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炎症性肠病患者输注 1 小时 10mg/kg 英夫利昔单抗的耐受性。

Tolerability of one hour 10 mg/kg infliximab infusions in patients with inflammatory bowel disease.

机构信息

Inserm, U954 and Department of Hepato-Gastroenterology, University Hospital of Nancy, Université Henri Poincaré 1, Vandoeuvre-lès-Nancy, France.

出版信息

J Crohns Colitis. 2013 Mar;7(2):129-33. doi: 10.1016/j.crohns.2012.03.007. Epub 2012 Apr 1.

DOI:10.1016/j.crohns.2012.03.007
PMID:22472090
Abstract

BACKGROUND AND AIM

In patients with inflammatory bowel disease (IBD) tolerating 2-h infusions of 5mg/kg infliximab scheduled maintenance therapy, the infusion time can be shortened to 1-h with good tolerability. The tolerability of one 1-hour 10 mg/kg infliximab infusion in patients with IBD is unknown.

METHODS

Between August and September 2011, 8 patients received one 1-hour 10mg/kg infliximab infusion. All patients were treated in our infusion unit under standard operating procedures. Intravenous steroid premedication was given to all patients. These 8 patients were compared to 26 IBD patients who received one 1-hour 5mg/kg infliximab infusion during the same study period at Nancy University Hospital. The charts of these 34 patients were reviewed to assess tolerability of 1-hour infliximab infusions.

RESULTS

A total of 34 patients with IBD on infliximab maintenance therapy (82.4% Crohn's disease, 17.6% ulcerative colitis; 22 females) received one 1-hour 5 or 10mg/kg infusion. Four patients were receiving concomitant immunomodulators. No severe infusions reactions were reported in the 34 IBD patients. Two mild acute reactions (7.7%) and two delayed reactions (7.7%) occurred in the 5mg/kg infliximab group. We did not observe any acute or delayed infliximab reactions in the 10mg/kg patients group.

CONCLUSIONS

In patients with inflammatory bowel disease receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab appears to be well tolerated. Large prospective studies are needed to confirm our findings.

摘要

背景与目的

在能够耐受 5mg/kg 英夫利昔单抗 2 小时输注的炎症性肠病(IBD)患者中,将输注时间缩短至 1 小时可保持良好的耐受性。但对于 IBD 患者,单次 1 小时 10mg/kg 英夫利昔单抗输注的耐受性尚不清楚。

方法

2011 年 8 月至 9 月,8 例患者接受单次 1 小时 10mg/kg 英夫利昔单抗输注。所有患者均按照标准操作规程在我们的输液单元中接受治疗。所有患者均给予静脉用类固醇预治疗。将这 8 例患者与同期在南锡大学医院接受单次 1 小时 5mg/kg 英夫利昔单抗输注的 26 例 IBD 患者进行比较。回顾这些 34 例患者的病历,以评估 1 小时英夫利昔单抗输注的耐受性。

结果

共有 34 例接受英夫利昔单抗维持治疗的 IBD 患者(82.4%克罗恩病,17.6%溃疡性结肠炎;22 例女性)接受单次 1 小时 5 或 10mg/kg 输注。4 例患者同时接受免疫调节剂治疗。34 例 IBD 患者中未报告严重输注反应。在接受 5mg/kg 英夫利昔单抗的患者中,发生 2 例轻度急性反应(7.7%)和 2 例迟发性反应(7.7%)。在接受 10mg/kg 英夫利昔单抗的患者中,未观察到任何急性或迟发性英夫利昔单抗反应。

结论

在接受英夫利昔单抗维持治疗的炎症性肠病患者中,1 小时输注时间的 10mg/kg 英夫利昔单抗似乎具有良好的耐受性。需要进行大型前瞻性研究来证实我们的发现。

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引用本文的文献

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Accelerated Infliximab Infusion: Safety, Factors Predicting Adverse Events, Patients' Satisfaction and Cost Analysis. A Cohort Study in IBD Patients.英夫利昔单抗加速输注:安全性、不良事件预测因素、患者满意度及成本分析。一项针对炎症性肠病患者的队列研究。
PLoS One. 2016 Nov 16;11(11):e0166443. doi: 10.1371/journal.pone.0166443. eCollection 2016.
2
The Tolerability and Efficacy of Rapid Infliximab Infusions in Patients with Inflammatory Bowel Disease.英夫利昔单抗快速输注对炎症性肠病患者的耐受性和疗效
Dig Dis Sci. 2016 Feb;61(2):589-96. doi: 10.1007/s10620-015-3893-4. Epub 2015 Oct 6.