康柏西普注射液治疗新生血管性眼病的临床研究

Clinical trial of conbercept injection in the treatment of neovascular eye disease

目的观察康柏西普注射液治疗新生血管性眼病的临床疗效及安全性。方法入选30例新生血管性眼病患者为研究对象,均于玻璃体腔内注射康柏西普0. 2 m L进行治疗。于术前和术后3个月,观察患者视力、黄斑中心凹厚度(CMT)、血清血管内皮生长因子(VEGF)水平和视网膜血流的变化,以及药物不良反应的发生情况。结果术后3个月和术前,患者视力分别为(0. 49±0. 05)和(0. 68±0. 12) log MAR,CMT分别为(196. 48±11. 60)和(250. 23±16. 45)μm,VEGF水平分别为(96. 85±14. 61)和(152. 04±13. 75) ng·L^(-1),收缩期峰速度分别为(10. 90±1. 87)和(8. 38±1. 46) cm·s^(-1),舒张末期速度分别为(3. 21±0. 37)和(2. 06±0. 29) cm·s-1,阻力指数分别为(0. 57±0. 09)和(0. 70±0. 11),收缩期最大流速分别为(7. 27±0. 82)和(8. 55±1. 09) cm·s-1,舒张期最小流速分别为(4. 04±0. 81)和(5. 08±0. 99) cm·s^(-1),差异均有统计学意义(均P <0. 05)。治疗期间,所有患者均未发生明显的药物不良反应。结论康柏西普注射液治疗新生血管性眼病可显著降低血清VEGF水平,改善患者视力,且安全性较高。

Objective To observe the clinical efficacy and safety of conbercept injection in the treatment of neovascular eye disease.Methods Thirty patients with neovascular eye disease were selected as research objects,which were given conbercept 0.2 m L,injected into the glass cavity.Before operation and 3 months after operation,the changes of vision,central macular thickness(CMT),serum levels of vascular endothelial growth factor(VEGF),retinal blood flow and adverse drug reactions were observed.Results 3 months after operation and before operation,the vision were(0.49±0.05)and(0.68±0.12)logMAR,CMT were(196.48±11.60)and(250.23±16.45)μm,VEGF were(96.85±14.61)and(152.04±13.75)ng·L-1,peak systolic velocity were(10.90±1.87)and(8.38±1.46)cm·s-1,end-diastolic velocity were(3.21±0.37)and(2.06±0.29)cm·s-1,resistance indexes were(0.57±0.09)and(0.70±0.11),maximum systolic flow velocity were(7.27±0.82)and(8.55±1.09)cm·s-1,minimum diastolic flow velocity were(4.04±0.81)and(5.08±0.99)cm·s-1,the differences were statistically significant(all P<0.05).There were no adverse drug reactions observed in all patients during the treatment.Conclusion Conbercept injection has a safety in the treatment of neovascular eye disease,which can significantly decrease the patients’serum levels of VEGF and improve the vision.