英夫利昔单抗在激素依赖型溃疡性结肠炎患者中的疗效与安全性。

Efficacy and safety of infliximab in steroid-dependent ulcerative colitis patients.

作者信息

Gavalas Emmanuel, Kountouras Jannis, Stergiopoulos Christos, Zavos Christos, Gisakis Dimitrios, Nikolaidis Nikolaos, Giouleme Olga, Chatzopoulos Dimitrios, Kapetanakis Nikolaos

机构信息

Department of Gastroenterology, Second Medical Clinic, Ippokration Hospital Aristotle University of Thessaloniki, Greece.

出版信息

Hepatogastroenterology. 2007 Jun;54(76):1074-9.

PMID:17629042

Abstract

BACKGROUND/AIMS: Limited data exist concerning infliximab administration in steroid-dependent ulcerative colitis (UC) patients. The aim of this study was to evaluate the efficacy and safety of infliximab in steroid-dependent disease.

METHODOLOGY

Sixteen corticosteroid-dependent patients who received infusions of infliximab (5 mg/kg) at 0, 2 and 6 weeks and thereafter every 8 weeks (Group A), were compared with eight patients treated with methylprednisolone (0.8-1 mg/kg body weight) daily for three weeks followed by a tapering regimen up to the minimal dose to maintain a symptom-free condition (Group B). Steroid dependency was defined as recurrent flare-up on steroid reduction or withdrawal, or as the clinical need for steroid treatment twice within six consecutive months or three times within a year. Disease activity was assessed at recruitment, and clinical response was evaluated according to the two non-invasive indices [SEO and Simple Clinical Colitis Activity Index (SCCAI) scores].

RESULTS

In Group A, complete long-term response occurred in 68.75% and partial response in 18.75% of patients. Moreover, in the long-term follow-up, both SCCAI (10.37 +/- 2.27 vs. 3.31 +/- 2.65, p < 0.001) and SEO (209.33 +/- 13.6 vs. 123.3 +/- 34.8, p < 0.001) scores demonstrated a significant improvement. In group B, comparable features were also obtained regarding complete long-term (62.5%) and partial (25%) responses; both SCCAI (7.37 +/- 1.4 vs. 3.5 +/- 3.58, p = 0.039) and SEO (181.0 +/- 27.1 vs. 135.3 +/- 44.1, p = 0.038) scores also improved significantly. Six of eight patients in the methylprednisolone-treated group B developed Cushing-like symptoms.

CONCLUSIONS

Infliximab appears to be a good alternative therapeutic regimen in steroid-dependent UC patients associated with long-term potential toxicity.

摘要

背景/目的：关于在依赖类固醇的溃疡性结肠炎（UC）患者中使用英夫利昔单抗的数据有限。本研究的目的是评估英夫利昔单抗在依赖类固醇疾病中的疗效和安全性。

方法

16例依赖皮质类固醇的患者在第0、2和6周接受英夫利昔单抗（5mg/kg）静脉输注，此后每8周输注一次（A组），将其与8例患者进行比较，这8例患者每天接受甲泼尼龙（0.8 - 1mg/kg体重）治疗3周，随后逐渐减量至维持无症状状态的最小剂量（B组）。类固醇依赖定义为在类固醇减量或停药时复发，或在连续6个月内临床需要类固醇治疗两次或一年内需要三次。在招募时评估疾病活动度，并根据两个非侵入性指标[SEO和简单临床结肠炎活动指数（SCCAI）评分]评估临床反应。

结果

在A组中，68.75%的患者出现完全长期缓解，18.75%的患者出现部分缓解。此外，在长期随访中，SCCAI评分（10.37±2.27对3.31±2.65，p<0.001）和SEO评分（209.33±13.6对123.3±34.8，p<0.001）均显示出显著改善。在B组中，完全长期缓解（62.5%）和部分缓解（25%）也有类似情况；SCCAI评分（7.37±1.4对3.5±3.58，p = 0.039）和SEO评分（181.0±27.1对135.3±44.1，p = 0.038）也显著改善。甲泼尼龙治疗的B组8例患者中有6例出现库欣样症状。