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一项使用静脉注射甲泼尼龙脉冲疗法对简单型巨细胞动脉炎进行初始治疗的随机、多中心对照试验:164例患者的一年随访研究

A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients.

作者信息

Chevalet P, Barrier J H, Pottier P, Magadur-Joly G, Pottier M A, Hamidou M, Planchon B, El Kouri D, Connan L, Dupond J L, De Wazieres B, Dien G, Duhamel E, Grosbois B, Jego P, Le Strat A, Capdeville J, Letellier P, Agron L

机构信息

Department of Internal Medicine, University Hospital, Nantes, France.

出版信息

J Rheumatol. 2000 Jun;27(6):1484-91.

PMID:10852275
Abstract

OBJECTIVE

(1) To evaluate the corticosteroid sparing effect of an initial intravenous (i.v.) pulse of methylprednisolone (MP) in the treatment of simple forms of giant cell arteritis (GCA). (2) To analyze corticosteroid response, steroid related side effects, and GCA complications.

METHODS

Patients received a 240 mg i.v. pulse of MP followed by 0.7 mg/kg/day oral prednisone (Group 1) or 0.7 mg/kg/day prednisone without an i.v. pulse (Group 2, controls), or a 240 mg i.v. pulse of MP followed by 0.5 mg/kg/day prednisone (Group 3). Corticosteroid dosage was reduced after normalization of 2 biological inflammatory variables to obtain half-dosage after 4 weeks in Groups 1 and 2 and 20 mg/day after 2 weeks in Group 3. Tapering was systematically attempted from the 6th month of treatment.

RESULTS

One hundred sixty-four patients were included in the trial (1992-96). Cumulative doses of corticosteroids after one year were identical for all groups (p = 0.39). No significant differences were observed in the time required for normalization of C-reactive protein, corticosteroid resistance (13.5%), and corticosteroid related side effects (39% of patients; p = 0.37). Corticosteroid resistant patients received larger doses and showed a high risk of GCA related complications (p = 0.02).

CONCLUSION

MP pulses have no significant longterm, corticosteroid sparing effects in the treatment of simple forms of GCA and should be limited to complicated forms. Moreover, corticosteroid resistance is a real risk factor for GCA complications.

摘要

目的

(1)评估初始静脉注射甲基强的松龙(MP)脉冲疗法在治疗单纯型巨细胞动脉炎(GCA)中的糖皮质激素节省效应。(2)分析糖皮质激素反应、激素相关副作用及GCA并发症。

方法

患者接受240mg静脉注射MP脉冲治疗,随后给予0.7mg/kg/天口服泼尼松(第1组)或不进行静脉注射脉冲仅给予0.7mg/kg/天泼尼松(第2组,对照组),或接受240mg静脉注射MP脉冲治疗,随后给予0.5mg/kg/天泼尼松(第3组)。在两项生物学炎症指标恢复正常后减少糖皮质激素剂量,第1组和第2组在4周后减至半量,第3组在2周后减至20mg/天。从治疗第6个月开始系统性地尝试逐渐减量。

结果

164例患者纳入试验(1992 - 1996年)。所有组一年后糖皮质激素累积剂量相同(p = 0.39)。在C反应蛋白恢复正常所需时间、糖皮质激素抵抗(13.5%)及糖皮质激素相关副作用(39%的患者;p = 0.37)方面未观察到显著差异。糖皮质激素抵抗患者接受了更大剂量治疗且显示出GCA相关并发症的高风险(p = 0.02)。

结论

MP脉冲疗法在治疗单纯型GCA中无显著的长期糖皮质激素节省效应,应仅限于复杂型病例。此外,糖皮质激素抵抗是GCA并发症的一个真正风险因素。

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