玻璃体腔注射抗血管内皮生长因子单克隆抗体ranibizumab治疗特发性脉络膜新生血管的临床观察

目的 观察玻璃体腔注射抗血管内皮生长因子(VEGF)单克隆抗体ranibizumab(商品名Lucentis)治疗特发性脉络膜新生血管(ICNV)的临床疗效和安全性.方法 经临床检查确诊的ICNV患者54例54只眼纳入研究.其中,男性24例24只眼,女性30例30只眼；年龄21～49岁,平均年龄(32.57±7.06)岁；病程6 d～3个月.采用Snellen视力表行最佳矫正视力(BCVA)、早期糖尿病视网膜病变治疗研究(EDTRS)视力表行EDTRS视力检查,同时行间接检眼镜、荧光素眼底血管造影(FFA)、光相干断层扫描(OCT)等检查.患眼治疗前BCVA眼前手动～0.6,EDTRS视力平均字母数为(32.00±16.41)个.黄斑中心视网膜厚度(CRT)平均值为(337.31±76.91) μm.玻璃体腔注射10 mg/ml的ranibizumab 0.05 ml(含ranibizumab 0.5 mg).治疗后平均随访时间(15.56±6.54)个月.首次治疗后第1个月随访检查时如发现CNV病灶扩大或有新发CNV病灶,则行再次注射治疗.对比分析治疗前后BCVA、ETDRS视力、CRT及CNV病灶渗漏变化情况.结果 首次治疗后1个月,ETDRS视力平均字母数为(48.81±16.96)个,较治疗前平均字母数增加16.81个字母,差异有统计学意义(t=-11.991,P＜0.01).视力增加＞15个字母者25只眼,占46.30％;视力减少≥1个字母者2只眼,占3.70％.OCT检查显示,CRT平均值为(227.67±91.41)μm,与治疗前CRT平均值比较,差异有统计学意义(t=12.021,P＜0.01).末次随访检查时,患眼注射次数1～4次,平均注射次数(1.59±0.71)次.ETDRS视力平均字母数为(49.20±16.60)个,较治疗前平均字母数增加17.20个字母,差异有统计学意义(t=-11.390,P＜0.01).视力增加＞15个字母者27只眼,占50.00％;视力减少≥1个字母者3只眼,占5.56％.OCT检查显示,CRT平均值为(227.69±89.30) μm,与治疗前CRT平均值比较,差异有统计学意义(t=10.872,P＜0.01).CNV渗漏完全停止者35只眼,占64.81％;渗漏范围减少者11只眼,占20.37％;渗漏无明显变化或范围扩大者6只眼,占11.11％;出现新病灶者2只眼,占3.70％.随访中未见与注射及药物有关的眼部及全身不良反应.结论 玻璃体腔注射ranibizumab治疗ICNV安全有效,可提高患眼视力,减轻黄斑水肿；其远期疗效及安全性还有待进一步观察.

Clinical observation of intravitreal injection of ranibizumab for idiopathic choroidal neovascularization

Objective To observe the efficacy and safety of intravitreal injection of ranibizumab (Lucentis) to treat idiopathic choroidal neovascularization (ICNV).Methods Fifty-four eyes from 54 patients with ICNV were included in this study.There were 24 males and 30 females.The patients aged from 21 to 49 years with a mean age of 32.57 ± 7.06 years,The course of disease ranged from 6 days to 3 months with an average of 1.07±0.65 months.The examinations of best corrected visual acuity (BCVA)included Snellen chart and ETDRS visual acuity of ETDRS chart.Indirect ophthalmoscopy,fundus fluorescein angiography (FFA) and optic coherence tomography (OCT) were performed.The BCVA was hand motion - 0.6.The average score of ETDRS chart was 32.00± 16.41,and the average CRT (337.31±76.91) μm before treatment.All of the patients received an initial intravitreal injection of ranibizumab (0.5 mg,0.05 ml) and repeated treatments after the one-month follow-up if needed.The average follow-up period was 15.56±6.54 months.The changes of BCVA,ETDRS visual acuity,CRT and leakage of CNV before and after treatment were observed.Results One month after first injection,the mean number of ETDRS chart letters increased 16.81 to 48.81 ± 16.96 with a significant difference (t=- 11.991,P＜0.01),in which 25 eyes increased more than 15 (46.30 ％),while 2 eyes decreased more than 1 (3.70％).The mean CRT was (227.67± 91.41) μm,which significantly decreased compared with before treatment (t=12.021,P＜0.01).At the end of the follow-up period the number of repetitive intravitreal injections of ranibizumab was 1 - 4 times,with the mean of (1.59±0.71) times/eye.The mean number of ETDRS chart letters increased 17.20 to 49.20 ± 16.60 with a significant difference (t =-11.390,P＜0.01),in which 27 eyes increased more than 15 (50.00％),while 3 eyes decreased more than 1 (5.56％).The mean CRT was (227.69± 89.30) μm,which significantly decreased compared with before treatment (t =10.872,P＜0.01).There was complete CNV closure in 35 eyes (64.81 ％),partial closure in 11 eyes ( 20.37 ％),no change or expansion in 6 eyes (11.11 ％),and new CNV in 2 eyes (3.70％).No ocular or systemic adverse events were found after intravitreal injection of ranibizumab during the follow-up duration.Conclusions Intravitreal injection of ranibizumab is safe and effective for idiopathic choroidal neovascularization.It may improve the visual acuity and macular edema.However,long-term efficacy and safety remain to be further studied.