Meinão I M, Sato E I, Andrade L E, Ferraz M B, Atra E
Division of Rheumatology, Escola Paulista de Medicina, Universidade Federal de São Paulo, Brazil.
Lupus. 1996 Jun;5(3):237-41. doi: 10.1177/096120339600500313.
Antimalarials have been recognized as effective drugs for the treatment of articular and cutaneous manifestations of systemic lupus erythematosus (SLE), but its potential in the management of systemic features of the disease has not yet been thoroughly evaluated.
This study intended to evaluate the efficacy of chloroquine diphosphate (CDP) in preventing flares and in reducing the maintenance corticosteroid dose in patients with SLE without life-threatening manifestations.
Twenty-four SLE patients with no life-threatening manifestation were enrolled in a 12-month double blind placebo-controlled trial with CDP (250 mg/day). Patients were subjected each month to clinical examination by a rheumatologist and to SLE-relevant laboratory tests. At each visit, prednisone dose could be adjusted according to the clinical status. Ophthalmologic examination was performed every six months. Outcome measures included SLEDAI score and the required prednisone dose. SLE flare was defined as an increase in SLEDAI score of at least three points. Prednisone dose reduction was defined as a minimum 50% dose decrease with no concomitant disease flare.
Twenty-three patients completed the study. One patient in the placebo (PL) group dropped out due to severe dyspepsia. No major side-effect was observed in the remaining patients. PL and CDP groups showed no significant difference at the beginning of the study with regard to sex, age, ethnic classification, disease duration, SLEDAI and prednisone dose. Along the trial the prednisone dose became progressively lower in CDP group as compared to PL group and the difference reached statistical significance at 4, 6 and 12 months. SLEDAI score was higher in PL group in all evaluations, being the difference statistically significant at 4 months. Flare-up episodes were registered in two patients in CDP group and in ten patients in PL group. The estimated reactivation risk was 4.6 times greater in PL group as compared to CDP group.
CDP at a 250 mg/day dose was able to prevent disease exacerbation, reduce the required prednisone dose, and help inducing a better control of patients with non life-threatening SLE. These data suggest that antimalarials might have a broader indication in the treatment of SLE other than solely the management of skin and articular manifestations.
抗疟药已被公认为治疗系统性红斑狼疮（SLE）关节和皮肤表现的有效药物，但其在治疗该疾病全身症状方面的潜力尚未得到充分评估。
本研究旨在评估磷酸氯喹（CDP）在预防无威胁生命表现的SLE患者病情复发及减少维持性皮质类固醇剂量方面的疗效。
24例无威胁生命表现的SLE患者参加了一项为期12个月的双盲安慰剂对照试验，服用CDP（250毫克/天）。患者每月由风湿病学家进行临床检查，并进行与SLE相关的实验室检查。每次就诊时，可根据临床状况调整泼尼松剂量。每六个月进行一次眼科检查。观察指标包括SLE疾病活动指数（SLEDAI）评分和所需泼尼松剂量。SLE病情复发定义为SLEDAI评分至少增加3分。泼尼松剂量减少定义为剂量至少减少50%且无伴随疾病复发。
23例患者完成了研究。安慰剂（PL）组1例患者因严重消化不良退出。其余患者未观察到严重副作用。PL组和CDP组在研究开始时在性别、年龄、种族分类、病程、SLEDAI和泼尼松剂量方面无显著差异。在试验过程中，与PL组相比，CDP组的泼尼松剂量逐渐降低，在4、6和12个月时差异具有统计学意义。在所有评估中，PL组的SLEDAI评分均较高，在4个月时差异具有统计学意义。CDP组有2例患者出现病情复发，PL组有10例患者出现病情复发。PL组的估计复发风险比CDP组高4.6倍。
250毫克/天剂量的CDP能够预防疾病加重，减少所需泼尼松剂量，并有助于更好地控制无威胁生命的SLE患者。这些数据表明，抗疟药在SLE治疗中的适应证可能比仅用于治疗皮肤和关节表现更为广泛。
