英夫利昔单抗:对难治性克罗恩病和重度克罗恩病自上而下诱导治疗的益处

Jee Hyun Lee, H. Lee, Sung Eun Park, Y. Choe
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引用次数: 2

摘要

目的:本研究的目的是报道英夫利昔单抗的疗效,英夫利昔单抗是一种针对肿瘤坏死因子α的单克隆抗体,用于治疗难治性儿童克罗恩病(CD)和诱导缓解。方法:在2001年3月至2007年8月期间在三星医疗中心诊断为CD的儿童患者中,共有16例患者给予英夫利昔单抗治疗常规治疗难治性CD和严重活动性CD以诱导缓解。需要维持治疗的患者每8周输注一次英夫利昔单抗,出现瘘管的CD患者偶尔也会输注一次。采用配对t检验,通过比较儿童克罗恩病活动性指数(PCDAI)、Hct、ESR、CRP和血清白蛋白水平来评估治疗效果。结果:男女比例为13:3,中位年龄为13岁(范围21个月~ 15岁)。其中耐药难治性CD 7例,重度活动性CD 7例,瘘管性CD 2例。英夫利昔单抗治疗前PCDAI均值为34.19±14.96,末次输注后2 ~ 4周随访PCDAI均值为6.88±10.31,差异有统计学意义(p= 0.000)。血液学指标如ESR (p=0.000)、血清白蛋白(p=0.016)和CRP (p=0.009)也显著改善。4例难治性常规治疗患者中2例缓解。在3例类固醇依赖患者中,2例能够停止类固醇治疗,1例可以减少剂量。所有7例严重CD患者在未使用其他免疫调节剂的情况下,经自上而下治疗后,在6周内达到缓解。10例难治性瘘管性CD患者中有9例在英夫利昔单抗治疗后也出现改善。结论:英夫利昔单抗在儿童难治性乳糜泻诱导缓解和维持治疗中有效,在重度乳糜泻诱导治疗中也有效。此外,英夫利昔单抗有助于类固醇停止和剂量减少。未来需要长期随访评价来确定英夫利昔单抗的安全性和有效性。韩国儿科胃肠病学杂志2008;11: 28日∼35)
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Infliximab: The Benefit for Refractory Crohn Disease andTop-down Induction Therapy in Severe Crohn Disease
Purpose: The aim of this study is to report the efficacy of infliximab, a monoclonal antibody directed against tumor necrosis factor alpha which is used for both treatment of refractory pediatric Crohn disease (CD) and induction of remission. Methods: Among pediatric patients who were diagnosed with CD at Samsung Medical Center between March 2001 and August 2007, a total of 16 patients were given infliximab to treat conventional therapyresistant refractory CD and severe active CD for induction of remission. Patients needing maintenance therapy were treated with an infliximab infusion every 8 weeks, and fistulizing CD patients occasionally received the infusion upon the condition that a fistula developed. The efficacy of treatment was assessed by comparing the Pediatric Crohn Disease Activity Index (PCDAI), Hct, ESR, CRP, and serum albumin levels using paired t-test. Results: The male/female ratio was 13:3, and the median age was 13 years (range, 21 months∼15 years). The patients included 7 cases of therapy-resistant refractory CD, 7 cases of severe active CD, and 2 cases of fistulizing CD. Mean PCDAI before infliximab therapy was 34.19±14.96, and mean follow-up PCDAI within 2 to 4 weeks after the last infusion was significantly lower, at 6.88±10.31 (p= 0.000). Hematological markers such as ESR (p=0.000), serum albumin (p=0.016), and CRP (p=0.009) also improved significantly after infusion. Remission was achieved in 2 of 4 patients refractory to conventional therapy. Among 3 steroid-dependent patients, 2 were able to discontinue steroid therapy, and dose reduction was possible in 1 patient. Remission after top-down therapy without prior use of other immunomodulators was achieved in 6 weeks in all 7 of the patients who had severe CD. Nine of ten refractory fistulizing CD patients also showed improvement after infliximab therapy. Conclusion: Infliximab was effective in pediatric refractory CD for induction of remission and maintenance therapy, as well as in severe CD for top-down induction therapy. Furthermore, infliximab has contributed to steroid cessation and dose reduction. Long-term follow-up evaluation is needed to determine safety and efficacy of infliximab in the future. (Korean J Pediatr Gastroenterol Nutr 2008; 11: 28∼35)
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