Fox R I, Dixon R, Guarrasi V, Krubel S
Division of Rheumatology, Scripps Clinic and Research Foundation, La Jolla, CA 92037, USA.
Lupus. 1996 Jun;5 Suppl 1:S31-6.
To determine whether patients with primary Sjögren's syndrome (SS), diagnosed according to San Diego criteria, had improvement in their laboratory or clinical features during treatment with hydroxychloroquine (6-7 mg/kg/day) for at least two years.
The study population included 50 consecutive patients with primary SS who were diagnosed according to San Diego criteria, and in whom hydroxychloroquine was suggested as treatment. This group included 10 patients who were early dropouts (side effects or desire not to take antimalarial drugs) and 40 patients who received drugs for at least two years (range 24-48 months). In a subset of SS patients, values for ESR (westergren) and quantitative immunoglobulins were available for comparison. Improvement with therapy was defined as: (a) > or = 20% improvement in variables of tear flow (Schirmer's test I) or corneal integrity (rose Bengal): (b) > or = 20% salivary function (flow rate); and (c) improvement in at least two of the following measures: physicians assessment of global disease activity by > or = 20%, patient assessment of improvement in pain or fatigue by > or = 20%, and ESR improved by > or = 20 mm/hr.
In a retrospective study of SS patients who completed the trial, a significant improvement was noted in ocular symptoms (pain and dryness) in patients (55 and 57%) and improved corneal integrity (rose Bengal straining) in 53% of patients. The Schirmer's test was improved by > or = 2 mm/5 minutes in 50% in patients. Improvement was noted in oral symptoms (pain and dryness) in patients (57 and 60%) and salivary flow rate was increased in 82% of patients. In a subset of SS patients evaluated, the ESR improved by > or = 20 mm/hr in 17/32 patients (53%) and quantitative IgG level by > or = 20% in 8/13 patients (61%). Physician global assessment of overall patient status and patient assessment of overall status indicated improvement in over 62% of patients.
In a retrospective study of patients fulfilling San Diego Criteria for SS, we found: (a) sustained improvement of local symptoms (painful eyes, painful mouth) and improvement of systemic manifestations (arthralgias and myalgias) after treatment with hydroxychloroquine 6-7 mg/kg/day over mean three-year follow-up; (b) laboratory analysis showed a significant improvement in their ESR and their quantitative IgG levels; (c) no significant late toxicity was observed in this study cohort. A prospective study of hydroxychloroquine in patients fulfilling San Diego criteria for SS is indicated.
确定根据圣地亚哥标准诊断的原发性干燥综合征（SS）患者在接受羟氯喹（6 - 7毫克/千克/天）治疗至少两年期间，其实验室指标或临床特征是否有所改善。
研究人群包括50例连续的根据圣地亚哥标准诊断为原发性SS且建议使用羟氯喹治疗的患者。该组包括10例早期退出者（副作用或不想服用抗疟药物）和40例接受药物治疗至少两年（范围为24 - 48个月）的患者。在一部分SS患者中，可获得血沉（魏氏法）和定量免疫球蛋白值用于比较。治疗改善定义为：（a）泪液流量（Schirmer试验I）或角膜完整性（孟加拉玫瑰红）变量改善≥20%；（b）唾液功能（流速）改善≥20%；（c）至少在以下三项指标中的两项有所改善：医生对整体疾病活动的评估改善≥20%、患者对疼痛或疲劳改善的评估改善≥20%、血沉改善≥20毫米/小时。
在对完成试验的SS患者进行的回顾性研究中，发现患者眼部症状（疼痛和干燥）有显著改善（分别为55%和57%），53%的患者角膜完整性（孟加拉玫瑰红染色）得到改善。50%的患者Schirmer试验改善≥2毫米/5分钟。患者口腔症状（疼痛和干燥）有改善（分别为57%和60%），82%的患者唾液流速增加。在一部分接受评估的SS患者中，17/32例患者（53%）血沉改善≥20毫米/小时，8/13例患者（61%）定量IgG水平改善≥20%。医生对患者总体状况的整体评估和患者对总体状况的评估显示超过62%的患者有所改善。
在对符合圣地亚哥SS标准的患者进行的回顾性研究中，我们发现：（a）在平均三年的随访中，每天服用6 - 7毫克/千克羟氯喹治疗后，局部症状（眼痛、口腔疼痛）持续改善，全身表现（关节痛和肌痛）也有所改善；（b）实验室分析显示血沉和定量IgG水平有显著改善；（c）在本研究队列中未观察到明显的晚期毒性。建议对符合圣地亚哥SS标准的患者进行羟氯喹的前瞻性研究。
