长期应用羟氯喹治疗风湿免疫病眼部安全性的前瞻性研究

Prospective study on the long-term ocular toxicity of hydroxychloroquine in rheumatic diseases

目的研究羟氯喹（HCQ）的眼部安全性。方法选择2005年8月至2007年6月正在服用HCQ的170例自身免疫病患者。每例患者均进行视力、眼压、眼底等常规眼部检查，此外还进行了视野、视网膜电图（ERG）和眼电位图（EOG）检查。要求患者每6个月复诊1次。结果170例风湿免疫病患者人均服用HCQ为16．1个月，服用时间最短为半个月，最长为48个月。服用HCQ的总剂量为6-584g。用药过程中所有患者的视力、跟压、视野均正常。其中52例进行了ERG和EOG检查，ERG检查均在正常范围内，且随用药时间延长差异无统计学意义，2例患者EOG检测光峰／暗谷比值（Arden比）低于正常，患者均无眼部不适，其中1例为高度近视，其他检查均正常。结论研究表明HCQ具有良好的眼部安全性，尚需要进一步扩大样本量并延长随访时间了解其长期用药的安全性。

Objective In order to evaluate the long-term ocular safety of hydroxyehloroqine, we prospectively study the ocular symptoms, routine ophthalmological screening tests and eleetrophysiological tests in patients taking hydroxyehloroquine. Methods 170 cases of autoimmune diseases patients who had taken hydroxychloroqine during August, 2005 to June, 2007 were enrolled into the study. Visual acuity , intraocular pressure, and fundoscopy examination, visual field testing, eleetroretinogram （ERG） and electrooculogram （EOG） were examined every six months. Results The average duration of taking hydroxychloroquine was 16.1 month, ranging from 0.5 to 48 months. The total dose ranged from 6 g to 584 g. All patients＇ visual acuity and intraoeular pressure were normal. Fifty-two cases had performed ERG and EOG. The ERG tests were normal in 52 patients. The EOG test of 2 patients showed that the Arden ratio was lower than normal, in which one had severe myopia. Other tests done for these two persons were normal. Conclusion This observational study has shown that hydroxychloroquine has good ocular safety. Further studies with much longer follow-up period will be useful in evaluating the retinal toxicity of hydroxychloroquine.