Denburg S D, Carbotte R M, Denburg J A
Department of Psychiatry, McMaster University, Hamilton, Ontario, Canada.
Arthritis Rheum. 1994 Sep;37(9):1311-20. doi: 10.1002/art.1780370907.
This study was designed to assess the effects of corticosteroids on select aspects of nervous system functioning, specifically, cognition and mood, as well as disease-related symptoms in individual patients with mild systemic lupus erythematosus (SLE) and mild neuropsychiatric (NP) symptoms.
Ten women who had not been taking corticosteroids for at least 6 months were selected from a referral-based lupus clinic to participate in an N of 1 double-blind, controlled trial consisting of 3 randomly assigned drug/placebo pairings, with a drug dose of 0.5 mg/kg of prednisone daily.
Analysis of variance on the group data yielded significant positive drug effects for cognition (P = 0.02), mood (P = 0.003), and SLE symptom ratings (P = 0.0002). Drug efficacy was also evaluated by an objective decision rule, which yielded evidence of overall drug benefit in 5 of the 8 patients who completed the trial, and a deleterious drug effect in 1 patient. Posttrial clinical results indicated that for the 8 women who completed the trial, "acceptable" decisions, leading to remission of SLE symptoms or appropriate withholding of steroids, were made on the basis of this rule.
Improvement in cognition, mood, and/or SLE symptom ratings can be observed following brief exposure to relatively low doses of corticosteroids in individual women with mild SLE; these persist over repeated drug exposure. The current application of N of 1 methodology represents the first systematic study of steroid efficacy in central nervous system (CNS)-related problems in SLE. The results can now be applied to the design of randomized, controlled trials of the effects of corticosteroids on CNS function in SLE.
本研究旨在评估皮质类固醇对轻度系统性红斑狼疮（SLE）和轻度神经精神（NP）症状个体患者神经系统功能某些方面的影响，特别是认知和情绪以及疾病相关症状。
从一家基于转诊的狼疮诊所挑选出10名至少6个月未服用皮质类固醇的女性，参与一项单病例双盲对照试验，该试验由3种随机分配的药物/安慰剂配对组成，药物剂量为每日0.5mg/kg泼尼松。
对组数据的方差分析得出，药物对认知（P = 0.02）、情绪（P = 0.003）和SLE症状评分（P = 0.0002）有显著的积极影响。还通过客观决策规则评估了药物疗效，该规则显示，在完成试验的8名患者中，有5名患者总体上有药物益处，1名患者有药物有害作用。试验后的临床结果表明，对于完成试验的8名女性，基于该规则做出了“可接受”的决策，从而使SLE症状缓解或适当停用类固醇。
在轻度SLE个体女性中，短期接触相对低剂量的皮质类固醇后，可观察到认知、情绪和/或SLE症状评分有所改善；这些改善在反复接触药物后持续存在。目前单病例研究方法的应用代表了对SLE中枢神经系统（CNS）相关问题中类固醇疗效的首次系统研究。现在，这些结果可应用于设计皮质类固醇对SLE中枢神经系统功能影响的随机对照试验。
