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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 analyze the safety of domestic 1% cyclosporine eye drops in prevention and treatment of corneal graft rejection. Methods The clinical data of 2013 patients with conventional 1% cyclosporin eye drops after corneal transplantation (≤ 1 year) were analyzed and their adverse events / reactions and ophthalmological examinations were analyzed. Results Among the 2013 patients, 498 (795) had adverse events (24.74%), of which 352 (530 were adverse reactions). Adverse events / reactions are mainly eye discomfort, manifested as eye irritation, foreign body sensation, conjunctival hyperemia, photophobia, tearing, burning sensation, corneal epithelial rough and itch. Compared with the baseline, the incidence of conjunctival hyperemia and the incidence of corneal graft shedding in 1, 2, 3, 4 and 6 months after treatment were significantly decreased (all P <0.05). After treatment, the visual acuity was significantly improved and recovered in the operated eyes, and the intraocular pressure increased significantly compared with the baseline (P <0.05). Conclusion Domestic 1% cyclosporine eye drops prevent and treat corneal graft rejection. The main adverse reactions are mild eye discomfort and no systemic adverse reactions.