乌司奴单抗治疗肛周克罗恩病瘘管的疗效：真实世界经验和系统评价及荟萃分析。
Ustekinumab is effective for perianal fistulising Crohn's disease: a real-world experience and systematic review with meta-analysis.
机构信息
Department of Gastroenterology & Hepatology, Johns Hopkins University, Baltimore, Maryland, USA.
Department of Gastroenterology, Oklahoma University Medical Center, Oklahoma City, Oklahoma, USA.
出版信息
BMJ Open Gastroenterol. 2021 Dec;8(1). doi: 10.1136/bmjgast-2021-000702.
BACKGROUND
Perianal Crohn's disease (pCD) is a debilitating complication affecting up to 30% of Crohn's disease (CD) population, leading to increased morbidity, mortality and decreased quality of life. Despite the growing armamentarium of medications for luminal CD, their efficacy in pCD remains poorly studied.
AIM
To determine the efficacy of ustekinumab, a biologic approved for luminal CD, in pCD through a retrospective cohort study and systematic review.
METHODS
A retrospective cohort study on patients with CD with active perianal fistulae treated with ustekinumab from September 2013 to August 2019 was performed to determine perianal fistula response and remission at 6 and 12 months after ustekinumab induction. A systematic review was performed to further establish rates of fistula response and remission with ustekinumab.
RESULTS
At 6 months, 48.1% (13/27) patients achieved fistula response with none achieving fistula remission on provider exam, and 59.3% (16/27) achieved patient-reported symptomatic improvement with 3.7% (1/27) achieving symptomatic remission. At 1 year, on provider exam, 55.6% (5/9) had fistula response with none achieving fistula remission, and 100% (9/9) had symptomatic improvement with 22.2% (2/9) achieving symptomatic remission. There were no major safety signals during 1-year follow-up. The systematic review of 25 studies found 44% (92/209) of patients with active perianal fistulas had a clinical response within 6 months of follow-up, and 53.9% (85/152) of patients with 12 months of follow-up achieved clinical response.
CONCLUSION
Ustekinumab presents a safe and effective therapy for treatment of pCD. Prospective, randomised trials are needed to further elucidate long-term efficacy of ustekinumab for pCD.
背景
肛周克罗恩病（pCD）是一种影响高达 30%的克罗恩病（CD）患者的致残并发症，导致发病率、死亡率增加和生活质量下降。尽管有越来越多的药物用于腔道 CD，但它们在 pCD 中的疗效仍研究不足。
目的
通过回顾性队列研究和系统评价，确定生物制剂乌司奴单抗在 pCD 中的疗效。
方法
对 2013 年 9 月至 2019 年 8 月期间接受乌司奴单抗治疗的活动性肛周瘘管 CD 患者进行回顾性队列研究，以确定乌司奴单抗诱导治疗后 6 个月和 12 个月时的肛周瘘管反应和缓解情况。还进行了系统评价，以进一步确定乌司奴单抗治疗的瘘管反应和缓解率。
结果
在 6 个月时，48.1%（27 例中的 13 例）患者达到瘘管反应，无提供者检查时达到瘘管缓解，59.3%（27 例中的 16 例）患者报告症状改善，3.7%（27 例中的 1 例）患者达到症状缓解。在 1 年时，在提供者检查时，55.6%（9 例中的 5 例）有瘘管反应，无瘘管缓解，100%（9 例中的 9 例）有症状改善，22.2%（9 例中的 2 例）达到症状缓解。在 1 年的随访期间没有出现重大安全信号。对 25 项研究的系统评价发现，在 6 个月的随访中，44%（209 例中的 92 例）活动性肛周瘘管患者有临床反应，在 12 个月的随访中，53.9%（152 例中的 85 例）患者有临床反应。
结论
乌司奴单抗是治疗 pCD 的一种安全有效的治疗方法。需要前瞻性、随机试验来进一步阐明乌司奴单抗治疗 pCD 的长期疗效。
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