Low dose of azathioprine is effective to induce and maintain remission in active Crohn disease: A prospective observational study.
Low dose of azathioprine is effective to induce and maintain remission in active Crohn disease: A prospective observational study.
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低剂量硫唑嘌呤可有效诱导和维持活动性克罗恩病的缓解：一项前瞻性观察研究
DOI：
10.1097/md.0000000000011814
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发表时间：
2018-08
期刊：
影响因子：
1.6
通讯作者：
Ran Z
中科院分区：
文献类型：
--
作者：
Qian X;Wang T;Shen J;Ran Z
硫唑嘌呤（AZA）2 - 2.5 mg/kg/d被推荐用于欧洲克罗恩病（CD）患者，但一些亚洲研究报告低剂量AZA也可有效治疗CD。 为了证实这些观察结果，我们进行了这项前瞻性观察性研究，以比较低剂量和标准剂量AZA治疗活动性CD的疗效和安全性。这是一项前瞻性、开放标签观察性研究。226例活动期CD患者分为2组，分别给予AZA 1.5或2.0mg/kg/d，联合激素治疗。 患者随访96周。在第24、48和96周通过意向治疗（ITT）分析评估完全缓解（CR）率、缓解率、复发率和不良反应率。ITT分析显示，在第24、48或96周，硫唑嘌呤1.5 mg/kg/d与AZA 2 mg/kg/d相比，CR率、缓解率和复发率无显著差异（均P>.05）。 两组不良反应发生率无显著性差异（P> 0.05）。 21.7%（49/226）的患者报告了不良事件，其中69.4%（34/49）为骨髓抑制。硫唑嘌呤1.5 mg/kg/d联合类固醇与AZA 2.0 mg/kg/d联合治疗在前6个月内诱导活动性CD缓解，并在前2年内维持非活动性CD缓解，而不增加临床缓解后活动性CD的复发。 最常见的不良反应是骨髓抑制。
Azathioprine (AZA) 2 to 2.5 mg/kg/d is recommended for European patients with Crohn disease (CD), but several Asian studies reported that low dose of AZA was also effective to treat CD. To confirm those observations, we perform this prospective observational study to compare the efficacy and safety of low and standard doses of AZA in the treatment of active CD. This was a prospective, open-labeled observational study. Two hundred twenty-six active CD patients were divided into 2 groups and treated with AZA 1.5 or 2.0 mg/kg/d respectively, combined with steroid therapy. Patients were followed up for 96 weeks. The complete remission (CR) rate, response rate, relapse rate, and adverse effect rate were assessed at weeks 24, 48, and 96 by intention-to-treat (ITT) analysis. Azathioprine 1.5 mg/kg/d showed no significant difference compared with AZA 2 mg/kg/d in CR rate, response rate and relapse rate by ITT analysis at week 24, 48, or 96 (all P > .05). Their adverse effect rates had no significant difference either (P > .05). Up to 21.7% (49/226) of the patients reported adverse events and 69.4% (34/49) of them were myelosuppresion. Azathioprine 1.5 mg/kg/d combined with steroids is as effective as AZA 2.0 mg/kg/d to induce remission of active CD in the first 6 months, and to maintain remission of inactive CD in the first 2 years, without increasing the recurrence of active CD after clinical remission. The most common adverse effect is myelosuppression.