Maiden Laurence, Takeuchi Ken, Baur Rosie, Bjarnason Ingi, O'Donohue John, Forgacs Ian, Chung-Faye Guy, Sanderson Jeremy, Bjarnason Ingvar
Guy's, King's and St Thomas' Medical School, London, UK.
Inflamm Bowel Dis. 2008 Oct;14(10):1413-8. doi: 10.1002/ibd.20505.
We assessed whether selective granulocyte and monocyte/macrophage adsorption apheresis maintained clinical remission in asymptomatic inflammatory bowel disease (IBD) patients at significant risk of clinical relapse.
Sixty asymptomatic patients (age 18-70 years) with IBD (in clinical remission) with fecal calprotectin over 250 microg/g (which defines those at risk of clinical relapse with >80% specificity and sensitivity) were recruited for this open-label, prospective, randomized, controlled study. Twenty-nine underwent selective leukocytapheresis, undergoing 5, once weekly, out-patient sessions. Thirty-one had unchanged maintenance treatment and acted as controls. Follow-up for a clinical relapse was 6 months. The secondary outcome variable was the time to relapse.
The number of patients who remained in clinical remission at 6 months was significantly lower in controls (32.3%) than in the apheresis (72.4%) group (P = 0.0023, Fisher's exact test). The time to first relapse was significantly earlier in the control group (99 +/- 73 days) as compared with the apheresis group (161 +/- 44 days) (log-rank test; P = 0.0004). Mild and transient headache was reported by 16 of the 29 (55%) for up to 3 hours, but no serious side effects were observed.
This study represents a new approach to the treatment of IBD by targeting a group of asymptomatic patients for treatment who are at significant risk of relapse based on high fecal calprotectin concentrations. Selective leukocytapheresis significantly reduced the number of, and increased the time to, clinical relapse in these patients without serious side effects.
我们评估了选择性粒细胞和单核细胞/巨噬细胞吸附性血液成分分离术能否维持有显著临床复发风险的无症状炎症性肠病（IBD）患者的临床缓解状态。
招募了60名年龄在18至70岁之间、患有IBD（处于临床缓解期）且粪便钙卫蛋白超过250微克/克（这确定了那些临床复发风险特异性和敏感性>80%的患者）的无症状患者，进行这项开放标签、前瞻性、随机对照研究。29名患者接受选择性白细胞去除术，每周一次，门诊进行5次治疗。31名患者维持原治疗方案作为对照。临床复发的随访期为6个月。次要结局变量是复发时间。
6个月时仍处于临床缓解的患者数量，对照组（32.3%）显著低于血液成分分离术组（72.4%）（P = 0.0023，Fisher精确检验）。与血液成分分离术组（161±44天）相比，对照组首次复发的时间显著更早（99±73天）（对数秩检验；P = 0.0004）。29名患者中有16名（55%）报告出现轻度短暂头痛，持续长达3小时，但未观察到严重副作用。
本研究代表了一种治疗IBD的新方法，即针对一组基于高粪便钙卫蛋白浓度而有显著复发风险的无症状患者进行治疗。选择性白细胞去除术显著减少了这些患者的临床复发数量，并延长了复发时间，且无严重副作用。
