Park Jihye, Chun Jaeyoung, Park Soo Jung, Park Jae Jun, Kim Tae Il, Yoon Hyuk, Cheon Jae Hee
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Institute of Gastroenterology, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Therap Adv Gastroenterol. 2023 Aug 23;16:17562848231191664. doi: 10.1177/17562848231191664. eCollection 2023.
Methotrexate monotherapy is recommended as a maintenance therapy for Crohn's disease (CD). However, long-term follow-up data are scarce.
We aimed to examine the effectiveness and tolerability of methotrexate monotherapy in 94 CD patients from three inflammatory bowel disease Clinics in Korea.
This was a multicenter retrospective observational study.
Patients with active CD treated with methotrexate monotherapy were included. Clinical characteristics, laboratory indicators, endoscopy indices were evaluated at baseline, 6, 12, and 24 months. Independent factors associated with long-term clinical and endoscopic outcomes were determined.
Methotrexate was administered orally (70.2%) or parenterally (29.8%). The mean methotrexate induction dose was 15.3 ± 0.4 mg/week, and the mean duration of therapy was 26.2 months. Of 76 patients who were treated for >6 months, the clinical remission rates were 76.3%, 74.6%, and 80.0% at 6, 12, and 24 months, respectively, by per-protocol analysis. The mean CRP levels were 7.5 ± 1.3, 5.3 ± 1.2, 3.8 ± 0.7, and 2.6 ± 0.5 mg/L at 0, 6, 12, and 24 months, respectively. Of 31 patients who underwent follow-up endoscopy after 27.5 months, the endoscopic remission rate was 38.7%. Baseline hemoglobin level <10 g/dL was a significant independent factor negatively associated with clinical remission at 6 [odds ratio (OR): 0.023, 95% confidence interval (CI): 0.003-0.206, = 0.001] and 12 (OR: 0.079, 95% CI: 0.009-0.699, = 0.023) months. Parenteral administration was a significant independent factor positively associated with clinical remission (OR: 11.231, 95% CI: 1.027-122.811, = 0.047) and endoscopic remission (hazard ratio: 4.711, 95% CI: 1.398-15.874, = 0.012) at 12 months.
Methotrexate monotherapy was effective and tolerable as a maintenance therapy in CD patients.
甲氨蝶呤单药疗法被推荐作为克罗恩病（CD）的维持治疗方法。然而，长期随访数据稀缺。
我们旨在研究甲氨蝶呤单药疗法对来自韩国三家炎症性肠病诊所的94例CD患者的有效性和耐受性。
这是一项多中心回顾性观察研究。
纳入接受甲氨蝶呤单药治疗的活动期CD患者。在基线、6个月、12个月和24个月时评估临床特征、实验室指标、内镜检查指标。确定与长期临床和内镜检查结果相关的独立因素。
甲氨蝶呤通过口服给药（70.2%）或胃肠外给药（29.8%）。甲氨蝶呤诱导的平均剂量为15.3±0.4mg/周，平均治疗持续时间为26.2个月。在76例治疗时间超过6个月的患者中，根据符合方案分析，在6个月、12个月和24个月时临床缓解率分别为76.3%、74.6%和80.0%。在0个月、6个月、12个月和24个月时，平均CRP水平分别为7.5±1.3、5.3±1.2、3.8±0.7和2.6±0.5mg/L。在27.5个月后接受随访内镜检查的31例患者中，内镜缓解率为38.7%。基线血红蛋白水平<10g/dL是与6个月（比值比（OR）：0.023，95%置信区间（CI）：0.003 - 0.206，P = 0.001）和12个月（OR：0.079，95%CI：0.009 - 0.699，P = 0.023）时临床缓解呈负相关的显著独立因素。胃肠外给药是与12个月时临床缓解（OR：11.231，95%CI：1.027 - 122.811，P = 0.047）和内镜缓解（风险比：4.711，95%CI：1.398 - 15.874，P = 0.012）呈正相关的显著独立因素。
甲氨蝶呤单药疗法作为CD患者的维持治疗有效且耐受性良好。
Zotero 插件