背景 糖皮质激素玻璃体腔注射治疗黄斑水肿的临床效果已得到证实,其代表性药物为曲安奈德.但曲安奈德局部应用联合黄斑格栅样光凝治疗黄斑水肿的疗效及安全性值得关注. 目的 评价曲安奈德玻璃体腔注射联合黄斑格栅样光凝治疗黄斑水肿的疗效及安全性. 方法 采取队列研究试验设计,按照纳入标准收集糖尿病性黄斑水肿或视网膜静脉阻塞性黄斑水肿患者120例120眼,按随机数字表法将患者随机分为试验组和对照组,两组人口基线特征匹配.试验组实施玻璃体腔注射曲安奈德联合黄斑格栅样光凝,对照组仅行黄斑格栅样光凝,分别于术后1周,1、3、6个月行最佳矫正视力、眼压、光学相干断层扫描(OCT)、荧光素眼底血管造影(FFA)检查,对检查指标进行组间比较,对试验组术后检测结果与术前值进行比较.结果 与玻璃体腔注射前视力比较,试验组在注射后1周、1、3、6个月视力均有明显提高,差异均有统计学意义(均P=0.000),而对照组治疗后各时间点的视力与治疗前比较差异均无统计学意义(P＞0.05);治疗后各时间点对照组的视力均明显低于试验组,差异均有统计学意义(P=0.037、0.000、0.002、0.046).玻璃体腔注射后各时间点试验组黄斑水肿明显减轻,黄斑中心凹视网膜神经上皮层厚度明显下降,差异均有统计学意义(均P=0.000),而对照组黄斑中心凹视网膜神经上皮层厚度与治疗前比较差异均无统计学意义(P＞0.05),玻璃体腔注射后各时间点试验组黄斑中心凹视网膜神经上皮层厚度均显著低于对照组,差异均有统计学意义(P＜0.05).试验组中7例在玻璃体腔注射后4～6个月黄斑水肿复发,占11.67％;玻璃体腔注射后11例眼压升高至21 mmHg以上,占14.1％. 结论 曲安奈德玻璃体腔注射联合黄斑格栅样光凝可有效治疗黄斑水肿,但少数患者在6个月内出现复发及眼压升高.%Background Clinical effectiveness of intavitreal injection of glucocorticosteroid for macular edema has been verified,especially triamcinolone acetonide(TA).However,the efficacy and safety of combination of TA with macular laser grid photocoagulation for macular edema is concerned. Objective This clinical trial was to evaluate the efficacy and safety of intravitreal injection of TA combined with macular laser grid photocoagulation in the treatment of macular edema. Methods A case-cohort study was designed.One hundred and twenty eyes of 120 patients with macular edema from diabetes or retinal vein occlusion were included in this study.The patients were randomized into trial group and control group,with the matched age,course,visual acuity,intraocular pressure (IOP).The patients of the trial group received intravitreal injection of TA combined with macular laser grid photocoagulation,and those of the control group were managed with macular laser grid photocoagulation only.Best corrected visual acuity ( BCVA),optical coherence tomography(OCT),fundus fluorescein angiography(FFA) and IOP were examined before TA injection and 1 week,1 month,3 months,6 months after treatment and compared among different time points between two groups.Written informed consent was obtained from each patient prior to entering this trial. Results Compared with TA injection before,the BCVA was significantly elevated in the trial group 1 week,1 month,3 months and 6 months after TA injection( all P=0.000),however,no obvious improvement of visual acuity was found in the control group before and after treatment at any time point (P＞0.05 ).At various time points,the visual acuity was significantly improved in the trial group than the control group (P =0.037,0.000,0.002,0.046 ).Macular thickness was significantly decreased at various time points after TA injection in comparison with before TA injection in the trial group(all P=0.000),but no significant change in macular thickness in the control group between before and after treatment at any time point( P＞0.05 ).Macular thickness was lower in the trial group compared with the control group at various time points after treatment ( P＜0.05 ).Recurrence of macular edema was seen in 7 eyes ( 1 1.67％ ) 4-6 months,and the IOP raise( ＞21 mmHg)was found in 11 eyes( 14.1％ )after TA injection in the trial group.Conclusions Intravitreal injection of TA combined with macular laser grid photocoagulation can be an effective method in the treatment of macular edema.However,recurrence of macular edema or increase of IOP may occur in a few patients within 6 months after TA injection.A long-term follow-up should be performed for the evaluation of efficacy and safety after intravitreous injection of TA.
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