地塞米松玻璃体内植入剂Ozurdex治疗视网膜静脉阻塞继发黄斑水肿的短期疗效
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摘要
目的通过比较地塞米松玻璃体内植入剂Ozurdex与雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿(macular edema secondary to retinal vein occlusion,RVO-ME)的情况,评估Ozurdex的短期临床疗效。方法回顾性分析2018年1月至12月就诊于佛山市第二人民医院眼科中心的RVO-ME患者(42例42眼)的临床资料。将其分为DEX组(11例)和抗VEGF组(31例)。观察两组患者治疗前后的最佳矫正视力(best corrected visual acuity,BCVA)、中央视网膜厚度(central retinal thickness,CRT)、药效持续时间(复发率)、不良反应等。结果 DEX组治疗后1个月、2个月、3个月和4个月的BCVA与治疗前比较差异均有统计学意义(均为P<0.05),治疗后6个月与治疗前比较差异无统计学意义(P=0.054);DEX组治疗后1个月、2个月、3个月、4个月和6个月CRT与治疗前比较差异均有统计学意义(均为P<0.05)。抗VEGF组治疗后1个月BCVA、CRT与治疗前比较差异均有统计学意义(均为P<0.05)。治疗后1个月,DEX组与抗VEGF组间BCVA、CRT比较差异均无统计学意义(均为P>0.05)。DEX组内、抗VEGF组内及两者间视网膜分支静脉阻塞与视网膜中央静脉阻塞的BCVA、CRT比较除DXE组治疗后1个月CRT外,差异均无统计学意义(均为P>0.05)。DEX组的药效持续时间为3～4个月,抗VEGF组的药效持续时间<2个月。DEX组的高眼压发生率较抗VEGF组高,差异有统计学意义(P=0.004)。结论 Ozurdex在治疗RVO-ME上有明显的短期疗效,维持时间为3～4个月(少于6个月)。眼压仍是其需密切监控的主要不良反应。
Objective To evaluate the short-term clinical efficacy of Ozurdex by comparing intravitreal injection of Ozurdex with ranibizumab in the treatment of macular edema secondary to retinal vein occlusion(RVO-ME).Methods The clinical data of forty-two eyes of 42 RVO-ME patients who were admitted to the Department of Ophthalmology of the Second People's Hospital of Foshan City from January to December 2018 were retrospectively analyzed.They were divided into two groups:DEX group with 11 patients and anti-VEGF group with 31 patients.The best corrected visual acuity(BCVA),central retinal thickness(CRT),duration of drug efficacy(recurrence rate),and adverse reactions of the two groups were observed before and after treatment.Results The differences of BCVA at 1 month,2 months,3 months and 4 months after treatment in the DEX group were statistically significant than that before treatment(all P<0.05),while there was no statistical significance at 6 months after treatment(P=0.054).There were significant differences of CRT at 1 month,2 months,3 months,4 months and 6 months after treatment in the DEX group than that before treatment(all P<0.05).There were significant differences of BCVA and CRT in the anti-VEGF group at 1 month after treatment than those before treatment(both P<0.05).At 1 month after treatment,there were no significant differences of BCVA and CRT between the DEX group and the anti-VEGF group(both P>0.05).There were no significant differences between branch retinal vein occlusion and central retinal vein occlusion in the DEX group,the anti-VEGF group and between the two groups(all P>0.05),except for the CRT at 1 month after treatment in the DEX group.The duration of efficacy in the DEX group was 3 to 4 months,and the duration of efficacy in the anti-VEGF group was <2 months.The incidence of high intraocular pressure in the DEX group was higher than that in the anti-VEGF group,and the difference was statistically significant(P=0.004).Conclusion Ozurdex has a significant short-term efficacy in the treatment of RVO-ME for a period of 3 to 4 months(less than 6 months).Intraocular pressure is still the main adverse reaction that needs to be closely monitored.
Objective To evaluate the short-term clinical efficacy of Ozurdex by comparing intravitreal injection of Ozurdex with ranibizumab in the treatment of macular edema secondary to retinal vein occlusion(RVO-ME).Methods The clinical data of forty-two eyes of 42 RVO-ME patients who were admitted to the Department of Ophthalmology of the Second People's Hospital of Foshan City from January to December 2018 were retrospectively analyzed.They were divided into two groups:DEX group with 11 patients and anti-VEGF group with 31 patients.The best corrected visual acuity(BCVA),central retinal thickness(CRT),duration of drug efficacy(recurrence rate),and adverse reactions of the two groups were observed before and after treatment.Results The differences of BCVA at 1 month,2 months,3 months and 4 months after treatment in the DEX group were statistically significant than that before treatment(all P<0.05),while there was no statistical significance at 6 months after treatment(P=0.054).There were significant differences of CRT at 1 month,2 months,3 months,4 months and 6 months after treatment in the DEX group than that before treatment(all P<0.05).There were significant differences of BCVA and CRT in the anti-VEGF group at 1 month after treatment than those before treatment(both P<0.05).At 1 month after treatment,there were no significant differences of BCVA and CRT between the DEX group and the anti-VEGF group(both P>0.05).There were no significant differences between branch retinal vein occlusion and central retinal vein occlusion in the DEX group,the anti-VEGF group and between the two groups(all P>0.05),except for the CRT at 1 month after treatment in the DEX group.The duration of efficacy in the DEX group was 3 to 4 months,and the duration of efficacy in the anti-VEGF group was <2 months.The incidence of high intraocular pressure in the DEX group was higher than that in the anti-VEGF group,and the difference was statistically significant(P=0.004).Conclusion Ozurdex has a significant short-term efficacy in the treatment of RVO-ME for a period of 3 to 4 months(less than 6 months).Intraocular pressure is still the main adverse reaction that needs to be closely monitored.
引文
[1] ROGERS S,MCINTOSH R L,CHEUNG N,LIM L,WANG J J,MITCHELL P,et al.The prevalence of retinal vein occlusion:pooled data from population studies from the United States,Europe,Asia,and Australia[J].Ophthalmology,2010,117(2):313-319.
[2] THAPA R,BAJIMAYA S,PAUDYAL G,KHANAL S,TAN S,THAPA S S,et al.Prevalence,pattern and risk factors of retinal vein occlusion in an elderly population in Nepal:the Bhaktapur retina study[J].BMC Ophthalmol,2017,17(1):162.
[3] STANCA H T,MANEA G.Physiopathology of macular edema in central vein occlusion[J].Oftalmologia,2012,56(2):15-20.
[4] REHAK M,WIEDEMANN P.Retinal vein thrombosis:pathogenesis and management[J].J Thromb Haemost,2010,8(9):1886-1894.
[5] CHEN S D,SUNDARAM V,LOCHHEAD J,PATEL C K.Intravitreal triamcinolone for the treatment of ischemic macular edema associated with branch retinal vein occlusion[J].Am J Ophthalmol,2006,141(5):876-883.
[6] HUANG P,NIU W,NI Z,WANG R,SUN X.A meta-analysis of anti-vascular endothelial growth factor remedy for macular edema secondary to central retinal vein occlusion[J].PLoS One,2013,8(12):e82454.
[7] BRAITHWAITE T,NANJI A A,GREENBERG P B.Anti-vascular endothelial growth factor for macular edema secondary to central retinal vein occlusion[J].Cochrane Database Syst Rev,2010,10:CD007325.
[8] LONDON N J,CHIANG A,HALLER J A.The dexamethasone drug delivery system:indications and evidence[J].Adv Ther,2011,28(5):351-366.
[9] Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion.The Central Vein Occlusion Study Group M Report[J].Ophthalmology,1995,102(10):1425-1433.
[10] PATZ A.Argon laser photocoagulation for macular edema in branch vein occlusion[J].Am J Ophthalmol,1984,98(3):374-375.
[11] PIELEN A,FELTGEN N,ISSERSTEDT C,CALLIZO J,JUNKER B,SCHMUCKER C.Efficacy and safety of intravitreal therapy in macular edema due to branch and central retinal vein occlusion:a systematic review[J].PLoS One,2013,8(10):e78538.
[12] CHIQUET C,DUPUY C,BRON A M,APTEL F,STRAUB M,ISAICO R,et al.Intravitreal dexamethasone implant versus anti-VEGF injection for treatment-naive patients with retinal vein occlusion and macular edema:a 12-month follow-up study[J].Graefes Arch Clin Exp Ophthalmol,2015,253(12):2095-2102.
[13] POMMIER S,MEYER F,GUIGOU S,BARTHELEMY T,GOBERT F,HAJJAR C,et al.Long-term real-life efficacy and safety of repeated Ozurdex? injections and factors associated with macular edema resolution after retinal vein occlusion:The REMIDO 2 Study[J].Ophthalmologica,2016,236(4):186-192.
[14] LIN C J,CHEN H S,SU C W,TIEN P T,LIN J M,CHEN W L,et al.The effect of age and initial central retinal thickness on earlier need of repeat Ozurdex? treatment for macular edema due to retinal vein occlusion:a retrospective case series[J].J Ocul Pharmacol Ther,2017,33(10):763-772.
[15] KARAGIANNIS D A,KARAMPELAS M D,SOUMPLIS V M,AMARIOTAKIS C,GEORGALAS I,KANDARAKIS A.Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis)[J].Can J Ophthalmol,2011,46(6):486-490.
[16] HALLER J A,BANDELLO F,BELFORT R,BLUMENKRANZ M S,GILLIES M,HEIER J,et al.Randomized,sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion[J].Ophthalmology,2010,117(6):1134-1146.
[17] COSCAS G,AUGUSTIN A,BANDELLO F,DE SMET M D,LANZETTA P,STAURENGHI G,et al.Retreatment with Ozurdex for macular edema secondary to retinal vein occlusion[J].Eur J Ophthalmol,2014,24(1):1-9.
[18] CHANG-LIN J E,ATTAR M,ACHEAMPONG A A,ROBINSON M R,WHITCUP S M,KUPPERMANN B D,et al.Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant[J].Invest Ophthalmol Vis Sci,2011,52(1):80-86.
[19] QUERQUES L,QUERQUES G,LATTANZIO R,GIGANTE S R,DEL TURCO C,CORRADETTI G,et al.Repeated intravitreal dexamethasone implant (Ozurdex(R)) for retinal vein occlusion[J].Ophthalmologica,2013,229(1):21-25.
[20] PARRAVANO M,ODDONE F,BOCCASSINI B,GIORNO P,CHIARAVALLOTI A,TEDESCHI M,et al.Exploring the morphological and functional retinal changes after dexamethasone intravitreal implant (Ozurdex(R)) in macular edema due to retinal vein occlusion[J].Ophthalmic Res,2014,51(3):153-160.
[21] TSERVAKIS I,KOUTSANDREA C,PAPACONSTANTINOU D,PARASKEVOPOULOS T,GEORGALAS I.Safety and efficacy of dexamethasone intravitreal implant (Ozurdex) for the treatment of persistent macular edema secondary to retinal vein occlusion in eyes previously treated with anti-vascular endothelial growth factors[J].Curr Drug Saf,2015,10(2):145-151.
[22] OZKAYA A,TARAKCIOGLU H N,TANIR I.Ranibizumab versus dexamethasone implant in macular edema secondary to branch retinal vein occlusion:Two-year outcomes[J].Optom Vis Sci,2018,95(12):1149-1154.
[2] THAPA R,BAJIMAYA S,PAUDYAL G,KHANAL S,TAN S,THAPA S S,et al.Prevalence,pattern and risk factors of retinal vein occlusion in an elderly population in Nepal:the Bhaktapur retina study[J].BMC Ophthalmol,2017,17(1):162.
[3] STANCA H T,MANEA G.Physiopathology of macular edema in central vein occlusion[J].Oftalmologia,2012,56(2):15-20.
[4] REHAK M,WIEDEMANN P.Retinal vein thrombosis:pathogenesis and management[J].J Thromb Haemost,2010,8(9):1886-1894.
[5] CHEN S D,SUNDARAM V,LOCHHEAD J,PATEL C K.Intravitreal triamcinolone for the treatment of ischemic macular edema associated with branch retinal vein occlusion[J].Am J Ophthalmol,2006,141(5):876-883.
[6] HUANG P,NIU W,NI Z,WANG R,SUN X.A meta-analysis of anti-vascular endothelial growth factor remedy for macular edema secondary to central retinal vein occlusion[J].PLoS One,2013,8(12):e82454.
[7] BRAITHWAITE T,NANJI A A,GREENBERG P B.Anti-vascular endothelial growth factor for macular edema secondary to central retinal vein occlusion[J].Cochrane Database Syst Rev,2010,10:CD007325.
[8] LONDON N J,CHIANG A,HALLER J A.The dexamethasone drug delivery system:indications and evidence[J].Adv Ther,2011,28(5):351-366.
[9] Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion.The Central Vein Occlusion Study Group M Report[J].Ophthalmology,1995,102(10):1425-1433.
[10] PATZ A.Argon laser photocoagulation for macular edema in branch vein occlusion[J].Am J Ophthalmol,1984,98(3):374-375.
[11] PIELEN A,FELTGEN N,ISSERSTEDT C,CALLIZO J,JUNKER B,SCHMUCKER C.Efficacy and safety of intravitreal therapy in macular edema due to branch and central retinal vein occlusion:a systematic review[J].PLoS One,2013,8(10):e78538.
[12] CHIQUET C,DUPUY C,BRON A M,APTEL F,STRAUB M,ISAICO R,et al.Intravitreal dexamethasone implant versus anti-VEGF injection for treatment-naive patients with retinal vein occlusion and macular edema:a 12-month follow-up study[J].Graefes Arch Clin Exp Ophthalmol,2015,253(12):2095-2102.
[13] POMMIER S,MEYER F,GUIGOU S,BARTHELEMY T,GOBERT F,HAJJAR C,et al.Long-term real-life efficacy and safety of repeated Ozurdex? injections and factors associated with macular edema resolution after retinal vein occlusion:The REMIDO 2 Study[J].Ophthalmologica,2016,236(4):186-192.
[14] LIN C J,CHEN H S,SU C W,TIEN P T,LIN J M,CHEN W L,et al.The effect of age and initial central retinal thickness on earlier need of repeat Ozurdex? treatment for macular edema due to retinal vein occlusion:a retrospective case series[J].J Ocul Pharmacol Ther,2017,33(10):763-772.
[15] KARAGIANNIS D A,KARAMPELAS M D,SOUMPLIS V M,AMARIOTAKIS C,GEORGALAS I,KANDARAKIS A.Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis)[J].Can J Ophthalmol,2011,46(6):486-490.
[16] HALLER J A,BANDELLO F,BELFORT R,BLUMENKRANZ M S,GILLIES M,HEIER J,et al.Randomized,sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion[J].Ophthalmology,2010,117(6):1134-1146.
[17] COSCAS G,AUGUSTIN A,BANDELLO F,DE SMET M D,LANZETTA P,STAURENGHI G,et al.Retreatment with Ozurdex for macular edema secondary to retinal vein occlusion[J].Eur J Ophthalmol,2014,24(1):1-9.
[18] CHANG-LIN J E,ATTAR M,ACHEAMPONG A A,ROBINSON M R,WHITCUP S M,KUPPERMANN B D,et al.Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant[J].Invest Ophthalmol Vis Sci,2011,52(1):80-86.
[19] QUERQUES L,QUERQUES G,LATTANZIO R,GIGANTE S R,DEL TURCO C,CORRADETTI G,et al.Repeated intravitreal dexamethasone implant (Ozurdex(R)) for retinal vein occlusion[J].Ophthalmologica,2013,229(1):21-25.
[20] PARRAVANO M,ODDONE F,BOCCASSINI B,GIORNO P,CHIARAVALLOTI A,TEDESCHI M,et al.Exploring the morphological and functional retinal changes after dexamethasone intravitreal implant (Ozurdex(R)) in macular edema due to retinal vein occlusion[J].Ophthalmic Res,2014,51(3):153-160.
[21] TSERVAKIS I,KOUTSANDREA C,PAPACONSTANTINOU D,PARASKEVOPOULOS T,GEORGALAS I.Safety and efficacy of dexamethasone intravitreal implant (Ozurdex) for the treatment of persistent macular edema secondary to retinal vein occlusion in eyes previously treated with anti-vascular endothelial growth factors[J].Curr Drug Saf,2015,10(2):145-151.
[22] OZKAYA A,TARAKCIOGLU H N,TANIR I.Ranibizumab versus dexamethasone implant in macular edema secondary to branch retinal vein occlusion:Two-year outcomes[J].Optom Vis Sci,2018,95(12):1149-1154.