Results of the European Glaucoma Prevention Study
Results of the European Glaucoma Prevention Study
复制标题
DOI：
10.1016/j.ophtha.2004.11.030
复制
发表时间：
2005-03-01
期刊：
影响因子：
13.7
通讯作者：
Miglior, S
中科院分区：
文献类型：
--
作者：
Centofanti, M;Zeyen, T;Miglior, S
目的：欧洲青光眼预防研究旨在评价多唑胺降低眼压在预防或延缓高眼压患者原发性开角型青光眼(POAG)中的作用。设计：随机、双盲、对照临床试验。参与者：来自18个欧洲中心的1,081名患者(年龄大于或等于30岁)。患者符合一系列纳入标准，包括：眼压22~29 mm Hg；2个正常且可靠的视野(基于标准30/II Humphrey或Octopus视野计的平均偏差和校正模式标准差或校正损失方差)；正常视盘，由光盘阅读中心确定。干预：患者被随机分为多唑胺或安慰剂(多唑胺的载体)治疗。主要观察指标：疗效终点为视野、视盘改变或两者兼而有之。随访期间的视野改变必须通过另外两项阳性测试来确认。视盘改变的定义是基于评估视盘立体幻灯片的3个独立观察者中的2个人的同意。安全终点为连续2次检查眼压>35 mm Hg。结果：在研究过程中，多唑胺组6个月后眼压平均下降15%，5年后下降22%。安慰剂组的平均眼压在6个月后下降了9%，5年后下降了19%。在60个月时，多唑胺组和安慰剂组转换为疗效终点的累积概率分别为13.4%和14.1%(风险比，0.86；95%可信区间，0.58-1.26；P=0.45)。多唑胺组和安慰剂组发生有效或安全终点的累积概率分别为13.7%和16.4%(风险比0.73；95%可信区间0.51-1.06；P=0.1)。结论：在试验的5年中，多唑胺降低了15%~22%的眼压。然而，EGPS没有发现药物治疗和安慰剂在降低大量中等风险OHT患者POAG发生率方面的统计上的显著差异，因为安慰剂也显著且持续地降低眼压。(C)2005年由美国眼科学会颁发。
Objective: The European Glaucoma Prevention Study (EGPS) seeks to evaluate the efficacy of reduction of intraocular pressure (IOP) by dorzolamide in preventing or delaying primary open-angle glaucoma (POAG) in patients affected by ocular hypertension (OHT). Design: Randomized, double-masked, controlled clinical trial.Participants: One thousand eighty-one patients (age, greater than or equal to30 years) were enrolled by 18 European centers. The patients fulfilled a series of inclusion criteria, including: IOP 22 to 29 mmHg; 2 normal and reliable visual fields (on the basis of mean deviation and corrected pattern standard deviation or corrected loss variance of standard 30/II Humphrey or Octopus perimetry); normal optic disc as determined by the Optic Disc Reading Center.Intervention: Patients were randomized to treatment with dorzolamide or placebo (the vehicle of dorzolamide).Main Outcome Measures: Efficacy end points were visual field, optic disc changes, or both. A visual field change during follow-up had to be confirmed by 2 further positive tests. Optic disc change was defined on the basis of the agreement of 2 of 3 independent observers evaluating optic disc stereo slides. The safety end point was an IOP of more than 35 mmHg on 2 consecutive examinations.Results: During the course of the study, the mean percent reduction in IOP in the dorzolamide group was 15% after 6 months and 22% after 5 years. Mean IOP declined by 9% after 6 months and by 19% after 5 years in the placebo group. At 60 months, the cumulative probability of converting to an efficacy end point was 13.4% in the dorzolamide group and 14.1% in the placebo group (hazard ratio, 0.86; 95% confidence interval [CI], 0.58-1.26; P = 0.45). The cumulative probability of developing an efficacy or a safety end point was 13.7% in the dorzolamide group and 16.4% in the placebo group (hazard ratio, 0.73; 95% CI, 0.51-1.06; P = 0.1).Conclusions: Dorzolamide reduced IOP by 15% to 22% throughout the 5 years of the trial. However, the EGPS failed to detect a statistically significant difference between medical therapy and placebo in reducing the incidence of POAG among a large population of OHT patients at moderate risk for developing POAG, because placebo also significantly and consistently lowered IOP. (C) 2005 by the American Academy of Ophthalmology.