Holcroft J W, Vassar M J, Weber C J
Ann Surg. 1986 Apr;203(4):371-8. doi: 10.1097/00000658-198604000-00006.
A 7-day infusion of prostaglandin E1 (PGE1), an immunomodulator, was evaluated in a prospective, randomized, placebo-controlled, double-blinded trial in surgical patients with the adult respiratory distress syndrome (ARDS). The drug seemed to improve pulmonary function--only two PGE1 patients died with severe pulmonary failure compared with nine placebo patients (p = 0.01). Survival at 30 days after the end of the infusion--the predetermined end point of the study--was significantly better in the patients given PGE1 (p = 0.03), with 15 of 21 PGE1 patients (71%) alive at this time compared with seven of 20 placebo patients (35%). Improvement in overall survival in the PGE1 patients did not reach statistical significance (p = 0.08). Overall survival in patients initially free of severe organ failure, however, was significantly better in the PGE1 patients (p = 0.03). Of the six PGE1 patients free of severe organ failure at time of entry, all survived to leave the hospital; of the 10 placebo patients initially free of severe organ failure, four survived. The drug had no serious side effects and did not potentiate susceptibility to infection. PGE1 is a promising agent for the treatment of ARDS.
在一项针对患有成人呼吸窘迫综合征（ARDS）的外科患者的前瞻性、随机、安慰剂对照、双盲试验中，对免疫调节剂前列腺素E1（PGE1）进行了为期7天的输注评估。该药物似乎改善了肺功能——只有2名接受PGE1治疗的患者死于严重肺衰竭，而接受安慰剂治疗的患者有9名（p = 0.01）。在输注结束后30天的生存率——该研究预先设定的终点——接受PGE1治疗的患者明显更好（p = 0.03），此时21名接受PGE1治疗的患者中有15名（71%）存活，而20名接受安慰剂治疗的患者中有7名（35%）存活。PGE1治疗患者的总体生存率改善未达到统计学显著性（p = 0.08）。然而，最初没有严重器官衰竭的患者中，PGE1治疗组的总体生存率明显更好（p = 0.03）。在入组时没有严重器官衰竭的6名接受PGE1治疗的患者中，全部存活出院；在最初没有严重器官衰竭的10名接受安慰剂治疗的患者中，4名存活。该药物没有严重副作用，也没有增加感染易感性。PGE1是一种有前景的治疗ARDS的药物。
