McMaster University Medical School, Hamilton, Ont.
Can J Ophthalmol. 2010 Dec;45(6):590-5. doi: 10.3129/i10-082.
To assess the effectiveness of intravitreal ranibizumab for neovascular age-related macular degeneration (AMD) in a tertiary care retina practice and compare these results with published efficacy data from randomized clinical trials.
Nonrandomized, consecutive, single-centre, retrospective chart review analysis.
Ninety-four patients (95 eyes) with neovascular AMD.
All treatment-naïve patients with neovascular AMD who received ranibizumab and for whom 1 year of follow-up was available were included in the analysis. The following information was gathered from each patient's chart: age, sex, ocular history, treated eye, duration of symptoms at presentation, subtype of choroidal neovascular membrane, Snellen visual acuity at each visit, number of injections, visits, and optical coherence tomography measurements.
Subjects had a mean age of 81 (SD 7.11) years. The mean number of injections was 5.1 (SD 2.85) with a mean of 9.4 (SD 2.27) visits in the 12-month period. Overall, there was a gain of 2.88 (SD 24.6) letters in all eyes, and a loss of 2.5 (SD 23.1) letters in patients who met the visual acuity inclusion criteria for the clinical trials. Of the patients who met the inclusion criteria, 75% lost fewer than 15 letters and 11% gained more than 15 letters.
Visual outcomes in our study patients compared poorly with the clinical trials. Possibilities for the disparity include gaps in the number and frequency of follow-up visits, patient or doctor assessment fatigue, or gaps in optical coherence tomography utilization and the number of injections administered.
评估玻璃体腔雷珠单抗治疗新生血管性年龄相关性黄斑变性(AMD)在三级保健视网膜实践中的效果,并将这些结果与来自随机临床试验的已发表疗效数据进行比较。
非随机、连续、单中心、回顾性图表审查分析。
94 名新生血管性 AMD 患者(95 只眼)。
所有接受雷珠单抗治疗且可获得 1 年随访的初治新生血管性 AMD 患者均纳入分析。从每位患者的图表中收集了以下信息:年龄、性别、眼部病史、治疗眼、就诊时症状持续时间、脉络膜新生血管膜亚型、每次就诊的 Snellen 视力、注射次数、就诊次数和光学相干断层扫描测量。
受试者的平均年龄为 81 岁(标准差 7.11)。在 12 个月的时间内,平均注射次数为 5.1 次(标准差 2.85),平均就诊次数为 9.4 次(标准差 2.27)。总体而言,所有眼的视力均提高了 2.88 个字母(标准差 24.6),符合临床试验视力纳入标准的患者则损失了 2.5 个字母(标准差 23.1)。符合纳入标准的患者中,75%的患者损失的字母少于 15 个,11%的患者增加的字母多于 15 个。
与临床试验相比,我们研究患者的视力结果较差。差异的可能性包括随访次数和频率的差距、患者或医生评估疲劳,或者光学相干断层扫描利用率和注射次数的差距。