玻璃体内注射雷珠单抗治疗病理性近视继发脉络膜新生血管
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摘要
目的对比观察玻璃体内注射雷珠单抗的两种方案治疗病理性近视(pathological myopia,PM)继发脉络膜新生血管(choroidal neovascularization,CNV)的临床疗效。方法收集2016年1月至2017年6月在我院接受治疗的PM-CNV患者49例(49眼)纳入本研究。所有患眼均行玻璃体内注射雷珠单抗(0. 05 m L,含雷珠单抗0. 5 mg)治疗。依据接受治疗情况将患者分为1+PRN组(注射一次后再按需注射) 25例25眼、3+PRN组(连续注射3个月后再按需注射) 24例24眼。随访时间为12个月。比较治疗后两组患眼的平均治疗次数、最佳矫正视力(best corrected visual acuity,BCVA)、黄斑中心凹视网膜厚度(central macular thickness,CMT)以及CNV渗漏变化情况。结果 1+PRN组、3+PRN组患眼治疗次数分别为(1. 92±1. 12)次、(3. 21±0. 42)次,差异有统计学意义(Z=-4. 056,P=0. 000)。治疗后6个月、12个月,1+PRN组患眼BCVA分别为(0. 57±0. 28)log MAR、(0. 50±0. 26) log MAR,3+PRN组患眼BCVA分别为(0. 58±0. 22) log MAR、(0. 51±0. 25) log MAR,两组治疗后同一时间点BCVA比较,差异均无统计学意义(t=-0. 214、-0. 172,P=0. 831、0. 864)。治疗后6个月、12个月,1+PRN组患眼CMT值分别为(285. 16±66. 08)μm、(247. 40±55. 10)μm,3+PRN组患眼CMT值分别为(286. 29±29. 53)μm、(241. 04±35. 39)μm,两组治疗后同一时间点CMT比较,差异均无统计学意义(t’=-0. 080、-0. 480,P=0. 938、0. 632)。治疗后12个月,1+PRN组、3+PRN组治疗总有效率分别为84%、92%,两组患眼CNV渗漏治疗总有效率的比较,差异无统计学意义(χ~2=0. 146,P=0. 702)。结论 1+PRN方案在保证疗效的前提下减少了注药次数,提示1+PRN方案更适合于PM-CNV的治疗。
Objective To compare the clinical efficacy of two different intravitreal ranibizumab injection regimens in patients with choroidal neovascularization(CNV)secondary to pathological myopia(PM).M ethods Forty-nine eyes of 4 9 patients with PM-CNV in our hospital from January 2 0 1 6 to June 2 0 1 7 were enrolled into this study.All patients were treated with intravitreal injection of 0.0 5 mL ranibizumab(1 0 g·L~(-1)).The patients were divided into two groups:1+PRN group including 25 patients(25 eyes)treated with a single intravitreal injection and 3+PRN group including 24patients(2 4 eyes)treated with three consecutive monthly intravitreal injections.The follow-up period was 1 2 months.The mean times of injection,best corrected visual acuity(BCVA),central macular thickness(CMT)and leakage of CNV after treatment were compared.Results The mean times of injection in the 1+PRN group and 3+PRN group were 1.9 2±1.1 2 and 3.2 1±0.4 2 respectively,and the difference between the two groups was statistically significant(Z=-4.0 5 6,P=0.0 0 0).At 6months and 1 2 months after treatment,the BCVA was(0.5 7±0.2 8)logMAR and(0.50±0.26)logMAR in the 1+PRN group,and(0.58±0.22)logMAR and(0.51±0.25)logMAR in the 3+PRN group,respectively.There were no significant difference in BCVA between the two groups at each time point(t=-0.2 1 4,-0.1 7 2and P=0.8 3 1,0.8 6 4,respectively).The CMT values were(2 8 5.1 6±6 6.0 8)μm and(2 4 7.4 0±5 5.1 0)μm in the 1+PRN group,and(2 8 6.2 9±2 9.5 3)μm and(241.04±35.39)μm in the 3+PRN group at 6 months and 12 months after treat- ment,respectively.There were no statistical difference in CMT values of the two groups at the both time points(t’=-0.0 8 0,-0.4 8 0 and P=0.9 3 8,0.6 3 2,respectively).The overall rates of efficacy of CNV leakage were 8 4%and 9 2%in the 1+PRN group and 3+PRN group,respectively.At 1 2 months after treatment,the difference was not statistically significant(χ~2=0.1 4 6,P=0.7 0 2).Conclusion The 1+PRN regimen decreases the times of total injections for guaranteeing the efficacy,suggesting it is a more suitable therapy to PM-CNV.
Objective To compare the clinical efficacy of two different intravitreal ranibizumab injection regimens in patients with choroidal neovascularization(CNV)secondary to pathological myopia(PM).M ethods Forty-nine eyes of 4 9 patients with PM-CNV in our hospital from January 2 0 1 6 to June 2 0 1 7 were enrolled into this study.All patients were treated with intravitreal injection of 0.0 5 mL ranibizumab(1 0 g·L~(-1)).The patients were divided into two groups:1+PRN group including 25 patients(25 eyes)treated with a single intravitreal injection and 3+PRN group including 24patients(2 4 eyes)treated with three consecutive monthly intravitreal injections.The follow-up period was 1 2 months.The mean times of injection,best corrected visual acuity(BCVA),central macular thickness(CMT)and leakage of CNV after treatment were compared.Results The mean times of injection in the 1+PRN group and 3+PRN group were 1.9 2±1.1 2 and 3.2 1±0.4 2 respectively,and the difference between the two groups was statistically significant(Z=-4.0 5 6,P=0.0 0 0).At 6months and 1 2 months after treatment,the BCVA was(0.5 7±0.2 8)logMAR and(0.50±0.26)logMAR in the 1+PRN group,and(0.58±0.22)logMAR and(0.51±0.25)logMAR in the 3+PRN group,respectively.There were no significant difference in BCVA between the two groups at each time point(t=-0.2 1 4,-0.1 7 2and P=0.8 3 1,0.8 6 4,respectively).The CMT values were(2 8 5.1 6±6 6.0 8)μm and(2 4 7.4 0±5 5.1 0)μm in the 1+PRN group,and(2 8 6.2 9±2 9.5 3)μm and(241.04±35.39)μm in the 3+PRN group at 6 months and 12 months after treat- ment,respectively.There were no statistical difference in CMT values of the two groups at the both time points(t’=-0.0 8 0,-0.4 8 0 and P=0.9 3 8,0.6 3 2,respectively).The overall rates of efficacy of CNV leakage were 8 4%and 9 2%in the 1+PRN group and 3+PRN group,respectively.At 1 2 months after treatment,the difference was not statistically significant(χ~2=0.1 4 6,P=0.7 0 2).Conclusion The 1+PRN regimen decreases the times of total injections for guaranteeing the efficacy,suggesting it is a more suitable therapy to PM-CNV.
引文
[1] DING X Y,CHEN C L. Understanding the characteristics of myopic choroidal neovascularization to improve its diagnosis and treatment outcome and follow-up strategy[J]. Chin J Ocul Fundus Dis,2017,33(6):564-568.丁小燕,陈冲林.正确认识近视脉络膜新生血管的临床特征提高其诊断治疗及规范随访水平[J].中华眼底病杂志,2017,33(6):564-568.
[2] IKUNO Y,JO Y,HAMASAKI T,TANO Y. Ocular risk factors for choroidal neovascularization in pathologic myopia[J]. Invest Ophthalmol Vis Sci,2010,51(7):3721-3725.
[3] GHARBIYA M,GIUSTOLISI R,ALLIEVI F. Choroidal neovascularization in pathologic myopia:intravitreal ranibizumab versus bevacizumab--a randomized controlled trial[J]. Am J Ophthalmol,2010,149(3):458-464.
[4] ZENG M,SONG Y P,DING Q. Intravitreal Conbercept for treatment of choroidal neovascularization secondary to pathologic myopia[J]. Chin J Ocul Fundus Dis,2 0 1 6,3 2(1):1 7-2 1.曾苗,宋艳萍,丁琴.玻璃体腔注射康柏西普治疗病理性近视脉络膜新生血管疗效观察[J].中华眼底病杂志,2016,32(1):17-21.
[5] YIZUO H Z,CHEN C Z,ZHENG H M,WONG M,CAO S. Clinical observation of intravitreal ranibizumab for treatment of choroidal neovascularization secondary to pathologic myopia[J]. Chin J Ocul Fundus Dis,2013,29(4):367-371.易佐慧子,陈长征,郑红梅,翁铭,曹思.抗血管内皮生长因子单克隆抗体ranibizumab治疗病理性近视脉络膜新生血管疗效观察[J].中华眼底病杂志,2013,29(4):367-371.
[6] YANG X,DAI H. Intravitreal ranibizumab for the treatment of pathological myopia associated with choroidal neovascularization in Chinese patients[J]. Chin Med J(Engl),2014,127(16):2906-2910.
[7] WOLF S,BALCIUNIENE V J,LAGANOVSKA G,MENCHINI U,OHNO-MATSUI K,SHARMA T,et al. RADIANCE:a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia[J]. Ophthalmology,2014,121(3):682-692.
[8] TONG J P,CHAN W M,LIU D T,LAI T Y,CHOY K W,PANG C P,et al. Aqueous humor levels of vascular endothelial growth factor and pigment epithelium-derived factor in polypoidal choroidal vasculopathy and choroidal neovascularization[J]. Am J Ophthalmol,2006,141(3):456-462.
[9] NG D S,KWOK A K,CHAN C W. Anti-vascular endothelial growth factor for myopic choroidal neovascularization[J]. Clin Exp Ophthalmol,2012,40(1):e98-e110.
[10] MATRI L E,CHEBIL A,KORT F. Current and emerging treatment options for myopic choroidal neovascularization[J]. Clin Ophthalmol,2015,9(3):733-744.
[11] DING W Z,ZOU J. Research advances in pathogenesis of choroidal neovascularization of pathologic myopia[J]. Rec Adv Ophthalmol,2014,34(10):987-989.丁雯芝,邹俊.病理性近视脉络膜新生血管发病机制的研究进展[J].眼科新进展,2014,34(10):987-989.
[12] CUI L H,YANG Z,XU L. Efficacy of intravitreal Ranibizumab injection for choroidal neovascularization secondary to pathologic myopia[J]. Int Eye Sci,2016,16(3):526-528.崔丽红,杨智,徐丽.玻璃体腔注射雷珠单抗治疗病理性近视脉络膜新生血管[J].国际眼科杂志,2016,16(3):526-528.
[13] YAN P S,WAN G M,DONG Y,QIAN C,CHEN Y,LI F Z,et al.Analysis on the effect of Ranibizumab combined with photodynamic therapy in the treatment of age-related macular degeneration[J]. Int Eye Sci,2017,17(5):933-936.闫磐石,万光明,董一,钱诚,陈悦,李福祯,等.雷珠单抗联合光动力疗法对年龄相关性黄斑变性CNV的治疗效果[J].国际眼科杂志,2017,17(5):933-936.
[14] LIU L P,SONG H,JI L B,XIAO Y,LI M,CHEN Z. Intravitreal ranibizumab injections for pathologic myopia macular choroidal neovascularization[J]. Rec Adv Ophthalmol,2016,36(7):667-670.刘李平,宋徽,冀垒兵,肖云,李明,陈真.玻璃体内注射雷珠单抗治疗病理性近视黄斑部脉络膜新生血管[J].眼科新进展,2016,36(7):667-670.
[15] MENG L,WEI W B,LI Y L,HAN X D. Clinical observation of intravitreal Ranibizumab injection for choroidal neovascularization secondary to pathologic myopia[J]. Chin J Ocul Fundus Dis,2016,32(1):70-72.孟王乐,魏文斌,李燕龙,韩晓冬.玻璃体腔注射雷珠单抗治疗病理性近视脉络膜新生血管的疗效观察[J].中华眼底病杂志,2016,32(1):70-72.
[16] FIGURSKA M,STANKIEWICZ A. Anty-VEGF therapy in the treatment of myopic macular choroidal neovascularization--cases report[J]. Klin Oczna,2008,110(10-12):387-391.
[17] PASTORE M R,CAPUANO V,BRUYRE E,MIERE A,CORBELLI E,QUERQUES L,et al. Nine-year outcome of ranibizumab monotherapy for choroidal neovascularization secondary to pathologic myopia[J]. Ophthalmologica,2017,239(2-3):133-142.
[18] TUFAIL A,PATEL P J,SIVAPRASAD S,AMOAKU W,BROWNING A C,COLE M,et al. Ranibizumab for the treatment of choroidal neovascularization secondary to pathological myopia:interim analysis of the REPAIR study[J]. Eye,2013,27(6):709-715.
[19] CALVO-GONZLEZ C,RECHE-FRUTOS J,FERNNDEZ-VIGO J I,SENZ-FRANCS F,FERNNDEZ-PREZ C,GARCAFEIJO J. Long-term outcomes of two different InitialdDosing regimens of intravitreal ranibizumab used to treat myopic choroidal neovascularization[J]. Ophthalmologica,2017,238(4):196-204.
[20] RUIZ-MORENO J M,MONTERO J A,AMAT-PERAL P. Myopic choroidal neovascularization treated by intravitreal bevacizumab:comparison of two different initial doses[J]. Graefes Arch Clin Exp Ophthalmol,2011,249(4):595-599.
[21] RUIZ-MORENO J M,MONTERO J A,ARIAS L,ARAIZ J,GOMEZ-ULLA F,SILVA R,et al. Three versus one intravitreal bevacizumab injections as initial protocol to treat myopic choroidal neovascularization[J]. Acta Ophthalmol,2012,90(1):e82-e83.
[22] WAKABAYASHI T,IKUNO Y,GOMI F. Different dosing of intravitreal bevacizumab for choroidal neovascularization because of pathologic myopia[J]. Retina,2011,31(5):880-886.
[23] IKUNO Y,OHNO-MATSUI K,WONG T Y,KOROBELNIK J F,VITTI R,LI T,et al. Intravitreal aflibercept injection in patients with myopic choroidal neovascularization:the MYRROR study[J]. Ophthalmology,2015,122(6):1220-1227.
[24] MIYAKE M,YAMASHIRO K,AKAGIKURASHIGE Y,KUMAGAI K,NAKATA I,NAKANISHI H,et al. Vascular endothelial growth factor gene and the response to anti-vascular endothelial growth factor treatment for choroidal neovascularization in high myopia[J]. Ophthalmology,2014,121(1):225-233.
[25] WANG E,CHEN Y. Intravitreal anti-vascular endothelial growth factor for choroidal neovascularization secondary to pathologic myopia:systematic review and meta-analysis[J]. Retina,2013,33(7):1375-1392.
[26] INHOFFEN W,ZIEMSSEN F. Morphological features of myopic choroidal neovascularization:differences to neovascular age-related macular degeneration[J]. Ophthalmologe,2012,109(8):749-757.
[27] LI L,WANG W J,YUAN F,ZHAO N Q,YUAN Y Z. Comparison between age-related macular degeneration and pathologic myopia with choroidal neovascularization[J]. Rec Adv Ophthalmol,2005,25(1):49-51.黎蕾,王文吉,袁非,赵耐青,袁源智.年龄相关性黄斑变性和病理性近视合并脉络膜新生血管的比较[J].眼科新进展,2005,25(1):49-51.
[28] LU B W,WU X W. Recent advances in intravitreal injection of ranibizumab for myopic choroidal neovascularization[J]. Rec Adv Ophthalmol,2014,34(9):897-900.陆秉文,吴星伟. Ranibizumab玻璃体内注射治疗病理性近视脉络膜新生血管研究进展[J].眼科新进展,2014,34(9):897-900.
[2] IKUNO Y,JO Y,HAMASAKI T,TANO Y. Ocular risk factors for choroidal neovascularization in pathologic myopia[J]. Invest Ophthalmol Vis Sci,2010,51(7):3721-3725.
[3] GHARBIYA M,GIUSTOLISI R,ALLIEVI F. Choroidal neovascularization in pathologic myopia:intravitreal ranibizumab versus bevacizumab--a randomized controlled trial[J]. Am J Ophthalmol,2010,149(3):458-464.
[4] ZENG M,SONG Y P,DING Q. Intravitreal Conbercept for treatment of choroidal neovascularization secondary to pathologic myopia[J]. Chin J Ocul Fundus Dis,2 0 1 6,3 2(1):1 7-2 1.曾苗,宋艳萍,丁琴.玻璃体腔注射康柏西普治疗病理性近视脉络膜新生血管疗效观察[J].中华眼底病杂志,2016,32(1):17-21.
[5] YIZUO H Z,CHEN C Z,ZHENG H M,WONG M,CAO S. Clinical observation of intravitreal ranibizumab for treatment of choroidal neovascularization secondary to pathologic myopia[J]. Chin J Ocul Fundus Dis,2013,29(4):367-371.易佐慧子,陈长征,郑红梅,翁铭,曹思.抗血管内皮生长因子单克隆抗体ranibizumab治疗病理性近视脉络膜新生血管疗效观察[J].中华眼底病杂志,2013,29(4):367-371.
[6] YANG X,DAI H. Intravitreal ranibizumab for the treatment of pathological myopia associated with choroidal neovascularization in Chinese patients[J]. Chin Med J(Engl),2014,127(16):2906-2910.
[7] WOLF S,BALCIUNIENE V J,LAGANOVSKA G,MENCHINI U,OHNO-MATSUI K,SHARMA T,et al. RADIANCE:a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia[J]. Ophthalmology,2014,121(3):682-692.
[8] TONG J P,CHAN W M,LIU D T,LAI T Y,CHOY K W,PANG C P,et al. Aqueous humor levels of vascular endothelial growth factor and pigment epithelium-derived factor in polypoidal choroidal vasculopathy and choroidal neovascularization[J]. Am J Ophthalmol,2006,141(3):456-462.
[9] NG D S,KWOK A K,CHAN C W. Anti-vascular endothelial growth factor for myopic choroidal neovascularization[J]. Clin Exp Ophthalmol,2012,40(1):e98-e110.
[10] MATRI L E,CHEBIL A,KORT F. Current and emerging treatment options for myopic choroidal neovascularization[J]. Clin Ophthalmol,2015,9(3):733-744.
[11] DING W Z,ZOU J. Research advances in pathogenesis of choroidal neovascularization of pathologic myopia[J]. Rec Adv Ophthalmol,2014,34(10):987-989.丁雯芝,邹俊.病理性近视脉络膜新生血管发病机制的研究进展[J].眼科新进展,2014,34(10):987-989.
[12] CUI L H,YANG Z,XU L. Efficacy of intravitreal Ranibizumab injection for choroidal neovascularization secondary to pathologic myopia[J]. Int Eye Sci,2016,16(3):526-528.崔丽红,杨智,徐丽.玻璃体腔注射雷珠单抗治疗病理性近视脉络膜新生血管[J].国际眼科杂志,2016,16(3):526-528.
[13] YAN P S,WAN G M,DONG Y,QIAN C,CHEN Y,LI F Z,et al.Analysis on the effect of Ranibizumab combined with photodynamic therapy in the treatment of age-related macular degeneration[J]. Int Eye Sci,2017,17(5):933-936.闫磐石,万光明,董一,钱诚,陈悦,李福祯,等.雷珠单抗联合光动力疗法对年龄相关性黄斑变性CNV的治疗效果[J].国际眼科杂志,2017,17(5):933-936.
[14] LIU L P,SONG H,JI L B,XIAO Y,LI M,CHEN Z. Intravitreal ranibizumab injections for pathologic myopia macular choroidal neovascularization[J]. Rec Adv Ophthalmol,2016,36(7):667-670.刘李平,宋徽,冀垒兵,肖云,李明,陈真.玻璃体内注射雷珠单抗治疗病理性近视黄斑部脉络膜新生血管[J].眼科新进展,2016,36(7):667-670.
[15] MENG L,WEI W B,LI Y L,HAN X D. Clinical observation of intravitreal Ranibizumab injection for choroidal neovascularization secondary to pathologic myopia[J]. Chin J Ocul Fundus Dis,2016,32(1):70-72.孟王乐,魏文斌,李燕龙,韩晓冬.玻璃体腔注射雷珠单抗治疗病理性近视脉络膜新生血管的疗效观察[J].中华眼底病杂志,2016,32(1):70-72.
[16] FIGURSKA M,STANKIEWICZ A. Anty-VEGF therapy in the treatment of myopic macular choroidal neovascularization--cases report[J]. Klin Oczna,2008,110(10-12):387-391.
[17] PASTORE M R,CAPUANO V,BRUYRE E,MIERE A,CORBELLI E,QUERQUES L,et al. Nine-year outcome of ranibizumab monotherapy for choroidal neovascularization secondary to pathologic myopia[J]. Ophthalmologica,2017,239(2-3):133-142.
[18] TUFAIL A,PATEL P J,SIVAPRASAD S,AMOAKU W,BROWNING A C,COLE M,et al. Ranibizumab for the treatment of choroidal neovascularization secondary to pathological myopia:interim analysis of the REPAIR study[J]. Eye,2013,27(6):709-715.
[19] CALVO-GONZLEZ C,RECHE-FRUTOS J,FERNNDEZ-VIGO J I,SENZ-FRANCS F,FERNNDEZ-PREZ C,GARCAFEIJO J. Long-term outcomes of two different InitialdDosing regimens of intravitreal ranibizumab used to treat myopic choroidal neovascularization[J]. Ophthalmologica,2017,238(4):196-204.
[20] RUIZ-MORENO J M,MONTERO J A,AMAT-PERAL P. Myopic choroidal neovascularization treated by intravitreal bevacizumab:comparison of two different initial doses[J]. Graefes Arch Clin Exp Ophthalmol,2011,249(4):595-599.
[21] RUIZ-MORENO J M,MONTERO J A,ARIAS L,ARAIZ J,GOMEZ-ULLA F,SILVA R,et al. Three versus one intravitreal bevacizumab injections as initial protocol to treat myopic choroidal neovascularization[J]. Acta Ophthalmol,2012,90(1):e82-e83.
[22] WAKABAYASHI T,IKUNO Y,GOMI F. Different dosing of intravitreal bevacizumab for choroidal neovascularization because of pathologic myopia[J]. Retina,2011,31(5):880-886.
[23] IKUNO Y,OHNO-MATSUI K,WONG T Y,KOROBELNIK J F,VITTI R,LI T,et al. Intravitreal aflibercept injection in patients with myopic choroidal neovascularization:the MYRROR study[J]. Ophthalmology,2015,122(6):1220-1227.
[24] MIYAKE M,YAMASHIRO K,AKAGIKURASHIGE Y,KUMAGAI K,NAKATA I,NAKANISHI H,et al. Vascular endothelial growth factor gene and the response to anti-vascular endothelial growth factor treatment for choroidal neovascularization in high myopia[J]. Ophthalmology,2014,121(1):225-233.
[25] WANG E,CHEN Y. Intravitreal anti-vascular endothelial growth factor for choroidal neovascularization secondary to pathologic myopia:systematic review and meta-analysis[J]. Retina,2013,33(7):1375-1392.
[26] INHOFFEN W,ZIEMSSEN F. Morphological features of myopic choroidal neovascularization:differences to neovascular age-related macular degeneration[J]. Ophthalmologe,2012,109(8):749-757.
[27] LI L,WANG W J,YUAN F,ZHAO N Q,YUAN Y Z. Comparison between age-related macular degeneration and pathologic myopia with choroidal neovascularization[J]. Rec Adv Ophthalmol,2005,25(1):49-51.黎蕾,王文吉,袁非,赵耐青,袁源智.年龄相关性黄斑变性和病理性近视合并脉络膜新生血管的比较[J].眼科新进展,2005,25(1):49-51.
[28] LU B W,WU X W. Recent advances in intravitreal injection of ranibizumab for myopic choroidal neovascularization[J]. Rec Adv Ophthalmol,2014,34(9):897-900.陆秉文,吴星伟. Ranibizumab玻璃体内注射治疗病理性近视脉络膜新生血管研究进展[J].眼科新进展,2014,34(9):897-900.