摘要
目的观察地塞米松玻璃体腔植入剂(DEX)起始联合雷珠单抗新策略治疗视网膜静脉阻塞(RVO)继发黄斑水肿(ME)(RVO-ME)的短期有效性及安全性。方法前瞻性临床干预性研究。2020年5月至2021年9月于安徽理工大学第一附属医院眼科检查确诊的RVO-ME患者78例78只眼纳入研究。其中,男性35例,女性43例;均为单眼患病。视网膜分支静脉阻塞(BRVO)40例40只眼,视网膜中央静脉阻塞(CRVO)38例38只眼。根据治疗策略,患者随机分为起始DEX和雷珠单抗联合治疗组(起始联合治疗组)、DEX治疗组、雷珠单抗治疗组,分别为29、26、23只眼。不同类型RVO分为BRVO、CRVO不同治疗方案组。所有患眼均行最佳矫正视力(BCVA)、频域光相干断层扫描检查。BCVA检查采用国际标准视力表进行,统计分析时换算为最小分辨角对数(logMAR)视力。起始联合治疗组、DEX治疗组、雷珠单抗治疗组患眼logMAR BCVA(χ^(2)=2.376)、中心凹视网膜厚度(CRT)(F=0.052)比较,差异均无统计学意义(P>0.05)。治疗后每一个月随访1次,连续6个月。观察随访期间各组患眼BCVA、CRT变化以及不良反应发生情况。差异性比较采用单因素方差分析和Kruskal-WallisH检验。结果随访期间,与基线时比较,起始联合治疗组、DEX治疗组、雷珠单抗治疗组患眼BCVA明显改善(Z=110.970、90.359、207.303),CRT明显降低(F=107.172、88.418、61.040),差异均有统计学意义(P<0.01)。治疗后1、2、3、4、5、6个月,起始联合治疗组、DEX治疗组、雷珠单抗治疗组BCVA平均变化值比较,差异均有统计学意义(χ^(2)=34.522、29.570、14.199、7.000、6.434、6.880,P<0.05);治疗后1、2、3、6个月,平均CRT变化值比较,差异均有统计学意义(F=4.313、7.520、3.699、3.152,P<0.05)。起始联合治疗组、DEX治疗组、雷珠单抗治疗组患眼BCVA改善0.1 logMAR单位所需时间分别为5.73(3.21,8.48)、9.97(6.29,18.78)、20.00(9.41,37.89)d;CRT降至300μm所需时间分别为24.31(21.32,26.15)、29.42(25.65,31.37)、29.17(25.28,36.94)d。起始联合治疗组患眼BCVA改善0.1 logMAR单位、CRT降至300μm所需时间短于DEX治疗组、雷珠单抗治疗组,差异均有统计学意义(Z=-3.533、-4.445、-3.670、-4.030,P<0.01)。BRVO不同治疗方案组:治疗后1、2、3、5、6个月,平均BCVA变化值差异均有统计学意义(χ^(2)=24.989、21.652、11.627、7.054、9.698,P<0.05);CRVO不同治疗方案组:治疗后1、2个月,平均BCVA变化值差异均有统计学意义(χ^(2)=11.137、9.746,P<0.05)。治疗后2个月,BRVO、CRVO不同治疗方案组患眼CRT变化值比较,差异均有统计学意义(F=3.960、3.722,P<0.01)。BRVO、CRVO联合治疗组患眼BCVA改善0.1 logMAR单位所需时间短于BRVO、CRVO DEX治疗组和BRVO、CRVO雷珠单抗治疗组,差异均有统计学意义(BRVO:Z=-2.687、-3.877,P<0.05;CRVO:Z=-2.437、-3.575,P<0.05)。CRVO联合治疗组患眼CRT降至300μm所需时间明显短于CRVO DEX治疗组、CRVO雷珠单抗治疗组,差异均有统计学意义(F=6.910,P<0.01);BRVO不同方案治疗组差异无统计学意义(F=1.786,P>0.05)。起始联合治疗组、DEX治疗组接受再治疗眼数少于雷珠单抗治疗组,差异均有统计学意义(χ^(2)=18.330、7.224,P<0.05)。起始联合治疗组患眼再治疗间隔时间明显长于DEX治疗组、雷珠单抗治疗组,差异有统计学意义(P<0.01)。起始联合治疗组、DEX治疗组、雷珠单抗治疗组高眼压发生率比较,差异无统计学意义(χ^(2)=0.058,P>0.05)。结论起始DEX联合雷珠单抗新策略治疗RVO-ME短期疗效较好;再治疗间隔时间较单药治疗组短,视力和解剖学获益速度更快,药效持续时间更久;安全性较好。
Objective To observe the short-term efficacy and safety of a new strategy of dexamethasone intravitreal implant(DEX)combined with ranibizumab in the treatment of retinal vein occlusion(RVO)secondary to macular edema(ME)(RVO-ME).Methods A prospective clinical interventional study.From May 2020 to September 2021,78 RVO-ME patients with 78 eyes diagnosed in the eye examination of Department of Ophthalmology of The First Affiliated Hospital of Anhui University of Science&Technology were included in the study.Among them,there were 35 males and 43 females,all with monocular disease.Branch retinal vein occlusion(BRVO)was found in 40 patients with 40 eyes;central retinal vein occlusion(CRVO)was found in 38 patients with 38 eyes.According to the treatment strategies,patients were randomly divided into DEX and ranibizumab combination therapy group(initial combination therapy group),DEX monotherapy group and ranibizumab monotherapy group,with 29 eyes,26 eyes and 23 eyes respectively.Different types of RVO were divided into different treatment groups of BRVO and CRVO.Best corrected visual acuity(BCVA)and frequency domain optical coherence tomography were performed.The BCVA examination was carried out using the international standard visual acuity chart,which was converted into the logarithmic minimum angle of resolution(logMAR)visual acuity during statistics.There were no significant differences in logMAR BCVA(χ^(2)=2.376)and central retinal thickness(CRT)(F=0.052)among the three groups(P>0.05).After treatment,the patients were followed up every month for 6 months.The changes of BCVA,CRT and the incidence of adverse reactions were observed during follow-up.One-way ANOVA and Kruskal-Wallis H test were used to compare the differences.Results During the follow-up period,compared with the baseline,the BCVA of the eyes in the initial combination treatment group,DEX treatment group and ranibizumab treatment group were significantly improved(Z=110.970,90.359,207.303),and CRT was significantly decreased(F=107.172,88.418,61.040),the difference was statistically significant(P<0.01).At 1,2,3,4,5,and 6 months after treatment,there were significant differences in the mean changes in BCVA between the initial combined treatment group,DEX treatment group,and ranibizumab treatment group(χ^(2)=34.522,29.570,14.199,7.000,6.434,6.880;P<0.05);1,2,3,and 6 months after treatment,the differences were statistically significant(F=4.313,7.520,3.699,3.152;P<0.05).The time required to improve BCVA by 0.1 logMAR units in the initial combination treatment group,DEX treatment group,and ranibizumab treatment group was 5.73(3.21,8.48),9.97(6.29,18.78),and 20.00(9.41,37.89)d,respectively;The time required for CRT to drop to 300μm was 24.31(21.32,26.15),29.42(25.65,31.37),and 29.17(25.28,36.94)d,respectively.The BCVA improvement of 0.1 logMAR unit and the time required for CRT to decrease to 300μm in the eyes of initial combined treatment group were shorter than those in the eyes of DEX treatment group and the ranibizumab treatment group,and the differences were statistically significant(Z=-3.533,-4.445,-3.670,-4.030;P<0.01).Different BRVO treatment groups:1,2,3,5,and 6 months after treatment,the mean BCVA changes were significantly different(χ^(2)=24.989,21.652,11.627,7.054,9.698;P<0.05);CRVO was different treatment group:1 and 2 months after treatment,there were significant differences in mean BCVA changes(χ^(2)=11.137,9.746;P<0.05).Two months after treatment,there were significant differences in CRT changes between BRVO and CRVO groups with different treatment regimens(F=3.960,3.722;P<0.01).The time required to improve BCVA by 0.1 logMAR unit in the eyes of BRVO and CRVO combined treatment group was shorter than that in the eyes of BRVO,CRVO DEX treatment group and the BRVO,CRVO ranibizumab treatment group,and the differences were statistically significant(BRVO:Z=-2.687,-3.877;P<0.05;CRVO:Z=-2.437,-3.575;P<0.05).The time required for CRT to drop to 300μm in the CRVO combined treatment group was significantly shorter than that in the CRVO DEX treatment group and the CRVO ranibizumab treatment group,and the difference was statistically significant(F=6.910,P<0.010);there was no statistically significant difference between the different BRVO treatment groups(F=1.786,P>0.05).The number of re-treated eyes in the initial combined treatment group and DEX treatment group was less than that in the ranibizumab treatment group,and the difference was statistically significant(χ^(2)=18.330,7.224;P<0.05).The retreatment interval of the eyes in the initial combined treatment group was significantly longer than that in the DEX treatment group and the ranibizumab treatment group,and the difference was statistically significant(P<0.01).There was no significant difference in the incidence of intraocular hypertension among the initial combined treatment group,DEX treatment group and ranibizumab treatment group(χ^(2)=0.058,P>0.05).Conclusions The new strategy of initial combination therapy with DEX and ranibizumab in the treatment of RVO-ME has a better short-term effect.Compared with the monotherapy group,the retreatment interval is shorter,the visual and anatomical benefits are faster,the efficacy lasts longer,and the safety is better.
作者
徐玥
谢驰
方严
Xu Yue;Xie Chi;Fang Yan(Department of Ophthalmology,The First Affiliated Hospital of Anhui University of Science&Technology,Eye Institute of Anhui University of Science&Technology,Huainan 232000,China)
出处
《中华眼底病杂志》
CAS
CSCD
北大核心
2022年第9期729-738,共10页
Chinese Journal of Ocular Fundus Diseases
基金
2021年安徽省医疗卫生重点专科建设项目
2020年淮南市指导性科技计划项目(2020044)。
关键词
视网膜静脉闭塞
黄斑水肿
地塞米松
血管生成抑制剂
玻璃体内注射
起始联合治疗
Retinal vein occlusion
Macular edema
Dexamethasone
Angiogenesis inhibitors
Intravitreal injections
Initial combination therapy
