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甲氨蝶呤用于早期基孔肯雅热关节炎:一项为期6个月的随机对照开放标签试验。

Methotrexate in Early Chikungunya Arthritis: A 6 Month Randomized Controlled Open-label Trial.

作者信息

Adarsh M B, Sharma Shefali K, Dwivedi Preksha, Singh Mini P, Dhir Varun, Jain Sanjay

机构信息

Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Department of Virology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Curr Rheumatol Rev. 2020;16(4):319-323. doi: 10.2174/1573397115666190925154140.

Abstract

OBJECTIVE

Evidence for treating chikungunya arthritis early in the course of illness is scarce. This study assesses the efficacy of Methotrexate in early Chikungunya arthritis.

METHODS

It is a randomized controlled open-label assessor-blinded trial with a crossover design. Sixty patients with persistent post chikungunya arthritis with at least 3 or more tender or swollen joints (28 joint count) were recruited. MTX arm was given oral Methotrexate and NSAID arm was given NSAIDs (Naproxen 1 gm/day or Etoricoxib 120 mg/day). Patients were followed at 1, 2, 4 and 6 months. After 2 months patients in NSAID arm who have not achieved remission were given MTX. The primary endpoint was remission (no tender or swollen joints by 28 joint count) at 6 months. Secondary endpoints were change in CDAI, Indian HAQ, total steroid use, total NSAID use, and serious adverse effects. Intention to treat analysis was used.

RESULTS

TJC, SJC, CDAI and HAQ were matched between two at baseline. Remission was achieved by 28 patients (93%, CI- 78%-98%) in the NSAID arm and 26 patients (86%, CI-70%- 94%) in MTX arm (p=0.18). There was no significant difference in steroid need, change in HAQ, CDAI, TJC or SJC. Those who have not achieved remission had higher disease activity at baseline.

CONCLUSION

A protocol-based approach with steroid and NSAIDs helped to achieve remission in most patients with early subacute phase of post-Chikungunya arthritis and the effect was comparable to that of early initiation of methotrexate.

摘要

目的

关于在基孔肯雅热病程早期治疗关节炎的证据很少。本研究评估甲氨蝶呤在早期基孔肯雅热关节炎中的疗效。

方法

这是一项采用交叉设计的随机对照开放标签评估者盲法试验。招募了60例患有持续性基孔肯雅热后关节炎且至少有3个或更多压痛或肿胀关节(28个关节计数)的患者。甲氨蝶呤组给予口服甲氨蝶呤,非甾体抗炎药组给予非甾体抗炎药(萘普生1克/天或依托考昔120毫克/天)。在1、2、4和6个月对患者进行随访。2个月后,非甾体抗炎药组中未达到缓解的患者给予甲氨蝶呤。主要终点是6个月时的缓解(28个关节计数时无压痛或肿胀关节)。次要终点是疾病活动指数(CDAI)、印度健康评估问卷(HAQ)的变化、总类固醇使用量、总非甾体抗炎药使用量和严重不良反应。采用意向性分析。

结果

两组在基线时的压痛关节计数(TJC)、肿胀关节计数(SJC)、CDAI和HAQ相匹配。非甾体抗炎药组28例患者(93%,可信区间78%-98%)达到缓解,甲氨蝶呤组26例患者(86%,可信区间70%-94%)达到缓解(p=0.18)。在类固醇需求、HAQ、CDAI、TJC或SJC的变化方面没有显著差异。未达到缓解的患者在基线时疾病活动度更高。

结论

基于方案使用类固醇和非甾体抗炎药有助于大多数基孔肯雅热后关节炎亚急性期早期患者实现缓解,其效果与早期使用甲氨蝶呤相当。

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