雷珠单抗玻璃体腔内注射联合激光治疗缺血型视网膜中央静脉阻塞的临床研究

Clinical research of Leizhu McAb combined with laser in the treatment of ischemic central retinal vein occlusion

目的探讨雷珠单抗玻璃体腔内注射联合激光治疗缺血型视网膜中央静脉阻塞的临床疗效。方法收集2015年9月至2019年9月山西省临汾市尧都区眼科医院特检科就诊的缺血型视网膜中央静脉阻塞(CRVO)患者70例(72只眼)的病例资料。其中,男性36例(36只眼),女性34例(36只眼);年龄44~87岁,平均年龄(64.1±12.2)岁。采用雷珠单抗玻璃体腔内注射联合多波长激光全视网膜光凝术治疗。检查并收集术前、术后1周、术后1个月、术后3个月及术后6个月患者的视力、黄斑中心凹视网膜神经纤维层厚度、荧光素眼底血管造影图像、相干光断层扫描图像及并发症的发生情况。患者的视力,采用眼数和百分比描述,以广义线性混合效应模型进行比较;黄斑中心凹视网膜神经纤维层厚度,采用(均数±标椎差)表示,以重复测量方差分析进行比较。结果术前视力<0.1者,有47只眼(占65.28%);视力≥0.1且<0.2者,有11只眼(占15.28%);视力≥0.2且<0.3者,有11只眼(占15.28%);视力≥0.3且<0.4者,有1只眼(占1.39%);视力≥0.4且<0.5者,有1只眼(占1.39%);视力≥0.5者,有1只眼(占1.39%)。术后各时间点视力逐渐提高,经过广义线性混合效应模型分析,各时间点差异有统计学意义(χ~2=8.31,P<0.05)。进一步两两比较,术后各时间点与术前比较,差异有统计学意义(χ~2=12.39,10.24,14.26,11.78;P<0.05)。术前、术后1周、1个月、3个月和6个月患者的黄斑中心凹视网膜神经纤维层厚度分别为(715.57±213.18)μm、(303.03±66.03)μm、(300.83±63.68)μm、(258.71±39.02)μm及(243.43±47.51)μm,随时间变化逐渐降低。经单因素重复测量方差分析,各时间点差异有统计学意义(F=206.89,P<0.05)。进一步两两比较,术后1周、术后1个月、术后3个月及术后6个月与术前比较,差异有统计学意义(t=21.29,21.36,23.50,24.19;P<0.05)。术后3个月及术后6个月与术后1周比较,差异有统计学意义(t=2.26,3.00;P<0.05)。术后3个月及术后6个月与术后1个月比较,差异有统计学意义(t=2.17,2.90;P<0.05)。70例患者中,3例患者出现局限性结膜下出血,占4.29%;5例发生轻微眼压升高,占7.14%。全部患者均未出现眼内炎症、新生血管性青光眼及视网膜脱离等并发症。结论缺血型CRVO患者采用雷珠单抗玻璃体腔内注射联合多波长激光全视网膜光凝治疗,第1周有效,第3个月时明显好转。由此可见,采用雷珠单抗玻璃体腔内注射,每月注射1次,连续3个月,联合多波长激光全视网膜光凝治疗缺血型CRVO,疗效确切,安全性高,值得临床推广。

Objective The aim of this study was to discuss the clinical effect of Leizhu McAb combined with laser in treating ischemic central retinal vein occlusion.Methods The case of 70 patients(72 eyes)with ischemic central retinal vein occlusion in Special Examination Department of Ophthalmology of Linfen Yaodu District Eye Hospital,Shanxi Province from September 2015 to September 2019 were collected.There were 36 males(36 eyes)and 34 females(36 eyes);they were aged 44 to 87 years-old with the average age(64.1±12.2)years-old.Intraluinal injection of Leizhu Mcab and multi-wavelength laser therapy was performed.The preoperative and postoperative vision,nerve fiber layer thickness of macular fovea,fluorescein fundus angiography,coherent optical tomography and the occurrence of complications for1 week,1 month,3 months,and 6 months were examined and collected.Patient’s vision was described by the number of eyes and percentage and compared by the generalized linear mixed effect model.Thickness of retinal fiber layer in macular fovea was expressed as mean±standard deviation deviation and compared by ANOVA.Results There were 47 eyes,accouting for 65.28%in patients with preoperative visual acuity<0.1;11 eyes,accouting for 15.28%in patients with preoperative visual acuity≥0.1 and<0.2;11 eyes,accouting for 15.28%in patients with preoperative visual acuity≥0.2 and<0.3;1 eyes,accouting for1.39%in patients with preoperative visual acuity≥0.3 and<0.4;1 eyes,accouting for 1.39%in patients with preoperative visual acuity≥0.5.The visual acuity improved gradually at each time point.After the analyzation of model of generalized linear mixing effect,the differences at each time point were statistically significant(χ~2=8.31,P<0.05).Further pairwise comparison,there were differences between each time point before and after operation(χ~2=12.39,10.24,14.26,11.78;P<0.05).The thickness of macular fovea was 1 week,1 month,3 months and 6 months(715.57±213.18)μm,(303.03±66.03)μm,(300.83±63.68)μm,(258.71±39.02)μm and(243.43±47.51)μm,respectively.The thickness of macular fovea varied with time.After the analyzation of one-way ANOVA,the differences at each time point were statistically significant(F=206.89,P<0.05).Further pairwise comparisons the differences between1 week,1 month,3 months and 6 months were statistically significant(t=21.29,21.36,23.50,24.19;P<0.05).The differences between 3 months and 6 months after operation were statistically significant compared with that of 1 week after operation(t=2.26,3.00;P<0.05);compared with that of 1 month after operation(t=2.17,2.90;P<0.05).Of the 70 patients,3 cases accouting for 4.29%had localized subconjunctival hemorrhage.5 cases accouting for 7.14%had mild increase in intraocular pressure.The inflammation,neovascular glaucoma,retinal detachment and other complications were not found in all patients.Conclusions Patients with ischemic type CRVO were treated with intraluminal injection of Leizhu McAb and multi-wavelength laser therapy,which was valid for the first week and had the significant improvement after 3 months.Based on these,the treatment of ischemic type CRVO by the use of intraluminal injection of Leizhu McAb(once a month for 3 consecutive months)combined with multi-wavelength laser had an accurate curative effect,high safety,which is useful for clinical practice.