新型生物制剂英夫利西治疗克罗恩病1O例

Use of a novel biologics-infliximab in the treatment of ten patients with Crohn＇s disease

目的观察新型生物制剂英夫利西（infliximab）治疗10例克罗恩病（cD）患者的疗效及安全性。方法前瞻性开放性研究英夫利西静脉滴注治疗经常规治疗无效或激素依赖的中、重度活动性CD患者8例和以反复下消化道大出血为主要临床表现的CD患者2例。在第0、2、6周给予5mg／kg剂量作为诱导缓解，随后每隔8周给予相同剂量维持，临床与内镜随访30周。结果①治疗2周时，8例活动性CD患者中5例有效；30周时4例临床缓解（其中3例停用激素），1例有效；②2例以反复下消化道出血为主要临床表现者随访30周无再出血；③30周时复查肠镜6例，其中溃疡完全愈合或基本愈合4例；④7例发生不良事件，其中严重不良反应2例，分别为肺炎和迟发型过敏反应各1例。结论英夫利西可诱导并维持部分活动性CD缓解，促进CD肠黏膜病变愈合，严重不良反应发生率不高。

Objective To investigate the efficacy and safety of a novel biologics-infliximab in the treatment of patients with Crohn＇s disease （CD）. Methods A prospective study was conducted in 10 patients with CD（ 8 with active refractory CD and 2with severe lower gastrointestinal bleeding caused by CD）. All patients were intravenously infused with infliximab of 5 mg/kg body weight in an induction regimen of 3 doses at week 0, 2 and 6, followed by maintenance dosing every 8 weeks beginning at week 14. The clinical and endoscopic efficacy of infliximab were evaluated by follow-up of 30 weeks. Results ① Five out of 8 patients with active CD had initial clinical response at Week 2. Clinical remission was found in 4 patients at week 30, （3 of them in symptomatic remission without corticosteroids）. ② Two patients with severe lower gastrointestinal bleeding caused by CD were in control of bleeding and absence of further recurrence by 30 weeks follow-up. ③ Endoscopy was performed in 6 patients at week 30 to evaluate the healing of mucosal ulceration. Four patients were evaluated for complete or al- most mucosal healing. ④ Adverse events were seen in 7 out of 10 patients with infliximab treatment, among whom 2 cases had severe side effect including pneumonia in one and delayed hypersensitirity reaction in the other. Conclusion Infliximab has efficacy for the induction and maintenance of remission in part of patients with active CD. Some patients achieved mucosal healing with infliximab therapy and low incidence of serious adverse events.