抗血管内皮生长因子单克隆抗体Ranibizumab治疗湿性年龄相关性黄斑变性方案的探索

Exploration of intravitreal ranibizumab regimens for wet age-related macular degeneration

目的观察渗出性年龄相关性黄斑变性经玻璃体内注射Ranibizumab治疗前后的变化情况。方法对2012年10月至2014年3月在我院经眼科相关检查确诊为湿性年龄相关性黄斑变性的患者32例34眼,均接受Ranibizumab（10 mg·mL^-1）0.05 mL玻璃体内注射,22眼采用1＋PRN方案,另12只较为严重眼行3＋PRN方案注射,使用国际标准糖尿病早期治疗研究（EDTRS）视力表检查,术前查最佳矫正视力、眼压、OCT以及眼底荧光血管造影或吲哚青绿血管造影,随访3～11个月,分别于术后1周、2周、1个月、以后每个月观察黄斑OCT、视力、眼压,必要时查FFA、ICGA等相关指标并进行统计学分析。结果所有患眼注射（2.17±1.05）次,随访3个月、6个月时ETDRS视力分别为（34.37±12.75）个字母、（38.06±11.38）个字母,较治疗前分别提高（5.63±3.17）个字母、（9.27±5.01）个字母,差异有统计学意义（均为P=0.00）。治疗后1个月,黄斑区脉络膜新生血管基底部宽度、高度分别为（2001.83±90.71）μm、（347.23±63.73）μm,与治疗前（385.63±92.57）μm差异均有统计学意义（均为P=0.00）。治疗后1个月黄斑中心视网膜厚度为（336.90±82.11）,与治疗前差异有统计学意义（P=0.00）。随访期间未发现全身及眼部严重不良反应。结论湿性年龄相关性黄斑变性的玻璃体内注射Ranibizumab治疗能明显缩小病灶,消退黄斑水肿,相应改善视功能,OCT检查测量CNV生物学参数具有无创、安全可靠、简单易行的优点,是一种重要的观察方法。

Objective To observe the clinical efficacy of intravitreal ranibizumab on wet agerelated macular degeneration（ AMD）. Methods Thirty-four eyes of 32 patients with wet AMD from October 2012 to March 2014 in our hospital were included in the study. All affected eye were treated with intravitreal ranibizumab 0. 05 mL（ 10 mg·mL^-1）,22 eyes once per month for only one month,other serious 12 eyes once per month for 3 months. Further injection might be required if the monthly follow-up indicated. Before the injection,best-corrected visual acuity of early treatment of diabetic retinopathy study（ ETDRS）,non-contact tonometer,ophthalmoscope,fundus fluorescein anginograph（ FFA） and（ or） indocyanine green angiography（ ICGA）,optical coherence tomography（ OCT） examination were necessary. The patients were followed for 3 months to 9 months. Best-corrected visual acuity,OCT and ophthalmoscope examination were assessed monthy. If necessary,FFA and（ or） ICGA were used. Results All eyes received an average of（ 2.17 ±1.05） injections.Follow up of 3 months,6 months,average ETDRS visual acuity were（ 34.37 ± 12. 75） letters,（ 38. 06 ± 11. 38） letters,compared with those before treatment were improved respectively（ 5. 63 ± 3. 17） letters,（ 9. 27± 5. 01） letters. There were significant differences（ all P = 0. 00）. At postoperative 1 month,the width and height of macular choroidal neovascularization basement were（ 2001. 83 ± 90. 71） μm and（ 347. 23 ± 63. 73） μm,compared with pre-operation（ 385. 63 ± 92. 57） μm,there were significant differences（ all P = 0. 00）. At postoperative 1 month,the foveal thickness decreased to（ 336. 90 ± 82. 11） μm,compared with pre-operation（ 385. 63 ± 92. 57） μm,there were significant differences（ P = 0. 00）. There was no systermic or ocular serious adverse reaction. Conclusion Intravitreal injection of Ranibizumab for wet AMD can significantly shrink the lesion,reduce the macular edema,improve the visual function. Measuring the biological parameters by OCT had many advantages,such as non-invasion,safe and easy,is an important observation manner.