贝伐单抗与曲安耐德玻璃体腔注射治疗糖尿病黄斑水肿近期疗效的比较  

Comparison of efficacy and safety between intraocular becacizumab and triamcinoione for diabetic macular edema

作　　者：王丽丽[1] 张雯[1] 李立婕[1] 金丽英[1] 霍敏[1] 

机构地区：[1]西安市中心医院眼科,西安710003

出　　处：《中华实验眼科杂志》2011年第6期559-563,共5页Chinese Journal Of Experimental Ophthalmology

基　　金：陕西省科技攻关基金项目（2008K01-40）

摘　　要：背景黄斑水肿是糖尿病最常见的损害视力的原因，玻璃体腔注射贝伐单抗和曲安奈德（TA）的方法已被用于糖尿病黄斑水肿（DME）的治疗，但2种药物的临床效果和安全性的评价和比较是非常必要的。目的评价和比较玻璃体腔注射贝伐单抗和TA治疗DME的疗效及安全性。方法收集经OCT及荧光素眼底血管造影（FFA）确诊为DME者98例98眼，按就诊的先后时间分为贝伐单抗组和TA组，每组各49例49眼。贝伐单抗组患眼于角膜缘后4mm处行玻璃体腔注射贝伐单抗0．05ml（1．25mg），TA组玻璃体腔注射TA0．1ml（4mg）。术后4、8、12周观察并比较2组患眼的视力（国际视力表视力）、黄斑中心视网膜厚度（CMT）、眼压及并发症的情况。结果所有患者均完成临床试验。2组患者的人口基线特征比较差异均无统计学意义（P〉0．05）。TA组和贝伐单抗组患眼玻璃体注射后各时间点视力与注射前比较均明显提高，差异均有统计学意义（P〈0．01），贝伐单抗组在治疗后4～8周时视力最好，注射12周时视力较8周下降，差异有统计学意义（t=-11．579，P〈0．05）；玻璃体注射前后不同时间2组患眼间的视力比较差异均无统计学意义（P〉0．05）。玻璃体注射前后不同时问2组患眼间的CMT值比较差异均无统计学意义（P〉O．05），但TA组和贝伐单抗组患眼玻璃体注射后各时间点CMT值与注射前比较均明显减少，差异均有统计学意义（P〈O．01）。TA组患眼玻璃体注射后4、8、12周眼压值均明显高于贝伐单抗组，差异均有统计学意义（P〈0．05、P〈0．01），TA组患眼玻璃体注射后4、8、12周眼压值均高于注射前基线值（P〈0．01），贝伐单抗组4、8、12周眼压值与注射前比较差异无统计学意义（P〉0．05）。TA组患眼玻璃体注射后眼压升高的发生率14．3％。结论玻璃体腔注射贝伐单抗治疗DME与TA玻�Background Diabetic macular edema is the primary complication of diabetes. Becaeiznmab and triamcinolone acetonide （TA） have been intravitreally used to treat diabetic macular edema, but it is necessary to compare and evaluate their efficacy and safety. Objective The aim of this trial was to discuss and compare the safety and efficacy of intravitreal injection of becacizumab and TA for diabetic macular edema. Methods A case- controlled study was designed. In this pilot clinical trial, total 98 eyes of 98 patients determined as diabetic macular edema by optical coherence tomography （OCT） and fluoreseine funds angiography （FFA） were assigned to hecaeizumab group and TA group according to the visiting time. Becaeizumab of 0.05 ml（ 1. 25 rag） was injected into vitreous via 4 mm posterior to ]imbus in becaeizumab group and TA of 0. 1 ml（4 mg） was used at the same way. The visual acuity,central maeular thickness （CMT） and intraocular pressure （IOP） were examined before and 4,8,12 weeks after injection. The complication after injection was compared between these two groups. This study was approved by Ethic Committee of Xi＇ an Central Hospital. Written informed consent was obtained from each patient prior to this protocol. Results All of the patients finished the medical procedure and follow-up. No significant differences were found in the demographic characteristics between two groups （P〉0.05）. The vision was obviously improved in both becacizumab group and TA group in 4,8,12 weeks after injection in comparison with before injection （P〈0. 01 ） , but no evident differences were seen in vision at various time points between two groups （P〉0. 05 ）. The CMT values were reduced after injection compared with before injection in both two groups（ P〈0. 01 ）, however, there was no any difference was found in CMT value between becacizumab group and TA group whatever before and after injection （P〉0.05）. In 4,8,12 weeks after intravitreous injection,the IOPs were elevated in

关 键 词：贝伐单抗 曲安奈德 糖尿病 黄斑水肿 玻璃体注射 眼压 

分 类 号：R686[医药卫生—骨科学]