首页|抗VEGF联合用药治疗wAMD的真实世界研究

抗VEGF联合用药治疗wAMD的真实世界研究

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目的 基于真实世界研究抗血管内皮生长因子(VEGF)联合用药方案治疗湿性年龄相关性黄斑变性(wAMD)的疗效差异.方法 纳入2020年11月—2023年3月中国中医科学院西苑医院病历系统中的wAMD患者病历资料55份(62只眼).根据注射抗VEGF药物的类型和模式分为单抗组(只注射雷珠单抗)16只眼、融合蛋白组(只注射阿柏西普/康柏西普)24只眼和联合组(雷珠单抗和阿柏西普/康柏西普联合使用)22只眼.分别于治疗前和治疗后14 d、1、3、6、12、18、24个月测量患眼的最佳矫正视力(BCVA)、眼压(IOP)和黄斑中心凹厚度(CMT)的变化及注射频次,记录数据并做统计分析.结果 (1)BCVA:单抗组、融合蛋白组及联合组治疗后全程的BCVA与治疗前相比,差异均有统计学意义(单抗组:t14 d=4.597、t1个月=6.464、t3个月=4.690、t6个月=4.148、t12个月=4.291、t18个月=4.636、t24个月=5.429,均P=0.000;融合蛋白组:t14 d=4.048、t1个月=5.132、t3个月=5.817、t6个月=6.528、t12个月=7.700、t18个月=8.625、t24个月=8.855,均P=0.000;联合组:t14 d=4.909、t1个月=6.887、t3个月=5.608、t6个月=6.560、t12 个月=7.219、t18个月=7.987、t24个月=8.639,均P=0.000).在治疗后3、6、12个月,3组间BCVA比较,差异均无统计学意义(P>0.05);融合蛋白组治疗后18个月(t=2.265,P=0.027)和联合组治疗后18、24个月(t18个月=2.378,P=0.020;t24个月=2.235,P=0.029)的BCVA均高于单抗组,差异均有统计学意义;而融合蛋白组与联合组BCVA比较,差异无统计学意义(P>0.05).(2)IOP:3组治疗前后及各组间全程IOP比较,差异均无统计学意义(P>0.05).(3)CMT:单抗组、融合蛋白组及联合组治疗后多个时间点的CMT与治疗前相比,差异均有统计学意义(单抗组:t14 d=3.590、t1个月=3.744,均P=0.000;t3个月=3.497,P=0.001;t12个月=2.080,P=0.042;t18个月=3.009,P=0.004;t24个月=2.948,P=0.005.融合蛋白组:t12个月=2.331,P=0.023;t18个月=3.259,P=0.002;t24 个月=3.480,P=0.001;联合组:t14 d=4.034、t1个月=4.015、t12个月=4.213、t18个月=5.014、t24个月=5.380,均P=0.000;t3个月=2.874,P=0.006;t6个月=2.915,P=0.005).3组间CMT两两比较,治疗后14 d、1、3、6个月3组间平均CMT比较,差异无统计学意义(P>0.05);联合组治疗后12、18、24个月的CMT均高于单抗组,差异均有统计学意义(t12个月=2.178,P=0.033,t18个月=2.235,P=0.029,t24个月=2.720,P=0.009),单抗组与融合蛋白组之间CMT差异无统计学意义(P>0.05).(4)抗VEGF药物注射频次:3组平均注射频次比较,差异有统计学意义(H=12.644,P=0.002).联合组平均注射频次低于单抗组和融合蛋白组(t单抗组=3.410,P=0.001;t融合蛋白组=2.488,P=0.007),单抗组和融合蛋白组平均注射频次比较,差异无统计学意义(P>0.05).结论 联合应用单抗类和融合蛋白抗VEGF治疗既有早期快速提高视力和降低黄斑水肿的作用,又有中后期持续、稳定的治疗效果,且有减少注射次数的优势.
Real-world Study on Anti-VEGF Combination Therapy for wAMD
OBJECTIVE To evaluate the efficacy differences in treating wet age-related macular degeneration(wAMD)using real-world data on anti-VEGF combination therapy regimens.METHODS This study included medical records from 55 patients(62 eyes)with wAMD treated at Xiyuan Hospital,China Academy of Chinese Medical Sciences,from November 2020 to March 2023.The patients were divided into three groups based on the type and pattern of anti-VEGF injections:The monoclonal antibody group(16 eyes,treated with ranibizumab alone),the fusion protein group(24 eyes,treated with aflibercept/conbercept alone),and the combination group(22 eyes,treated with ranibizumab and aflibercept/conbercept).The best-corrected visual acuity(BCVA),intraocular pressure(IOP),and central macular thickness(CMT)were measured before treatment and at 14 days,one,three,six,12,18,and 24 months after treatment,along with the frequency of injections.Data were recorded and statistically analyzed.RESULTS(1)BCVA:In the monoclonal antibody group,fusion protein group,and combination group,BCVA improved significantly at all time points compared to before treatment(monoclonal antibody group:t14 d=4.597,t1 mon=6.464,t3 mon=4.690,t6 mon=4.148,t12 mon=4.291,t18 mon=4.636,t24 mon=5.429,all P=0.000;Fusion protein group:t14 d=4.048,t1 mon=5.132,t3 mon=5.817,t6 mon=6.528,t12 mon=7.700,t18 mon=8.625,t24 mon=8.855,all P=0.000;Combination group:t14 d=4.909,t1 mon=6.887,t3 mon=5.608,t6 mon=6.560,t12 mon=7.219,t18 mon=7.987,t24 mon=8.639,all P=0.000).There were no statistically significant differences in BCVA between the three groups at three,six,and 12 months after treatment(P>0.05).However,the fusion protein group at 18 months(t=2.265,P=0.027)and the combination group at 18 and 24 months(t18 mon=2.378,P=0.020;t24 mon=2.235,P=0.029)had significantly higher BCVA than the monoclonal antibody group.There were no statistically significant differences in BCVA between the fusion protein group and the combination group(P>0.05).(2)IOP:There were no statistically significant differences in IOP within or between the three groups before and after treatment(all P>0.05).(3)CMT:In the monoclonal antibody group,fusion protein group,and combination group,CMT decreased significantly at several time points compared to before treatment(monoclonal antibody group:t14 d=3.590,t1 mon=3.744,both P=0.000;t3 mon=3.497,P=0.001;t12 mon=2.080,P=0.042;t18 mon=3.009,P=0.004;t24 mon=2.948,P=0.005.Fusion protein group:t12 mon=2.331,P=0.023;t18 mon=3.259,P=0.002;t24 mon=3.480,P=0.001;combination group:t14 d=4.034,t1 mon=4.015,t12 mon=4.213,t18 mon=5.014,t24 mon=5.380,all P=0.000;t3 mon=2.874,P=0.006;t6 mon=2.915,P=0.005).There were no statistically significant differences in CMT among the three groups at 14 days,one month,three months,and six months after treatment(P>0.05).However,at 12,18,and 24 months after treatment,the combination group had significantly lower CMT compared to the monoclonal antibody group(t12 mon=2.178,P=0.033;t18 mon=2.235,P=0.029;t24 mon=2.720,P=0.009),while there were no significant differences between the monoclonal antibody group and the fusion protein group(P>0.05).(4)Anti-VEGF Injection Frequency:There were statistically significant differences in the mean injection frequency among the three groups(H=12.644,P=0.002).The combination group had a significantly lower mean injection frequency than the monoclonal antibody group and the fusion protein group(tMAG=3.410,P=0.001;tFPG=2.488,P=0.007),while there was no significant difference between the monoclonal antibody group and the fusion protein group(P>0.05).CONCLUSIONS The combination of monoclonal antibody and fusion protein anti-VEGF therapies not only provides early and rapid improvement in vision and reduction in macular edema but also offers sustained and stable therapeutic effects in the mid-to-late stages,with the added benefit of reducing the number of injections required.

wet age-related macular degenerationdrug combinationranibizumabafliber-ceptconbercept

茹姝婷、褚利群、陈水龄、周婉瑜、韦东、史航、刘璐、贺严、付文涛、梁玉

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中国中医科学院西苑医院,北京,100091

中国中医科学院研究生院,北京,100700

湿性年龄相关性黄斑变性 联合用药 雷珠单抗 阿柏西普 康柏西普

中国中医科学院新技术引进人才培养项目中国中医科学院科技创新工程重大攻关项目

XYRC-YL2020-02CI2021A03513

2024

中国中医眼科杂志
中国中医科学院

中国中医眼科杂志

CSTPCD
影响因子:0.476
ISSN:1002-4379
年,卷(期):2024.34(9)