[关键词]
[摘要]
目的:比较雷珠单抗早期联合地塞米松玻璃体内植入剂与单独使用雷珠单抗治疗视网膜静脉阻塞继发黄斑水肿(RVO-ME)的疗效和安全性。
方法:回顾性队列研究。选取2022-02/2023-02在山东第二医科大学附属医院眼科中心首次确诊为RVO-ME患者62例64眼。根据治疗方案不同分为两组:单药治疗组32例34眼只接受雷珠单抗治疗\〖3+按需(PRN)方案\〗; 联合治疗组30例30眼先注射雷珠单抗1次,3 wk后使用地塞米松玻璃体内植入剂(1+DEX方案)。比较两组患者治疗前后最佳矫正视力(BCVA)、黄斑中心凹厚度(CRT)、黄斑中心凹无血管区(FAZ)面积、视网膜深层血管复合体(DVC)层面的黄斑区血流密度(MVD)、眼部不良反应的发生情况、药物注射次数及总费用。
结果:两组患者治疗后3 wk,3、6 mo及末次随访,BCVA、CRT、DVC层MVD均较治疗前显著好转(均P<0.05); 治疗6 mo及末次随访,两组间BCVA及CRT比较均有差异(均P<0.05),治疗6 mo时联合治疗组BCVA字母数增加最明显。治疗后3、6 mo及末次随访时,两组间DVC层MVD比较均有差异(均P<0.05)。两组患者的FAZ面积治疗前后无明显变化(P>0.05)。联合治疗组在注药次数和总花费方面均低于单药治疗组。联合治疗组高眼压和白内障进展发生率略高于单药治疗组,但均无差异(均P>0.05),两组患者治疗后均未出现严重不良事件。
结论:雷珠单抗早期联合地塞米松玻璃体内植入剂治疗RVO-ME与单独使用雷珠单抗治疗相比,在长期随访中发现能显著提高患者视力,减轻黄斑水肿,并且可有效减少注药次数及治疗总费用。CRT和DVC层MVD是评价RVO-ME患者预后的可靠指标。
[Key word]
[Abstract]
AIM:To compare the efficacy and safety of early combination therapy with ranibizumab and dexamethasone intravitreal implants versus ranibizumab monotherapy for the treatment of macular edema secondary to retinal vein occlusion(RVO-ME).
METHODS: A retrospective cohort study was conducted on a total of 62 cases(64 eyes)of patients who were first diagnosed with RVO-ME at the Eye Centre of the Affiliated Hospital of Shandong Second Medical University between February 2022 and February 2023. The subjects were divided into two groups according to the different treatment regimens: 32 cases(34 eyes)in the monotherapy group received only ranibizumab \〖3+pro re nata(PRN)regimen\〗, and 30 cases(30 eyes)in the combination therapy group were injected with ranibizumab once first, followed by dexamethasone intravitreal implant 3 wk later(1+DEX regimen). The best corrected visual acuity(BCVA), central retina thickness(CRT), foveal avascular zone(FAZ)area, macular vascular density(MVD)at the level of the deep vascular complex(DVC)of the retina, the incidence of ocular adverse effects, the number of drug injections, and the total cost between the two groups were compared before and after treatment.
RESULTS: At 3 wk, 3 and 6 mo, and at the final follow-up of the two groups of patients, the improvement in BCVA, CRT, and MVD in the DVC layer was significantly better than that before treatment(all P<0.05); there were differences in the comparisons of BCVA and CRT between the two groups at 6 mo and the final follow-up(all P<0.05), and the increase in the number of letters of BCVA was the most pronounced in the combination therapy group at 6 mo of treatment. Statistical significant difference was observed in the comparison of MVD in the DVC layer between the two groups at 3 and 6 mo after treatment and at the final follow-up(all P<0.05). However, no significant change in FAZ area was evident before and after treatment in both groups(P>0.05). The combination therapy group exhibited a reduced number of injections and total cost in comparison to the monotherapy group. The combination therapy group exhibited a slightly higher incidence of high intraocular pressure and cataract progression compared to the monotherapy group, with no statistical significant difference(all P>0.05). Furthermore, no serious adverse events were observed in either group following treatment.
CONCLUSION:Compared with ranibizumab alone, ranibizumab combined with dexamethasone intravitreal implant significantly improved vision, reduced macular edema, and lowered the frequency of injections and total treatment cost in patients with RVO-ME. CRT and MVD in the DVC layer are reliable prognostic indicators for patients with RVO-ME.
[中图分类号]
[基金项目]
潍坊市卫生健康委科研项目(No.WFWSJK-2024-109)