Babić Nikola, Andreić Veljko, Miljković Aleksandar, Canadanović Vladimir, Barisić Sava
Klinika za ocne bolesti, Klinicki centar Vojvodinc, Novi Sad.
Med Pregl. 2011 May-Jun;64(5-6):310-4. doi: 10.2298/mpns1106310b.
This study was aimed at evaluating the safety and efficacy of brinzolamide 1% suspension (Azopt 1%) and travoprost 0.004% (Travatan) combined therapy in patients with open-angle glaucoma or ocular hypertension who are in need of additional intraocular pressure lowering.
This is a prospective, three-month, open-label, clinical study. Forty patients (80 eyes) with primary open-angle glaucoma or ocular hypertension on Travatan treatment and with unsatisfactory results in lowering intraocular pressure were included in the study. The qualifying intraocular pressure on previous treatment with Travatan (at least 6 weeks) was 22-36 mmHg in at least one eye at 8 a.m. intraocular pressure measurements at three eligibility visits. The patients received brinzolamide 1% twice a day in addition to travoprost 0.004% given once a day in the evening for 3 months. The follow-up examinations assessing the safety and efficacy of combined therapy of brinzolamide 1% and travoprost 0.004% were performed after 1 and 3 months.
Adjunctive therapy with brinzolamide resulted in statistically significant reductions in intraocular pressure from the travoprost baseline at all visits. Treatment with brinzolamide/travoprost caused statistically significant sustained reduction in intraocular pressure with the reduction of 17.39% (p < 0.001) after 4 weeks and 20.08% (p < 0.001) after 12 weeks. The intraocular pressure change from the baseline ranged from -3.9 mmHg after 4 weeks to -4.48 mmHg after 12 weeks. The most frequently related adverse effect was abnormal taste and blurred vision.
Brinzolamide 1% (b.i.d) used adjunctively with travoprost 0.004% (q.d.) lowers intraocular pressure significantly compared to travoprost alone. Both drugs were well tolerated and safe in the studied patients.
本研究旨在评估1%布林佐胺混悬液(阿佐普特1%)与0.004%曲伏前列素(适利达)联合治疗对需要进一步降低眼压的开角型青光眼或高眼压症患者的安全性和有效性。
这是一项为期三个月的前瞻性开放标签临床研究。研究纳入了40例(80只眼)接受适利达治疗但眼压降低效果不理想的原发性开角型青光眼或高眼压症患者。在三次符合入组标准的就诊时,上午8点测量眼压,之前使用适利达治疗(至少6周)时,至少一只眼的合格眼压为22 - 36 mmHg。患者在每晚一次给予0.004%曲伏前列素的基础上,每天两次使用1%布林佐胺,持续3个月。在1个月和3个月后进行随访检查,评估1%布林佐胺与0.004%曲伏前列素联合治疗的安全性和有效性。
在所有就诊时,与曲伏前列素基线相比,布林佐胺辅助治疗使眼压有统计学意义的显著降低。布林佐胺/曲伏前列素治疗使眼压有统计学意义的持续降低,4周后降低17.39%(p < 0.001),12周后降低20.08%(p < 0.001)。眼压相对于基线的变化范围为4周后-3.9 mmHg至12周后-4.48 mmHg。最常见的相关不良反应是味觉异常和视力模糊。
与单独使用曲伏前列素相比,1%布林佐胺(每日两次)与0.004%曲伏前列素(每日一次)联合使用可显著降低眼压。在研究患者中,两种药物耐受性良好且安全。