羟氯喹治疗原发性干燥综合征：一项为期两年的双盲交叉试验。
Hydroxychloroquine treatment for primary Sjögren's syndrome: a two year double blind crossover trial.
作者信息
Kruize A A, Hené R J, Kallenberg C G, van Bijsterveld O P, van der Heide A, Kater L, Bijlsma J W
机构信息
Section of Clinical Immunology, University Hospital Utrecht, The Netherlands.
出版信息
Ann Rheum Dis. 1993 May;52(5):360-4. doi: 10.1136/ard.52.5.360.
OBJECTIVES
In 1985 and 1988 a positive effect of treatment of primary Sjögren's syndrome with hydroxychloroquine was reported in two small open studies. To investigate further the clinical and laboratory effects of hydroxychloroquine in primary Sjögren's syndrome a two year study was performed.
METHODS
The design of the study included a prospective, placebo controlled, two year double blind crossover trial in 19 patients.
RESULTS
A significant decrease in IgG and IgM and a tendency for a decrease in the erythrocyte sedimentation rate (ESR) during treatment with hydroxychloroquine compared with treatment with placebo were found. No beneficial clinical effect of the use of hydroxychloroquine as expressed in preference for treatment with hydroxychloroquine or placebo with regard to symptoms and signs of primary Sjögren's syndrome could be shown, however, nor any relevant change in tear gland activity and sequelae of peripheral tear function deficiency, nor salivary gland scintigraphy.
CONCLUSIONS
The use of hydroxychloroquine at a dose of 400 mg daily taken over a 12 month period does not have a worthwhile clinical benefit in patients with primary Sjögren's syndrome despite an improvement of hyperglobulinaemia and slight changes in the ESR and IgM.
目的
1985年和1988年，两项小型开放性研究报告了羟氯喹治疗原发性干燥综合征有积极效果。为进一步研究羟氯喹对原发性干燥综合征的临床和实验室影响，开展了一项为期两年的研究。
方法
该研究设计为对19名患者进行前瞻性、安慰剂对照、为期两年的双盲交叉试验。
结果
与使用安慰剂治疗相比，发现使用羟氯喹治疗期间IgG和IgM显著降低，红细胞沉降率（ESR）有下降趋势。然而，在原发性干燥综合征的症状和体征方面，未显示出使用羟氯喹治疗优于安慰剂治疗的有益临床效果，泪腺活动、周边泪液功能缺陷后遗症以及唾液腺闪烁扫描也未出现任何相关变化。
结论
尽管高球蛋白血症有所改善，ESR和IgM略有变化，但原发性干燥综合征患者连续12个月每日服用400毫克羟氯喹并无值得重视的临床益处。
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