Lee Yoo Min, Kang Ben, Lee Yoon, Kim Mi Jin, Choe Yon Ho
*Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine †Department of Pediatrics, Korea University Anam Hospital, Korea University College of Medicine, Seoul ‡Department of Pediatrics, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea.
J Pediatr Gastroenterol Nutr. 2015 Jun;60(6):737-43. doi: 10.1097/MPG.0000000000000711.
We aimed to compare the efficacy of remission maintenance between infliximab "top-down" and "step-up" strategies in moderate to severe pediatric Crohn disease during 3 years. We also aimed to determine prognostic factors that may influence the relapse-free rate in these patients.
The present study was a retrospective review of a prospective cohort, based on an infliximab treatment protocol for pediatric Crohn disease used at Samsung Medical Center. A total of 31 patients (group A) were treated with early infliximab induction ("top-down" strategy) and 20 patients (group B) refractory to conventional therapy underwent infliximab treatment ("step-up" strategy). The efficacy of infliximab treatment was assessed by relapse-free rate and remission period rate for 3 years. A total of 11 prognostic factors that may influence the relapse-free rate were further analyzed.
The relapse-free rates at 3 years were 35.5% (95% confidence interval [CI] 0.194-0.519) in group A and 15.0% (95% CI 0.037-0.335) in group B (P = 0.0094). Overall remission period rate for 3 years also showed a significant difference between the 2 groups (92.1% ± 7.2% vs 78.3% ± 16.6%; P = 0.005). Multivariable analysis revealed that the duration from the initial diagnosis to infliximab infusion was the only factor associated with relapse-free remission for 3 years (hazard ratio = 1.077; 95% CI 1.025-1.131).
"Top-down" strategy had a longer remission period compared with the "step-up" strategy in pediatric Crohn disease during a study period of 3 years, based on relapse-free rate and remission period rate. Earlier introduction of infliximab is recommended in pediatric patients with moderate to severe Crohn disease.
我们旨在比较英夫利昔单抗“自上而下”和“逐步升级”策略在3年期间对中度至重度小儿克罗恩病缓解维持的疗效。我们还旨在确定可能影响这些患者无复发率的预后因素。
本研究是一项基于三星医疗中心使用的小儿克罗恩病英夫利昔单抗治疗方案的前瞻性队列回顾性研究。共有31例患者（A组）接受早期英夫利昔单抗诱导治疗（“自上而下”策略），20例对传统治疗无效的患者接受英夫利昔单抗治疗（“逐步升级”策略）。通过3年的无复发率和缓解期率评估英夫利昔单抗治疗的疗效。进一步分析了总共11个可能影响无复发率的预后因素。
A组3年无复发率为35.5%（95%置信区间[CI]0.194 - 0.519），B组为15.0%（95%CI 0.037 - 0.335）（P = 0.0094）。两组3年总体缓解期率也有显著差异（92.1% ± 7.2%对78.3% ± 16.6%；P = 0.005）。多变量分析显示，从初始诊断到英夫利昔单抗输注的时间是与3年无复发缓解相关的唯一因素（风险比 = 1.077；95%CI 1.025 - 1.131）。
基于无复发率和缓解期率，在3年的研究期内，小儿克罗恩病中“自上而下”策略的缓解期比“逐步升级”策略更长。建议对中度至重度克罗恩病小儿患者更早引入英夫利昔单抗。
