巩膜后注射曲安奈德治疗糖尿病性黄斑水肿的疗效和安全性

Efficacy and safety of post-sclera injecting triamcinolone acetonide for diabetic macular edema

背景糖尿病性黄斑水肿（DME）是糖尿病常见的眼部严重并发症之一，以往常用激光光凝、球周注射曲安奈德（TA）和玻璃体腔注射雷珠单抗疗法，但存在疗效欠佳、较严重并发症发生和经济负担等问题，寻找安全、有效和经济的治疗方法对DME的治疗有重要的临床意义。目的评价采用新型巩膜后装置对DME患者行TA的巩膜后注射，并与球周注射TA、玻璃体腔注射雷珠单抗疗法进行比较，评价巩膜后注射TA对DME的疗效和安全性。方法采用前瞻性非随机对照的临床研究设计，于2013年3月至2016年7月在第三军医大学第一附属医院眼科纳入DME患者60例60眼，将患者分为巩膜后注射组、球周注射组和玻璃体腔注射组，每组20眼，各组患者人口基线特征匹配。巩膜后注射组采用自行研制的新型巩膜后注射装置由巩膜后途径接近黄斑区部位注射TA 20 mg；球周注射组用常规注射针在眼球周围注射TA 20 mg；玻璃体腔注射组行玻璃腔内雷珠单抗0.5 mg注射，分别于注射后1个月和3个月检查注射眼最佳矫正视力（BCVA），并采用OCT测定黄斑区视网膜平均厚度，比较各组注射后并发症发生情况。结果注射后1个月和3个月，巩膜后注射组和玻璃体腔注射组患眼BCVA较注射前明显改善，巩膜后注射组和玻璃体腔注射组BCVA均明显优于球周注射组，差异均有统计学意义（均P＝0.000），注射后各时间点巩膜后注射组BCVA与玻璃体腔注射组比较，差异均无统计学意义（P＝0.244、0.397）。OCT检查显示，注射后1个月和3个月巩膜后注射组和玻璃体腔注射组患眼黄斑区视网膜神经上皮下低反射区逐渐消失，而球周注射组至注射后3个月黄斑区视网膜下低反射区仍然存在。注射后1个月巩膜后注射组、球周注射组和玻璃体腔注射组黄斑区视网膜平均厚度分别为（321.85±31.98）、（382.75±39.28）和（315.75±40.43）μm，注射后3个月分别为（311.95±32.73）、（393.65±33.84）和（302.65±38.99）μm，巩膜后注射组和玻璃体腔注射组患眼黄斑区视网膜平均厚度值均明显低于注射前，差异均有统计学意义（均P＝0.000），球周注射组患眼黄斑区视网膜平均厚度较注射前轻度变薄，但差异均无统计学意义（P＝0.121、0.460），注射后1个月和3个月巩膜后注射组患眼黄斑区视网膜平均厚度明显薄于同时间点球周注射组，差异均有统计学意义（均P＝0.000）。注射后1个月和3个月，巩膜后注射组和玻璃体腔注射组黄斑区视网膜厚度值下降百分率均明显高于球周注射组，差异均有统计学意义（均P〈0.01）。各组患眼注射后均未发生结膜出血、眼内感染、玻璃体积血等并发症。结论巩膜后注射TA的疗效和安全性与玻璃体腔注射雷珠单抗的疗效相近，均优于球周注射TA法。

BackgroundDiabetic macular edema （DME） is one of serious ocular complications of diabetes mellitus and is often treated by laser photocoagulation, peribulbar injection of triamcinolone acetonide （TA） and intravitreal injection of ranibizumab.However, some adverse responses occur in each approach.To seek a safe, effective and ecnomic therapy for DME is of clinical significance.ObjectiveThis study was to observe the safety and efficacy of post-sclera injection of TA with a self-made innovative device for DME and compare the outcome with peribulbar injection of TA and the intravitreal injection of ranibizumab.MethodsA prospective non-randomized controlled study was performed.This study protocol was approved by Ethic Committee of Southwest Hospital of Third Military Medical University and complied with Helsinki declaration.Written informed consent was obtained from each patient before any medical treatment.Sixty eyes of 60 patients with DME were included in Southwest Hospital of Third Military Medical University from March 2013 to July 2016.The eyes were divided into post-sclera injection group, peribulbar injection group and intravitreal injection group, with 20 eyes for each group.TA at the dose of 20 mg was injected via posterior sclera with a self-made divice in the post-sclera injection group and via periphery of eyeball in the peribulbar injection group, and 0.5 mg ranibizumab was intravitreally injected in the intravitreal injection group.Best corrected visual acuity （BCVA） was examined and retinal thickness at macular area was measured by OCT in 1 month and 3 months after injection respectively.The outcome and complication were grouply compared.ResultsThe BCVA was significantly improved 1 month and 3 months after injection in comparison with before injection in the post-sclera injection group and intravitreal injection group, and BCVA in the post-sclera injection group and intravitreal injection group was superior to that in the peribulbar injection group （all at P=0.000） .No significant difference was found in post-injected BCVA between post-sclera injection group and intravitreal injection group （P=0.244, 0.397）. Retinal edema at macular area was gradually disappeared in the post-sclera injection group and intravitreal injection group and that in the peribulbar injection group was still visible after injection.The retinal thickness at macula was （321.85±31.98）, （382.75±39.28） and （315.75±40.43）μm at 1 month and was （311.95±32.73）, （393.65±33.84） and （302.65±38.99）μm at 3 months after injection in the post-sclera injection group, peribulbar injection group and intravitreal injection group respectively, and the retinal thickness values at macula in the post-sclera injection group and intravitreal injection group were significantly lower than those in the peribulbar injection group （all at P=0.000）. The decrease rate of retinal thickness was higher in the post-sclera injection group and intravitreal injection group than that in the peribulbar injection group at various time points after injection （all at P〈0.01）.ConclusionsThe efficacy and safety of post-sclera injection of TA for DME are similar to intravitreal injection of ranibizumab, which are superior to peribulbar injection of TA.