Sterling R K, Luketic V A, Sanyal A J, Shiffman M L
Medical College of Virginia, Virginia Commonwealth University, Richmond, VA 23298-0711, USA.
Liver Transpl Surg. 1998 Sep;4(5):424-31. doi: 10.1002/lt.500040501.
Fulminant hepatic failure (FHF) is a severe, life-threatening disorder. Previous studies have suggested that intravenous prostaglandin treatment may improve survival in FHF. The present study was performed to further investigate the possible benefit of intravenous prostaglandin E1 (PGE1) for patients with FHF. A total of 18 patients, all excluded as candidates for hepatic transplantation, were studied. Thirteen of 18 participated in a randomized, double-blind, placebo-controlled trial. PGE1 was administered by continuous infusion at a dose of 10 to 40 microg/h as tolerated. After 48 hours of blinded treatment, 3 of 7 patients randomized to placebo were converted to open-label PGE1 for lack of biochemical and/or clinical improvement. Mean values for alanine transaminase, aspartate transaminase, total bilirubin, prothrombin time, factor V percent, factor VII percent, hepatic encephalopathy score, days from onset of symptoms to initiation of treatment, and cause of FHF were similar between treatment groups. Ten of 18 patients (55%) enrolled in this trial survived. However, survival was not different between PGE1-(60%) and placebo (50%) treated patients. The greatest predictor of survival was the number of days from onset of symptoms to hospitalization, which was significantly (P = .002) shorter for survivors (3.3 v 12.4 days), regardless of PGE1 treatment. Six of 8 patients (75%) who began PGE1 therapy and 4 of 5 placebo-treated patients (80%) hospitalized within 10 days of onset of symptoms survived. By contrast, all 5 patients who were hospitalized and subsequently began PGE1 treatment 10 days or longer after the onset of symptoms died. We conclude that early recognition and hospitalization is the most important factor in reduction of mortality from FHF. It is unclear whether PGE1 treatment is beneficial when administered during this period. However, it is apparent that PGE1 was not effective for treatment of FHF if treatment started more than 10 days after onset of this clinical syndrome.
暴发性肝衰竭（FHF）是一种严重的、危及生命的疾病。先前的研究表明，静脉注射前列腺素治疗可能会提高FHF患者的生存率。本研究旨在进一步探讨静脉注射前列腺素E1（PGE1）对FHF患者可能带来的益处。共研究了18例均被排除肝移植候选资格的患者。18例中有13例参与了一项随机、双盲、安慰剂对照试验。PGE1以10至40微克/小时的剂量持续输注，具体剂量视耐受情况而定。经过48小时的盲法治疗后，随机分配至安慰剂组的7例患者中有3例因生化指标和/或临床症状未改善而转为开放标签的PGE1治疗。治疗组之间的丙氨酸转氨酶、天冬氨酸转氨酶、总胆红素、凝血酶原时间、因子V百分比、因子VII百分比、肝性脑病评分、从症状出现到开始治疗的天数以及FHF病因的平均值相似。参与该试验的18例患者中有10例（55%）存活。然而，接受PGE1治疗（60%）和接受安慰剂治疗（50%）的患者生存率并无差异。生存的最大预测因素是从症状出现到住院的天数，无论是否接受PGE1治疗，幸存者的该天数显著较短（3.3天对12.4天，P = 0.002）。在症状出现后10天内开始PGE1治疗的8例患者中有6例（75%）存活，接受安慰剂治疗的5例患者中有4例（80%）存活。相比之下，所有在症状出现10天或更长时间后住院并随后开始PGE1治疗的5例患者均死亡。我们得出结论，早期识别和住院是降低FHF死亡率的最重要因素。在此期间给予PGE1治疗是否有益尚不清楚。然而，显然如果在该临床综合征出现后10天以上开始治疗，PGE1对FHF治疗无效。
