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联合使用 DMARDs 的诱导治疗优于甲氨蝶呤单药治疗:tREACH 试验的初步结果。

Induction therapy with a combination of DMARDs is better than methotrexate monotherapy: first results of the tREACH trial.

机构信息

Department of Rheumatology, University Medical Center, ErasmusMC, Rotterdam, Netherlands.

出版信息

Ann Rheum Dis. 2013 Jan;72(1):72-8. doi: 10.1136/annrheumdis-2011-201162. Epub 2012 Jun 7.

Abstract

OBJECTIVE

To determine the most effective induction disease-modifying antirheumatic drug (DMARD) strategy in early rheumatoid arthritis (RA), second to compare one single dose of intramuscular glucocorticoids (GCs) with daily oral GCs during the induction phase.

METHODS

The 3-month data of a single-blinded clinical trial in patients with recent-onset arthritis (tREACH) were used. Patients were included who had a high probability (>70%) of progressing to persistent arthritis, based on the prediction model of Visser. Patients were randomised into three induction therapy strategies: (A) combination therapy (methotrexate (MTX) + sulfasalazine + hydroxychloroquine) with GCs intramuscularly; (B) combination therapy with an oral GC tapering scheme and (C) MTX with oral GCs similar to B. A total of 281 patients were randomly assigned to strategy (A) (n=91), (B) (n=93) or (C) (n=97).

RESULTS

The Disease Activity Score (DAS) after 3 months was lower in patients receiving initial combination therapy than in those receiving MTX monotherapy (0.39 (0.67 to 0.11, 95% CI)). DAS did not differ between the different GC bridging treatments. After 3 months 50% fewer biological agents were prescribed in the combination therapy groups. Although the proportion of patients with medication adjustments differed significantly between the treatment arms, no differences were seen in these adjustments due to adverse events after stratification for drug.

CONCLUSION

Triple DMARD induction therapy is better than MTX monotherapy in early RA. Furthermore, no differences were seen in medication adjustments due to adverse events after stratification for drug. Intramuscular and oral GCs are equally effective as bridging treatments and both can be used.

摘要

目的

确定早期类风湿关节炎(RA)中最有效的诱导疾病修饰抗风湿药物(DMARD)策略,其次比较在诱导期内单次肌内糖皮质激素(GC)与每日口服 GC 的效果。

方法

使用单盲临床试验(tREACH)中 3 个月的数据。根据 Visser 预测模型,纳入高概率(>70%)进展为持续性关节炎的患者。患者随机分为三种诱导治疗策略:(A)联合治疗(甲氨蝶呤(MTX)+柳氮磺胺吡啶+羟氯喹)加肌内 GC;(B)联合治疗口服 GC 逐渐减量方案和(C)MTX 加类似 B 的口服 GC。共有 281 例患者随机分配至策略(A)(n=91)、(B)(n=93)或(C)(n=97)。

结果

接受初始联合治疗的患者 3 个月后的疾病活动评分(DAS)低于接受 MTX 单药治疗的患者(0.39(0.67 至 0.11,95%CI))。不同 GC 桥接治疗之间 DAS 无差异。治疗 3 个月后,联合治疗组中生物制剂的处方减少了 50%。尽管治疗组之间药物调整的患者比例存在显著差异,但分层后药物不良反应导致的调整无差异。

结论

早期 RA 三联 DMARD 诱导治疗优于 MTX 单药治疗。此外,分层后药物不良反应导致的药物调整无差异。肌内和口服 GC 作为桥接治疗同样有效,均可使用。

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