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玻璃体切除手术联合雷珠单抗不同给药方案治疗增生性糖尿病视网膜病变

赵明贵  张士红  孙玉波  房克爽  游启生   

  1. 276807 山东,日照市第二人民医院(赵明贵、张士红、孙玉波、房克爽);美国俄勒冈卫生科学大学Casey眼科中心(游启生)
  • 收稿日期:2018-05-11 出版日期:2019-03-25 发布日期:2019-03-28
  • 通讯作者: 赵明贵,Email: zhaominggui888@163.com

Vitrectomy combined with different dosing regimen of ranibizumab for treatment of proliferative diabetic retinopathy

ZHAO Ming-gui1, ZHANG Shi-hong1, SUN Yu-bo1, FANG Ke-shuang1, YOU Qi-sheng2   

  1. 1. The Second People’s Hospital of Rizhao, Rizhao  Shandong 276807, China; 2. Casey Eye Institute, Oregon Health & Science University
  • Received:2018-05-11 Online:2019-03-25 Published:2019-03-28
  • Contact: ZHAO Ming-gui, Email: zhaominggui888@163.com

摘要:

 目的 探讨玻璃体切除手术联合雷珠单抗不同给药方案治疗增生性糖尿病视网膜病变(PDR),对黄斑中心凹厚度(CFT)、视力恢复及血清胱抑素C(CysC)、血管内皮生长因子(VEGF)水平的影响。 设计 前瞻性病例系列。研究对象 2016年1月-2017年12月日照市第二人民医院治疗的PDR患者96例(96眼)。方法 所有患者均择期行玻璃体切除手术,依据随机数字表格法分为3组,各32例,A组患者术前给予雷珠单抗玻璃体注射,B组患者术毕玻璃体注射雷珠单抗,C组未注射药物。手术前后测定最佳矫正视力(BCVA),相干光断层扫描(OCT)对CFT测定,酶联免疫吸附法(ELISA)测定血清CysC、VEGF水平。主要指标 BCVA、CFT、血清CysC、VEGF。结果 三组患者术前与术后3个月CFT比较:A组(392±36)μm、(316±35)μm(P<0.001),B组(399±38)μm 、(302±46)μm(P<0.001),C组(403±42)μm、(363±39)μm(P<0.001);血清CysC比较:A组(1.42±0.36)mg/L、(0.45±0.25)mg/L(P<0.001), B组(1.41±0.38)mg/L、(0.42±0.29)mg/L(P<0.001),C组(1.42±0.40)mg/L、(0.73±0.21)mg/L(P<0.001);VEGF:A组(310.68±42.91)pg/mL、(131.25±32.5)pg/mL(P<0.001),B组(312.26±43.20)pg/mL、(128.36±35.1)pg/mL(P<0.001),C组(308.69±42.00)pg/mL、(185.87±37.34)pg/mL(P<0.001);A、B两组术后3个月视力改善均显著优于C组,A组81.3% vs. C组56.3%(P=0.03);B组84.4% vs. C组56.3%(P=0.01);A组术后3个月CFT优于C组(P=0.02),B组术后3个月CFT优于C组(P=0.001);A组术后3个月血清CysC优于C组(P<0.001),B组术后3个月血清CysC优于C组(P<0.001);A组术后3个月VEGF水平均显著低于C组(P<0.001),B组术后3个月VEGF水平均显著低于C组(P<0.001);但A、B两组组间比较差异均无统计学意义,CFT:P=0.23,血清CysC:P=0.62;血清VEGF:P=0.53。A组术中大量出血、术中医源性视网膜裂孔发生率分别为3.1%、6.3%,B组发生率分别为3.1%、3.1%,均显著低于C组的21.9%、25.0%(P=0.012,0.012);B组术后玻璃体再积血发生率3.1%,显著低于C组的28.1%(P=0.017),与A组的12.5%比较差异无统计学意义(P=0.13)。术前或术中雷珠单抗辅助玻璃体切除手术治疗均能显著降低CFT,改善PDR患者视力,显著降低血清CysC、VEGF水平,减少并发症发生,其中术毕雷珠单抗相比术前玻璃体腔注射效果略好。(眼科,2019, 28: 115-119)

关键词: 增生性糖尿病视网膜病变, 玻璃体切除术, 雷珠单抗, 血管内皮生长因子

Abstract:

 Objective To investigate the effect of vitrectomy combined with different dosing regimen of ranibizumab on the central foveal thickness (CFT), visual recovery, serum cystatin C (CysC) and vascular endothelial growth factor (VEGF) levels in patients with proliferative diabetic retinopathy (PDR). Design Prospective case series. Participants Ninety-six patients (96 eyes) with PDR diagnosed and treated in the hospital from January 2016 to December 2017 were enrolled. Methods All patients underwent elective vitrectomy, and they were divided into 3 groups using the random number table method, 32 cases in each group. Group A was treated with intravitreal injection of ranibizumab before surgery. Group B was treated with intravitreal injection of ranibizumab during surgery and group C was not injected any drugs. The best-corrected visual acuity (BCVA) was measured before and after surgery. The optical coherence tomography (OCT) was used to measure CFT and serum levels of CysC and VEGF were determined by enzyme linked immunosorbent assay (ELISA).  Main Outcome Measures The BCVA before and after surgery, improvement of visual acuity, CFT, serum CysC and VEGF levels. Results The CFT, serum CysC and VEGF levels in the 3 groups were significantly decreased at 3 months after surgery (all P<0.05). The improvement of visual acuity in group A and group B at 3 months after surgery was significantly better than that in group C (both P<0.05). The CFT, serum CysC and VEGF levels in group A and group B at 3 months after surgery were significantly lower than those in group C (all P<0.05), but there was no significant difference between group A and group B (all P>0.05). The incidence rates of massive hemorrhage and iatrogenic retinal hole in group A (3.1% and 6.3%) and group B (3.1% and 3.1%) during surgery were significantly lower than those in group C (21.9% and 25.0%) (both P<0.05). The incidence of vitreous re-hemorrhage in group B was significantly lower than that in group C (3.1% vs 28.1%) (P<0.05), and there was no significant difference, compared with that in group A (12.5%) (P>0.05). Conclusion The injection of ranibizumab before or during surgery combined with vitrectomy can significantly reduce the CFT, improve the visual acuity of patients with PDR, significantly decrease serum CysC and VEGF levels and complications. In addition, the effect of intravitreal injection of ranibizumab during surgery is slightly better than injection before surgery. (Ophthalmol CHN, 2019, 28: 115-119)

Key words: proliferative diabetic retinopathy, vitrectomy, ranibizumab, vascular endothelial growth factor