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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 observe the efficacy and safety of bromfenac sodium eye drops in the treatment of inflammation after cataract surgery. Methods A total of 134 patients with cataract were divided into experimental group (66 cases) and control group (68 cases). The control group and the experimental group were dropped with imported bromfenac sodium hydrate eye drops and domestic bromfenac sodium eye drops twice a day, each drop of 1, 2 groups were medication 14 d. The clinical efficacy and adverse drug reactions of the two groups were compared. Results After treatment, the cure rate of the experimental group was 53.97% (34/63 cases), the effective rate was 46.03% (29/63 cases); the cure rate of the control group was 67.74% (42/62 cases), the effective rate was 32.26% 20/62 cases), there was no significant difference between the two groups (P> 0.05). There were no significant differences between the two groups (P> 0.05), including 134 cases of safety data set. After 3, 7 and 14 days of medication, there was no significant difference between the groups in eye tolerance, burning sensation, itching and punctate corneal epithelial scoring. In the control group, there were 1 case of foreign body sensation, 2 cases of liver dysfunction, 2 cases of abnormal urine leukocyte, and 7.35% (5/68 cases) of adverse drug reaction. One case of urinary tract infection and 1 case of dizziness For example, there was 1 case of primary acute angle-closure glaucoma in right eye, 1 case of mild left anterior chamber reaction, and 6.06% (4/66 cases) of adverse drug reactions. The difference was not statistically significant (P> 0.05) . Conclusion Domestic bromfenac sodium eye drops for the treatment of inflammation after cataract surgery curative effect, the incidence of adverse drug reactions is low, similar to the import of bromfenac sodium eye drops.