Tilg H, Vogelsang H, Ludwiczek O, Lochs H, Kaser A, Colombel J-F, Ulmer H, Rutgeerts P, Krüger S, Cortot A, D'Haens G, Harrer M, Gasche C, Wrba F, Kuhn I, Reinisch W
Department of Gastroenterology and Hepatology and Biostatistics, University Hospital Innsbruck, Austria.
Gut. 2003 Dec;52(12):1728-33. doi: 10.1136/gut.52.12.1728.
Pilot studies of interferon alpha (IFN-alpha) suggest a high remission rate in the treatment of active ulcerative colitis. We evaluated the safety of pegylated interferon alpha (PegIFN) and its role in induction of remission in patients with active ulcerative colitis, in a multicentre placebo controlled trial.
Sixty patients with a clinical activity score (CAI) of >6 were randomised to receive placebo (n=20), PegIFN 0.5 microg/kg (n=19), or PegIFN 1.0 microg/kg body weight (n=21) once weekly (PegIntron; Schering-Plough, USA) over 12 weeks. Patients receiving 5-aminosalicylates, steroids, and/or azathioprine in stable dosages were included.
Serious adverse events were seen in none of the placebo patients, in 3/19 patients in the PegIFN 0.5 microg/kg group (hospitalisation due to disease flare up n=3), and in 3/21 in the PegIFN 1.0 microg/kg group (hospitalisation due to disease flare up n=1; thrombosis n=1; grand mal seizure n=1). Otherwise, we observed only minor IFN-alpha side effects. Clinical remission rates at week 12 (CAI < or =4) were 7/20 (35%) in the placebo, 9/19 (47%) in the PegIFN 0.5 microg/kg group, and 7/21 (33%) in the PegIFN 1.0 microg/kg group (NS). Early withdrawal from the study was observed in 11/20 placebo patients, in 6/19 in the PegIFN 0.5 microg/kg group, and in 10/21 in the PegIFN 1.0 microg/kg group, mainly due to lack of efficacy. The higher PegIFN dose was associated with a significant decrease in levels of C reactive protein (p=0.003, day 0 v 85).
PegIFN is safe but not effective, at the dosages used, in patients with ulcerative colitis.
干扰素α（IFN-α）的初步研究表明，其在治疗活动性溃疡性结肠炎方面缓解率较高。在一项多中心安慰剂对照试验中，我们评估了聚乙二醇化干扰素α（PegIFN）的安全性及其在诱导活动性溃疡性结肠炎患者缓解中的作用。
60例临床活动评分（CAI）>6的患者被随机分为三组，分别接受安慰剂（n = 20）、0.5μg/kg的PegIFN（n = 19）或1.0μg/kg体重的PegIFN（n = 21），每周一次（PegIntron；美国先灵葆雅公司），共治疗12周。纳入正在接受稳定剂量的5-氨基水杨酸、类固醇和/或硫唑嘌呤治疗的患者。
安慰剂组患者均未出现严重不良事件，PegIFN 0.5μg/kg组19例中有3例（因病情复发住院n = 3），PegIFN 1.0μg/kg组21例中有3例（因病情复发住院n = 1；血栓形成n = 1；癫痫大发作n = 1）。此外，我们仅观察到轻微的IFN-α副作用。第12周时的临床缓解率（CAI≤4），安慰剂组为7/20（35%），PegIFN 0.5μg/kg组为9/19（47%），PegIFN 1.0μg/kg组为7/21（33%）（无显著性差异）。安慰剂组20例中有11例、PegIFN 0.5μg/kg组19例中有6例、PegIFN 1.0μg/kg组21例中有10例提前退出研究，主要原因是缺乏疗效。较高剂量的PegIFN与C反应蛋白水平显著降低相关（p = 0.003，第0天与第85天相比）。
对于溃疡性结肠炎患者，所用剂量的PegIFN安全但无效。
