玻璃体切除加内界膜剥除联合视网膜下注射平衡盐溶液治疗难治性DME的临床疗效

Clinical effect of utilizing vitrectomy accompanied by internal limiting-membrane peeling and subretinal balanced salt-solution injection for treatment-resistant diabetic macular edema

目的探讨玻璃体切除加内界膜剥除联合视网膜下注射平衡盐溶液治疗难治性糖尿病性黄斑水肿(DME)的临床疗效。方法回顾性队列研究。纳入2021年12月—2023年3月于蚌埠医科大学第一附属医院确诊为难治性DME的患者47例,其中男18例、女29例,年龄46~79(61.7±7.0)岁。47例均为单眼发病,其中左眼29例、右眼18例。根据不同治疗方式分组:接受玻璃体切除加内界膜剥除联合视网膜下注射平衡盐溶液治疗的患者24例纳入注射组,仅接受玻璃体切除加内界膜剥除,未联合注射平衡盐溶液治疗的患者23例纳入非注射组。比较2组患者的性别、患眼侧别、年龄、DME病程、糖尿病病程、术前眼压、术前空腹血糖、术前糖化血红蛋白(%)、术前玻璃体腔注射抗血管内皮生长因子药物次数等基线资料。观察并比较2组患者术前、术后1周、术后1个月、术后3个月及末次随访时患者的最佳矫正视力(BCVA)、黄斑中央厚度(CMT)、视网膜浅层血流密度(SVD)和深层血流密度(DVD),以及术后黄斑水肿改善情况。结果注射组和非注射组患者的基线资料比较差异均无统计学意义(P值均>0.05)。患者手术均顺利,术后均获随访6~8(6.7±0.7)个月,期间仅1例注射组患者出现高眼压。(1)2组患者术后1、3个月及末次随访时BCVA均较术前改善,差异均有统计学意义(P值均<0.05)。2组间比较,术前、术后1周、术后1个月及术后3个月BCVA差异均无统计学意义(P值均>0.05);但末次随访时,注射组BCVA(0.58±0.22)logMAR小于非注射组(0.70±0.13)logMAR,视力提高情况优于非注射组,差异均有统计学意义(t=2.25、Z=-2.27,P值均<0.05)。(2)2组患者术后CMT逐渐下降,且术后不同时间点均较术前改善,差异均有统计学意义(P值均<0.05)。2组间CMT比较,术前差异无统计学意义(t=0.37,P=0.717),术后1周、术后1个月及术后3个月时差异均有统计学意义(P值均<0.05);末次随访时,注射组CMT[(263.00±62.74)μm]明显小于非注射组[(336.22±47.10)μm],黄斑水肿改善情况优于非注射组,差异均有统计学意义(t=4.51、Z=-2.01,P值均<0.05)。(3)2组患者SVD和DVD术后不同时间点较术前均无明显改变,且2组间各时点比较差异均无统计学意义(P值均>0.05)。结论玻璃体切除加内界膜剥除联合视网膜下注射平衡盐溶液手术是治疗难治性DME的有效方式,可以减轻黄斑水肿,提高患者术后视力。临床试验注册机构及注册号:蚌埠医科大学第一附属医院伦理委员会审核批准(2023YJS283)

ObjectiveThis study aimed to investigate the clinical effect of vitrectomy plus internal limiting-membrane peeling combined with subretinal injection of balanced salt solution for the treatment of refractory diabetic macular edema(DME).MethodsWe performed a retrospective cohort study.Forty-seven eyes of 47 patients diagnosed with refractory DME at the First Affiliated Hospital of Bengbu Medical University from December 2021 to March 2023 were included.Among them,18 were males and 29 were females aged 46-79(61.7±7.0)years old.DME occurred in the left eye for 29 patients and in the right eye for 18.According to different treatment methods,24 patients who received vitrectomy plus internal limiting-membrane peeling combined with the subretinal injection of balanced salt solution were included in the injection group.Twenty-three patients who received only vitrectomy and internal limiting-membrane peeling without combined injection of balanced salt solution were included in the non-injection group.We then compared the baseline characteristics between the two groups of patients,including gender,eye laterality,age,duration of DME,duration of diabetes mellitus,preoperative intraocular pressure,preoperative fasting blood glucose,preoperative glycated hemoglobin(%),and number of preoperative intravitreal injections of anti-vascular endothelial growth factor drugs.The best corrected visual acuity(BCVA),central macular thickness(CMT),superficial retinal vessel density(SVD),and deep retinal vessel density(DVD)of patients in both groups were observed at baseline,as well as at postoperative 1 week,1 month,3 months,and final follow-up.Differences among the various parameters,namely,postoperative visual acuity,and improvement in macular edema postoperatively,were compared.ResultsAll patients underwent successful surgeries and were followed up for 6 to 8(6.7±0.7)months,during which only one patient in the injection group experienced elevated intraocular pressure.No statistically significant differences in baseline data existed between the injection and non-injection groups(all P values>0.05).(1)Intra-group comparison of BCVA showed significant improvements at 1 and 3 months postoperatively,as well as at the final follow-up compared with preoperative values(all P values<0.05).Inter-group comparison of BCVA revealed no statistically significant differences at baseline,1 week postoperatively,1 month postoperatively,and 3 months postoperatively(all P values>0.05).However,at the final follow-up,the BCVA in the injection group was significantly lower than that in the non-injection group([0.58±0.22]logMAR vs.[0.70±0.13]logMAR),indicating better visual improvement in the injection group,with statistically significant differences(t=2.25,Z=-2.27,all P values<0.05).(2)Intra-group comparison of CMT showed gradual decreases at different time points postoperatively,and all significantly improved compared with preoperative values(all P values<0.05).Inter-group comparison of CMT revealed no statistically significant differences at baseline(t=0.37,P=0.717),but significant differences were observed at 1 week,1 month,and 3 months postoperatively(all P values<0.05).At the final follow-up,the CMT in the injection group was significantly lower than that in the non-injection group(263.00±62.74µm vs.336.22±47.10µm).This finding indicated better improvement in macular edema in the injection group,with statistically significant differences(t=4.51,Z=-2.01,all P values<0.05).(3)Comparison of SVD and DVD between the two groups showed no significant changes at different time points postoperatively compared with preoperative values.No statistically significant differences existed between the two groups(all P values>0.05).ConclusionVitrectomy combined with internal limiting-membrane peeling combined with the subretinal injection of the balanced salt solution can effectively treat refractory DME.It can reduce macular edema and thus provide better treatment results for patients.Clinical trial registration body and registration number:Approved by Ethics Committee of the First Affiliated Hospital of Bengbu Medical University(2023YJS283)