Bigatello L M, Greene R E, Sprung C L, Panacek E A, Straube R C, Zimmerman J L, Maunder R J, Lanken P N, Pile-Spellmann E, Stanek K S
Department of Anaesthesia, Harvard Medical School, Massachusetts General Hospital, Boston 02114.
Intensive Care Med. 1994 May;20(5):328-34. doi: 10.1007/BF01720904.
To evaluate the effects of HA-1A, a human monoclonal antiendotoxin antibody, in septic patients with ARDS.
Substudy of a multicenter, double-blinded, placebo-controlled trial of HA-1A in septic patients.
63 septic patients with ARDS at the time of study entry.
A single intravenous injection of HA-1A (100 mg) or placebo.
A quantitative radiographic score, the PaO2/FIO2 ratio and an index of the severity of ARDS did not show a significant difference between the treatment and placebo groups at 3, 5 and 7 days after treatment. The duration of endotracheal intubation did not differ between the two groups. 15 of 30 HA-1A treated patients (50%) and 23 of 33 placebo-treated patients (69.7%) died within 28 days. The daily mortality was always lower in the HA-1A group, but this difference was not statistically significant at 28 days. The 28-day survival curves for the two treatment groups adjusted by covariate analysis were not significantly different (p = 0.07). Using logistic regression, a significant independent effect of HA-1A treatment was detected upon the early survival rate at 7 days (p = 0.03) but not at 14 and 28 days.
A single injection of HA-1A in septic patients with ARDS did not reverse acute respiratory failure or improve long-term survival.
评估人源单克隆抗内毒素抗体HA-1A对脓毒症并发急性呼吸窘迫综合征（ARDS）患者的疗效。
HA-1A用于脓毒症患者的多中心、双盲、安慰剂对照试验的子研究。
研究入组时63例脓毒症并发ARDS患者。
单次静脉注射HA-1A（100毫克）或安慰剂。
治疗后3天、5天和7天，定量影像学评分、动脉血氧分压/吸入氧分数值（PaO2/FIO2）及ARDS严重程度指数在治疗组和安慰剂组之间未显示出显著差异。两组气管插管持续时间无差异。30例接受HA-1A治疗的患者中有15例（50%）、33例接受安慰剂治疗的患者中有23例（69.7%）在28天内死亡。HA-1A组每日死亡率始终较低，但在28天时这种差异无统计学意义。经协变量分析调整后的两个治疗组28天生存曲线无显著差异（p = 0.07）。采用逻辑回归分析，发现HA-1A治疗对7天早期生存率有显著独立影响（p = 0.03），但对14天和28天无影响。
对脓毒症并发ARDS患者单次注射HA-1A不能逆转急性呼吸衰竭或改善长期生存。
