Di Munno O, Imbimbo B, Mazzantini M, Milani S, Occhipinti G, Pasero G
Department of Rheumatology, Pisa University, Italy.
J Rheumatol. 1995 Aug;22(8):1492-8.
To assess the clinical efficacy and equivalence of a daily vs alternate day regimen, and the potency ratio between 2 glucocorticoids, deflazacort and 6-methylprednisolone.
Thirty-one patients with recent onset polymyalgia rheumatica (PMR) were randomly assigned to deflazacort (n = 16) or 6-methylprednisolone (n = 15), according to a 2 period (duration of each period = 6 weeks), crossover, open design for comparing 2 dose regimens (daily vs alternate day), and according to a between-patients, double blind design for comparing the therapeutic effects of the 2 glucocorticoids (deflazacort vs 6-methylprednisolone). The patients, either during alternate day or daily regimen, were treated with fixed oral doses for the first 2 weeks (assuming a potency ratio deflazacort/6-methylprednisolone of 1.5 mg/1.0 mg: deflazacort 24 mg or 6-methylprednisolone 16 mg, daily; deflazacort 48 mg or 6-methylprednisolone 32 mg, alternate day), and with titrated doses for the next 10 weeks.
Two patients dropped out during the first 6 week period. The time course and extent of the improvement of disease activity indices (limb-girdle pain, morning stiffness, erythrocyte sedimentation rate, C-reactive protein, and plasma fibrinogen) were not statistically different under the 2 regimens. The satisfactory equivalent glucocorticoid response observed in 12 pairs of patients treated with deflazacort and 6-methylprednisolone progressed significantly from baseline to the end of the study, under daily or alternate day regimen, with no significant difference between the 2 glucocorticoids. Deflazacort proved less potent than 6-methylprednisolone (1.78 mg: 1.0 mg minimum effective daily dose; 1.68: 1.0, alternate day), but equally effective.
The 2 dose regimens, 6-methylprednisolone and deflazacort showed no significant differences in terms of efficacy during the short term treatment of PMR. Deflazacort proved less potent than initially estimated.
评估每日给药方案与隔日给药方案的临床疗效及等效性，以及两种糖皮质激素（地夫可特和6-甲基泼尼松龙）之间的效价比。
31例近期发病的风湿性多肌痛（PMR）患者，根据2个周期（每个周期持续6周）的交叉开放设计，比较两种给药方案（每日给药与隔日给药），并根据患者间双盲设计，比较两种糖皮质激素（地夫可特与6-甲基泼尼松龙）的治疗效果，随机分为地夫可特组（n = 16）或6-甲基泼尼松龙组（n = 15）。患者在隔日或每日给药方案期间，前2周给予固定口服剂量（假设地夫可特/6-甲基泼尼松龙的效价比为1.5 mg/1.0 mg：地夫可特每日24 mg或6-甲基泼尼松龙16 mg；地夫可特隔日48 mg或6-甲基泼尼松龙32 mg），接下来10周给予滴定剂量。
在第一个6周期间，有2例患者退出。两种给药方案下，疾病活动指数（肢带肌疼痛、晨僵、红细胞沉降率、C反应蛋白和血浆纤维蛋白原）改善的时间进程和程度无统计学差异。在每日或隔日给药方案下，12对地夫可特和6-甲基泼尼松龙治疗的患者中观察到的令人满意的等效糖皮质激素反应从基线到研究结束有显著进展，两种糖皮质激素之间无显著差异。地夫可特的效力低于6-甲基泼尼松龙（最低有效日剂量为1.78 mg：1.0 mg；隔日为1.68：1.0），但疗效相同。
在PMR的短期治疗中，6-甲基泼尼松龙和地夫可特这两种给药方案在疗效方面无显著差异。地夫可特的效力低于最初估计。
