Willert Robert P, Lawrance Ian Craig
Department of Gastroenterology, Fremantle Hospital, Fremantle 6059, WA, Australia.
World J Gastroenterol. 2008 Apr 28;14(16):2544-9. doi: 10.3748/wjg.14.2544.
To determine if infliximab can prevent or delay surgery in refractory ulcerative colitis (UC).
UC patients who failed to have their disease controlled with conventional therapies and were to undergo colectomy if infliximab failed to induce a clinical improvement were reviewed. Patients were primarily treated with a single 5 mg/kg infliximab dose. The Colitis Activity Index (CAI) was used to determine response and remission. Data of 8 wk response and colectomy rates at 6 mo and 12 mo were collected.
Fifteen patients were included, 7 with UC unresponsive or intolerant to i.v. hydrocortisone, and 8 with active disease despite oral steroids (all but one with therapeutic dosage and duration of immunomodulation). All the i.v. hydrocortisone-resistant/intolerant patients had been on azathioprine/6-MP < 8 wk. At 8 wk, infliximab induced a response in 86.7% (13/15) with 40% in remission (6/15). Within 6 mo of treatment 26.7% (4/15) had undergone colectomy and surgery was avoided in 46.6% (7/15) at 12 mo. The colectomy rate at 12 mo in those on immunomodulatory therapy < 8 wk at time of infliximab was 12.5% (1/8) compared with 100% (7/7) in patients who were on long-term maintenance immunomodulators (P < 0.02).
Infliximab prevented colectomy due to active disease in immunomodulatory-naive, refractory UC patients comparable to the use of Cyclosporine. In patients, however, on effective dosage and duration of immunomodulation at time of infliximab therapy colectomy was not avoided.
确定英夫利昔单抗能否预防或延迟难治性溃疡性结肠炎(UC)患者的手术。
回顾性分析那些采用传统疗法未能控制病情、若英夫利昔单抗未能诱导临床改善则需接受结肠切除术的UC患者。患者主要接受单次5 mg/kg剂量的英夫利昔单抗治疗。采用结肠炎活动指数(CAI)来确定反应和缓解情况。收集8周反应数据以及6个月和12个月时的结肠切除率。
纳入15例患者,7例对静脉注射氢化可的松无反应或不耐受,8例尽管使用口服类固醇仍患有活动性疾病(除1例患者外,其余患者均接受了治疗剂量和疗程的免疫调节治疗)。所有对静脉注射氢化可的松耐药/不耐受的患者使用硫唑嘌呤/6-巯基嘌呤的时间均<8周。8周时,英夫利昔单抗诱导缓解率为40%(6/15),反应率为86.7%(13/15)。治疗6个月内,26.7%(4/15)的患者接受了结肠切除术,12个月时46.6%(7/15)的患者避免了手术。英夫利昔单抗治疗时免疫调节治疗时间<8周的患者,12个月时结肠切除率为12.5%(1/8),而长期接受维持性免疫调节剂治疗的患者结肠切除率为100%(7/7)(P<0.02)。
英夫利昔单抗可预防免疫调节初治的难治性UC患者因活动性疾病而进行结肠切除术,其效果与环孢素相当。然而,在英夫利昔单抗治疗时接受有效剂量和疗程免疫调节治疗的患者,未能避免结肠切除术。