Caruso R C, Nussenblatt R B, Csaky K G, Valle D, Kaiser-Kupfer M I
Ophthalmic Genetics and Visual Function Branch, National Eye Institute, National Institutes of Health, Bethesda, MD 20892-1860, USA.
Arch Ophthalmol. 2001 May;119(5):667-9. doi: 10.1001/archopht.119.5.667.
To assess the course of change of visual function outcome variables in 5 patients with gyrate atrophy before a gene replacement therapy clinical trial.
The outcome variables selected were visual field sensitivity and electroretinogram amplitude. The course of change of these outcome variables was determined by calculation of their half-lives.
In the 4 to 6 years during which each patient was followed up for this study, median visual field half-lives were 17.0 years (static perimetry) and 11.4 years (kinetic perimetry). Median electroretinogram half-lives were 16.0 years (maximal response) and 10.7 years (flicker response).
The course of the decline of visual function outcome variables is frequently slow. Thus, a long-term clinical trial would be required to assess the efficacy of the intervention in the preservation of visual function.
在一项基因替代疗法临床试验之前，评估5例回旋状萎缩患者视觉功能结局变量的变化过程。
选择的结局变量为视野敏感度和视网膜电图振幅。通过计算这些结局变量的半衰期来确定其变化过程。
在本研究对每位患者进行随访的4至6年期间，视野半衰期的中位数分别为17.0年（静态视野检查）和11.4年（动态视野检查）。视网膜电图半衰期的中位数分别为16.0年（最大反应）和10.7年（闪烁反应）。
视觉功能结局变量的下降过程通常较为缓慢。因此，需要进行长期临床试验来评估干预措施在保护视觉功能方面的疗效。
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