Jeroen Geldof, Marie Truyens, Michiel Hanssens, Emily Van Gucht, Tom Holvoet, Ainara Elorza, Vincent Bouillon, Sónia Barros, Viviana Martins, Konstantinos Argyriou, Spyridon Potamianos, Mircea Diculescu, Tudor Stroie, Peter Bossuyt, Annick Moens, Eirini Theodoraki, Ioannis E Koutroubakis, Juliana Pedro, Samuel Fernandes, Pinelopi Nikolaou, Konstantinos Karmiris, Filip J Baert, Rocio Ferreiro-Iglesias, Harald Peeters, Sophie Claeys, Maria José Casanova, Piotr Eder, Ross J Porter, Ian Arnott, Tarkan Karakan, Francisco Mesonero, Joana Revés, Evi Van Dyck, Aranzazu Jauregui-Amezaga, Míriam Mañosa, Pauline Rivière, Lucia Marquez Mosquera, Francisco Portela, Raquel Pimentel, Triana Lobaton
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引用次数: 0
Abstract
Background and aims: No consensus exists on optimal strategy to prevent postoperative recurrence [POR] after ileocaecal resection [ICR] for Crohn's disease [CD]. We compared early medical prophylaxis versus expectant management with treatment driven by findings at elective endoscopy 6-12 months after ICR.
Methods: A retrospective, multicentric, observational study was performed. CD patients undergoing first ICR were assigned to Cohort 1 if a biologic or immunomodulator was [re]started prophylactically after ICR, or to Cohort 2 if no postoperative prophylaxis was given and treatment was started as reaction to elective endoscopic findings. Primary endpoint was rate of endoscopic POR [Rutgeerts >i1]. Secondary endpoints were severe endoscopic POR [Rutgeerts i3/i4], clinical POR, surgical POR, and treatment burden during follow-up.
Results: Of 346 included patients, 47.4% received prophylactic postoperative treatment [proactive/Cohort 1] and 52.6% did not [reactive/Cohort 2]. Endoscopic POR [Rutgeerts >i1] rate was significantly higher in Cohort 2 [41.5% vs 53.8%, OR 1.81, p = 0.039] at endoscopy 6-12 months after surgery. No significant difference in severe endoscopic POR was found [OR 1.29, p = 0.517]. Cohort 2 had significantly higher clinical POR rates [17.7% vs 35.7%, OR 3.05, p = 0.002] and numerically higher surgical recurrence rates [6.7% vs 13.2%, OR 2.59, p = 0.051]. Cox proportional hazards regression analysis showed no significant difference in time to surgical POR of proactive versus expectant/reactive approach [HR 2.50, p = 0.057]. Quasi-Poisson regression revealed a significantly lower treatment burden for immunomodulator use in Cohort 2 [mean ratio 0.53, p = 0.002], but no difference in burden of biologics or combination treatment.
Conclusions: The PORCSE study showed lower rates of endoscopic POR with early postoperative medical treatment compared with expectant management after first ileocaecal resection for Crohn's disease.
背景和目的：我们比较了早期药物预防与预期管理，并根据回盲部切除术（ICR）后 6-12 个月的择期内镜检查结果进行治疗：我们进行了一项多中心回顾性观察研究。如果首次接受ICR的CD患者在ICR后预防性地（重新）开始使用生物制剂或免疫调节剂，则被归入队列1；如果术后未进行预防性治疗，而是根据择期内镜检查结果开始治疗，则被归入队列2。主要终点是内镜下 POR 的发生率（Rutgeerts>i1）。次要终点是严重内镜下 POR（Rutgeerts i3/i4）、临床 POR、手术 POR 和随访期间的治疗负担：346名纳入患者中，47.4%接受了术后预防性治疗（proactive/cohort1），52.6%未接受治疗（reactive/cohort2）。术后6-12个月进行内镜检查时，内镜下POR（Rutgeerts>i1）发生率在cohort2中明显更高（41.5% vs 53.8%，OR1.81，P=0.039）。严重内镜POR无明显差异（OR1.29，P=0.517）。队列2的临床POR率明显更高（17.7% vs 35.7%，OR3.05，P=0.002），手术复发率也明显更高（6.7% vs 13.2%，OR2.59，P=0.051）。Cox比例危险回归分析显示，主动与期待/主动方法的手术POR时间无显著差异（HR2.50，P=0.057）。准泊松回归显示，队列2中使用免疫调节剂的治疗负担明显较低（平均比值为0.53，P=0.002），但使用生物制剂或联合治疗的负担没有差异：PORCSE研究显示，与克罗恩病首次回盲部切除术后的预期治疗相比，术后早期药物治疗的内镜下POR发生率更低。
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