雷珠单抗治疗黄斑区脉络膜新生血管的疗效观察

Clinical efficacy of intravitreal injection of ranibizumab for choroidal neovascularization （CNV）

目的 观察玻璃体腔注射雷珠单抗（ranibizumab,商品名Lucentis）治疗黄斑区脉络膜新生血管（CNV）的临床疗效.方法 回顾性研究,收集2012年7月～2013年6月期间在成都中医药大学附属医院眼科就诊,经眼底镜检查、荧光素钠眼底血管造影（FFA）和（或）吲哚青绿血管造影（ICGA）、光学相干断层扫描（OCT）确诊为CNV（包括高度近视性黄斑病变及年龄相关性黄斑病变）并接受玻璃体腔注射雷珠单抗（单次剂量0.5 mg/0.05ml）的患者26例（32只眼）,首次治疗之前及之后每个月均行最佳矫正视力（BCVA）、OCT、眼底镜检查以观察其疗效.随访时间6个月.随访过程中,若患者黄斑中心小凹厚度（CMT）≥250μm,或FFA显示仍有荧光渗漏或自觉视力明显下降、事物变形加重者,需再次注射雷珠单抗,间隔时间均≥1月.结果 首次治疗后视力较首次治疗前平均提高：1周时（1.84±1.65）行,1月（1.59±2.24）行,2月（1.66±2.96）行,3月（2.06±2.34）行,4月（1.94±2.49）行,5月（1.94±2.54）行,6月（1.81±2.97）行.首次治疗后各时间段之间视力差异无统计学意义（F=0.584,P=0.60＞0.05）,较首次治疗之前,差异均有统计学意义（P＜0.05）.首次治疗后各时间段有效率差异无统计学意义（x2=1.961,P=0.923＞0.05）.首次治疗后各时间段CMT较首次治疗前降低的平均值分别为：1周（131.10±146.07）μm,1月（154.84±190.13）μm,2月（141.38±160.34）μm,3月（124.75±173.24）μm,4月（98.31±173.44）μm,5月（88.69±183.50）μm,6月（81.60±196.70）μm.首次治疗后各时间段与首次治疗前CMT比较,差异有统计学意义（P＜0.05）.首次治疗之后各时间段CMT差异无统计学意义（F=3.079,P=0.063＞0.05）.术前、术后及随访期间未发现全身及眼部严重不良反应.结论 雷珠单抗治疗黄斑区脉络膜新生血管是安全有效的.

Qbjective To evaluate the clinical efficacy of intravitreal injections of anti-vascular endothelial growth factor （VEGF）ranibizumab on choroidal neovascularization （CNV）. Methods Retrospective study. 32eyes of 26 patients with CNV were collected from July 2012 to June 2013 in teaching hospital of Chengdu T. C. M. All cases were taken ophthalmoscope exam, fundus fluorescein angiograph （FFA） and （or） indocyanine green angiography （ ICGA）, and optical coherence tomography （OCT） before treated with 0.05 ml （10 mg/ml） intravitreal rannibizumab. Best-corrected visual acuity（BCVA）,OCT and ophthalmoscope examination were assessed before and after the first treatment. All of the patients received an initial intravitreal injection of ranibizumab （0.5 mg,0.05 ml） and followed by repeated injections at 6 months postoperatively on the basis of central macular thickness（CMT）and angiographic features. Injections interval time≥l month. Results One week after the first injection,the BCVA improved to 1.84±1.65rows （P=0. 042,〈0.05） ,after one month to 1.59±2.24 rows （P=0. 047,〈0.05） ,after two month to1.66±2.96 rows（P=0.04,〈0.05） ,after three month to2.06±2.34 rows（P=0. 037,〈0.05） ,after four month to 1.94±2.49rows （P=0. 031,〈0.05）,after five month to 1.94±2.54 rows （P=0. 009,〈0.05） ,after six month to 1.81±2.97 rows （P=0. 004,〈0.05）. The BCVA was significantly improved after the first injection,and there was no difference between each follow-up measurement neither the BCVA nor the effective rate. The mean CMT was decreased 1.84± 1.65μm one week after the first treatment,and 1.59±2.24μm one month follow-up, 1.66±2.96μm two months follow-up, 2.06±2.34μm three months follow up,1.94±2. 49μm four months follow-up, 1. 94±2. 54μm five month follow-up,and 1. 81±2. 98μm six month follow-up. The CMT was different at each follow-up measurement compared with that of before. Noserious systemic or ocular adverse events were noticed. Conclusion The effective rate of ranibizumab in the treatment of choroidal neovascularization （CNV） was 65. 2%. The BCVA and CMT were stable post injection.