur Haleema, Soler Caridad, Stocker Reto, Svoboda Petr, Trenkler Stefan, Venkataramana N K, Wasserberg Jonathan, Yates David, Yutthakasemsunt Surakrant

出版信息

Lancet. 2005;365(9475):1957-9. doi: 10.1016/S0140-6736(05)66552-X.

DOI:10.1016/S0140-6736(05)66552-X

PMID:15936423

Abstract

MRC CRASH is a randomised controlled trial (ISRCTN74459797) of the effect of corticosteroids on death and disability after head injury. We randomly allocated 10,008 adults with head injury and a Glasgow Coma Scale score of 14 or less, within 8 h of injury, to a 48-h infusion of corticosteroid (methylprednisolone) or placebo. Data at 6 months were obtained for 9673 (96.7%) patients. The risk of death was higher in the corticosteroid group than in the placebo group (1248 [25.7%] vs 1075 [22.3%] deaths; relative risk 1.15, 95% CI 1.07-1.24; p=0.0001), as was the risk of death or severe disability (1828 [38.1%] vs 1728 [36.3%] dead or severely disabled; 1.05, 0.99-1.10; p=0.079). There was no evidence that the effect of corticosteroids differed by injury severity or time since injury. These results lend support to our earlier conclusion that corticosteroids should not be used routinely in the treatment of head injury.

摘要

MRC CRASH是一项关于皮质类固醇对颅脑损伤后死亡和残疾影响的随机对照试验（ISRCTN74459797）。我们将10008名颅脑损伤且格拉斯哥昏迷量表评分在14分及以下的成年人，在受伤后8小时内随机分配接受为期48小时的皮质类固醇（甲泼尼龙）输注或安慰剂治疗。9673名（96.7%）患者获得了6个月时的数据。皮质类固醇组的死亡风险高于安慰剂组（死亡人数分别为1248例[25.7%]和1075例[22.3%]；相对风险1.15，95%可信区间1.07 - 1.24；p = 0.0001），死亡或严重残疾的风险也是如此（死亡或严重残疾人数分别为1828例[38.1%]和1728例[36.3%]；1.05，0.99 - 1.10；p = 0.079）。没有证据表明皮质类固醇的效果因损伤严重程度或受伤时间而异。这些结果支持了我们早期的结论，即皮质类固醇不应常规用于颅脑损伤的治疗。