地塞米松玻璃体内植入剂早期联合康柏西普在抗血管内皮生长因子治疗反应不佳糖尿病性黄斑水肿中的应用

Application of intravitreal dexamethasone implant combined with Conbercept in the treatment of diabetic macular edema with poor response to anti-vascular endothelial growth factor therapy

目的对比观察地塞米松玻璃体内植入剂(IDI)早期联合康柏西普与康柏西普单药治疗在抗血管内皮生长因子(VEGF)治疗反应不佳糖尿病性黄斑水肿(DME)中的临床疗效及安全性。方法回顾性研究。2018年8月至2022年3月于云南大学附属医院检查确诊的累及黄斑中心凹的DME患者50例50眼纳入研究。患者分为康柏西普单药治疗组(单药组)及IDI早期联合康柏西普治疗组(联合组),联合组首针康柏西普治疗后2周行IDI注射,2组均在首针康柏西普治疗后1个月继续每个月1次康柏西普治疗共4次后改为2个月1次,共3次治疗至观察终点48周。采用国际标准视力表行最佳矫正视力(BCVA)检查,采用OCT仪测量同部位黄斑中心凹厚度(CMT)。对比分析两组患者患眼BCVA及CMT的变化情况。BCVA及CMT比较采用单因素方差分析。安全性指标包括:高眼压、白内障、视网膜脱离及眼内炎。结果治疗第8周,联合组患眼BCVA优于单药组,差异有统计学意义(P<0.05)。联合组患眼在视力提升上的优势持续到第24周,48周时,联合组患眼BCVA较单药组仍较好,差异有统计学意义(P<0.05)。在治疗的第4周至第48周中,联合组患眼CMT均低于单药组,差异均有统计学意义(均为P<0.05)。安全性指标:联合组较单药组高眼压发生率高(24%比8%),差异有统计学意义(P<0.05),均发生于治疗后1~2个月,予抗青光眼药物治疗均得到有效控制;2组均未出现视网膜脱离及眼内炎。结论IDI早期联合康柏西普可快速缓解抗VEGF治疗反应不佳DME患眼黄斑水肿,获得更好的持续性视力改善,其效果优于康柏西普单药治疗。联合治疗需关注患者眼压增高的可能,尤其在注射后1~2个月为高峰期。

Objective To compare the clinical efficacy and safety of intravitreal dexamethasone implant(IDI)combined with Conbercept in the early stage and Conbercept alone in the treatment of diabetic macular edema(DME)with poor response to anti-vascular endothelial growth factor(VEGF)therapy.Methods A total of 50 patients(50 eyes)with DME involving the macular fovea diagnosed in the Affiliated Hospital of Yunnan University from August 2018 to March 2022 were included in this retrospective study.These patients were divided into the Conbercept treatment group(monotherapy group)and the IDI combined with Conbercept treatment group(combination therapy group).Patients in the combination therapy group received an IDI injection 2 weeks after the first dose of Conbercept.Both groups continued the Conbercept treatment one month after the first dose of Conbercept,once a month,totaling 4 treatments.Afterwards,patients continued the Conbercept treatment three times,once every two months,until the end of the observation period,which lasted 48 weeks.The best corrected visual acuity(BCVA)was examined according to the international standard visual acuity chart.The central macular thickness(CMT)at the same area was measured by optical coherence tomography.BCVA and CMT changes were analyzed and compared between the two groups using the one-way analysis of variance.Safety evaluation indexes included high intraocular pressure(IOP),cataract,retinal detachment,and endophthalmitis.Results At the 8th week of treatment,the BCVA in the combination therapy group was significantly better than that in the monotherapy group(P<0.05).The advantage of the combination therapy group in improving the visual acuity persisted until the 24th week,and at the 48th week,the BCVA in the combination therapy group was still better than that in the monotherapy group(P<0.05).From the 4th to 48th week of treatment,the CMT in the combination therapy group was lower than that in the monotherapy group(all P<0.05).The incidence of high IOP in the combination therapy group was higher than that in the monotherapy group(24%vs.8%)(P<0.05).High IOP occurred within 1-2 months after treatment and was effectively controlled with the anti-glaucoma drug treatment.No retinal detachment or endophthalmitis occurred in both groups.Conclusion IDI combined with Conbercept can rapidly alleviate the macular edema in DME patients with poor response to anti-VEGF therapy and help them get continuous visual improvement.The effect of the combination therapy is better than that of Conbercept alone.However,attention should be paid to the possibility of high IOP,especially during the peak period of 1-2 months after injection.