黄斑下放疗研究（SFRADS）中的视觉功能与生活质量：SFRADS报告2
Visual functioning and quality of life in the SubFoveal Radiotherapy Study (SFRADS): SFRADS report 2.
作者信息
Stevenson M R, Hart P M, Chakravarthy U, Mackenzie G, Bird A C, Owens S L, Chisholm I H, Hall V, Houston R F, McCulloch D W, Plowman N
机构信息
Ophthalmology and Vision Science, Royal Hospitals, Belfast BT12 6BA, UK.
出版信息
Br J Ophthalmol. 2005 Aug;89(8):1045-51. doi: 10.1136/bjo.2003.030445.
AIMS
To determine whether or not self reported visual functioning and quality of life in patients with choroidal neovascularisation caused by age related macular degeneration (AMD) is better in those treated with 12 Gy external beam radiotherapy in comparison with untreated subjects.
METHODS
A multicentre single masked randomised controlled trial of 12 Gy of external beam radiation therapy (EBRT) delivered as 6 x 2 Gy fractions to the macula of an affected eye versus observation. Patients with AMD, aged 60 years or over, in three UK hospital units, who had subfoveal CNV and a visual acuity equal to or better than 6/60 (logMAR 1.0).
METHODS
Data from 199 eligible participants who were randomly assigned to 12 Gy teletherapy or observation were available for analysis. Visual function assessment, ophthalmic examination, and fundus fluorescein angiography were undertaken at baseline and at 3, 6, 12, and 24 months after study entry. To assess patient centred outcomes, subjects were asked to complete the Daily Living Tasks Dependent on Vision (DLTV) and the SF-36 questionnaires at baseline, 6, 12, and 24 months after enrolment to the study. Cross sectional and longitudinal analyses were conducted using arm of study as grouping variable. Regression analysis was employed to adjust for the effect of baseline co-variates on outcome at 12 months and 24 months.
RESULTS
Both control and treated subjects had significant losses in visual functioning as seen by a progressive decline in mean scores in the four dimensions of the DLTV. There were no statistically significant differences between treatment and control subjects in any of dimensions of the DLTV at 12 months or 24 months after study entry. Regression analysis confirmed that treatment status had no effect on the change in DLTV dimensional scores.
CONCLUSIONS
The small benefits noted in clinical measures of vision in treated eyes did not translate into better self reported visual functioning in patients who received treatment when compared with the control arm. These findings have implications for the design of future clinical trials and studies.
目的
确定年龄相关性黄斑变性（AMD）所致脉络膜新生血管患者中，接受12 Gy外照射放疗的患者与未接受治疗的患者相比，自我报告的视觉功能和生活质量是否更好。
方法
一项多中心单盲随机对照试验，将12 Gy外照射放疗（EBRT）以6×2 Gy分次照射患眼黄斑区与观察进行对比。英国三个医院科室中年龄在60岁及以上、患有黄斑下脉络膜新生血管且视力等于或优于6/60（logMAR 1.0）的AMD患者。
方法
199名随机分配至12 Gy远距离治疗或观察组的符合条件参与者的数据可供分析。在基线以及研究入组后3、6、12和24个月进行视觉功能评估、眼科检查和眼底荧光血管造影。为评估以患者为中心的结局，要求受试者在基线、入组研究后6、12和24个月完成依赖视力的日常生活任务（DLTV）和SF-36问卷。使用研究组作为分组变量进行横断面和纵向分析。采用回归分析调整基线协变量对12个月和24个月结局的影响。
结果
如DLTV四个维度的平均得分逐渐下降所示，对照组和治疗组患者的视觉功能均有显著丧失。研究入组后12个月或24个月时，治疗组和对照组患者在DLTV的任何维度上均无统计学显著差异。回归分析证实治疗状态对DLTV维度得分的变化无影响。
结论
与对照组相比，接受治疗的患眼在视力临床测量中显示的微小益处并未转化为患者更好的自我报告视觉功能。这些发现对未来临床试验和研究的设计具有启示意义。
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