Department of Colorectal Surgery, Affiliated Hospital of Nanjing University of Chinese Medicine, 155 Hanzhong Road, Nanjing, Jiangsu, China.
Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.
BMC Gastroenterol. 2022 Jan 10;22(1):15. doi: 10.1186/s12876-021-02078-9.
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.
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.
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).
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.
近期研究证实，联合手术和抗 TNF 治疗可改善肛周瘘型克罗恩病（PFCD）患者的结局。然而，手术干预后使用英夫利昔单抗输注的最佳时机尚不确定。我们旨在确定 PFCD 患者手术后早期使用英夫利昔单抗的长期疗效。
我们对 2010 年至 2018 年在一家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将患者分为两组，<6 周为早期英夫利昔单抗诱导组，>6 周为延迟英夫利昔单抗诱导组。主要结局是比较早期和延迟英夫利昔单抗诱导组的手术再干预情况。次要结局是瘘管愈合以及与早期英夫利昔单抗诱导方法相关的这些结局的预测因素。
共纳入 117 例患者（早期英夫利昔单抗诱导组 73 例，延迟英夫利昔单抗诱导组 44 例）。早期英夫利昔单抗诱导组手术和英夫利昔单抗起始之间的中位时间间隔为 9.0（IQR 5.5-17.0）天，延迟英夫利昔单抗诱导组为 188.0（IQR 102.25-455.75）天。中位随访 36 个月后，早期英夫利昔单抗诱导组和延迟英夫利昔单抗诱导组分别有 61.6%和 65.9%的患者实现瘘管愈合（p=0.643）。早期英夫利昔单抗诱导组和延迟英夫利昔单抗诱导组的累积再干预率分别为 23%、32%和 34%、16%、25%和 25%，在 1、2 和 3 年时（p=0.235）。基线时存在脓肿（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（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。基线时存在脓肿也对瘘管愈合产生负面影响（HR=3.429，95%CI，1.216-9.668；p=0.02）。
与延迟英夫利昔单抗诱导组相比，尽管未显示出明显的益处，但手术后早期使用英夫利昔单抗可为 PFCD 患者带来有希望的结果。在输注英夫利昔单抗之前，对于伴有脓肿或需要长期英夫利昔单抗维持治疗的患者，需要进行持久的引流。
