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甲氨蝶呤在急性结节病中可减少类固醇用量:一项双盲随机试验的结果

Methotrexate is steroid sparing in acute sarcoidosis: results of a double blind, randomized trial.

作者信息

Baughman R P, Winget D B, Lower E E

机构信息

Department of Internal Medicine, University of Cincinnati Medical Center, Ohio 45267-0564, USA.

出版信息

Sarcoidosis Vasc Diffuse Lung Dis. 2000 Mar;17(1):60-6.

PMID:10746262
Abstract

BACKGROUND AND AIM OF THE WORK

Methotrexate has been steroid sparing for some patients with chronic sarcoidosis. We wished to determine whether methotrexate can be steroid sparing in the first year of corticosteroid therapy in sarcoidosis.

METHODS

Patients with new onset, symptomatic disease within four weeks of starting on prednisone were randomized to receive either methotrexate or placebo for the next year. They were seen monthly and prednisone dosage was tapered following a pre-determined schedule.

RESULTS

Of 24 patients enrolled, only 15 received at least six months of therapy. Since methotrexate appears to take six months to be effective, only patients who completed six or more months of therapy were evaluated. The amount of prednisone per day decreased for both groups: methotrexate (First 6 months: Median 26 (Range 15-37) mg/day); Second 6 months 8 (1-22) mg/day, p < 0.01) and placebo (First 6 Months 28 (24-33) mg/day; Second 6 months 16 (11-22) mg/day, p < 0.02), with less prednisone used for the methotrexate patients versus placebo in the last six months (p < 0.01). There was also less weight gain for those patients receiving methotrexate. There was no difference in toxicity between methotrexate and placebo. The difference between methotrexate versus placebo was not seen when all patients (including the dropouts) were analyzed.

CONCLUSIONS

Methotrexate can be a steroid sparing agent in acute sarcoidosis.

摘要

工作背景与目的

甲氨蝶呤对一些慢性结节病患者具有减少类固醇用量的作用。我们希望确定在结节病患者接受皮质类固醇治疗的第一年,甲氨蝶呤是否能减少类固醇用量。

方法

在开始使用泼尼松四周内出现新的症状性疾病的患者被随机分组,在接下来的一年中分别接受甲氨蝶呤或安慰剂治疗。每月对他们进行检查,并按照预先确定的时间表逐渐减少泼尼松的剂量。

结果

在纳入的24例患者中,只有15例接受了至少六个月的治疗。由于甲氨蝶呤似乎需要六个月才会起效,因此仅对完成六个月或更长时间治疗的患者进行了评估。两组患者每天的泼尼松用量均有所减少:甲氨蝶呤组(前6个月:中位数26(范围15 - 37)mg/天);后6个月8(1 - 22)mg/天,p < 0.01)和安慰剂组(前6个月28(24 - 33)mg/天;后6个月16(11 - 22)mg/天,p < 0.02),在最后六个月中,甲氨蝶呤组患者使用的泼尼松比安慰剂组少(p < 0.01)。接受甲氨蝶呤治疗的患者体重增加也较少。甲氨蝶呤和安慰剂在毒性方面没有差异。当分析所有患者(包括退出者)时,未发现甲氨蝶呤与安慰剂之间的差异。

结论

甲氨蝶呤在急性结节病中可作为一种减少类固醇用量的药物。

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