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英夫利昔单抗治疗小儿炎症性肠病的安全性。

Safety of infliximab treatment in pediatric patients with inflammatory bowel disease.

作者信息

Friesen Craig A, Calabro Cheryl, Christenson Kathy, Carpenter Ellen, Welchert Eleanor, Daniel James F, Haslag Sara, Roberts Charles C

机构信息

Section of Gastroenterology, The Children's Mercy Hospital and Clinics, Kansas City, Missouri 64108, USA.

出版信息

J Pediatr Gastroenterol Nutr. 2004 Sep;39(3):265-9. doi: 10.1097/00005176-200409000-00008.

DOI:10.1097/00005176-200409000-00008
PMID:15319627
Abstract

BACKGROUND

Infliximab appears to be efficacious in the treatment of pediatric Crohn disease (CD). There are few large-scale pediatric studies on the complications of infliximab therapy.

METHODS

A retrospective review of all infliximab infusions administered to IBD patients at a tertiary children's hospital was undertaken. Data was obtained from an infliximab infusion database maintained in the section of Pediatric Gastroenterology, pharmacy records and patient charts.

RESULTS

594 infusions were administered to 111 IBD patients (88 CD and 23 UC; 55 male and 56 female; ages 4 to 20 years; mean age, 13.4 years). The number of infusions ranged from 1 to 24 with a mean of 5.4/patient. Infusion reactions occurred in 8.1% of patients (seven early and two delayed) and in 1.5% of all infusions. Reactions occurred more frequently in female patients (14% versus 2%; P = 0.03). All reactions were mild and responded rapidly to treatment. Four patients had infections deemed unusual, including three cutaneous tinea infections and one case of shingles.

CONCLUSION

Infliximab is safe in pediatric IBD patients with a low incidence of generally mild reactions that respond rapidly to intervention. Infusion reactions are more common in female patients. Our patients had no serious infectious complications, although cutaneous tinea infection may represent a newly reported associated complication.

摘要

背景

英夫利昔单抗在治疗儿童克罗恩病(CD)方面似乎有效。关于英夫利昔单抗治疗并发症的大规模儿科研究较少。

方法

对一家三级儿童医院给予炎症性肠病(IBD)患者的所有英夫利昔单抗输注进行回顾性分析。数据来自儿科胃肠病学科维护的英夫利昔单抗输注数据库、药房记录和患者病历。

结果

对111例IBD患者(88例CD和23例UC;55例男性和56例女性;年龄4至20岁;平均年龄13.4岁)进行了594次输注。输注次数从1次到24次不等,平均每位患者5.4次。8.1%的患者发生了输注反应(7例早期反应和2例延迟反应),占所有输注的1.5%。女性患者反应更频繁(14%对2%;P = 0.03)。所有反应均为轻度,对治疗反应迅速。4例患者发生了被认为不寻常的感染,包括3例皮肤癣菌感染和1例带状疱疹。

结论

英夫利昔单抗在儿科IBD患者中是安全的,一般反应发生率低,对干预反应迅速。输注反应在女性患者中更常见。我们的患者没有严重的感染并发症,尽管皮肤癣菌感染可能是一种新报道的相关并发症。

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