地塞米松玻璃体腔植入剂治疗视网膜静脉阻塞继发黄斑水肿一年临床观察

One year clinical observation of dexamethasone intravitreal implant （Ozurdex） in the treatment of macular edema secondary to retinal vein occlusion

目的 观察地塞米松玻璃体腔植入剂（Ozurdex）治疗视网膜静脉阻塞（RVO）继发黄斑水肿（ME）的临床疗效和安全性.方法 临床确诊为RVO继发ME的39例患者39只眼纳入研究.其中,男性27例,女性12例;平均年龄（41.9±16.3）岁,平均病程（5.0±5.3）个月.所有患眼均行最佳矫正视力（BCVA）、眼压检查;同时采用光相干断层扫描（OCT）测量黄斑中心视网膜厚度（CMT）.视力检查采用早期治疗糖尿病视网膜病变研究视力表进行.患眼BCVA（13.4±15.3）个字母;眼压（14.1±2.8）mmHg（1 mmHg=0.133 kPa）;CMT（876.1±437.9） μm.39只眼中,视网膜中央静脉阻塞33只眼,视网膜分支静脉阻塞6只眼.缺血型18只眼（缺血型组）,非缺血型21只眼（非缺血型组）.既往接受过玻璃体腔注射曲安奈德或雷珠单抗等药物治疗22只眼（既往治疗组）,既往未接受过治疗17只眼（初始治疗组）.所有患眼均行玻璃体腔注射Ozurdex治疗.注射后1、2、3、6、9、12个月定期复诊,重复行视力、眼压及OCT检查.随诊3个月后,对于ME复发或疗效不佳者,根据患者自身条件考虑玻璃体腔再次注射Ozurdex、曲安奈德或雷珠单抗.观察患眼注射前后BCVA、眼压以及CMT的变化,并行配对t检验.同时观察眼部不良反应及全身并发症的发生情况.结果 与注射前比较,注射后1个月所有患眼BCVA、眼压明显提高,CMT明显下降,差异有统计学意义（t=3.70、3.69、4.32、3.08、4.25、6.09、6.25、4.02、5.49、8.18、6.54、5.73,P＜0.05）;于注射后2个月时各指标变化最为明显,差异有统计学意义（t=4.93、6.80、6.71、5.53、4.97、5.89、5.13、7.68、7.31、8.67、8.31、5.82,P＜0.05）.注射后12个月,缺血型组、既往治疗组患眼BCVA较注射前无明显变化,差异无统计学意义（t=1.86、0.67,P＞0.05）;非缺血型组、初始治疗组患眼BCVA较注射前明显提高,差异有统计学意义（f=2.27、2.30,P＜0.05）.与注射前比较,注射后12个月所有患眼眼压明显提高,CMT明显下降,差异有统计学意义（t=0.30、0.13、4.60、3.26、0.64、1.53、3.00、4.87,P＜0.05）.39只眼中,共有27只眼ME复发,占69.2％,平均复发时间（4.5±1.5）个月.随访期间眼压升高为最常见眼部不良反应,41.0％的患眼眼压≥25 mmHg,经局部点降压药物后大部分可降至正常水平.4只眼出现明显的白内障进展并需要手术治疗,占10.3％,均为视网膜中央静脉阻塞患眼.所有患者均未出现玻璃体积血、视网膜脱离、眼内炎等严重眼部不良反应或全身并发症.结论 玻璃体腔注射Ozurdex治疗RVO继发ME在早期提高视力以及降低CMT方面效果好,注射后1个月即有显著改善,注射后2个月左右疗效最为显著;非缺血型及初始治疗者长期随访视力更好.69.2％的患眼在平均注射后4个月时ME复发.其短期眼部不良反应主要为眼压升高,长期眼部不良反应为白内障进展.

Objective To evaluate the efficacy and safety of dexamethasone intravitreal implant （Ozurdex） in the treatment of macular edema （ME） secondary to retinal vein occlusion （RVO）.Methods Thirty-nine patients （39 eyes） with ME secondary to RVO were enrolles in this study.Of the patients,27 were male and 12 were female.The mean age was （41.9 ± 16.3） years.The mean course of disease was （5.0± 5.3） months.The best corrected visual acuity （BCVA）,intraocular pressure and optical coherence tomography （OCT） were performed.BCVA was measured by Early Treatment Diabetic Retinopathy Study charts.Central macular thickness （CMT） was measured by OCT.The mean BCVA was （13.4± 15.3） letters.The mean intraocular pressure （IOP） was （14.1 ±2.8） mmHg （1 mmHg=0.133 kPa）.The mean CMT was （876.1 ±437.9） μm.Of the 39 eyes,33 were central RVO,6 were branch RVO.Patients were categorized into ischemic （18 eyes）/non-ischemic （21 eyes） groups and previous treatment （22 eyes）/treatment naive （17 eyes） groups.All eyes underwent intravitreal 0.7 mg Ozurdex injections.BCVA,IOP and CMT were assessed at 1,2,3,6,9,12 months after injection.Three months after injection,intravitreal injections of Ozurdex,triamcinolone acetonide or ranibizumab could be considered for patients with ME recurrence or poor treatment effects.Change of BCVA,IOP and CMT were evaluated with paired t test.The presence of ocular and systemic adverse events were assessed.Results BCVA,IOP significantly increased and CMT significantly decreased at 1 month after injection compared to baseline in all groups （t=3.70,3.69,4.32,3.08,4.25,6.09,6.25,4.02,5.49,8.18,6.54,5.73;P〈0.05）.Two months after injection,change of BCVA,IOP and CMT was most significant （t=4.93,6.80,6.71,5.53,4.97,5.89,5.13,7.68,7.31,8.67,8.31,5.82;P〈0.05）.Twelve months after injection,there was no statistical difference regarding BCVA of ischemic RVO group and previous treatment group,compared to baseline （t=1.86,0.67;P〉0.05）;BCVA ofnon-ischemic RVO group and treatment naive group significantly increased compared to baseline （t=2.27,2.30;P〈0.05）;IOP significantly increased and CMT significantly decreased in all groups （t=0.30,0.13,4.60,3.26,0.64,1.53,3.00,4.87;P〈0.05）.Twenty-seven eyes （69.2%） experiences ME recurrence （4.5± 1.5） months after injection.Most common side-effect was secondary glaucoma.41.0% eyes had IOP more than 25 mmHg,most of which were lowered to normal range with use of topical IOP lowering drugs.Four eyes （10.3%） presented with significant cataract progression and needed surgical treatment,all were central RVO eyes.No serious ocular or systemic adverse events such as vitreous hemorrhage,retinal detachment or endophthalmitis were noted.Conclusions Intravitreal injection of Ozurdex for patients with ME secondary to RVO is effective in increasing BCVA and lowering CMT in the first few months.Significant treatment effect could be seen at 1 month after injection and was most significant at 2 months after injection.The long-term vision of eyes in non-ischemic RVO group and treatment naive group are better.69.2% eyes experience ME recurrence at 4 months after injection.Short term adverse events were mostly secondary glaucoma and long term adverse events are mostly cataract progression.