Beneficial effects of a 3-week course of intramuscular glucocorticoid injections in patients with very early inflammatory polyarthritis: results of the STIVEA trial
Beneficial effects of a 3-week course of intramuscular glucocorticoid injections in patients with very early inflammatory polyarthritis: results of the STIVEA trial
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DOI：
10.1136/ard.2009.119149
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发表时间：
2010-03-01
影响因子：
27.4
通讯作者：
Symmons, D. P. M.
中科院分区：
文献类型：
--
作者：
Verstappen, S. M. M.;McCoy, M. J.;Symmons, D. P. M.
目的 评估通过肌肉注射 (IM) 醋酸甲基泼尼松龙 3 周疗程治疗极早期炎症性多关节炎 (IP) 患者是否可以推迟对缓解病情抗风湿药物 (DMARD) 的需求并防止 IP 发展为类风湿性关节炎 (RA)。 方法 极早期 IP 患者（持续时间 4-10 周）被随机分为 3 组 每周注射一次 80 mg 肌内注射醋酸甲泼尼龙或安慰剂。每月进行一次评估，直到第一次注射后 6 个月为止，然后在 12 个月时结束。主要结果是需要通过 6 个月的评估开始 DMARD。次要结局包括疾病活动度和风湿病专家在 12 个月时的最终临床诊断。 结果 安慰剂组患者 (76%) 在试验的前 6 个月内比糖皮质激素组患者 (61%) 更有可能需要 DMARD（调整后 OR = 2.11，95% CI 1.16 至 3.85，p = 0.015）。 12 个月时，两组之间的疾病活动度没有差异，这可能是因为安慰剂组中的许多患者在研究早期就开始使用 DMARD。 12 个月后，安慰剂组中有 9.9% (11/111) 的患者和糖皮质激素治疗组中有 19.8% (22/111) 的患者关节炎已得到缓解，无需使用 DMARD（调整后 OR = 0.42，95% CI 0.18 至 0.99，p = 0.048）。 结论 采用 IM 治疗极早期 IP 患者醋酸甲泼尼龙似乎 推迟 DMARD 的处方并防止十分之一的患者进展为 RA。
Objective To evaluate whether treating patients with very early inflammatory polyarthritis (IP) with a 3-week course of intramuscular (IM) methylprednisolone acetate may postpone the need for disease-modifying antirheumatic drugs (DMARDs) and prevent IP from evolving into rheumatoid arthritis (RA).Methods Patients with very early IP (4-10 weeks' duration) were randomised to receive three injections of either 80 mg IM methylprednisolone acetate or placebo, given at weekly intervals. Assessments were monthly until 6 months after the first injection, and then concluded at 12 months. The primary outcome was the need to start DMARDs by the 6-month assessment. Secondary outcomes included disease activity and final clinical diagnosis by the rheumatologist at 12 months.Results Patients in the placebo group (76%) were more likely to need DMARDs during the first 6 months of the trial than patients in the glucocorticoid group (61%) (adjusted OR = 2.11, 95% CI 1.16 to 3.85, p = 0.015). Disease activity did not differ between the two groups at 12 months, probably because many patients in the placebo group started DMARDs early in the study. After 12 months, the arthritis had resolved without the need for DMARDs in 9.9% (11/111) of the patients in the placebo group and in 19.8% (22/111) in the glucocorticoid-treated group (adjusted OR = 0.42, 95% CI 0.18 to 0.99, p = 0.048).Conclusion Treatment of patients with very early IP with IM methylprednisolone acetate appears to postpone the prescription of DMARDs and prevent one in 10 patients from progressing into RA.