青光眼临床试验中的平均眼压与最高眼压分析。

Average versus highest intraocular pressure analyses in glaucoma clinical trials.

机构信息

Department of Ophthalmology, Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

出版信息

Ophthalmic Res. 2013;49(1):49-51. doi: 10.1159/000343773. Epub 2012 Oct 30.

DOI:10.1159/000343773

PMID:23128328

Abstract

PURPOSE

To evaluate methods which account for both eyes as a single, independent variable in glaucoma clinical trials.

METHODS

A review of clinical trial articles published between January 1995 and April 2011 evaluating currently used topical glaucoma medications.

RESULTS

This analysis included 17 articles with 36 treatment arms of which 14 were prostaglandins, 13 β-blockers, 6 topical carbonic anhydrase inhibitors and 3 α-agonists. Twenty-four articles used average intraocular pressure (IOP) analysis, 12 used the highest IOP analysis and none utilized the randomized eye method. At untreated baseline, there was a difference in the IOP between average IOP and highest baseline IOP analyses at 8 a.m. (p = 0.001) and for the diurnal curve (p = 0.02) as well as specifically for β-blockers (p = 0.002) at 8 a.m. and β-blockers for the diurnal curve (p = 0.01).

CONCLUSIONS

This study suggests that the highest IOP analysis method generally provides slightly higher IOPs at baseline than the average IOP analysis method.

摘要

目的

评估在青光眼临床试验中同时将双眼作为单一独立变量的方法。

方法

对 1995 年 1 月至 2011 年 4 月间发表的评估现有局部青光眼药物的临床试验文章进行回顾。

结果

本分析共纳入 17 篇文章，涉及 36 种治疗方案，其中 14 种为前列腺素类药物，13 种为β-受体阻滞剂，6 种为局部碳酸酐酶抑制剂，3 种为α-激动剂。24 篇文章采用平均眼压（IOP）分析，12 篇文章采用最高眼压分析，没有一篇文章采用随机眼法。在未经治疗的基础期，平均 IOP 和最高基础期 IOP 分析在 8 点时的 IOP 存在差异（p = 0.001），且在日间曲线（p = 0.02）以及特定的β-受体阻滞剂（p = 0.002）和β-受体阻滞剂的日间曲线（p = 0.01）中也存在差异。