Adjunctive antihypertensive therapy of primary glaucoma with a fixed combination drug of 1% brinzolamide and 0.5% timolol: efficacy and safety

Q4 Medicine
S. Petrov, O. M. Kalinina, L. V. Yakubova, S. M. Kosakyan, L. V. Vasilenkova, O. M. Filippova, A. Zhuravleva, O. I. Markelova
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Abstract

Purpose: a comparative study of the efficacy and safety of the combination drug Brinzopt Plus and the original drug Azarga used as adjunctive therapy in patients with primary open-angle glaucoma (POAG) previously treated with latanoprost.Material and methods. 30 patients (42 eyes) with advanced and far advanced POAG were randomly divided into 2 groups of equal size. The patients of the main group (21 eyes) received Brinzopt Plus, those of the control group had the original drug Azarga, one instillation 2 times a day. The target points were intraocular pressure (IOP), visual acuity, perimetric indices (MD, PSD), mean retinal nerve fiber layer thickness, minimal neuroretinal rim width, retinal nerve fiber layer thickness in the macula, ganglion cell layer thickness in the macula, inner plexiform layer thickness, as well as the number of adverse events. The observation period was 12 weeks. IOP was measured at 4 and 12 weeks.Results. After 2 weeks, both groups showed a statistically significant decrease in IOP, which remained stable after 4 and 12 weeks. The average decrease in IOP in Brinzopt Plus recipients was 25% and revealed no statistically significant differences with the original drug at any control point. A positive dynamic of visual acuity, static perimetry and optical coherence tomography values, which showed no significant intergroup differences, was recorded. Among the adverse events, manifestations of mild local discomfort were recorded in 4 out of 15 patients of the main group and in 3 out of 15 patients of the control group. No serious or systemic adverse events were noted.Conclusion. Brinzopt Plus has an efficacy comparable to the original drug and a favorable safety profile.
1%布林唑胺和0.5%替洛尔固定联合治疗原发性青光眼的疗效和安全性
目的:比较联合用药Brinzot-Plus和原研药Azarga辅助治疗拉坦前列素治疗原发性开角型青光眼(POAG)的疗效和安全性。材料和方法。30例(42眼)晚期和晚期POAG患者随机分为大小相等的2组。主要组患者(21眼)接受Brinzopt Plus治疗,对照组患者接受阿扎尔加原始药物治疗,每天滴注2次。目标点为眼压(IOP)、视力、周长指数(MD、PSD)、平均视网膜神经纤维层厚度、最小神经视网膜边缘宽度、黄斑视网膜神经纤维厚度、黄斑神经节细胞层厚度、内丛状层厚度以及不良事件数。观察期为12周。在第4周和第12周测量IOP。后果2周后,两组的眼压均出现统计学显著下降,在4周和12周后保持稳定。Brinzopt Plus受试者的IOP平均下降了25%,在任何对照点与原始药物没有统计学上的显著差异。记录了视力、静态视野和光学相干断层扫描值的正动态,组间无显著差异。在不良事件中,主要组的15名患者中有4名出现轻度局部不适症状,对照组的15例患者中有3例出现轻微局部不适。未发现严重或系统性不良事件。结论Brinzopt Plus的疗效与原始药物相当,安全性良好。
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来源期刊
CiteScore
0.50
自引率
0.00%
发文量
107
审稿时长
16 weeks
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