溴芬酸钠滴眼液治疗白内障术后炎症的临床研究

发布时间：2018-04-20 04:10

本文选题：溴芬酸钠滴眼液 + 白内障手术　；参考：《中国临床药理学杂志》2017年10期

【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(P0.05)。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(P0.05)。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(P0.05)。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。
[Abstract]:Objective to observe the efficacy and safety of bromofenac sodium eye drops in the treatment of postoperative inflammation of cataract. Methods 134 patients were divided into experimental group (66 cases) and control group (68 cases). The control group and the experimental group were treated with imported bromofenac sodium hydrate eye drops and domestic bromofenac sodium eye drops twice a day for 14 days. The clinical efficacy and adverse drug reactions were compared between the two groups. Results after treatment, the cure rate of the trial group was 53.97 / 34 / 63, the effective rate was 46.0329 / 63, and the control group was 67.7442 / 62 / 62, and the effective rate was 32.26 / 20 / 62. There was no significant difference between the two groups (P 0.05). 134 cases were included in the safety data set. The scores of eye tolerance, burning sensation, eye itching and corneal epithelium dotted exfoliation were not significantly different between the two groups (P 0.05). In the control group, there were 1 case of foreign body sensation, 2 cases of abnormal liver function, 2 cases of abnormal urine white blood cell, the incidence of adverse drug reaction was 7.35% 5 / 68 cases, and 1 case of urinary tract infection, 1 case of dizziness, 1 case of urinary tract infection and 1 case of dizziness in the control group. Primary acute angle closure glaucoma occurred in 1 case of right eye and mild reaction of left anterior chamber in 1 case. The incidence of adverse drug reaction was 6.06 / 4 / 66 cases. There was no significant difference between the two groups (P 0.05). Conclusion domestic bromofenac sodium eye drops are effective in the treatment of postoperative inflammation of cataract, and the incidence of adverse drug reactions is low, which is similar to that of imported bromofenac sodium eye drops.
【作者单位】：温州医科大学附属眼视光医院药物临床试验中心;温州医科大学附属眼视光医院眼科;杭州国光药业有限公司;
【基金】：国家重大新药创制专项基金资助项目(2014ZX09303301)
【分类号】：R988.1

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