Methotrexate for Refractory Crohn's Disease Compared with Thiopurines: A Retrospective Non-head-to-head Controlled Study
Methotrexate for Refractory Crohn's Disease Compared with Thiopurines: A Retrospective Non-head-to-head Controlled Study
复制标题
甲氨蝶呤与硫嘌呤治疗难治性克罗恩病：一项回顾性非头对头对照研究
DOI：
10.1097/mib.0000000000001022
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发表时间：
2017-03-01
影响因子：
4.9
通讯作者：
Gao, Xiang
中科院分区：
文献类型：
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作者：
Huang, Zicheng;Chao, Kang;Gao, Xiang
背景：本研究评估了甲氨蝶呤（MTX）与硫嘌呤（TPs）治疗难治性克罗恩病的疗效和安全性。方法：回顾性分析连续51例TPs难治性或不耐受性及类固醇依赖的患者。采用MTX （20mg /周，皮下）诱导和维持临床缓解（CR）。57例首次使用免疫抑制剂和处方硫唑嘌呤（2 mg·kg−1·d−1）或巯基嘌呤（1 mg·kg−1·d−1）的患者同时被招募。结果：第16周时，MTX组和TPs组的CR率分别为68.6%和78.9% （P = 0.222）。病程≥3年的患者使用MTX更有可能达到CR（优势比= 7.667,P = 0.019）。到第64周，MTX组和TPs组患者在第16周达到缓解的CR率分别为45.7%和44.4% （P = 0.910）。第16周时高敏c反应蛋白水平（相对风险= 11.221,P = 0.003）和血小板计数（相对风险= 9.672,P = 0.004）的正常化预测MTX维持缓解的有效性。在第16周缓解的患者中，第36周MTX组粘膜愈合率为47.4%，TPs组为47.1% （P≈1.000）。MTX组15例（29.4%），TPs组25例（43.9%）出现不良事件（P = 0.121）。结论：MTX可有效诱导和维持难治性克罗恩病患者的CR并实现粘膜愈合，其疗效与TPs对初治患者的疗效相当。甲氨蝶呤的副作用是轻微和可耐受的。
Background: This study assessed the efficacy and safety of methotrexate (MTX) compared with thiopurines (TPs) for refractory Crohn's disease. Methods: Fifty-one consecutive patients who were refractory or intolerant to TPs and steroid-dependent were retrospectively analyzed. MTX (20 mg/wk, subcutaneous) was adopted for inducing and maintaining clinical remission (CR). Fifty-seven patients who were naive to immunosuppressant and prescribed azathioprine (2 mg·kg−1·d−1) or mercaptopurine (1 mg·kg−1·d−1) were simultaneously recruited. Results: By week 16, the CR rate was 68.6% and 78.9% in the MTX and TPs groups, respectively (P = 0.222). Patients with disease duration ⩽3 years were more likely to achieve CR with MTX (odds ratio = 7.667, P = 0.019). By week 64, the CR rate of patients achieved remission at week 16 was 45.7% and 44.4% in the MTX and TPs groups, respectively (P = 0.910). Normalization of high-sensitivity C-reactive protein level (relative risk = 11.221, P = 0.003) and platelet count (relative risk = 9.672, P = 0.004) at week 16 predicted the efficacy of maintaining remission with MTX. Among patients with remission at week 16, the mucosal healing rates at week 36 were 47.4% with MTX and 47.1% with TPs (P ≈ 1.000). Fifteen (29.4%) patients on MTX and 25 (43.9%) on TPs experienced adverse events (P = 0.121). Conclusions: MTX is effective in inducing and maintaining CR and achieving mucosal healing in patients with refractory Crohn's disease, and its efficacy is comparable to that of TPs for naive patients. The side effects of MTX were mild and tolerable.