Kass Michael A, Gordon Mae O, Gao Feng, Heuer Dale K, Higginbotham Eve J, Johnson Chris A, Keltner John K, Miller J Philip, Parrish Richard K, Wilson M Roy
Ocular Hypertension Treatment Study Coordinating Center, Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, Box 8203, 660 S Euclid Ave, St Louis, MO 63110, USA.
Arch Ophthalmol. 2010 Mar;128(3):276-87. doi: 10.1001/archophthalmol.2010.20.
To compare the safety and efficacy of earlier vs later treatment in preventing primary open-angle glaucoma (POAG) in individuals with ocular hypertension.
One thousand six hundred thirty-six individuals with intraocular pressure (IOP) from 24 to 32 mm Hg in 1 eye and 21 to 32 mm Hg in the fellow eye were randomized to observation or to topical ocular hypotensive medication. Median time of treatment in the medication group was 13.0 years. After a median of 7.5 years without treatment, the observation group received medication for a median of 5.5 years. To determine if there is a penalty for delaying treatment, we compared the cumulative proportions of participants who developed POAG at a median follow-up of 13 years in the original observation group and in the original medication group.
Cumulative proportion of participants who developed POAG.
The cumulative proportion of participants in the original observation group who developed POAG at 13 years was 0.22 (95% confidence interval [CI], 0.19-0.25), vs 0.16 (95% CI, 0.13-0.19) in the original medication group (P = .009). Among participants at the highest third of baseline risk of developing POAG, the cumulative proportion who developed POAG was 0.40 (95% CI, 0.33-0.46) in the original observation group and 0.28 (95% CI, 0.22-0.34) in the original medication group. There was little evidence of increased adverse events associated with medication.
Absolute reduction was greatest among participants at the highest baseline risk of developing POAG. Individuals at high risk of developing POAG may benefit from more frequent examinations and early preventive treatment.
clinicaltrials.gov Identifier: NCT00000125.
比较早期治疗与晚期治疗在预防高眼压症患者原发性开角型青光眼（POAG）方面的安全性和有效性。
1636例患者，一只眼眼压为24至32mmHg，另一只眼眼压为21至32mmHg，被随机分为观察组或局部使用降眼压药物组。药物治疗组的中位治疗时间为13.0年。在未经治疗的中位时间7.5年后，观察组接受药物治疗的中位时间为5.5年。为了确定延迟治疗是否有不良影响，我们比较了在原始观察组和原始药物治疗组中，随访13年时发生POAG的参与者的累积比例。
发生POAG的参与者的累积比例。
原始观察组中13年时发生POAG的参与者的累积比例为0.22（95%置信区间[CI]，0.19 - 0.25），而原始药物治疗组为0.16（95%CI，0.13 - 0.19）（P = 0.009）。在发生POAG基线风险最高的三分之一参与者中，原始观察组发生POAG的累积比例为0.40（95%CI，0.33 - 0.46），原始药物治疗组为0.28（95%CI，0.22 - 0.34）。几乎没有证据表明药物治疗会增加不良事件。
在发生POAG基线风险最高的参与者中，绝对降低率最大。发生POAG风险高的个体可能受益于更频繁的检查和早期预防性治疗。
clinicaltrials.gov标识符：NCT00000125。
