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Comparison between bimatoprost and latanoprost-timolol fixed combination for efficacy and safety after switching patients from?latanoprost

机译:比马前列素与拉坦前列素-替莫洛尔固定组合在患者转为拉坦前列素后的疗效和安全性比较

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Background: The purpose of this study was to prospectively evaluate and compare intraocular pressure (IOP) reduction efficacy and safety between bimatoprost and latanoprost-timolol fixed combination (LTFC) in Japanese patients with open-angle glaucoma.Methods: In this prospective, randomized, non-masked study, after enrolling 70 eyes of 70 Japanese open-angle glaucoma patients who had used latanoprost monotherapy for more than 4 weeks, the subjects were randomly divided into a bimatoprost group or an LTFC group. Both groups were switched from latanoprost to bimatoprost or LTFC for 12 weeks. IOP, conjunctival injection score, corneal epitheliopathy score (area density classification; AD score), tear film break-up time, heart rate, and blood pressure were evaluated at 0, 4, and 12 weeks after switching. The paired t-test and Mann–Whitney U-test were used for the statistical analysis.Results: After 13 of the 70 patients dropped out, 57 were analyzed for IOP reduction and safety. There was a significant decrease in mean IOP at 4 weeks compared with week 0 in both groups (both P<0.0001). Comparisons between the two groups showed no statistically significant differences. The conjunctival injection score was higher in the bimatoprost group than in the LTFC group at 12 weeks (P=0.0091). There were no statistically significant differences between the two drugs in relation to AD score, tear film break-up time, heart rate, and blood pressure.Conclusion: Bimatoprost and LTFC exhibited similar efficacy for reduction of IOP. Safety results indicated that only the conjunctival injection score at 12 weeks was higher in the bimatoprost group compared with the LTFC group.
机译:背景:本研究的目的是前瞻性评估和比较在日本开角型青光眼患者中比马前列素与拉坦前列素-替莫洛尔固定组合(LTFC)之间的眼内压(IOP)降低效果和安全性。方法:在一项非掩盖研究中,纳入70名使用拉坦前列素单药治疗超过4周的日本开角型青光眼患者的70只眼后,将受试者随机分为比马前列素组或LTFC组。两组均从拉坦前列素转换为比马前列素或LTFC,持续12周。分别在切换后0、4和12周评估IOP,结膜注射评分,角膜上皮病变评分(区域密度分类; AD评分),泪膜破裂时间,心率和血压。结果采用统计学处理。配对t检验和Mann-Whitney U检验用于统计学分析。结果:在70例患者中有13例退出后,对57例的IOP降低和安全性进行了分析。两组的平均眼压均比第0周显着降低(均P <0.0001)。两组之间的比较显示无统计学显着差异。在12周时,比马前列素组的结膜注射评分高于LTFC组(P = 0.0091)。两种药物在AD评分,泪膜破裂时间,心率和血压方面均无统计学差异。结论:比马托前列素和LTFC在降低眼压方面具有相似的功效。安全性结果表明,比马前列素组仅12周时的结膜注射评分高于LTFC组。

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