Ranibizumab治疗渗出型老年黄斑变性的1年疗效观察及视力恢复的预测因素分析

Efficacy of Ranibizumab for the treatment of exudative age-related macular degeneration: one-year results and analysis of prognosis of visual recovery

目的观察抗血管内皮生长因子(VEGF)单克隆抗体雷珠单抗Ranibizumab(商品名Lucentis)玻璃体腔注射治疗渗出型老年黄斑变性(AMD)的临床疗效,并探讨长期视力恢复的相关因素。方法经荧光素眼底血管造影(FFA)和(或)吲哚青绿眼底血管造影(ICGA)检查确诊的32例(36只眼)患者纳入研究。采用10 mg/ml的Ranibizumab 0.05 ml玻璃体腔注射治疗,1个月/次,连续注射3次,随后根据每1个月的检查情况决定是否行再次注射,共计随访12个月。对比分析治疗前后最佳矫正视力(BCVA)及黄斑中心凹视网膜厚度(CMT)变化情况,观察是否有术后不良反应及并发症发生,并将末次随访时BCVA与治疗前BCVA差值的Log MAR值即最终视力恢复值(FVG)从性别、年龄、病程、治疗前BCVA、治疗前CMT、有无系统疾病等方面分别分析以筛选术后视力恢复影响因素。结果治疗后1、3、6、12个月BCVA均高于首次治疗前,并呈上升趋势,CMT值均低于首次治疗前,并呈下降趋势,差异有统计学意义(均为P<0.001)。病程与FVG显著正相关(r=0.471,P=0.004),治疗前BCVA与FVG显著负相关(r=-0.450,P=0.006),而性别(P=0.347)、年龄(P=0.053)、治疗前CMT(P=0.175)、有无系统疾病(P=0.193)与FVG无关。术后除6例局部球结膜下出血,未见眼内炎、视网膜脱离等严重不良反应及并发症发生。结论 Ranibizumab玻璃体腔注射治疗渗出型AMD可使视力提高、视网膜水肿减轻,且安全性很好。病程和治疗前BCVA是长期术后视力恢复的预测因素。

Objective To observe the clinical efficacy of intravitreal Ranibizumab treatment for exudative age-related macular degeneration（ AMD） and to investigate the factors associated with long-term visual recovery. Methods 36 eyes from 32 patients with AMD diagnosed by fundus fluorescein angiography（ FFA） and indocyanine green angiography（ ICGA） were enrolled in this study. All patients received intravitreal injection of 0. 05ml（ 10mg/ml） Ranibizumab,once per month for 3 consecutive months. Further injection may be required if the monthly follow-up indicated. The follow-up duration was 12 months. The best corrected visual acuity（ BCVA） and central macular thickness（ CMT） before and after treatment were analyzed. Postoperative adverse reactions and complications were detected at the same time. The final visual gain（ FVG）（ converted into log MAR） were evaluated based on sex,age,duration,baseline VA,baseline CMT,and presence or absence of systemic diseases to identify the associated predictors of visual recovery. Results 1 month,3months,6 months,12 months after treatment,BCVA was higher than before treatment,and showed a descending trend.CMT was lower than before treatment,and showed a rising trend. These differences were statistically significant（ P〈0. 05）. FVG positively correlated with short disease duration（ r = 0. 471,P = 0. 004） and worse baseline BCVA（ r =0. 450,PP = 0. 006）,while the patients＇ sex（ P = 0. 347）,age（ P = 0. 053）,baseline CMT（ P = 0. 175）,and presence or absence of systemic diseases（ P = 0. 193） did not affect FVG. There was no serious adverse reaction or complication. Conclusions Intravitreal injection of Ranibizumab improves BCVA and alleviates the macular edema safely in exudative age-related macular degeneration patients. Disease duration and baseline BCVA are the predictive factors of the longterm visual recovery.