Einhorn Clinical Research Center, New York Eye and Ear Infirmary, New York, USA.
Am J Ophthalmol. 2012 Oct;154(4):702-11. doi: 10.1016/j.ajo.2012.04.015. Epub 2012 Jul 25.
To investigate risk factors associated with visual field progression in the Low-pressure Glaucoma Treatment Study, a prospective trial designed to compare the effects of the alpha2-adrenergic agonist brimonidine tartrate 0.2% to the beta-adrenergic antagonist timolol maleate 0.5% on visual function in low-pressure glaucoma.
Prospective cohort study.
Low-pressure Glaucoma Treatment Study patients with ≥5 visual field tests during follow-up were included. Progression was determined using pointwise linear regression analysis, defined as the same 3 or more visual field locations with a slope more negative than -1.0 dB/year at P < 5%, on 3 consecutive tests. Ocular and systemic risk factors were analyzed using Cox proportional hazards model and further tested for independence in a multivariate model.
A total of 253 eyes of 127 subjects (mean age, 64.7 ± 10.9 years; mean follow-up, 40.6 ± 12 months) were analyzed. Eyes randomized to timolol progressed faster than those randomized to brimonidine (mean rates of progression, -0.38 ± 0.9 vs 0.02 ± 0.7 dB/y, P < .01). In the final multivariate model adjusting for all tested covariates, older age (hazard ratio [HR] = 1.41/decade older, 95% confidence interval [CI] = 1.05 to 1.90, P = .022), use of systemic antihypertensives (HR = 2.53, 95% CI = 1.32 to 4.87, P = .005), and mean ocular perfusion pressure (HR = 1.21/mm Hg lower, 95% CI = 1.12 to 1.31, P < .001) were associated with progression whereas randomization to brimonidine revealed a protective effect (HR = 0.26, 95% CI = 0.12 to 0.55, P < .001).
While randomization to brimonidine 0.2% was protective compared to timolol 0.5%, lower mean ocular perfusion pressure increased the risk for reaching a progression outcome in the Low-pressure Glaucoma Treatment Study. This suggests that the beneficial effect of randomization to the brimonidine arm was independent of possible differences in ocular perfusion pressures between the 2 treatment arms. The current results and large number of drop-outs in the brimonidine 0.2% arm suggest that more research is necessary before altering clinical practice paradigms.
研究与低压性青光眼治疗研究中的视野进展相关的危险因素。这是一项前瞻性试验,旨在比较α2-肾上腺素能激动剂酒石酸溴莫尼定 0.2%与β-肾上腺素能拮抗剂马来酸噻吗洛尔 0.5%对低压性青光眼患者视觉功能的影响。
前瞻性队列研究。
纳入了在随访过程中至少有 5 次视野检查的低压性青光眼治疗研究患者。采用逐点线性回归分析确定进展,定义为在 3 次连续检查中,有 3 个或更多相同的视野位置的斜率比-1.0dB/年更负,P<5%。使用 Cox 比例风险模型分析眼和全身危险因素,并在多变量模型中进一步检验其独立性。
共分析了 127 例患者的 253 只眼(平均年龄 64.7±10.9 岁;平均随访时间 40.6±12 个月)。随机分配至噻吗洛尔组的眼比随机分配至溴莫尼定组的眼进展更快(平均进展速度分别为-0.38±0.9dB/y 和 0.02±0.7dB/y,P<0.01)。在调整所有测试协变量的最终多变量模型中,年龄较大(危险比[HR]为每增加 10 岁增加 1.41,95%置信区间[CI]为 1.05 至 1.90,P=0.022)、使用全身降压药(HR=2.53,95%CI=1.32 至 4.87,P=0.005)和平均眼灌注压(HR=每降低 1mmHg 增加 1.21,95%CI=1.12 至 1.31,P<0.001)与进展相关,而随机分配至溴莫尼定则显示出保护作用(HR=0.26,95%CI=0.12 至 0.55,P<0.001)。
与噻吗洛尔 0.5%相比,随机分配至溴莫尼定 0.2%具有保护作用,但平均眼灌注压降低增加了达到低压性青光眼治疗研究进展结果的风险。这表明,随机分配至溴莫尼定组的有益效果独立于两种治疗组之间可能存在的眼灌注压差异。目前的结果和溴莫尼定 0.2%组大量的脱落率表明,在改变临床实践模式之前,还需要进行更多的研究。