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甲氨蝶呤和羟氯喹联合治疗与甲氨蝶呤单药治疗早期类风湿关节炎患者的效果比较。

The effects of methotrexate and hydroxychloroquine combination therapy vs methotrexate monotherapy in early rheumatoid arthritis patients.

机构信息

Department of Rheumatology, Sint Maartenskliniek, the Netherlands.

Department of Rheumatology, Radboudumc, Nijmegen, the Netherlands.

出版信息

Rheumatology (Oxford). 2019 Jan 1;58(1):131-134. doi: 10.1093/rheumatology/key275.

DOI:10.1093/rheumatology/key275
PMID:30189019
Abstract

OBJECTIVES

To investigate the added value of MTX-HCQ combination therapy (CTG) in early RA in a controlled cohort study. MTX monotherapy (MTG) is recommended as (part of) first choice treatment but no head-to-head comparisons are available comparing MTX-HCQ CTG with MTG.

METHODS

RA patients from the Sint Maartenskliniek and Radboudumc Nijmegen who started MTX with or without concomitant HCQ from April 2010 to October 2015 were included. The primary outcome was the between-group ΔDAS28-CRP at 6 months, and secondary outcomes were ΔDAS28-CRP at 12 months, EULAR response at 6 and 12 months, and treatment intensification. Regression modelling was used to correct for confounding.

RESULTS

We included 325 patients, with only small between-group differences at baseline. The DAS28-CRP improvement at 6 months was larger in the CTG (Δ = 0.38 (CI: 0.01, 0.76)), and the difference between groups in DAS28-CRP improvement was smaller at 12 months (Δ = 0.22 points (CI:-0.19, -0.62)). At 6 months, a higher percentage of patients had a good EULAR response in the CTG (Δ = 15% (CI: 2.7%, 27%)). This difference was reduced at 12 months (Δ = 6% (CI -6.4%, 19%)). Treatment intensification with conventional synthetic DMARDs was more likely in the MTG (Δ = 31% (CI: -43%, 19%)). The proportion of patients starting biologic DMARD treatment during the observation period was comparable (Δ = 2% (CI: -8%, 12%)).

DISCUSSION

In contrast to indirect comparison review data, MTX-HCQ seems somewhat more effective after 6 months than MTX monotherapy in early RA patients. After 12 months, we observed no significant differences between the two strategies, probably due to treat-to-target efforts.

摘要

目的

在对照队列研究中,探究 MTX-HCQ 联合治疗(CTG)在早期 RA 中的附加价值。MTX 单药治疗(MTG)被推荐为(部分)首选治疗方法,但尚无 MTX-HCQ CTG 与 MTG 头对头比较的研究。

方法

纳入 2010 年 4 月至 2015 年 10 月期间在 Sint Maartenskliniek 和 Radboudumc Nijmegen 开始 MTX 联合或不联合 HCQ 治疗的 RA 患者。主要结局为治疗 6 个月时两组间的 DAS28-CRP 差值(ΔDAS28-CRP),次要结局为治疗 12 个月时的 DAS28-CRP 差值、6 个月和 12 个月时的 EULAR 缓解率,以及治疗强化情况。采用回归模型校正混杂因素。

结果

共纳入 325 例患者,两组基线时仅有微小差异。CTG 组在治疗 6 个月时 DAS28-CRP 改善更大(Δ = 0.38(CI:0.01,0.76)),而两组在 12 个月时 DAS28-CRP 改善的差异更小(Δ = 0.22 点(CI:-0.19,-0.62))。治疗 6 个月时,CTG 组有更高比例的患者达到 EULAR 缓解(Δ = 15%(CI:2.7%,27%))。该差异在 12 个月时有所降低(Δ = 6%(CI:-6.4%,19%))。MTG 组更有可能强化使用传统合成 DMARDs(Δ = 31%(CI:-43%,19%))。观察期间开始使用生物 DMARD 治疗的患者比例相似(Δ = 2%(CI:-8%,12%))。

讨论

与间接比较综述数据相反,MTX-HCQ 在早期 RA 患者中治疗 6 个月后似乎比 MTX 单药治疗更有效。治疗 12 个月后,两种策略之间未观察到显著差异,这可能归因于达标治疗的努力。

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