抗血管内皮生长因子单克隆抗体ranibizumab治疗渗出型老年性黄斑变性的一年疗效观察

目的 观察连续12个月玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab(商品名Lucentis)治疗渗出型老年性黄斑变性(AMD)的临床疗效和安全性.方法 前瞻、无对照、开放性研究.经荧光素眼底血管造影(FFA)和吲哚青绿血管造影(ICGA)检查确诊的22例渗出型AMD患者22只眼纳入研究.患者中,男性18例,女性4例；年龄46～79岁,平均年龄(68.2±9.3)岁.采用国际标准视力表行最佳矫正视力(BCVA)和光相干断层扫描(OCT)检查,非接触眼压计测量眼压.为便于统计分析,视力换算为最小分辨角对数视力(logMAR).患眼BCVA 0.01～0.9,平均BCVA 0.26±0.22,平均logMAR0.76±0.44;黄斑中心视网膜厚度(CRT) 182～559 μm,平均CRT值为(302.62±90.18)μm.眼压均正常.玻璃体腔注射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg),每一个月1次,连续12个月.每次治疗后1h和治疗后1d行眼压检查.每一个月均采用首次治疗前的方法和设备行视力、眼压、眼底、OCT检查；3个月行FFA、ICGA检查.22例患者中,完成了12个月随访者13例.13例患者平均logMAR 0.74±0.37,平均CRT值为(305.77±99.69) μm,平均眼压为(12.07±3.93) mm Hg(1 mm Hg=0.133 kPa).采用配对t检验对比分析治疗过程中视力、CRT变化.结果 所有患眼治疗后1个月,平均logMAR为0.52±0.32,与首次治疗前平均logMAR比较,差异有统计学意义(t=4.518,P＜0.05)；治疗后3个月,平均logMAR为0.37±0.27,与首次治疗前比较,差异有统计学意义(t=6.237,P＜0.05).完成12个月随访的13只眼,治疗后1、3、12个月平均logMAR分别为0.51±0.34、0.35±0.26、0.34±0.30,与首次治疗前平均logMAR比较,差异均有统计学意义(t=3.443,5.438,4.756；P＜0.05).治疗后1、3个月平均CRT值分别为(228.85±54.93)、(231.00±38.94) μm,与首次治疗前平均CRT值比较,差异有统计学意义(t=2.914,3.199;P＜0.05)；治疗后12个月平均CRT值为(262.92±70.48)μm,与首次治疗前平均CRT值比较,差异无统计学意义(t=1.408,P＞0.05).前3次治疗视力提高最快,6只眼视力从0.1～＜0.5提高到0.5及以上；随访第1个月时CRT降低幅度最大.玻璃体注射ranibizumab后1h眼压升高,1d后降至治疗前水平.随访中未见眼内感染等与玻璃体腔注射相关的并发症.结论 每一个月玻璃体腔注射1次ranibizumab可以提高患眼视力,减轻黄斑水肿；无与治疗相关的不良反应发生.

Clinical observation of intravitreal injection of ranibizumab for 12 consecutive months treating exudative agerelated macular degeneration

Objective To observe the efficacy and safety of intravitreal injection of ranibizumab (Lucentis) for 12 consecutive months treating exudative age-related macular degeneration (EAMD).Methods This is an open and prospective study without control trial.Twenty-two eyes from 22 patients (18 males and 4 females) with EAMD diagnosed by fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were enrolled in this study.The patients aged from 46 to 79 years with the mean of 68.2± 9.3 years.All of the patients received intravitreal injection of ranibizumab (0.5 mg,0.05 ml)once a month for 12 consecutive months.The best-corrected visual acuity (BCVA) was obtained using the international standard visual acuity chart (converted into logMAR for statistical analysis).Central retinal thickness (CRT) was measured by optical coherence tomography (OCT) before and after each monthly treatment.Intraocular pressure (IOP) was measured using non-contact tonometry before treatment and 1 hour and 1 day after treatment.FFA and ICGA were performed every 3 months.The BCVA was 0.01 - 0.9with the average of 0.26±0.22.The average IogMAR BCVA was 0.76 ±0.44,the CRT was 182 559 μm with the mean of (302.62± 90.18) μm,and the IOP was normal before treatment.Only 13 of 22 patients completed 12 months of follow up.The BCVA,CRT and IOP after treatment were compared with baseline using paired t test.Results Of all the 22 patients,the mean logMAR BCVA at 1 and 3 months after treatment were 0.52 ± 0.32 and 0.37 ± 0.27 respectively,both of which were significantly different compared with before treatment (t=4.518,6.237; P＜0.05).Of the 13 patients,the mean logMAR BCVA at 1,3 and 12 months after treatment was 0.51±0.34,0.35±0.26,0.34±0.30 respectively.All of these measures were significantly different compared with 0.74 ± 0.37 before treatment (t =3.443,5.438,4.756:P ＜ 0.05 ).The mean CRT at 1,3 and 12 months after treatment were (228.85 ± 54.93),(231.00±38.94) and (262.92 ± 70.48) μm.There were significant differences among before and 1,3 months after treatment (t=2.914,3.199 ; P＜0.05),but not between before and 12 months after treatment (t=1.408,P＞0.05).The first 3 injections contributed to the most BCVA gain with 6 patients' BCVA increasing from 0.1-0.5 to 0.5 or above.The greatest CRT reduction was obtained at 1 month after the first injection.IOP increased 1 hour after treatment and recovered within 1 day.No intravitreal injectionrelated side effects such as endophthalmitis were observed during the follow up period.Conclusions Monthly intravitreal injections of ranibizumab may improve BCVA and macular edema.There was no adverse event during the follow up duration.