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单次玻璃体内注射贝伐单抗治疗累及黄斑中心的糖尿病性黄斑水肿患者的短期预后

Short-term outcomes in patients with center-involving diabetic macular edema after a single dose of intravitreal bevacizumab.

作者信息

Turski Christopher A, Jacobs Mitchell A, Abou-Jaoude Michelle M, Fowler Nicholas H, Harpole Ryan, Altman Emily, Chadwell John B, Kindl Gabriel, James Hayley R, Reddy Shivani V, Maldonado Ramiro S

机构信息

Department of Ophthalmology, University of Kentucky, Lexington, KY, USA.

Department of Ophthalmology, Duke University Eye Center, 2351 Erwin Rd, Durham, NC, 27710, USA.

出版信息

Int J Retina Vitreous. 2022 Nov 17;8(1):81. doi: 10.1186/s40942-022-00430-z.

Abstract

BACKGROUND

A significant portion of diabetic macular edema (DME) is refractory to anti-vascular endothelial growth factor (anti-VEGF) agents. This study investigates morphological and functional outcomes to a single intravitreal bevacizumab (IVB) injection in patients with center-involving DME (ciDME) at 4-6 weeks and compares treatment responders and non-responders based on spectral domain optical coherence tomography (SD-OCT) features.

METHODS

IRB approved observational, retrospective chart review of patients with ciDME, identified by ICD-10 code, who received IVB and underwent baseline and 4-6 weeks follow-up SD-OCT imaging between January 1, 2016 and January 19, 2021. Patients who had received previous treatment with anti-VEGF or intraocular steroids within 1 year were excluded. Variables included best-corrected visual acuity (BCVA), central subfield thickness (CST) and total macular volume (TMV). Eyes were classified as responders if CST reduction was greater than 10%. OCT scans were graded qualitatively by two masked graders using Imagivault software. Paired Student's t-tests, Wilcoxon signed rank tests and Chi-Square tests were used for analysis.

RESULTS

A total of 334 prospective subjects were identified, and after applying exclusion criteria 52 eyes from 46 patients (mean age 64.22 ± 8.12 years, 58.7% male) were included. Mean BCVA did not significantly change with treatment, 63.9 ETDRS letters (~ 20/50) at baseline and 65.9 ETDRS letters (~ 20/50) post-treatment (p = 0.07). Mean CST decreased from 466 ± 123 μm at baseline to 402 ± 86 μm post-treatment (p < 0.001). 22 (42.3%) of eyes were categorized as responders and 30 (57.7%) as non-responders. Average change in CST from baseline in responders was -164 μm (p < 0.001) and + 9 μm in non-responders (p = 0.47). Vitreomacular adhesion (VMA) was more prevalent in non-responders (28.7% vs. 4.8%, p = 0.03). In addition, cyst location in the inner nuclear layer (INL) was present more frequently in responders (95.5% vs. 73.3%, p = 0.037) as was subretinal fluid (45.5% vs. 13.3%, p = 0.01).

CONCLUSION

The short-term response to a single IVB was sub-optimal with structural but no functional improvements. Greater baseline CST, presence of INL cysts and subretinal fluid may represent factors indicative of a better treatment response.

摘要

背景

相当一部分糖尿病性黄斑水肿(DME)患者对抗血管内皮生长因子(anti-VEGF)药物治疗无效。本研究调查了累及黄斑中心凹的DME(ciDME)患者单次玻璃体内注射贝伐单抗(IVB)后4至6周的形态学和功能学结果,并根据频域光学相干断层扫描(SD-OCT)特征比较了治疗反应者和无反应者。

方法

通过IRB批准的对ciDME患者的观察性、回顾性病历审查,这些患者通过ICD-10编码识别,于2016年1月1日至2021年1月19日期间接受了IVB治疗,并进行了基线和4至6周随访的SD-OCT成像。排除在1年内接受过抗VEGF或眼内类固醇治疗的患者。变量包括最佳矫正视力(BCVA)、中心子野厚度(CST)和黄斑总体积(TMV)。如果CST降低大于10%,则将眼部分类为反应者。两名盲态评分者使用Imagivault软件对OCT扫描进行定性评分。采用配对t检验、Wilcoxon符号秩检验和卡方检验进行分析。

结果

共识别出334名前瞻性受试者,应用排除标准后,纳入了46例患者的52只眼(平均年龄64.22±8.12岁,男性占58.7%)。治疗后平均BCVA无显著变化,基线时为63.9 ETDRS字母(约20/5)治疗后为65.9 ETDRS字母(约20/50)(p=0.07)。平均CST从基线时的466±123μm降至治疗后的402±86μm(p<0.001)。22只眼(42.3%)被分类为反应者,30只眼(57.7%)为无反应者。反应者CST相对于基线的平均变化为-164μm(p<0.001),无反应者为+9μm(p=0.47)。玻璃体黄斑粘连(VMA)在无反应者中更常见(28.7%对4.8%,p=0.03)。此外,反应者中内核层(INL)的囊肿位置更常见(95.5%对73.3%,p=0.037),视网膜下液也是如此(45.5%对13.3%,p=0.01)。

结论

单次IVB的短期反应不理想,虽有结构改善但无功能改善。更高的基线CST、INL囊肿的存在和视网膜下液可能代表了更好治疗反应的指示因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/32cb/9673338/9d3df6cba361/40942_2022_430_Fig1_HTML.jpg

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