D'Haens G, Lemmens L, Geboes K, Vandeputte L, Van Acker F, Mortelmans L, Peeters M, Vermeire S, Penninckx F, Nevens F, Hiele M, Rutgeerts P
Department of Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium.
Gastroenterology. 2001 May;120(6):1323-9. doi: 10.1053/gast.2001.23983.
BACKGROUND & AIMS: Cyclosporine has been effective in patients with steroid-refractory attacks of ulcerative colitis (UC). We investigated the effects of intravenous (IV) cyclosporine as single IV therapy (without glucocorticosteroids) for severe UC and compared these with the response to glucocorticosteroids.
Patients with a severe attack of UC were randomized to treatment with IV cyclosporine, 4 mg x kg(-1) x day(-1), or with methylprednisolone, 40 mg/day, in a randomized, double-blind, controlled trial. After 8 days, patients who had a response received the same medication orally in combination with azathioprine. Patients were followed up clinically, endoscopically, and by scintigraphy. Renal function was assessed using urinary inulin clearances. Endpoints were clinical improvement, discharge from the hospital, and remission up to 12 months after intravenous therapy.
Thirty patients were included. After 8 days, 8 of 15 patients (53%) who received methylprednisolone had a response to therapy vs. 9 of 14 (64%) receiving cyclosporine. In nonresponders, 3 of 7 methylprednisolone patients and 1 of 3 cyclosporine patients improved when both treatments were combined. No serious drug-related toxicity was observed with either treatment. At 12 months, 7 of 9 patients (78%) initially controlled with cyclosporine maintained their remission vs. 3 of 8 (37%) initially treated with methylprednisolone. No clinically significant decrease of renal function was observed.
Cyclosporine monotherapy is an effective and safe alternative to glucocorticosteroids in patients with severe attacks of UC.
环孢素对溃疡性结肠炎（UC）激素抵抗性发作的患者有效。我们研究了静脉注射（IV）环孢素作为重度UC的单一静脉治疗（不使用糖皮质激素）的效果，并将其与糖皮质激素的反应进行比较。
在一项随机、双盲、对照试验中，将重度UC发作的患者随机分为接受4mg·kg⁻¹·d⁻¹静脉注射环孢素治疗组或40mg/d甲泼尼龙治疗组。8天后，有反应的患者口服相同药物并联合硫唑嘌呤。对患者进行临床、内镜和闪烁扫描随访。使用尿菊粉清除率评估肾功能。终点指标为临床改善、出院以及静脉治疗后12个月内的缓解情况。
共纳入30例患者。8天后，接受甲泼尼龙治疗的15例患者中有8例（53%）对治疗有反应，而接受环孢素治疗的14例患者中有9例（64%）有反应。在无反应者中，两种治疗联合使用时，7例甲泼尼龙患者中有3例、3例环孢素患者中有1例病情改善。两种治疗均未观察到严重的药物相关毒性。12个月时，最初用环孢素控制病情的9例患者中有7例（78%）维持缓解，而最初用甲泼尼龙治疗的8例患者中有3例（37%）维持缓解。未观察到肾功能有临床显著下降。
对于重度UC发作的患者，环孢素单药治疗是糖皮质激素的一种有效且安全的替代疗法。
