Motolko Michael A
Ivey Eye Institute, University of Western Ontario, London, ON, Canada.
Curr Med Res Opin. 2008 Sep;24(9):2663-7. doi: 10.1185/03007990802333167. Epub 2008 Aug 7.
To evaluate the incidence of ocular allergy in glaucoma patients prospectively treated with 0.2% brimonidine-0.5% timolol fixed combination (Combigan) compared with the incidence of ocular allergy in patients treated with 0.2% brimonidine (Alphagan) monotherapy.
This was a comparative, non-randomized, single-site, interventional study involving patients with primary open-angle glaucoma or exfoliation syndrome who had not previously used brimonidine in any formulation and had no history of ocular allergy. In one study arm, 102 patients were prospectively treated with twice-daily 0.2% brimonidine-0.5% timolol fixed combination. In the other study arm, medical charts at the same center were reviewed to identify a control group of 102 patients who had been treated with twice-daily 0.2% brimonidine monotherapy. Follow-up was at 1, 3, 6, 9, 12, 15, and 18 months of treatment.
Ocular allergy defined as the presence of follicles and redness severe enough to warrant discontinuation of the medication.
The incidence of ocular allergy over 18 months of treatment was 8.8% (9/102) in the fixed-combination group compared with 17.6% (18/102) in the brimonidine group (p=0.097). Kaplan-Meier survival analysis suggested that ocular allergy may be reduced or delayed in patients treated with the brimonidine-timolol fixed combination (p=0.066).
The brimonidine-timolol fixed combination was associated with a 50% lower incidence in ocular allergy compared with 0.2% brimonidine monotherapy. This difference between treatments was not statistically significant (p=0.097) but is likely to be clinically important. Additional studies are needed to evaluate the incidence of ocular allergy associated with brimonidine-timolol fixed combination treatment.
前瞻性评估接受0.2%酒石酸溴莫尼定-0.5%噻吗洛尔固定复方制剂(Combigan)治疗的青光眼患者眼部过敏的发生率,并与接受0.2%酒石酸溴莫尼定(Alphagan)单药治疗的患者眼部过敏发生率进行比较。
这是一项比较性、非随机、单中心的干预性研究,纳入未曾使用过任何剂型酒石酸溴莫尼定且无眼部过敏史的原发性开角型青光眼或剥脱综合征患者。在一个研究组中,102例患者前瞻性接受每日两次的0.2%酒石酸溴莫尼定-0.5%噻吗洛尔固定复方制剂治疗。在另一个研究组中,回顾同一中心的病历以确定一个由102例接受每日两次0.2%酒石酸溴莫尼定单药治疗的患者组成的对照组。随访时间为治疗的第1、3、6、9、12、15和18个月。
眼部过敏定义为出现滤泡且眼红严重到足以停药。
固定复方制剂组在18个月治疗期间眼部过敏发生率为8.8%(9/102),而酒石酸溴莫尼定组为17.6%(18/102)(p=0.097)。Kaplan-Meier生存分析表明,接受酒石酸溴莫尼定-噻吗洛尔固定复方制剂治疗的患者眼部过敏可能减少或延迟(p=0.066)。
与0.2%酒石酸溴莫尼定单药治疗相比,酒石酸溴莫尼定-噻吗洛尔固定复方制剂使眼部过敏发生率降低了50%。两种治疗方法之间的这种差异无统计学意义(p=0.09),但可能具有临床重要性。需要进一步研究以评估酒石酸溴莫尼定-噻吗洛尔固定复方制剂治疗相关的眼部过敏发生率。