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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:一项前瞻性多中心队列研究。

Tolerability of one hour 10mg/kg infliximab infusions in inflammatory bowel diseases: a prospective multicenter cohort study.

机构信息

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

Departemental of Hepato-Gastroenterology, University Hospital of Saint Etienne, France.

出版信息

J Crohns Colitis. 2014 Feb;8(2):161-5. doi: 10.1016/j.crohns.2013.08.004. Epub 2013 Aug 30.

DOI:10.1016/j.crohns.2013.08.004
PMID:23994253
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. A retrospective study with small sample size demonstrated the feasibility of 1-hour infusion time for 10mg/kg infliximab in IBD patients.

METHODS

Between November 2011 and July 2012, 63 patients received 1-hour 10mg/kg infliximab infusions under standard operating procedures and were enrolled in a prospective observational study. Intravenous steroid premedication was given to all patients.

RESULTS

Sixty-three IBD patients on infliximab maintenance therapy (43 Crohn's disease, 34 males) received 1-hour 10mg/kg infusions during the study period. A total of 182 infliximab infusions were administered. Seventeen (26%) patients were receiving concomitant immunomodulators. Two patients experienced (2/182, 1%) severe acute infusion reactions consisting on a cutaneous lupus and one severe anaphylactic reaction. We also observed one (1/182, 0.5%) severe delayed reaction after the first 1-hour infliximab infusion consisting on acne generalis. All 3 reactions led to infliximab discontinuation. No mild acute reactions and 6 mild delayed reactions (6/182, 3%) occurred.

CONCLUSIONS

In patients with IBD receiving infliximab scheduled maintenance therapy, 1-hour infusion time for 10mg/kg infliximab seems to be well tolerated. This option might be considered in clinical practice in order to decrease the extra-burden of infliximab infusions in this patient population.

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,可将输注时间缩短至 1 小时,且具有良好的耐受性。一项小样本量的回顾性研究表明,IBD 患者使用 10mg/kg 英夫利昔单抗进行 1 小时输注是可行的。

方法

2011 年 11 月至 2012 年 7 月,63 例患者根据标准操作规程接受了 1 小时 10mg/kg 英夫利昔单抗输注,并纳入了一项前瞻性观察性研究。所有患者均给予静脉类固醇预治疗。

结果

63 例 IBD 患者(43 例克罗恩病,34 例男性)在研究期间接受了英夫利昔单抗维持治疗 1 小时 10mg/kg 输注。共输注英夫利昔单抗 182 次。17 例(26%)患者同时接受免疫调节剂治疗。2 例(2/182,2%)患者发生严重急性输注反应,包括皮肤狼疮和 1 例严重过敏反应。我们还观察到首次 1 小时英夫利昔单抗输注后 1 例(1/182,0.5%)严重迟发性反应,表现为全身痤疮。所有 3 例反应均导致英夫利昔单抗停药。发生轻度急性反应 6 例(6/182,3%),无迟发性反应。

结论

在接受英夫利昔单抗维持治疗的 IBD 患者中,10mg/kg 英夫利昔单抗 1 小时输注时间似乎具有良好的耐受性。在这种患者人群中,为了减少英夫利昔单抗输注的额外负担,该方案可能在临床实践中得到考虑。

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