羟氯喹治疗原发性干燥综合征前瞻性临床研究初探

目的 评价羟氯喹治疗原发性干燥综合征的疗效和安全性,尤其是长期应用后眼的安全性.方法 对40例原发性干燥综合征患者进行为期1年的前瞻性研究;每天服用羟氯喹400 mg;每3个月以VAS方法记录患者口干、眼干、关节痛等主观症状,同时检测红细胞沉降率(ESR)、免疫球蛋白、类风湿因子、抗核抗体、抗可提取核抗原抗体、唾液流率、滤纸试验,并监测肝肾功能、血常规变化和眼底情况,数据应用SAS软件进行分析和统计.结果 治疗3个月后,患者主观症状(口干、眼干关节痛)和治疗前比较有不同程度的改善(P＜0.01或P＜0.05);ESR、血清IgG、IgM明显下降(P＜0.01),其他客观指标无明显变化;所有患者血常规、肝肾功能均未见异常;1例患者眼底检查诊断为双眼特发性中心性浆液性脉络膜视网膜病变,与羟氯喹的视网膜病变不完全符合.结论 羟氯喹可部分改善患者口眼干、关节痛的主观症状;可降低ESR、免疫球蛋白、类风湿因子;羟氯喹具有较好的安全性,但长期服用仍有发生眼底病变可能,建议服药期间每间隔6个月进行眼科检查.

Hydroxychloroquine treatment for primary Sj(o)gren's syndrome:a prospective,open labeled clinical trial

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.