RVS College of Pharmaceutical Sciences, Sulur, Coimbatore-641 402, Tamilnadu, India.
Indian J Pharmacol. 2010 Dec;42(6):362-5. doi: 10.4103/0253-7613.71917.
This study was designed to compare the bimatoprost/timolol combination and dorzolamide/timolol combination in glaucoma for efficacy, safety, and cost-effectiveness in a local population of Trichy in the state of Tamilnadu.
Eight-week, randomized, parallel group, open-label study was conducted on 48 patients of open angle glaucoma or ocular hypertension. After initial clinical assessment and baseline investigations, bimatoprost/timolol combination (Group A) was prescribed to 22 patients (2 patients lost after initial assessment) and dorzolamide/timolol combination (Group B) to 24 patients. The patients were reviewed after second and eighth weeks for cure rate and adverse drug reaction monitoring.
At the end of 8 weeks, the mean reduction in intraocular pressure from baseline was 13.04 mmHg (95% confidence interval (CI): 10.67-14.70) with bimatoprost/timolol combination once daily (P < 0.01) and 9.46 mmHg (95% CI: 7.47-10.5) with dorzolamide/timolol combination twice daily. Both the treatments were safe. Cost-effective range of bimatoprost/timolol combination was lower than that of dorzolamide/timolol combination.
The fixed combination of bimatoprost/timolol was slightly more effective than that of dorzolamide/timolol combination in reducing IOP, and both treatments were generally well tolerated. Bimatoprost/timolol combination was more cost-effective (cost-effective analysis) than dorzolamide/timolol combination.
本研究旨在比较在泰米尔纳德邦特里奇的当地人群中,贝美前列素/噻吗洛尔联合治疗与多佐胺/噻吗洛尔联合治疗开角型青光眼或高眼压症的疗效、安全性和成本效益。
进行了一项为期 8 周、随机、平行组、开放性标签研究,纳入 48 例开角型青光眼或高眼压症患者。在初始临床评估和基线调查后,为 22 例患者(2 例在初始评估后失访)开处方贝美前列素/噻吗洛尔联合治疗(A 组),为 24 例患者开处方多佐胺/噻吗洛尔联合治疗(B 组)。在第 2 周和第 8 周时对患者进行复查,以评估治愈率和药物不良反应监测情况。
在第 8 周末,与每日一次多佐胺/噻吗洛尔联合治疗(眼压降低 9.46mmHg,95%置信区间[CI]:7.47-10.5)相比,贝美前列素/噻吗洛尔联合治疗(眼压降低 13.04mmHg,95%CI:10.67-14.70)可使眼压平均降低 13.04mmHg(95%CI:10.67-14.70)(P<0.01)。两种治疗均安全。贝美前列素/噻吗洛尔联合治疗的成本效益范围低于多佐胺/噻吗洛尔联合治疗。
贝美前列素/噻吗洛尔固定联合治疗在降低眼压方面略优于多佐胺/噻吗洛尔联合治疗,且两种治疗均普遍耐受良好。贝美前列素/噻吗洛尔联合治疗的成本效益(成本效益分析)优于多佐胺/噻吗洛尔联合治疗。