1%环孢素滴眼液防治角膜移植排斥反应的安全性分析  

The safety analysis of 1% cyclosporine eye drops in prevention and treatment of corneal allograft rejection

作　　者：李玉凤[1] 姚家琳[1] 张静[1] 王秒[1] 李翠娟[1] 赵庆华[1] 

机构地区：[1]华北制药股份有限公司研发中心医学部,石家庄市050015

出　　处：《临床合理用药杂志》2017年第4期43-45,共3页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的分析国产1%环孢素滴眼液防治角膜移植排斥反应的安全性。方法分析角膜移植术后(≤1年)常规应用国产1%环孢素滴眼液的2013例患者的临床资料,总结其不良事件/反应和眼科检查情况。结果 2013例患者中发生不良事件498例(795例次)占24.74%,其中不良反应352例(530例次)。不良事件/反应主要为眼部不适感,表现为眼部刺激感、异物感、结膜充血、畏光、流泪、灼热感、角膜上皮粗糙和痒等。与基线比较,用药后1、2、3、4及6个月眼部结膜充血发生率和角膜植片脱落发生率均降低,差异均有统计学意义(P<0.05)。治疗后,手术眼的视力均明显改善和恢复,眼压增高,与基线比较差异均有统计学意义(P<0.05)。结论国产1%环孢素滴眼液防治角膜移植排斥反应,主要不良反应表现为轻度眼部不适感,无全身不良反应。Objective To analysis the safety of 1% cyclosporine eye drops in prevention and treatment of corneal al- lograft rejection. Methods Analysis the clinical date of 2013 cases patients with corneal transplantation （ ≤ 1 year） treated by made 1% cyclosporine eye drops, and summarize the adverse events/reactions and eye inspection. Results Adverse events oc- curred in 498 cases （795 times） in 2013 patients accounted for 24.74 %, in whitch 352 cases of adverse reactions （530 times）. Adverse events/reactions mainly for eye discomfort,manifested as eye irritation,foreign body sensation, conjunctival hyperemia, photophobia, tearing, burning sensation, corneal epithelium rough and itchy. Compared with baseline, the incidence of conjuncti- val hyperemia and corneal graft loss decreased at 1,2,3,4 and 6 months after treatment,the difference was statistically signifi- cant （P 〈 0.05 ）. After treatment, the visual acuity of the operative eyes improved significantly and recovered, and the intraoeu- lar pressure increased, which was significantly different from the baseline （ P 〈 0.05 ）. Conclusion 1% cyclosporine eye drops to prevent corneal allograft rejection, the main adverse reactions were mild eye discomfort, no systemic adverse reactions.

关 键 词：1%环孢素滴眼液 角膜移植 安全性 

分 类 号：R779.65[医药卫生—眼科]