视网膜下注射复方电解质眼内冲洗液治疗伴硬性渗出物的糖尿病黄斑水肿的临床疗效观察

Clinical observation of subretinal injection of compound electrolyte intraocular irrigation solution in the treatment of diabetic macular edema with hard exudate

目的观察玻璃体切割、内界膜剥除、视网膜下注射复方电解质眼内冲洗液(CEIIS)联合康柏西普治疗糖尿病黄斑水肿(DME)伴硬性渗出物(HE)(DME-HE)的临床疗效。方法前瞻性临床研究。2020年6月至2022年2月于潍坊眼科医院检查确诊的DME-HE患者33例36只眼纳入研究。其中,男性15例16只眼,女性18例20只眼;年龄(62.00±6.54)岁。所有患者均行最佳矫正视力(BCVA)、扫描激光检眼镜、光相干断层扫描(OCT)、多焦视网膜电图(mf-ERG)检查。采用Snellen视力表行BCVA检查,统计时换算为最小分辨角对数(logMAR)视力;采用OCT仪测量黄斑中心凹视网膜厚度(CMT)及黄斑容积(MV);采用RETIsan检查系统行mf-ERG检查,测量1环P1波振幅密度。患者随机分为A组、B组,分别为17例18只眼、16例18只眼。两组患者年龄、logMAR BCVA、HE面积、CMT、MV、1环P1波振幅密度比较,差异均无统计学意义(t=0.403、0.972、0.291、0.023、-0.268、-0.206,P>0.05)。A组行玻璃体切割、内界膜剥除以及视网膜下注射CEIIS、康柏西普治疗(联合治疗);B组行玻璃体腔注射康柏西普(IVC)治疗。治疗后两组患眼均按需给予IVC治疗。治疗后随访时间12个月。对比观察组内和组间治疗后BCVA、HE面积、CMT、MV、1环P1波振幅密度变化,以及治疗后注药次数及并发症发生情况。两组间比较采用独立样本t检验。结果治疗后12个月,与治疗前比较,A组患眼logMAR BCVA(F=14.837)、HE面积(χ2=94.522)、CMT(χ2=199.212)、MV(χ2=81.914)、1环P1波振幅密度(F=8.933)的差异均有统计学意义(P<0.05);B组患眼CMT(F=5.540)、MV(F=7.836)的差异有统计学意义(P<0.05)。两组患眼间比较,logMAR BCVA:治疗后1周及6、12个月时,差异有统计学意义(t=2.231、-2.122、-3.196,P<0.05);HE面积:除治疗后1周外,治疗后其他时间差异均有统计学意义(t=-2.422、-3.107、-3.540、-4.119,P<0.05);CMT、MV、1环P1波振幅密度:治疗后12个月时,差异均有统计学意义(t=-2.653、-2.455、2.204,P<0.05)。随访期间,A组、B组患者注药次数分别为(3.06±1.89)、(5.56±2.04)次,差异有统计学意义(t=-3.815,P<0.05);A组、B组患眼中出现黄斑裂孔、玻璃体积血各1只眼。结论玻璃体切割、内界膜剥除、视网膜下注射CEIIS联合康柏西普治疗DME-HE能有效清除HE,减轻黄斑水肿,有效改善患眼BCVA,降低CMT和MV;联合治疗可减少IVC再治疗次数。

Objective To observe the clinical effect of vitrectomy,inner limiting membrane(ILM)peeling,subretinal injection of compound electrolyte intraocular irrigation solution(CEIIS)and conbercept in the treatment of diabetic macular edema(DME)with hard exudate(HE)(DME-HE).Methods A prospective clinical study.Thirty-three patients with DME-HE diagnosed by examination in Weifang Eye Hospital from June 2020 to February 2022 were included in the study.Among them,there were 15 males(16 eyes)and 18 females(20 eyes),with the mean age of(62.00±6.54)years.All patients underwent the examinations of best corrected visual acuity(BCVA),scanning laser ophthalmoscope,optical coherence tomography(OCT),and multifocal electroretinography(mf-ERG).Snellen visual acuity chart was used for BCVA examination,which was converted into logarithm of the minimum angle of resolution(logMAR)BCVA for statistic analysis.Macular foveal retinal thickness(CMT)and macular volume(MV)were measured by OCT.The 1 ring P1 wave amplitude density was measured by mf-ERG.The patients were randomly divided into group A and group B,with 17 patients(18 eyes)and 16 patients(18 eyes),respectively.There were no significant differences in age,logMAR BCVA,HE area,CMT,MV,and 1 ring P1 wave amplitude density between the two groups(t=0.403,0.972,0.291,0.023,-0.268,-0.206;P>0.05).Group A was treated with vitrectomy,ILM peeling,and subretinal injection of CEIIS and conbercept(combined therapy).Group B was treated with intravitreal injection of conbercept(IVC).Follow-up was 12 months after treatment.The changes of BCVA,HE area,CMT,MV,1 ring P1 wave amplitude density were compared between groups and groups after treatment.The times of injection and complications after treatment were observed.Independent sample t test was used for comparison between the two groups.Results At 12 months after treatment,compared to before treatment,there were significant differences in logMAR BCVA(F=14.837),HE area(χ2=94.522),CMT(χ2=199.212),MV(χ2=81.914)and 1 ring P1 wave amplitude density(F=8.933)in group A(P<0.05);there were significant differences in CMT(F=5.540)and MV(F=7.836)in group B(P<0.05).Compared between the two groups,logMAR BCVA:1 week and 6 and 12 months after treatment,the difference was statistically significant(t=2.231,-2.122,-3.196;P<0.05);HE area:except 1 week after treatment,there were statistically significant differences at other times after treatment(t=-2.422,-3.107,-3.540,-4.119;P<0.05).CMT,MV,1 ring P1 wave amplitude density:12 months after treatment,the differences were statistically significant(t=-2.653,-2.455,2.204;P<0.05).During the follow-up period,the injection times of group A and group B were(3.06±1.89)and(5.56±2.04),respectively,and the difference was statistically significant(t=-3.815,P<0.05).Macular hole and vitreous hematoma were found in 1 eye in group A and 1 eye in group B.Conclusion Vitrectomy,ILM peeling,subretinal injection of CEIIS and conbercept to treat DME-HE can effectively remove HE,alleviate macular edema,improve BCVA,and reduce CMT and MV.Combination therapy can reduce the number of IVC re-treatments.