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甲氨蝶呤能否作为一种糖皮质激素节约剂用于治疗风湿性多肌痛和巨细胞动脉炎?

Can methotrexate be used as a steroid sparing agent in the treatment of polymyalgia rheumatica and giant cell arteritis?

作者信息

van der Veen M J, Dinant H J, van Booma-Frankfort C, van Albada-Kuipers G A, Bijlsma J W

机构信息

Department of Rheumatology, University Hospital Utrecht, The Netherlands.

出版信息

Ann Rheum Dis. 1996 Apr;55(4):218-23. doi: 10.1136/ard.55.4.218.

Abstract

OBJECTIVE

To investigate whether methotrexate (MTX) has a steroid sparing effect in the treatment of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).

METHODS

We carried out a randomised double blind, placebo controlled study in 40 patients with PMR, six of whom also had clinical symptoms of GCA. A temporal artery biopsy specimen was available from 37 patients; GCA was found in six of the specimens. Among the six patients with clinical signs of GCA, three had a positive biopsy specimen. All patients were started on prednisone 20 mg/day, irrespective of clinical signs and biopsy result, supplemented with a weekly, blinded capsule containing either MTX 7.5 mg or placebo. The prednisone dose was decreased as soon as clinical symptoms disappeared and erythrocyte sedimentation rate, C reactive protein level, or both, had normalised.

RESULTS

Twenty one patients were followed for two years, or at least one year after discontinuing medication. No differences were found between the MTX group and the placebo group concerning time to achieve remission, duration of remission, number of relapses, or cumulative prednisone doses. After 21 weeks the mean daily prednisone dose was reduced by 50%. Forty percent of all patients were able to discontinue prednisone within two years. Median duration of steroid treatment was 47.5 weeks (range 3-104). No serious complications from GCA were encountered.

CONCLUSIONS

With a (rapid) steroid tapering regimen, it was possible to reduce the mean daily prednisone dose by 50% in 21 weeks and to cease prednisone in 40% of the patients within two years. With this regimen, no steroid sparing effect of MTX in a dosage of 7.5 mg/week was found.

摘要

目的

研究甲氨蝶呤(MTX)在治疗多肌痛(PMR)和巨细胞动脉炎(GCA)时是否具有激素节省效应。

方法

我们对40例PMR患者进行了一项随机双盲、安慰剂对照研究,其中6例同时具有GCA的临床症状。37例患者可获取颞动脉活检标本;6例标本中发现有GCA。在6例具有GCA临床体征的患者中,3例活检标本呈阳性。所有患者均开始服用泼尼松20mg/天,无论临床体征和活检结果如何,并补充每周一次的盲法胶囊,其中包含7.5mg MTX或安慰剂。一旦临床症状消失且红细胞沉降率、C反应蛋白水平或两者均恢复正常,泼尼松剂量即降低。

结果

21例患者随访了两年,或停药后至少一年。MTX组和安慰剂组在达到缓解的时间、缓解持续时间、复发次数或累积泼尼松剂量方面未发现差异。21周后,平均每日泼尼松剂量降低了50%。所有患者中有40%能够在两年内停用泼尼松。激素治疗的中位持续时间为47.5周(范围3 - 104周)。未遇到GCA的严重并发症。

结论

采用(快速)激素减量方案,有可能在21周内将平均每日泼尼松剂量降低50%,并在两年内使40%的患者停用泼尼松。采用该方案,未发现每周剂量为7.5mg的MTX具有激素节省效应。

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