背景:最近的研究证实,联合手术和抗TNF治疗可以改善肛周瘘克罗恩病(PFCD)患者的预后。然而,手术干预后输注英夫利昔单抗的最佳时机尚不确定.我们旨在确定PFCD患者术后早期开始英夫利昔单抗的长期疗效。
方法:我们对2010年至2018年在三级转诊医院接受英夫利昔单抗联合手术治疗的PFCD患者进行了一项回顾性队列研究。根据手术和英夫利昔单抗输注之间的时间间隔对患者进行分组,早期英夫利昔单抗诱导组<6周,延迟英夫利昔单抗诱导组>6周。主要结果是比较早期和延迟英夫利昔单抗诱导组之间的手术再干预。次要结果是瘘管愈合和与早期英夫利昔单抗诱导方法的这些结果相关的预测因素。
结果:纳入了117例患者(73例早期英夫利昔单抗诱导,44在延迟英夫利昔单抗诱导中)。早期英夫利昔单抗诱导组手术和英夫利昔单抗开始之间的中位间隔为9.0(IQR5.5-17.0)天,延迟英夫利昔单抗诱导组为188.0(IQR102.25-455.75)天。随访中位数为36个月后,早期英夫利昔单抗诱导组中61.6%的患者和延迟英夫利昔单抗诱导组中65.9%的患者获得瘘管愈合(p=0.643)。累计再干预率为23%,32%,早期英夫利昔单抗诱导组为34%,16%,25%,延迟英夫利昔单抗诱导组25%,分别在1年,2年和3年(p=0.235)。基线存在脓肿(HR=5.283;95%CI,1.61-17.335;p=0.006)和英夫利昔单抗维持治疗>3次输注(HR=3.691;95%CI,1.233-11.051;p=0.02)与早期英夫利昔单抗诱导组的再干预相关。基线时脓肿的存在也会对瘘管愈合产生负面影响(HR=3.429,95%CI,1.216-9.668;p=0.02)。
结论:尽管与延迟英夫利昔单抗诱导组相比没有明显的益处,PFCD患者在手术后早期开始使用英夫利昔单抗可以取得有希望的结果.输注英夫利昔单抗前,合并脓肿或长期英夫利昔单抗维持治疗的患者需要持久引流.
BACKGROUND: Recent studies have confirmed that combined surgery and anti-TNF therapy could improve outcomes in patients with
perianal fistulising Crohn\'s disease (PFCD). However, the optimal timing for infliximab infusion after surgical intervention is uncertain. We aimed to determine the long-term efficacy of early initiation of infliximab following surgery among PFCD patients.
METHODS: We performed a retrospective cohort study of PFCD patients who received combined infliximab and surgical treatment between 2010 and 2018 at a tertiary referral hospital. Patients were grouped according to the time interval between surgery and infliximab infusion, with < 6 weeks into early infliximab induction group and > 6 weeks into delayed infliximab induction group. The primary outcome was to compare surgical re-intervention between early and delayed infliximab induction groups. The secondary outcomes were fistula healing and predictors associated with these outcomes of early infliximab induction approach.
RESULTS: One hundred and seventeen patients were included (73 in early infliximab induction, 44 in delayed infliximab induction). The median interval between surgery and infliximab initiation was 9.0 (IQR 5.5-17.0) days in early infliximab induction group and 188.0 (IQR 102.25-455.75) days in delayed infliximab induction group. After followed-up for a median of 36 months, 61.6% of patients in early infliximab induction group and 65.9% in delayed infliximab induction group attained fistula healing (p = 0.643). The cumulative re-intervention rate was 23%, 32%, 34% in early infliximab induction group and 16%, 25%, 25% in delayed infliximab induction group, at 1, 2, and 3 years respectively (p = 0.235). Presence of abscess at baseline (HR = 5.283; 95% CI, 1.61-17.335; p = 0.006) and infliximab maintenance therapy > 3 infusions (HR = 3.691; 95% CI, 1.233-11.051; p = 0.02) were associated with re-intervention in early infliximab induction group. Presence of abscess at baseline also negatively influenced fistula healing (HR = 3.429, 95% CI, 1.216-9.668; p = 0.02).
CONCLUSIONS: Although no clear benefit was shown compared with delayed infliximab induction group, early initiation of infliximab after surgery could achieve promising results for PFCD patients. Before infliximab infusion, durable drainage is required for patients with concomitant abscess or prolonged infliximab maintenance therapy.