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类风湿关节炎患者每两周一次甲氨蝶呤治疗。一项双盲、安慰剂对照的前瞻性研究。

Every-other-week methotrexate in patients with rheumatoid arthritis. A double-blind, placebo-controlled prospective study.

作者信息

Kremer J M, Davies J M, Rynes R I, Fink S, Lawrence D A, Petrillo G F, Mullaly P M

机构信息

Division of Rheumatology, Albany Medical College, NY 12208, USA.

出版信息

Arthritis Rheum. 1995 May;38(5):601-7. doi: 10.1002/art.1780380504.

DOI:10.1002/art.1780380504
PMID:7748214
Abstract

OBJECTIVE

To determine if patients with rheumatoid arthritis (RA) that is stable with weekly methotrexate (MTX) therapy could be switched to an every-other-week regimen of MTX.

METHODS

Forty-seven patients with classic or definite RA who had received MTX for at least 8 months were studied. Clinical measurements consisted of the number of tender and swollen joints, physician and patient global evaluation of disease activity on a 5-point scale, grip strength, patient evaluation of pain, morning stiffness, and the interval to onset of fatigue from time of awakening. Laboratory measures included the erythrocyte sedimentation rate (ESR), rheumatoid factor, C-reactive protein (CRP), and baseline serum folate levels. Uptake of MTX was measured with tritiated thymidine from peripheral blood mononuclear cells (PBMC) from patients ex vivo. Serum measures of interleukin-1 beta (IL-1 beta), IL-6, and tumor necrosis factor alpha (TNF alpha) were performed in sera, and TNF alpha was also measured on PBMC supernatants.

RESULTS

Twelve of the 23 patients receiving every-other-week MTX (52%) were able to complete 6 months of this treatment without experiencing a disease flare. Eleven of the 23 patients receiving every-other-week MTX (48%) withdrew from the study before completing 6 months of treatment, because of a flare. No significant differences in clinical or laboratory parameters were seen when the 24 patients receiving weekly MTX were compared with the 12 patients in the every-other-week MTX group who successfully completed 6 months of the study. None of the changes in serum cytokine levels were significantly different between the patients receiving MTX weekly versus those receiving it every other week, and changes in ESR and CRP did not differ between groups. Age, sex, RA disease duration, MTX weekly dose or duration, baseline joint counts, or serum folate status did not predict a flare. Tritiated MTX uptake did not differ between groups.

CONCLUSION

Some patients with RA that is stable on weekly dosing are able to change to every-other-week dosing without experiencing a flare in their disease activity.

摘要

目的

确定使用甲氨蝶呤(MTX)每周治疗病情稳定的类风湿关节炎(RA)患者是否可以改为MTX隔日治疗方案。

方法

对47例接受MTX治疗至少8个月的典型或确诊RA患者进行研究。临床测量包括压痛和肿胀关节数、医生和患者对疾病活动的5级整体评估、握力、患者对疼痛的评估、晨僵以及从醒来至疲劳发作的间隔时间。实验室测量包括红细胞沉降率(ESR)、类风湿因子、C反应蛋白(CRP)和基线血清叶酸水平。通过体外测量患者外周血单核细胞(PBMC)中的氚化胸苷来测定MTX摄取。对血清进行白细胞介素-1β(IL-1β)、IL-6和肿瘤坏死因子α(TNFα)的测量,同时也对PBMC上清液进行TNFα测量。

结果

23例接受MTX隔日治疗的患者中有12例(52%)能够完成6个月的该治疗且未出现疾病复发。23例接受MTX隔日治疗的患者中有11例(48%)在完成6个月治疗前因病情复发退出研究。将24例接受MTX每周治疗的患者与12例成功完成6个月研究的MTX隔日治疗组患者进行比较时,未发现临床或实验室参数有显著差异。接受MTX每周治疗的患者与接受MTX隔日治疗的患者之间,血清细胞因子水平的变化均无显著差异,ESR和CRP的变化在两组之间也无差异。年龄、性别、RA病程、MTX每周剂量或疗程、基线关节计数或血清叶酸状态均不能预测病情复发。两组之间氚化MTX摄取无差异。

结论

一些每周给药病情稳定的RA患者能够改为隔日给药而不出现疾病活动复发。

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