Division of Pediatric Endocrinology, University of Virginia, Charlottesville, VA 22908, USA.
J Pediatr Gastroenterol Nutr. 2012 Apr;54(4):486-90. doi: 10.1097/MPG.0b013e3182382ee3.
Infliximab is used increasingly as maintenance therapy for inflammatory bowel disease (IBD); however, the effects of a single maintenance dose of infliximab are unclear with respect to the quality of life and hormones related to growth and puberty. The aim of the present study was to determine the time course of inflammatory, hormonal, and quality-of-life changes following a single dose of infliximab in the context of ongoing therapy, as related to presence of IBD symptoms at time of administration.
Children and adolescents with IBD receiving ongoing therapy with infliximab for clinical indications were recruited. The Pediatric Crohn's Disease Activity Index was determined at baseline and laboratory measures of high-sensitivity C-reactive protein (hsCRP) and hormones of growth and puberty were determined on days 0, 2, and 14. IBD-related quality of life (IMPACT III questionnaire) was tested on days 0 and 14. Subjects who had symptoms of IBD were compared with asymptomatic subjects.
Subjects overall and in the symptomatic group exhibited improved hsCRP by day 2 following treatment. Symptomatic subjects had higher Pediatric Crohn's Disease Activity Index scores and lower quality-of-life scores than asymptomatic subjects on day 0, whereas at day 14 there were no significant differences in quality-of-life scores between the 2 groups.
Even in the context of ongoing treatment, a single dose of infliximab results in decreased hsCRP, an improvement that is particularly noted among subjects who are symptomatic at the time of treatment. Although randomized trials are needed, these observational data may assist clinicians, patients, and families regarding expectations about timing and extent of these changes following a single treatment dose.
英夫利昔单抗(一种肿瘤坏死因子-α拮抗剂)越来越多地被用作炎症性肠病(IBD)的维持治疗;然而,关于单次维持剂量英夫利昔单抗对与生长和青春期相关的生活质量和激素的影响尚不清楚。本研究的目的是确定在持续治疗的情况下,单次给予英夫利昔单抗后炎症、激素和生活质量变化的时间过程,同时与治疗时 IBD 症状的存在相关。
招募正在接受英夫利昔单抗维持治疗以治疗临床指征的 IBD 儿童和青少年。在基线时测定儿科克罗恩病活动指数(PCDAI),在第 0、2 和 14 天测定高敏 C 反应蛋白(hsCRP)和生长和青春期激素的实验室指标。在第 0 和 14 天测定与 IBD 相关的生活质量(IMPACT III 问卷)。比较有 IBD 症状的受试者和无症状受试者。
总体而言,所有受试者和症状组在治疗后第 2 天 hsCRP 均得到改善。在第 0 天,有症状的受试者的 PCDAI 评分较高,生活质量评分较低,而在第 14 天,两组之间的生活质量评分无显著差异。
即使在持续治疗的情况下,单次给予英夫利昔单抗也会降低 hsCRP,这种改善在治疗时出现症状的患者中更为明显。尽管需要进行随机试验,但这些观察数据可能会帮助临床医生、患者和家属了解单次治疗剂量后这些变化的时间和程度的预期。