局部应用异丙前列素对渗出性年龄相关性黄斑变性患者黄斑萎缩进展的影响。

Effect of topical isopropyl unoprostone on macular atrophy progression in eyes with exudative age-related macular degeneration.

作者信息

Shiragami Chieko, Miyake Masahiro, Fujiwara Atsushi, Morizane Yuki, Tsujikawa Akitaka, Yamashita Ayana, Shiraga Fumio

机构信息

Department of Ophthalmology, Kagawa University Faculty of Medicine, Kagawa Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto Department of Ophthalmology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.

出版信息

Medicine (Baltimore). 2017 Mar;96(12):e6422. doi: 10.1097/MD.0000000000006422.

BACKGROUND

To evaluate the efficacy and safety of topical isopropyl unoprostone (IU) in treating macular atrophy in age-related macular degeneration (AMD) patients.

METHODS

Fifty-two AMD patients with macular atrophy were included and randomly assigned (1:1) to the treatment (topical 0.15% IU) or placebo group. Subjects used study eye drops 3 times a day for 54 weeks. The macular atrophy was documented on fundus autofluorescence photographs and measured using RegionFinder. The enlargement rate of macular atrophy and the changes in visual acuity were examined statistically between baseline and 54 weeks.

RESULTS

Forty-eight subjects were included in the analyses because 4 subjects withdrew from the study. The differences between the IU and placebo groups in mean and median area of macular atrophy were not statistically significant at baseline. The baseline median lesion size of macular atrophy was 2.33 mm in the IU group and 1.63 mm in the placebo group (P = 0.51). The intergroup difference in the enlargement ratio of macular atrophy (21 ± 15% in the IU group and 111 ± 96% in the placebo group) was statistically significant (P < 0.001). Additionally, visual acuity tended to improve over baseline in the IU group. No serious adverse events were observed.

CONCLUSIONS

Topical IU therapy is safe and effective for treating macular atrophy in AMD patients.

背景

评估局部应用异丙前列酮（IU）治疗年龄相关性黄斑变性（AMD）患者黄斑萎缩的疗效和安全性。

方法

纳入52例患有黄斑萎缩的AMD患者，并随机（1:1）分配至治疗组（局部应用0.15% IU）或安慰剂组。受试者每天使用研究眼药水3次，持续54周。通过眼底自发荧光照片记录黄斑萎缩情况，并使用RegionFinder进行测量。在基线和54周时，对黄斑萎缩的扩大率和视力变化进行统计学检验。

结果

48例受试者纳入分析，因为4例受试者退出研究。IU组和安慰剂组在黄斑萎缩平均面积和中位数面积上的差异在基线时无统计学意义。IU组黄斑萎缩的基线中位数病变大小为2.33 mm，安慰剂组为1.63 mm（P = 0.51）。黄斑萎缩扩大率的组间差异（IU组为21 ± 15%，安慰剂组为111 ± 96%）具有统计学意义（P < 0.001）。此外，IU组的视力相对于基线有改善趋势。未观察到严重不良事件。