Hydroxychloroquine treatment for primary Sj(o)gren's syndrome:a prospective,open labeled clinical trial
- VernacularTitle:羟氯喹治疗原发性干燥综合征前瞻性临床研究初探
- Author:
Qun SHI
;
Yan ZHAO
;
Ling LI
;
Zhaowen WANG
;
Yi DONG
- Publication Type:Journal Article
- Keywords:
Hydroxychloroquine;
Sj(o)gren's syndrome;
Prospective studies
- From:
Chinese Journal of Rheumatology
2008;12(4):258-260,插2
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety,particularly eye safety of hydroxychloro-quine(HCQ)treatment in primary Sj(o)gren's syndrome(pSS)patients.Methods Forty pSS patients were en-rolled and treated with HCQ 400 mg/day for 12 months.This is a prospective open-label study.Clinical mani-festations,clinical efficacy,biochemical and immunoserological parameters as well as ophthalmological exami-nations were investigated every three months to assess the safety and tolerability.Results There were signifi-cant decrease in the erythrocyte sedimentation rate(ESR),immunoglobulin G(IgG),immunoglobulin M (IgM)and rheumatoid factor(RF)level after 6 months treatment with HCQ(P＜0.01 or P＜0.05).No changewas detected in serum antinuclear antibody(ANA),anti-SSA/SSB antibodies after treated for 12 months.Somepatients had partial improvement in symptoms such as dry mouth,dry eyes and arthralgia.During the treat-ment,no significant effect on serum alanine aminotransferase (ALT),blood urea (BUN),serum creatinine (Cr),whole blood count(WBC)or hemoglobin(Hb)could be discovered.Central semus retinopathv(CSR)was found in one patient after 6 months treatment with HCQ.However,its association with HCQ could not be confirmed since it was not compatible with the usual HCQ retinopathy.Conclusion HCQ can improve svmp-toms of some pSS patients and can significantly decrease ESR,IgG,IgM and RF level.The safety profile of HCQ is generally good.However,ophthalmological examination before and after a 6-month interval may be necessary in long term HCQ treatment.
