抗VEGF联合微脉冲激光按需治疗糖尿病性黄斑水肿的真实世界研究

Real-World Evidence of Diabetic Macular Edema Treated by Micro-Pulse Laser Therapy Combined with Anti-VEGF

摘要: 目的：分析真实世界中抗VEGF联合微脉冲激光治疗糖尿病性黄斑水肿(DME)的临床效果。方法：采用前瞻性队列研究方案，绵阳万江眼科医院2016年11月至2017年11月共73例(125眼)DME纳入分析，按糖尿病视网膜病变(DR)的程度分为非增殖期(NPDR)组33例(45眼)和增殖期(PDR)组40例(80眼)。治疗方案采用按需治疗原则，即：当视网膜中央厚度(CMT)大于400 um时给予抗VEGF治疗(康柏西普玻璃体注射)，当CMT小于400 um则采用微脉冲激光治疗。观察两组注药次数、微脉冲激光次数，BCVA和CMT，随访时间半年。结果：两组末次随访BCVA和CMT均较基线值有改善，NPDR组BCVA从4.43 ± 0.9提高到4.76 ± 1.7 (t = 2.27, p < 0.05)；CMT从492.5 ± 72.6减小为238.6 ± 29.7 (t = 27.52, p < 0.05)。PDR组BCVA从4.23 ± 0.8提高到4.52 ± 1.1 (t = 2.84, p < 0.05)；CMT从516.7 ± 23.4降低到287.6 ± 17.3 (t = 62.65, p < 0.05)。两组末次随访BCVA比较无明显统计学差异(t = 0.80, p > 0.05)。两组末次随访CMT比较有统计学意义(t = 11.67, p < 0.05)。NPDR组平均注药3.5 ± 1.2次和平均微脉冲激光4.7 ± 2.3次，少于PDR组平均注药4.8 ± 2.4次和平均微脉冲激光5.2 ± 1.7次，p值均<0.05。结论：在真实世界中，微脉冲激光联合抗VEGF按需治疗DME可有效改善患者视力和黄斑水肿程度，NPDR合并DME治疗次数少于PDR患者。

Abstract: Objective: To observe the effect of anti-VEGF and micro-pulse laser in the treatment of macular disease in real-world. Methods: In this prospective cohort study, 73 patients (125 eyes) of DME were included to analysis. The data include BCVA, CMT, times of laser treatment and anti-VEGF from November 2016 to November 2017 in Mianyang Wanjiang Eye Hospital. Patients were divided into two groups according to the severity of diabetic retinopathy. 33 patients (45 eyes) were in NPDR group and 40 patients (80 eyes) were in PDR group. The therapeutic schedule was drawn up with treat as needed: anti-VEGF (Conbercept) was given when CMT > 400 um and laser treatment was given when CMT < 400 um. The follow-up was 6 months. Results: Compared with the baseline, both groups gain better BCVA and CMT. In NPDR Group, the BCVA was from 4.43 ± 0.9 to 4.76 ± 1.7 (t = 2.27, p < 0.05); CMT was from 492.5 ± 72.6 to 238.6 ± 29.7 (t = 27.52, p < 0.05). In PDR group, the BCVA was from 4.23 ± 0.8 to 4.52 ± 1.1 (t = 2.84, p < 0.05); CMT was from 516.7 ± 23.4 to 287.6 ± 17.3 (t = 62.65, p < 0.05). In the last follow-up, the BCVA was not different (t = 0.80, p > 0.05), but CMT (t = 11.67, p < 0.05) was different between two groups. The average anti-VEGF times were 3.5 ± 1.2 and the average laser treatment was 4.7 ± 2.3 in NPDR group. They were less than in PDR group with 4.8 ± 2.4 injects and 5.2 ± 1.7 laser treatments (P < 0.05). Conclusions: The real-world evidence shows that it is effective for DME with treat as needed by micro-pulse laser therapy combined with anti-VEGF. Less treatment times were taken in NPDR than PDR patients.