玻璃体腔注射雷珠单抗治疗CRVO继发黄斑水肿的有效性和安全性

Efficacy and safety of intravitreal injection of Ranibizumab in the treatment of macular edema secondary to central retinal vein occlusion

目的：观察雷珠单抗对视网膜中央静脉阻塞（ central retinal vein occlusion,CRVO ）继发黄斑水肿治疗的有效性和安全性。 方法：根据标准将入组的24例视网膜中央静脉阻塞继发黄斑水肿患者,年龄30~70（平均51.58±10.32）岁,双盲随机分配到组玉和组Ⅱ。组玉前3mo,每月1次0.5mg雷珠单抗玻璃体腔注射并给予复方血栓通胶囊药物,组Ⅱ前3 mo仅给予复方血栓通胶囊药物。组玉和组Ⅱ从第3 mo起均开始雷珠单抗,PRN（ Prore nata）治疗。两组治疗前最佳矫正视力（ best-corrected visual acuity,BCVA）及中心视网膜厚度（ central retinal thickness,CRT）比较差异无统计学意义（ P〉0.05）。统计分析两组治疗期间的 BCVA、CRT、实验室检查结果、眼部及全身不良反应。 结果：组玉治疗前最佳矫正视力（ BCVA ）为52.67±1.78,治疗1wk,1、2、3、4、6、12mo的BCVA分别为63.67±1.61、66.25±1.60、69.58±1.68、70.75±5.22、65.58±4.34、68.92±3.4、70.17±3.7,与治疗前比较有显著统计学差异（P〈0.05）,组玉治疗前 CRT 为539.00±10.94μm,治疗1wk,1、2、3、4、6、12mo 的 CRT 分别是326.67±20.83、264.58±17.11、232.00±13.04、231.25±78.68、316.00±172.48、218.00±105.25、220.58±33.43μm,与治疗前比较有显著统计学差异（P〈0.05）,组Ⅱ治疗前BCVA为52.25±2.83,CRT为539.92±12.21μm,组Ⅱ治疗3mo BCVA 为57.08±3.12,与组玉治疗3mo BCVA比较有统计学差异（ P〈0.05）,组Ⅱ治疗3mo CRT为497.92±11.91μm,与组玉治疗3mo CRT比较有统计学差异（P〈0.05）,治疗访视过程中未发现眼部及全身明显不良反应。 结论：玻璃体腔注射雷珠单抗能在短期内能减轻黄斑水肿并提高视力,减少黄斑区荧光渗漏,但在眼内作用的持续时间短,需反复注射。雷珠单抗在CRVO继发黄斑水肿的治疗中具有很好的有效性和安全性。

AIM：To observe the efficacy and safety of intravitreal injection of Ranibizumab in the treatment of macular edema secondary to central retinal vein occlusion （ CRVO） . METHODS：According to the standard, 24 patients with macular edema secondary to CRVO were double-blind randomized to groupⅠand groupII. They were aged 30~70 years old, average （51. 58±10. 32） years. Patients of groupⅠ were treated with intravitreal injection of 0. 5mg ranibizumab monthly for the first three months and given compound thrombosis capsule. Compared with groupⅠ, patients of group II were only given compound thrombosis capsule. Subjects of two groups use PRN （ Pro re nata ） therapy with ranibizumab from the third month. No significant difference was found between the two groups in the best-corrected visual acuity （ BCVA ） and central retinal thickness （ CRT ） before the treatment （P〉0. 05）. BCVA, CRT, laboratory results and ocular and systemic adverse reactions of the two groups during treatment were conducted and statistically analyzed. RESULTS： BCVA of group Ⅰ was 52. 67±1. 78 before treatment, and BCVA were respectively 63. 67±1. 61, 66. 25±1. 60, 69. 58±1. 68, 70. 75±5. 22, 65. 58±4. 34, 68. 92±3. 4, 70.17±3. 7 at 1wk, 1, 2, 3, 4, 6, and 12mo after treatmentwith significant difference compared with before injections （P〈0. 05）. CRT of group Ⅰ was 539. 00±10. 94μm before the treatment, and that were respectively 326. 67±20. 83, 264. 58±17. 11, 232. 00±13. 04, 231. 25±78. 68, 316. 00±172.48, 218. 00±105. 25, 220. 58±33. 43μm at 1wk, 1, 2, 3, 4, 6, and 12mo after treatment with significant difference compared with before injections （ P〈 0. 05 ）. BCVA of group II was 52. 25±2. 83 and CRT was 539. 92±12. 21μm, BCVA of group II was 57. 08±3. 12μm 3mo after treatment and significant difference was found compared with group玉3mo after treatment （P〈0. 05）. CRT of group II was 497. 92 ± 11.91μm 3mo after treatment and significant difference was found compared with group Ⅰ 3mo after treatment （ P 〈 0. 05 ）. Ocular and systemic obviously adverse reactions were not found during treatment. CONCLUSION： Intravitreal injection of ranibizumab contributes to relieving macular edema, improving visual acuity and reducing fluorescence leakage of macular area in short - term. But patients need repeated injection. Ranibizumab is effectiveness and safety in the treatment of macular secondary to CRVO.