溴芬酸钠滴眼液治疗白内障术后炎症的临床研究  

Clinical trial of bromfenac sodium eye drop in the treatment of postoperative inflammation of cataract

作　　者：包志淑[1] 李瑾[2] 郁引飞[1] 沈汞民 金艳[3] 赵云娥[2] 

机构地区：[1]温州医科大学附属眼视光医院药物临床试验中心,浙江温州325000 [2]温州医科大学附属眼视光医院眼科,浙江温州325000 [3]杭州国光药业有限公司,杭州310000

出　　处：《中国临床药理学杂志》2017年第10期877-879,883,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家重大新药创制专项基金资助项目(2014ZX09303301)

摘　　要：目的观察溴芬酸钠滴眼液治疗白内障术后炎症的有效性和安全性。方法将134例白内障术后患者分为试验组66例,对照组68例。对照组和试验组分别滴用进口溴芬酸钠水合物滴眼液和国产溴芬酸钠滴眼液,每天2次,每次1滴,2组均用药14 d。比较2组患者的临床疗效和药物不良反应发生情况。结果治疗后,试验组痊愈率为53.97%(34/63例),显效率为46.03%(29/63例);对照组痊愈率为67.74%(42/62例),显效率为32.26%(20/62例),组间差异无统计学意义(P>0.05)。纳入安全数据集134例,用药3,7,14 d后,眼部耐受性、烧灼感、眼痒及角膜上皮点状脱落评分,组间差异无统计学意义(P>0.05)。对照组发生术眼用药后异物感1例,肝功能异常2例,尿白细胞异常2例,药物不良反应发生率为7.35%(5/68例);试验组发生泌尿系统感染1例,头晕1例,右眼原发性急性闭角型青光眼发作1例,左眼前房轻度反应1例,药物不良反应发生率为6.06%(4/66例),差异无统计学意义(P>0.05)。结论国产溴芬酸钠滴眼液用于白内障术后炎症的治疗疗效确切,药物不良反应发生率低,与进口溴芬酸钠滴眼液作用相似。Objective To evaluate clinical efficacy and safety of domestic and imported bromfenac sodium eye drops in the treatment of posto-perative inflammation of cataract. Methods A total of 134 cataract patients were divided into treatment group （ n = 66 ） and control group （n = 68 ）. Control group was treated with imported bromfenac sodium eye drops, and treatment group was given domestic bromfenac sodium eye drops, 1 drop in morning and evening respectively. All patients were treated for 14 d. The clinical efficacy and adverse drug reactions in two groups were compared. Results After treatment, the cured rate and effective rate in treatment group were 53.97% （34/63 cases）, 46.03% （29/63 cases）. The cured rate and effective rate in control group were 67.74% （42/62 cases） , 32. 26% （20/62 cases）. There was no signifi cant difference between two groups （P 〉 0. 05 ）. There were no statistical differences between the two groups in ocular tolerance, burning sensation, ophthalmic itching and corneal epithelium spotting at 3, 7, 14 d after treatment （ P 〉 0. 05 ）. There were 1 case of eye discomfort, 2 cases of liver function abnormal and 2 cases of urine leukocyteabnormal in control group, with the incidence rate of 7.35 % （5/68 cases）. There were 1 case of infection in urinary system, 1 case of dizziness, 1 case of pathogenesis of primary acute angle - closure glaucoma in right eye, 1 case of floating cells in anterior chamber, with the incidence rate of 6. 06% （4/66 cases,P 〉0. 05）. Conclusion The clinical efficacy of domestic bromfenac sodium eye drops in the treatment of cataract patients is comparable to imported bromfenac sodium eye drops. The clinical efficacy is exactly, with lower adverse drug reactions and price.

关 键 词：溴芬酸钠滴眼液 白内障手术 炎症 

分 类 号：R988.1[医药卫生—药品]