康柏西普与曲安奈德玻璃体腔注射治疗视网膜中央静脉阻塞继发黄斑水肿临床疗效的比较

A comparative study on conbercept and triamcinolone acetoinde intravitreal injection for macular edema secondary to central retinal vein occlusion

背景黄斑水肿是视网膜中央静脉阻塞（CRVO）常见的并发症之一，目前的治疗方法是激光疗法和抗新生血管药物的玻璃体腔注射。康柏西普是人源化血管内皮生长因子（VEGF）受体抗体，临床上常用于眼底新生血管性疾病的治疗，其在治疗CRVO继发性黄斑水肿方面疗效的研究较少。目的比较康柏西普和曲安奈德（TA）玻璃体腔注射对CRVO继发黄斑水肿的疗效及安全性。方法采用非随机对照临床研究方法，纳入2012年3月至2013年8月在潍坊市益都中心医院诊断为CRVO继发黄斑水肿者60例60眼，按照就诊日期分为康柏西普组和TA组，每组30例30眼，2个组患者人口基线特征接近。2个组患眼分别行0．05ml康柏西普或0．05ml（0．05mg）TA玻璃体腔注射，分别于注射前和注射后1周、1个月、3个月、6个月进行复查。主要评价指标包括注射眼最佳矫正视力（BCVA）和OCT检查的黄斑中心凹厚度（CMT），次要指标包括注射前后眼压变化和眼部并发症。结果康柏西普组和TA组患眼玻璃体腔注射后1周、1个月、3个月和6个月BCVA均明显优于注射前，差异均有统计学意义（均P〈0．01）；注射后1个月TA组注射眼平均BCVA优于康柏西普组，差异有统计学意义（P〈0．05）。康柏西普组患眼注射前及注射后1周、1个月、3个月和6个月CMT值分别为（572．00±100．01）、（325．12±91．55）、（280．00±92．37）、（258．65±88．65）、（300．00±87．64）μm，TA组分别为（570．00±102．21）、（345．12±89．31）、（290．00±80．27）、（309．65±84．13）和（303．00±90．59）μm，2个组患眼注射后CMT值较注射前均明显降低，差异均有统计学意义（P〈0．05），注射后3个月康柏西普组患眼CMT值下降更明显，与TA组比较差异有统计学意义（P〈0．05）。TA组患眼注射前及注射后1周、1个月、3个月和6个月眼压值分别为（15．20±3．52）、（21．20±3．80）、（26．40±4．00）、（23．60±3．73）和（21．50±3．27）mmHg（1mmHg=0．133kPa），注射后各时间点眼压值均明显高于注射前，且TA组注射后各时间点患眼眼压均明显高于康柏西普组，差异均有统计学意义（均P〈0．05），而康柏西普组注射前后患眼眼压变化差异无统计学意义（P〉0．05）。结论玻璃体腔注射TA及康柏西普治疗CRVO所致黄斑水肿有效，可减轻视网膜水肿并改善视力。与TA相比，玻璃体腔注射康柏西普无眼压升高的风险，更加安全可靠。

Background Macular edema is one of the serious complications of central retinal vein occlusion （CRVO） ,and the present therapies are laser coagulation and intravitreal injection of anti-vascular endothelial growth factor （VEGF） drugs. Conbercept is humanized-monoclonal VEGF antibody and used for the treatment of retinal vascular diseases. However,fewer studies were focused on its application in macular edema secondary to CRVO. Objective The aim of this study was to compare the effectiveness and safety of conbercept with triamcinolone acetonide （TA） by intravitreal injections for macular edema secondary to CRVO. Methods A non-randomized controlled study was carried out under the approval of the informed consent of patients. Sixty eyes of 60 patients with macular edema secondary to CRVO were included in Weifang Yidu Central Hospital from March 2012 to August 2013. The eyes were divided into the conbercept group and TA group with 30 for each group. Conbercept and TA of 0.05 ml were intravitreally injected in different groups, and the best corrected visual acuity （BCVA） , central macular thickness （CMT） measured by OCT, intraocular pressure （IOP） and relavant complications were examined before injection and 1 week, 1 month, 3 months and 6 months after injection. The treatment outcomes were compared intergrouply and along with time. Results The BCVA was evidently better in 1 week, 1 month,3 months and 6 months after injection than that before injection both in conbercept group and TA group （ all at P〈0.01 ） , and the BCVA of TA group was better than that of conbercept group 1 week after injection （P〈0. 05 ）. The CMT values of Conbercept were （572.00± 100.01 ） , （325.12±91.55）, （280.00±92. 37 ）, （258.65 ±88.65 ）, （300.00±87.64） μm, and those of TA group were （ 570. 00± 102.21 ）, （ 345. 12± 89.31 ）, （ 290.00± 80. 27 ）, （ 309.65 ± 84. 13 ） and （ 303.00± 90. 59）μm,and CMT value after injection was significantly lower in 1 week, 1 nmnth,3 months and 6 months after injection than that before injection both in the conbercept group and the TA group （ all at P〈0.05 ） , and CMT value was evidently reduced in the conbercept group compared with the TA group 3 months after injection （ P〈0.05 ）. The IOPwas （15.20±3.52）,（21.20±3.80）,（26.40±4.00）,（23.60±3.73） and （ 21. 50 ± 3. 27 ） mmHg in the TA group before injection and 1 week, 1 month,3 months and 6 months after injection,showing significnatly elavation after injection （ all at P〈0.05 ） , and the IOP at different time points was higher in the TA group than that in the conbercept group （ all at P〈0.05 ）. However, there was no considerable change of IOP before and after injection in conbercept group （ all at P〈0.05 ）. Conelutions Both conbercept and TA are effective for maeular edema secondary to CRVO by intravtreal injection. Compared with TA,conbereept is much safer because of less risk of lOP rising after intravtreal injection.