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对于那些对英夫利昔单抗维持剂量失去应答的克罗恩病患者,缩短给药间隔至每六周一次的疗效。

The efficacy of shortening the dosing interval to once every six weeks in Crohn's patients losing response to maintenance dose of infliximab.

机构信息

Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Tel-Aviv University, Ramat-Gan, Israel.

出版信息

Aliment Pharmacol Ther. 2011 Feb;33(3):349-57. doi: 10.1111/j.1365-2036.2010.04523.x. Epub 2010 Dec 1.

Abstract

BACKGROUND

Patients treated with infliximab for Crohn's disease (CD) frequently require intensified dosage due to loss of response. There are scant data regarding the efficacy of shortening the dosing interval to 6 weeks.

AIM

We sought to investigate the efficacy of a once every 6 weeks' strategy compared with dose-doubling.

METHODS

This work was a multicentre retrospective study of infliximab-treated CD patients who required dose escalation. The clinical outcome of patients treated by intensification to 5 mg/kg/6 weeks (6-week group) was compared with the outcome of patients whose infliximab was double-dosed (10 mg/kg/8 weeks or 5 mg/kg/4 weeks).

RESULTS

Ninety-four patients (mean age: 29.8 years) were included in the study, 55 (59%) in the 6-week group and 39 (41%) in the double-dose group. Demographics and disease characteristics were similar between the two groups, although patients with re-emerging symptoms 5-7 weeks postinfusion were more likely to receive 5 mg/kg/6 weeks dosing (OR: 3.4, 95% CI: 1.4-8.8, P < 0.01). Early response to dose-intensification occurred in 69% of patients in the 6-week group and 67% in the double-dose group (P = N.S.). Regained response was maintained for 12 months in 40% compared with 29% of the patients respectively (P = N.S.).

CONCLUSION

In CD patients who lost response to standard infliximab dose, especially when symptoms re-emerge 5-7 weeks postinfusion, shortening the dosing interval to 6 weeks appears to be at least as effective as doubling the dose to 10 mg/kg or halving the infusion intervals to once in 4 weeks.

摘要

背景

接受英夫利昔单抗治疗的克罗恩病(CD)患者经常需要强化剂量,因为失去了反应。关于将给药间隔缩短至 6 周的疗效数据很少。

目的

我们旨在研究每 6 周一次的方案与剂量加倍相比的疗效。

方法

这是一项多中心回顾性研究,纳入了需要剂量升级的英夫利昔单抗治疗的 CD 患者。将强化至 5mg/kg/6 周(6 周组)的患者的临床结果与英夫利昔单抗剂量加倍的患者(10mg/kg/8 周或 5mg/kg/4 周)的结果进行比较。

结果

研究纳入了 94 例患者(平均年龄:29.8 岁),其中 55 例(59%)在 6 周组,39 例(41%)在双倍剂量组。两组患者的人口统计学和疾病特征相似,但在输注后 5-7 周出现症状复发的患者更可能接受 5mg/kg/6 周的剂量(OR:3.4,95%CI:1.4-8.8,P < 0.01)。6 周组的早期反应率为 69%,双倍剂量组为 67%(P = N.S.)。40%的患者在 12 个月时维持了应答,而双倍剂量组的患者为 29%(P = N.S.)。

结论

在对标准英夫利昔单抗剂量失去反应的 CD 患者中,特别是在输注后 5-7 周出现症状复发时,将给药间隔缩短至 6 周似乎至少与将剂量加倍至 10mg/kg 或将输注间隔减半至每 4 周一次一样有效。

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