英夫利昔单抗治疗炎症性肠病的安全性和有效性：临床实践。

Safety and effectiveness of infliximab for inflammatory bowel diseases in clinical practice.

机构信息

Division of Gastroenterology, "Michele Sarcone" Hospital, Terlizzi, Bari, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2010 Jan;14(1):47-55.

PMID:20184089

Abstract

BACKGROUND AND OBJECTIVES

Our aim was to assess the efficacy and safety of infliximab (IFX) in clinical practice in three Primary Care, Hospital Centers.

MATERIAL AND METHODS

From September 2004 to December 2008 62 patients (28 males, 34 females, mean age 30.25 years, range 15-55 years), affected by ulcerative colitis (UC) (23 pts) or by Crohn's disease (CD) (39 patients) were treated. Clinical efficacy, safety, mucosal healing and quality of life were assessed both in UC and CD.

RESULTS

A total of 746 infusions were performed. IFX was administered for a mean of 26 months (range 8-44 months). 33/39 (84.61%) pts with CD were in remission under treatment with IFX for a mean time of 19 months (range 12-44 months). Mean Crohn Disease Activity Index (CDAI) score decreased from 295 (range 258-346) to 136 (range 98-136) (p < 0.005). Inflammatory Bowel Disease Quality of Life (IBDQL) improved from 48 (at entry) to 198 (at the end of the study) (p < 0.005). 20/23 (86.95%) patients with UC were in remission under treatment with IFX for a mean of 18 months (range 8-34 months). Mean Disease Activity Index (DAI) decreased from 11 (range 9-12) to < 3 (range 2-3) (p < 0.05). Mean Mayo Subscore for Endoscopy decreased from 3 to < 1 (range 0-1). IBDQL improved from 56 (at entry) to 194 (at the end of the study) (p < 0.005). Only 5 patients (8.06%) experienced side-effects.

CONCLUSIONS

Long-term outpatients treatment with IFX seems to be safe and effective in managing patients affected by IBD in clinical practice.

摘要

背景与目的

我们旨在评估英夫利昔单抗（IFX）在三个基层医疗、医院中心的临床实践中的疗效和安全性。

材料与方法

从 2004 年 9 月至 2008 年 12 月，共 62 名患者（28 名男性，34 名女性，平均年龄 30.25 岁，范围 15-55 岁），患有溃疡性结肠炎（UC）（23 例）或克罗恩病（CD）（39 例）接受治疗。在 UC 和 CD 中，评估了临床疗效、安全性、黏膜愈合和生活质量。

结果

共进行了 746 次输注。IFX 的治疗平均时间为 26 个月（范围 8-44 个月）。39 例 CD 患者中有 33 例（84.61%）在接受 IFX 治疗后平均 19 个月（范围 12-44 个月）缓解。克罗恩病活动指数（CDAI）评分从 295（范围 258-346）降至 136（范围 98-136）（p < 0.005）。炎症性肠病生活质量（IBDQL）从 48（入组时）提高至 198（研究结束时）（p < 0.005）。23 例 UC 患者中有 20 例（86.95%）在接受 IFX 治疗后平均 18 个月（范围 8-34 个月）缓解。疾病活动指数（DAI）从 11（范围 9-12）降至 < 3（范围 2-3）（p < 0.05）。内镜下 Mayo 亚评分从 3 降至 < 1（范围 0-1）。IBDQL 从 56（入组时）提高至 194（研究结束时）（p < 0.005）。仅有 5 名患者（8.06%）出现不良反应。