英夫利昔单抗在临床实践中治疗克罗恩病：罗马尼亚一家单一中心的经验

Gheorghe Liana, Gheorghe Cristian, Badea Mihaela, Vădan Roxana, Pârvulescu Iuliana, Toader Cristina, Tugui Letiţia, Papuc Octavian, Ionescu Radu, Preda Carmen, Călin Ion, Diculescu Mircea

Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Sos. Fundeni no. 258, 71637 Bucharest, Romania.

Rom J Gastroenterol. 2003 Mar;12(1):7-13.

AIM

The aim of the study was to report the efficacy and tolerability of infliximab therapy in the first 24 patients with refractory and fistulizing Crohn's disease (CD) treated at our center between August 2000-May 2002.

PATIENTS AND METHODS

The medical records of 24 patients (13 males, 11 females) treated with infliximab for refractory or fistulizing CD were reviewed. CD was diagnosed using conventional clinical, endoscopical and histological criteria. Infliximab was administered at a dose of 5 mg/kg body mass as a 2-hours i.v. infusion in a single infusion for inflammatory CD, and a triple infusion regimen for fistulizing CD (at 0, 2, and 6 weeks). Efficacy was analysed by means of 1) clinical outcome, 2) mucosal healing, 3) steroid tapering/sparing effect and 4) need for surgery.

RESULTS

Sixteen patients were treated for inflammatory CD, 7 patients for fistulizing CD and 1 patient for both inflammatory and fistulizing CD. A total number of 49 infusions were administered during the study interval (median number 2); the median time of follow-up was 26 weeks (12-79 weeks). An overall positive clinical response was seen in 12/16 patients (75 % with inflammatory CD and 5/7 patients (71.4 %) with fistulizing CD. The median time to clinical response was 5.6 days (range 1-11 days) and the median duration of clinical response was 6.53 mo. (4 weeks-21 months). Mucosal healing was noted in 10/17 (58 %). Steroid tapering or cessation was succesfully attempted in 17 patients (80.9 %), complete steroid withdrawal being possible in 15 patients (71.4 %). Three non-responder patients required surgical therapy. Infusion-related adverse reactions were seen in 4 patients (16.6 %). Two patients (8.3 %) developed severe adverse events; one of them, a young female patient with intrapartum onset of a severe CD developed sepsis and deceased from intavascular disseminated coagulopathy. During the follow-up, none of our patients developed serious infections, tuberculosis or malignancy.

CONCLUSION

Our study provides additional evidence that infliximab is beneficial and safe in clinical practice for refractory and fistulizing CD patients. Additionally, our study proved the high mucosal healing rate and the steroid-sparing and surgery-saving properties of infliximab

目的

本研究旨在报告2000年8月至2002年5月期间在我们中心接受治疗的首批24例难治性瘘管性克罗恩病（CD）患者使用英夫利昔单抗治疗的疗效和耐受性。

患者与方法

回顾了24例（13例男性，11例女性）接受英夫利昔单抗治疗难治性或瘘管性CD患者的病历。采用传统的临床、内镜和组织学标准诊断CD。英夫利昔单抗以5mg/kg体重的剂量静脉输注2小时，对于炎症性CD单次输注，对于瘘管性CD采用三联输注方案（在0、2和6周）。通过以下方式分析疗效：1）临床结果，2）黏膜愈合，3）类固醇减量或节省效应，4）手术需求。

结果

16例患者接受炎症性CD治疗，7例患者接受瘘管性CD治疗，1例患者同时接受炎症性和瘘管性CD治疗。研究期间共进行了49次输注（中位数为2次）；中位随访时间为26周（12 - 79周）。12/16例患者（炎症性CD患者中的75%）和5/7例患者（瘘管性CD患者中的71.4%）出现总体阳性临床反应。临床反应的中位时间为5.6天（范围1 - 11天），临床反应的中位持续时间为6.53个月（4周 - 21个月）。10/17例（58%）患者出现黏膜愈合。17例患者（80.9%）成功尝试了类固醇减量或停用，15例患者（71.4%）能够完全停用类固醇。3例无反应患者需要手术治疗。4例患者（16.6%）出现与输注相关的不良反应。2例患者（8.3%）发生严重不良事件；其中1例为年轻女性患者，在产时发生严重CD，并发败血症，死于血管内弥散性凝血。在随访期间，我们的患者均未发生严重感染、结核病或恶性肿瘤。