Pittet D, Harbarth S, Suter P M, Reinhart K, Leighton A, Barker C, Macdonald F, Abraham E
Infection Control Program and Division of Surgical Intensive Care, Geneva University Hospitals, Geneva, Switzerland.
Am J Respir Crit Care Med. 1999 Sep;160(3):852-7. doi: 10.1164/ajrccm.160.3.9809033.
We assessed the impact, over a 28-d period, of therapy with the tumor necrosis factor (TNF) neutralizing receptor fusion protein (p55-IgG) on the incidence of end-organ failures in patients with severe sepsis or early septic shock in a subgroup of 165 patients recruited into a randomized, multicenter clinical trial to receive placebo (n = 78) or a single infusion of p55-IgG, 0.083 mg/kg (n = 87). At study entry, distribution of organ dysfunctions and other baseline characteristics were similar for the two study groups. Treatment with p55-IgG was associated with a trend toward reduced 28-d mortality (p = 0.07), a decreased incidence of new organ dysfunctions (relative risk [RR], 0.57; 95% confidence interval [95% CI] 0.29 to 1.10, p = 0.10), and a decreased overall incidence-density of organ failures (RR 0.65; 95% CI 0.60 to 0.71, p = 0.0001). Patients treated with p55-IgG had more organ failure-free days after study entry than those who received placebo. Average intensive care unit (ICU) stay was 2.6 d shorter (95% CI 0.2 to 5.0) for patients who received p55-IgG than for those who received placebo. For those patients who survived, this difference was 4.1 d (95% CI 1.6 to 6.6). Duration of ventilatory support was 3.2 d shorter (95% CI 0.1 to 6.3) among 28-d survivors who received p55-IgG, compared with placebo. In conclusion, in the population of septic patients studied, treatment with p55-IgG was associated with a trend toward shorter need for mechanical ventilatory support, a decreased length of stay (LOS), and a decreased incidence and duration of organ failure.
在一项随机、多中心临床试验的165例患者亚组中，我们评估了肿瘤坏死因子（TNF）中和受体融合蛋白（p55-IgG）治疗28天对严重脓毒症或早期脓毒性休克患者终末器官功能衰竭发生率的影响。这些患者被随机分为两组，一组接受安慰剂（n = 78），另一组接受单次输注0.083 mg/kg的p55-IgG（n = 87）。研究开始时，两个研究组的器官功能障碍分布和其他基线特征相似。p55-IgG治疗与28天死亡率降低趋势相关（p = 0.07），新器官功能障碍发生率降低（相对风险[RR]，0.57；95%置信区间[95%CI]0.29至1.10，p = 0.10），以及器官功能衰竭总体发病率密度降低（RR 0.65；95%CI 0.60至0.71，p = 0.0001）。接受p55-IgG治疗的患者在研究开始后无器官功能衰竭的天数比接受安慰剂的患者更多。接受p55-IgG治疗的患者平均重症监护病房（ICU）住院时间比接受安慰剂的患者短2.6天（95%CI 0.2至5.0）。对于那些存活的患者，这种差异为4.1天（95%CI 1.6至6.6）。在28天存活的患者中，接受p55-IgG治疗的患者与接受安慰剂的患者相比，机械通气支持时间短3.2天（95%CI 0.1至6.3）。总之，在所研究的脓毒症患者群体中，p55-IgG治疗与机械通气支持需求缩短趋势、住院时间（LOS）缩短、器官功能衰竭发生率和持续时间降低相关。
