Panés J, Esteve M, Cabré E, Hinojosa J, Andreu M, Sans M, Fernandez-Bañares F, Feu F, Gassull M A, Piqué J M
Gastroenterology Department, Institut Clinic de Malalties Digestives, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona.
Gastroenterology. 2000 Oct;119(4):903-8. doi: 10.1053/gast.2000.18159.
BACKGROUND & AIMS: Unfractionated heparin has been found to reduce symptoms and improve healing as adjuvant therapy in patients with ulcerative colitis. The current study evaluated the efficacy and safety of unfractionated heparin in the treatment of ulcerative colitis in comparison with methylprednisolone.
A multicenter randomized trial with blinded endpoint evaluation was conducted in patients hospitalized for moderate or severe ulcerative colitis. Patients were randomized to receive heparin as a continuous infusion or methylprednisolone (0.75-1 mg x kg(-1) x day(-1)).
Twenty-five patients entered the study: 13 received methylprednisolone and 12 received heparin. By day 10, 69% of patients in the methylprednisolone group, but none in the heparin group, achieved significant improvement or remission. C-reactive protein levels significantly decreased in the methylprednisolone group but not in the heparin group. Three patients in the heparin group were withdrawn before day 10 because of an adverse event: rectal bleeding needing transfusion (2 cases) or surgery (1 case). The proportion of patients with persistent rectal bleeding at day 10 was 31% in the methylprednisolone group and 90% in the heparin group (P<0.05).
Unfractionated heparin as monotherapy is not effective in the treatment of moderate or severe ulcerative colitis and is associated with significant bleeding complications.
已发现普通肝素作为溃疡性结肠炎患者的辅助治疗可减轻症状并促进愈合。本研究比较了普通肝素与甲泼尼龙治疗溃疡性结肠炎的疗效和安全性。
对因中度或重度溃疡性结肠炎住院的患者进行了一项终点评估盲法的多中心随机试验。患者被随机分为接受持续输注肝素或甲泼尼龙（0.75 - 1 mg·kg⁻¹·d⁻¹）。
25名患者进入研究：13名接受甲泼尼龙，12名接受肝素。到第10天时，甲泼尼龙组69%的患者病情显著改善或缓解，而肝素组无患者达到此效果。甲泼尼龙组C反应蛋白水平显著下降，而肝素组未下降。肝素组有3名患者在第10天前因不良事件退出：2例因直肠出血需要输血，1例因直肠出血需要手术。第10天时持续性直肠出血患者的比例在甲泼尼龙组为31%，在肝素组为90%（P<0.05）。
普通肝素单药治疗中度或重度溃疡性结肠炎无效，且与严重出血并发症相关。
