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高眼压症治疗研究中的视网膜静脉阻塞发生率。

The incidence of retinal vein occlusion in the ocular hypertension treatment study.

机构信息

Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, Missouri 63110, USA.

出版信息

Ophthalmology. 2010 Mar;117(3):484-8. doi: 10.1016/j.ophtha.2009.08.022. Epub 2010 Jan 19.

DOI:10.1016/j.ophtha.2009.08.022
PMID:20031222
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3077045/
Abstract

OBJECTIVE

To determine the incidence of retinal vein occlusion (RVO) in the Ocular Hypertension Treatment Study (OHTS).

DESIGN

Retrospective analysis of data from a randomized clinical trial.

PARTICIPANTS

We included 1636 ocular hypertensive participants with a mean follow-up of 9.1 years. Participants in the medication and observation groups were managed according to their original randomization assignment until June 1, 2002. At that time, the observation participants were offered ocular hypotensive treatment. Data to July 1, 2005, are included in this report.

METHODS

Occurrences of RVO in study participants, categorized as branch, central or hemicentral vein occlusion, were documented. Potential RVO events were identified by a keyword search of Adverse Event Reports, the Optic Disc Reading Center database, Endpoint Committee reviews, and by response to a written request for information sent to each clinical site. To confirm a potential RVO, the complete OHTS chart was reviewed. Statistical analyses included t tests, chi-square tests and Cox proportional hazards models.

MAIN OUTCOME MEASURES

Incidence of RVO.

RESULTS

Twenty-six RVOs-5 branch, 14 central, and 7 hemicentral RVOs-were confirmed in 23 participants (15 observation and 8 medication). The 10-year cumulative incidence of RVO was 2.1% in the observation group and 1.4% in the medication group (P = 0.14; log-rank test). At baseline, participants who later developed a RVO were significantly older (65.1 vs 55.3 years; P = 0.01), and had greater horizontal cup-to-disc ratios (P = 0.0004).

CONCLUSIONS

Although the incidence of RVO was higher in the observation group than the medication group, this difference did not attain significance. Consistent with some previous studies, older age and greater cup-to-disc ratio were associated with the development of RVO.

摘要

目的

确定在高眼压治疗研究(OHTS)中视网膜静脉阻塞(RVO)的发生率。

设计

对一项随机临床试验数据的回顾性分析。

参与者

我们纳入了 1636 名平均随访 9.1 年的眼压升高参与者。根据其原始随机分组,药物组和观察组的参与者一直接受治疗,直至 2002 年 6 月 1 日。此时,观察组参与者接受了降眼压治疗。本报告包括截至 2005 年 7 月 1 日的数据。

方法

记录研究参与者中 RVO 的发生情况,分为分支、中央或半中央静脉阻塞。通过对不良事件报告、视盘读数中心数据库、终点委员会审查的关键字搜索,以及对每个临床站点发送的书面信息请求的回复,来识别潜在的 RVO 事件。为了确认潜在的 RVO,对完整的 OHTS 图表进行了审查。统计分析包括 t 检验、卡方检验和 Cox 比例风险模型。

主要观察指标

RVO 的发生率。

结果

在 23 名参与者(15 名观察组和 8 名药物组)中,共确诊了 26 例 RVO(5 例分支,14 例中央,7 例半中央 RVO)。观察组的 10 年累积 RVO 发生率为 2.1%,药物组为 1.4%(P = 0.14;对数秩检验)。在基线时,以后发生 RVO 的参与者年龄明显较大(65.1 岁比 55.3 岁;P = 0.01),杯盘比也更大(P = 0.0004)。

结论

尽管观察组的 RVO 发生率高于药物组,但差异无统计学意义。与一些先前的研究一致,年龄较大和杯盘比较大与 RVO 的发生相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbdd/3077045/57899f290bc2/nihms167508f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbdd/3077045/57899f290bc2/nihms167508f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbdd/3077045/57899f290bc2/nihms167508f1.jpg

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