AMA：羟氯喹未能对改善原发性干燥综合征症状
对于全身性自身免疫性疾病患者的原发性干燥综合征（primary Sjögren syndrome），羟氯喹是这种疾病最常见的处方治疗药物，但根据JAMA杂志上上的一项研究证实：与安慰剂相比，羟氯喹在治疗的第24周并没有改善症状。
原发性干燥综合征的特征是嘴和眼干燥，疼痛，疲劳，发生在大约三分之一的全身性自身免疫性疾病患者。尽管在临床治疗中广泛使用羟氯喹，但关于它的功效的证据是有限的。
Jacques-Eric Gottenberg医师及其同事随机分配120例原发性干燥综合征患者，接受羟氯喹或安慰剂治疗，直至第24周。后24周所有病人（治疗组和安慰剂组）给予羟氯喹治疗，因此羟氯喹组患者接受羟氯喹治疗48周，安慰剂组接受羟氯喹治疗24周。
在第24周时，达到主要终点的患者比例，羟氯喹组为17.9％（10/56），安慰剂组为17.2％（11/ 64）。在测试舍格伦（Sjögren）（抗SSA抗体，IgG水平）活性的某些实验中，羟氯喹也不与症状改善相关联。
在第24周时，羟氯喹组有2例严重不良事件，安慰剂组有3例。在后24周（第48周）时，安慰剂组有3例，羟氯喹组有4例。另外，在本研究中，与安慰剂相比，羟氯喹没有表现对原发性干燥综合症的主要症状干燥，疼痛，疲劳等表现出改善功效。
但研究人员表示：还需要进一步研究，以评估羟氯喹的长期结果。（生物谷Bioon.com）
Effects of Hydroxychloroquine on Symptomatic Improvement in Primary Sojgren Syndrome
Jacques-Eric Gottenberg, MD, et al.
Importance Primary Sjogren syndrome is a systemic autoimmune disease characterized by mouth and eye dryness, pain, and fatigue. Hydroxychloroquine is the most frequently prescribed immunosuppressant for the syndrome. However, evidence regarding its efficacy is limited.
Objective To evaluate the efficacy of hydroxychloroquine for the main symptoms of primary Sjogren syndrome: dryness, pain, and fatigue.
Design, Setting, and Participants From April 2008 to May 2011, 120 patients with primary Sjogren syndrome according to American-European Consensus Group Criteria from 15 university hospitals in France were randomized in a double-blind, parallel-group, placebo-controlled trial. Participants were assessed at baseline, week 12, week 24 (primary outcome), and week 48. The last follow-up date for the last patient was May 15, 2012.
Interventions Patients were randomized (1:1) to receive hydroxychloroquine (400 mg/d) or placebo until week 24. All patients were prescribed hydroxychloroquine between weeks 24 and 48.
Main Outcomes and Measures The primary end point was the proportion of patients with a 30% or greater reduction between weeks 0 and 24 in scores on 2 of 3 numeric analog scales (from 0 [best] to 10 [worst]) evaluating dryness, pain, and fatigue.
Results At 24 weeks, the proportion of patients meeting the primary end point was 17.9% (10/56) in the hydroxychloroquine group and 17.2% (11/64) in the placebo group (odds ratio, 1.01; 95% CI, 0.37-2.78; P=.98). Between weeks 0 and 24, the mean (SD) numeric analog scale score for dryness changed from 6.38 (2.14) to 5.85 (2.57) in the placebo group and 6.53 (1.97) to 6.22 (1.87) in the hydroxychloroquine group. The mean (SD) numeric analog scale score for pain changed from 4.92 (2.94) to 5.08 (2.48) in the placebo group and 5.09 (3.06) to 4.59 (2.90) in the hydroxychloroquine group. The mean (SD) numeric analog scale for fatigue changed from 6.26 (2.27) to 5.72 (2.38) in the placebo group and 6.00 (2.52) to 5.94 (2.40) in the hydroxychloroquine group. All but 1 patient in the hydroxychloroquine group had detectable blood levels of the drug. Hydroxychloroquine had no efficacy in patients with anti-SSA autoantibodies, high IgG levels, or systemic involvement. During the first 24 weeks, there were 2 serious adverse events in the hydroxychloroquine group and 3 in the placebo group; in the last 24 weeks, there were 3 serious adverse events in the hydroxychloroquine group and 4 in the placebo group.
Conclusions and Relevance Among patients with primary Sjogren syndrome, the use of hydroxychloroquine compared with placebo did not improve symptoms during 24 weeks of treatment. Further studies are needed to evaluate longer-term outcomes.
