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英夫利昔单抗治疗重度溃疡性结肠炎:不同输注方案的短期结果及长期随访

Infliximab in severe ulcerative colitis: short-term results of different infusion regimens and long-term follow-up.

作者信息

Kohn A, Daperno M, Armuzzi A, Cappello M, Biancone L, Orlando A, Viscido A, Annese V, Riegler G, Meucci G, Marrollo M, Sostegni R, Gasbarrini A, Peralta S, Prantera C

机构信息

Azienda Ospedaliera San Camillo Forlanini, Rome, Italy.

出版信息

Aliment Pharmacol Ther. 2007 Sep 1;26(5):747-56. doi: 10.1111/j.1365-2036.2007.03415.x.

Abstract

BACKGROUND

Severe ulcerative colitis is a life-threatening disorder, despite i.v. glucocorticoids treatment. Infliximab has been proposed as a safe rescue therapy.

AIM

To evaluate short- and long-term effectiveness and safety of infliximab in severe refractory ulcerative colitis.

METHODS

Eighty-three patients with severe ulcerative colitis (i.v. glucocorticoids treatment-refractory) were treated with infliximab in 10 Italian Gastroenterology Units. Patients underwent one or more infusions according to the choice of treating physicians. Short-term outcome was colectomy/death 2 months after the first infusion. Long-term outcome was survival free from colectomy. Safety data were recorded.

RESULTS

Twelve patients (15%) underwent colectomy within 2 months. One died of Legionella pneumophila infection 12 days after infliximab. Early colectomy rates were higher in patients receiving one infusion (9/26), compared with those receiving two/more infusions (3/57, P = 0.001, OR = 9.53). Seventy patients who survived colectomy and did not experience any fatal complications were followed-up for a median time of 23 months; 58 patients avoided colectomy during the follow-up. Forty-two patients were maintained on immunosuppressive drugs. No clinical features were associated with outcomes.

CONCLUSIONS

Infliximab is an effective and relatively safe therapy to avoid colectomy and maintain long-term remission for patients with severe refractory ulcerative colitis. In the short term, two or more infusions seem to be more effective than one single infusion.

摘要

背景

尽管采用静脉注射糖皮质激素治疗,严重溃疡性结肠炎仍是一种危及生命的疾病。英夫利昔单抗已被提议作为一种安全的挽救疗法。

目的

评估英夫利昔单抗治疗严重难治性溃疡性结肠炎的短期和长期疗效及安全性。

方法

83例严重溃疡性结肠炎患者(静脉注射糖皮质激素治疗无效)在10个意大利胃肠病科接受英夫利昔单抗治疗。患者根据治疗医生的选择接受一次或多次输注。短期结局为首次输注后2个月内行结肠切除术/死亡。长期结局为未行结肠切除术的生存情况。记录安全性数据。

结果

12例患者(15%)在2个月内行结肠切除术。1例在英夫利昔单抗治疗后12天死于嗜肺军团菌感染。接受一次输注的患者早期结肠切除率(9/26)高于接受两次或更多次输注的患者(3/57,P = 0.001,OR = 9.53)。70例结肠切除术后存活且未发生任何致命并发症的患者中位随访时间为23个月;58例患者在随访期间避免了结肠切除术。42例患者继续使用免疫抑制药物。无临床特征与结局相关。

结论

对于严重难治性溃疡性结肠炎患者,英夫利昔单抗是一种有效且相对安全的疗法,可避免结肠切除术并维持长期缓解。短期内,两次或更多次输注似乎比单次输注更有效。

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