Dries D J, Jurkovich G J, Maier R V, Clemmer T P, Struve S N, Weigelt J A, Stanford G G, Herr D L, Champion H R, Lewis F R
Department of Surgery and Shock Trauma Institute, Loyola University Medical Center, Maywood, Ill.
Arch Surg. 1994 Oct;129(10):1031-41; discussion 1042. doi: 10.1001/archsurg.1994.01420340045008.
To assess the efficacy of interferon gamma in reducing infection and death in patients sustaining severe injury.
Multicenter, randomized, double-blind, placebo-controlled trial with observation for 60 days and until discharge for patients with major infection on day 60.
Nine university-affiliated level 1 trauma centers.
Four hundred sixteen patients with severe injuries, assessed by Injury Severity Score and degree of contamination.
Recombinant human interferon gamma, 100 micrograms, was administered subcutaneously once daily for 21 days (or until patient discharge if prior to 21 days) as an adjunct to standard antibiotic and supportive therapy.
Incidence of major infection, death related to infection, and death.
Infection rates were similar in both treatment groups; however, patients treated with interferon gamma experienced fewer deaths related to infection (seven [3%] vs 18 [9%]; P = .008) and fewer overall deaths (21 [10%] vs 30 [14%]; P = .17). While 12 early deaths (days 1 through 7) occurred in each treatment group, late death occurred in 18 placebo-treated patients and nine in interferon gamma-treated patients. The results were dominated by findings at one center, which had the highest enrollment and higher infection and death rates. Statistical analysis did not eliminate the possibility of an unidentified imbalance between arms as an explanation for the results.
Further evaluation is required to determine the validity of the observed reduction in infection-related deaths in patients treated with interferon gamma.
评估γ干扰素在降低重伤患者感染率及死亡率方面的疗效。
多中心、随机、双盲、安慰剂对照试验，观察60天，对于在第60天发生严重感染的患者则观察至出院。
9家大学附属的一级创伤中心。
416例重伤患者，根据损伤严重程度评分和污染程度进行评估。
重组人γ干扰素100微克，每日皮下注射1次，共21天（若在21天前出院则注射至出院），作为标准抗生素和支持治疗的辅助治疗。
严重感染发生率、感染相关死亡率及总死亡率。
两个治疗组的感染率相似；然而，接受γ干扰素治疗的患者感染相关死亡较少（7例[3%]对18例[9%]；P = 0.008），总死亡也较少（21例[10%]对30例[14%]；P = 0.17）。每个治疗组均有12例早期死亡（第1至7天），晚期死亡在安慰剂治疗组有18例，γ干扰素治疗组有9例。结果受一个中心的研究结果主导，该中心入组人数最多，感染率和死亡率更高。统计分析并未排除两组间存在未识别的不平衡作为结果解释的可能性。
需要进一步评估以确定观察到的接受γ干扰素治疗患者感染相关死亡减少的有效性。
