摘要
目的研究玻璃体腔内注射三种不同抗血管内皮生长因子(VEGF)药治疗累及黄斑中心凹的糖尿病性黄斑水肿(CIDME)的有效性和安全性。方法选取2018年7月至2020年1月在广东省佛山市第二人民医院眼科中心行玻璃体腔内注射抗VEGF药治疗CIDME患者97例(97眼),进行前瞻性临床研究,按随机数字表法分成三组:A组(31眼)阿柏西普2.0 mg/0.05 ml、B组(34眼)康柏西普0.5 mg/0.05 ml和C组(32眼)雷珠单抗0.5 mg/0.05 ml,联合561 nm黄波长激光进行次/全/无视网膜激光光凝,采用1+PRN治疗模式,术后每4周复诊一次,于术前及首次注射术后4、12、24和52周对患者进行最佳矫正视力(BCVA)、裂隙灯眼前段、广角眼底照相、眼压、黄斑中心凹厚度(CMT)等详细检查,术前及术后12周进行FFA检查,比较三种抗VEGF药玻璃体腔内注射治疗CIDME患者的疗效和安全性。结果A、B、C三组患者使用抗VEGF药物采用1+PRN模式,部分联合561 nm视网膜激光治疗CIDME均能提高BCVA,术前BCVA分别为:(0.72±0.32)、(0.73±0.24)、(0.71±0.27)logMAR,三组比较,差异无统计学意义(P>0.05);术后4、12、24和52周,BCVA逐渐提高,术后52周时为:(0.49±0.22)、(0.50±0.21)、(0.50±0.23)logMAR,组内比较,差异有统计学意义(t_(A)=3.154,t_(B)=4.205,t_(C)=3.349,P<0.05),组间比较差异无统计学意义(P>0.05)。术前三组CMT比较,差异无统计学意义(P<0.05),术后4、12、24和52周,三组患者CMT逐渐下降,术前与术后52周比较,术前三组CMT:(466.64±95.37)、(456.46±100.31)、(475.73±98.27)μm;术后52周,(197.47±45.86)、(196.59±47.33)、(195.36±46.84)μm,组内比较,差异有统计学意义(t_(A)=14.162,t_(B)=13.045,t_(C)=14.340,P<0.05),组间比较差异无统计学意义(P>0.05)。至术后52周时,三组平均注射次数分别为(4.7±0.6)、(4.7±0.5)、(4.9±0.6)次,三组患者随访期间均未出现严重眼部及全身并发症。结论玻璃体腔内注射阿柏西普、康柏西普和雷珠单抗治疗CIDME是安全有效的,可提高CIDME患者视力,减轻黄斑水肿,三组患者术后52周时疗效相当。1+PRN治疗模式联合部分561 nm激光视网膜光凝治疗CIDME首年注射约5针。
Objective To study the efficacy and safety of intravitreal injection of three different anti-vascular endothelial growth factor(VEGF)agents in the treatment of central involved diabetic macular edema(CIDME).Methods A total of 97 patients(97 eyes)who underwent intravitreal injection of anti-VEGF agents for CIDME at the Ophthalmology Center of The Second People’s Hospital of Foshan in Guangdong Province from July 2018 to January 2020 were selected as subjects of a prospective clinical study.These patients were divided into three groups according to a random number table,with group A(31 eyes)treated with aflibercept 2.0 mg/0.05 ml,group B(34 eyes)with conbercept 0.5 mg/0.05 ml,and group C(32 eyes)with ranibizumab 0.5 mg/0.05 ml.All three groups of patients were also treated with sub-/pan-/no retinal photocoagulation with yellow laser of wavelength 561 nm in a 1+PRN treatment mode,and were subjected to postoperative subsequent visit every 4 w.Examinations involving the best corrected visual acuity(BCVA)(LogMAR),slit-lamp examination of the anterior segment,wide-angle fundus photography,intraocular pressure,and central macular thickness(CMT)were performed on patients before surgery and at 4,12,24 and 52 w after the first injection,and the fluorescein fundus angiography(FFA)was performed before surgery and at 12 w after surgery.The efficacy and safety of intravitreal injection of the three anti-VEGF agents in patients with CIDME were compared.Results The BCVA improved in patients with CIDME in groups A,B and C who were treated with anti-VEGF agents in 1+PRN mode and sub-retinal photocoagulation with 561 nm retinal laser,the preoperative BCVA was(0.72±0.32),(0.73±0.24),and(0.71±0.27)logMAR,respectively in groups A,B and C,with no statistically significant difference among the three groups(P>0.05).The BCVA gradually improved at 4,12,24 and 52 w after surgery,and it was(0.49±0.22),(0.50±0.21)and(0.50±0.23)logMAR respectively in groups A,B and C at 52 w after surgery,with a statistically significant difference in the same group before surgery and at 52 w after surgery(t_(A)=3.154,t_(B)=4.205,t_(C)=3.349,P<0.05),and no statistically significant difference between the groups(P>0.05).There was no significant difference among the three groups in CMT before surgery(466.64±95.37),(456.46±100.31)and(475.73±98.27)μm respectively in groups A,B and C,and the CMT gradually decreased in the three groups at 4,12,24 and 52 w after surgery(197.47±45.86),(196.59±47.33)and(195.36±46.84)μm respectively in groups A,B and C,with statistically significant difference in the same group before surgery and at 52 w after surgery(t_(A)=14.162,t_(B)=13.045,t_(C)=14.340,P<0.05),and no statistically significant difference between the groups(P>0.05).By the W52 postoperatively,the mean number of injections in the three groups was(4.7±0.6),(4.7±0.5)and(4.9±0.6)times,respectively,and no serious ocular or systemic complications occurred in any of the three groups during the follow-up period.Conclusion Intravitreal injection of aflibercept,conbercept and ranibizumab is safe and can effectively improve visual acuity and alleviate macular edema in patients with CIDME,with comparable efficacy in the three groups at 52 w after surgery.There are approximately 5 injections for 1+PRN treatment mode combined with sub-retinal photocoagulation with 561 nm retinal laser in treating CIDME in the first year.
作者
黄玉娟
孔祥斌
周立军
苏鹏
沈沛阳
曹艺
HUANG Yujuan;KONG Xiangbin;ZHOU Lijun;SU Peng;SHEN Peiyang;CAO Yi(Ophthalmology Center,the Second People’s Hospital of Foshan,Guangdong,Foshan 528000,China;Zhongshan Ophthamic Center,Sun Yat-Sen University,Guangdong,Guangzhou 510060,China)
出处
《中国医药科学》
2022年第8期21-26,59,共7页
China Medicine And Pharmacy
基金
广东省佛山市科技计划项目(2018AB003061)。
作者简介
通讯作者:孔祥斌。
