Talbot C, Sagar P M, Johnston M J, Finan P J, Burke D
Division of Colon and Rectal Surgery, The General Infirmary at Leeds, United Kingdom.
Colorectal Dis. 2005 Mar;7(2):164-8. doi: 10.1111/j.1463-1318.2004.00749.x.
To assess prospectively the efficacy and safety of treatment of perianal Crohn's disease by means of a combination of surgical management and a standardized protocol for the intravenous infusion of infliximab.
A consecutive series of patients who presented with complex perianal Crohn's fistulae between November 1999 and March 2003 were included in the study. Perianal sepsis was eradicated with drainage of collections and insertion of setons. Infliximab was infused at 5 mg/kg at 0, 2, and 6 weeks. Setons were removed after the second infliximab infusion. Endpoints were defined as either complete, partial or no response as noted at subsequent outpatient follow up. Adverse reactions were recorded.
Twenty-one patients had a median of three fistulae per patient (range 1-9). All patients tolerated the initial protocol, receiving a median of five infusions of infliximab (range 3-19); median follow up 20 months (range 12-52). Eleven patients (53%) were continued on maintenance therapy with 12 weekly infusions of infliximab for either a perceived clinical need for treatment or after a relapse of their symptoms. Ten (47%) patients experienced a complete response to treatment and the remaining 11 (53%) experienced a partial response. No patient failed to respond to treatment. Four adverse reactions were noted (2 mild allergies, 1 rash and 1 patient experienced joint pains). All adverse reactions settled with cessation of the drug infusion.
The combination of seton drainage and infusion of infliximab completely healed the perineum of 47% patients with complex fistulating perianal Crohn's disease. Partial response was seen in the remainder of patients. No serious adverse reactions reported.
前瞻性评估手术治疗联合英夫利昔单抗静脉输注标准化方案治疗肛周克罗恩病的疗效和安全性。
纳入1999年11月至2003年3月间连续收治的复杂性肛周克罗恩病肛瘘患者。通过引流脓肿和置入挂线消除肛周脓毒症。在第0、2和6周时按5mg/kg输注英夫利昔单抗。在第二次输注英夫利昔单抗后移除挂线。终点定义为后续门诊随访时观察到的完全缓解、部分缓解或无缓解。记录不良反应。
21例患者，每位患者的肛瘘中位数为3个（范围1 - 9个）。所有患者均耐受初始方案，英夫利昔单抗输注中位数为5次（范围3 - 19次）；中位随访时间20个月（范围12 - 52个月）。11例患者（53%）因临床治疗需求或症状复发，继续接受英夫利昔单抗每周1次共12次的维持治疗。10例（47%）患者治疗后完全缓解，其余11例（53%）患者部分缓解。无患者治疗无效。记录到4例不良反应（2例轻度过敏、1例皮疹和1例患者出现关节疼痛）。所有不良反应在停止药物输注后均得到缓解。
挂线引流联合英夫利昔单抗输注使47%的复杂性肛瘘性肛周克罗恩病患者的会阴完全愈合。其余患者出现部分缓解。未报告严重不良反应。
