真实世界中抗肿瘤坏死因子治疗克罗恩病内瘘的经验：一项回顾性多中心队列研究。
Real-world Experience of Anti-tumor Necrosis Factor Therapy for Internal Fistulas in Crohn's Disease: A Retrospective Multicenter Cohort Study.
机构信息
1Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan; 2Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan; 3IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan; 4Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; 5Department of Medicine, Shiga University of Medical Science, Shiga, Japan; 6Department of Internal Medicine, Sakura Medical Center, Toho University, Chiba, Japan; 7Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan; 8Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan; 9Department of Inflammatory Bowel Disease, Division of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan; 10Center for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital, Kamakura, Japan; 11Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 12Circulatory and Body Fluid Regulation, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan; 13Department of Gastroenterology Osaka City University Graduate School of Medicine, Osaka, Japan; 14Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan; 15Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan; 16Department of Gastroenterology and Hepatology, Mie University Graduate School of Medicine, Mie, Japan; 17Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan; 18Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan; 19Department of Gastroenterology, Kagawa Prefectural Central Hospital, Kagawa, Japan; 20Department of Gastroenterology and Hepatology, Gunma University, Gunma, Japan; and 21Division of Inflammatory Bowel Disease, Digestive Disease Center, Kitano Hospital, Osaka, Japan.
出版信息
Inflamm Bowel Dis. 2017 Dec;23(12):2245-2251. doi: 10.1097/MIB.0000000000001276.
BACKGROUND
Internal fistula in Crohn's disease is a condition likely to require surgery, although few reports showed successful medical treatments such as anti-tumor necrosis factor (TNF) therapy. We performed a multicenter retrospective cohort study to investigate the outcome of anti-TNF therapy for internal fistula in Crohn's disease.
METHODS
Data were retrospectively collected from patients with Crohn's disease diagnosed with internal fistula treated with anti-TNF agents (infliximab or adalimumab) between January 2002 and November 2015. Need for surgery and fistula closure were assessed as primary and secondary endpoints. Cumulative rate of surgery was evaluated by the Kaplan-Meier analysis. Prognostic factors for the outcomes were also assessed by univariate and multivariate analyses.
RESULTS
A total of 93 Crohn's disease cases were included in the study with a mean follow-up period of 1452.8 days. Fistula locations were entero-entero/colonic (n = 72, 77.4%), enterovesical (n = 16, 17.2%), or enterovaginal (n = 5, 5.4%). Cumulative surgery rate was 47.2%, and fistula closure rate was 27.0% at 5 years from the induction of anti-TNF agents. Lower Crohn's Disease Activity Index and shorter duration from the diagnosis of fistula were independently associated with the lower risk of surgery (P = 0.017 and 0.048, respectively). Single fistula was associated with the successful fistula closure. Second-line surgical treatments were mostly successful for anti-TNF failures.
CONCLUSIONS
In the present retrospective cohort study, approximately half of patients with internal fistulas avoided surgery for long periods. It may be reasonable to treat quiescent single internal fistulas with anti-TNF agents soon after the diagnosis of internal fistulas.
背景
克罗恩病的内瘘很可能需要手术治疗，尽管很少有报道显示抗肿瘤坏死因子（TNF）治疗有效。我们进行了一项多中心回顾性队列研究，以调查抗 TNF 治疗克罗恩病内瘘的结果。
方法
我们回顾性地收集了 2002 年 1 月至 2015 年 11 月期间接受抗 TNF 药物（英夫利昔单抗或阿达木单抗）治疗的克罗恩病患者的资料，这些患者诊断为患有内瘘。手术和瘘管闭合的需要被评估为主要和次要终点。手术累积率通过 Kaplan-Meier 分析进行评估。通过单因素和多因素分析评估结局的预测因素。
结果
本研究共纳入 93 例克罗恩病患者，平均随访时间为 1452.8 天。瘘管位置为肠-肠/结肠（n = 72，77.4%）、肠-膀胱（n = 16，17.2%）或肠-阴道（n = 5，5.4%）。从使用抗 TNF 药物开始的 5 年内，累积手术率为 47.2%，瘘管闭合率为 27.0%。较低的克罗恩病活动指数和较短的瘘管诊断时间与较低的手术风险独立相关（P = 0.017 和 0.048）。单瘘管与瘘管成功闭合相关。二线手术治疗对抗 TNF 失败的患者大多有效。
结论
在本回顾性队列研究中，约一半的内瘘患者在很长一段时间内避免了手术。对于刚诊断为内瘘的静止性单发内瘘，使用抗 TNF 药物治疗可能是合理的。
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