Faghihi Hooshang, Inanloo Bahman, Mirzaee Arash, Fadakar Kaveh, Mirshahi Ahmad, Ebrahimiadib Nazanin, Ghassemi Fariba, Bazvand Fatemeh, Amini Abdulrahman, Mirghorbani Masoud, Faghihi Shahin, Khalili Pour Elias, Riazi-Esfahani Hamid
Retina Service, Farabi Eye Hospital, Tehran University Of Medical Sciences, Qazvin Square, South Karegar Street, Tehran, 1336616351, Iran.
Int J Retina Vitreous. 2022 Oct 12;8(1):74. doi: 10.1186/s40942-022-00424-x.
To evaluate the additive effect of topical or sub-tenon injection of interferon (IFN)-α 2b in the treatment of refractory diabetic macular edema.
In this prospective study patients with center-involved DME who were unresponsive to 3 monthly consecutive IVB injections were recruited. Patients were divided into three groups: group1, received IFN- α 2b topical drop at a dose of 1mIU/ml four times a day for 3 months. Group 2, received a single sub-tenon injection of 1mIU/ml IFN- α 2b at the enrollment. Group 3 received artificial tears four times a day for 3 months (control group). All groups received three consecutive monthly IVB injections and were evaluated monthly up to 1 month following the last IVB injection.
In this study, 59 eyes of 35 patients with refractory DME were assessed. The final follow-up showed that although CMT decreased in all groups, only patients in Group 2 had statistically significant lower CMT compared to their baseline values (change in CMT: - 117 ± 213 µm; p-value = 0.025). Comparison of CMT changes between three groups showed no statistically significant difference, although it was higher in group 2 (change in CMT: - 117 ± 213 µm (Group2) vs. - 49 ± 173 (Group 1) vs. - 36 ± 86 (Group 3); p-value = 0.085). Considering eyes with baseline CMT > 400 µm, sub-tenon injection of IFN α2b led to a significant reduction of CMT at the first month and final follow-up visit (CMT change: - 166 ± 210, - 145 ± 231 µm; p-value = 0.018 and 0.035, respectively). In this subgroup, eyes in Group 2 had lower CMT at the first month following treatment in comparison with the control group (CMT: 444 ± 123 µm vs. 544 ± 96 µm, p-value = 0.042). Alterations of CDVA were not statistically significant among groups, although patients in Group 1 had a significant improvement in vision at second and last follow up (CDVA change: - 0.23 ± 0.39, - 0.20 ± 0.43 logMAR; p-value = 0.030 and 0.010, respectively).
In short term, Sub-tenon injection of IFN might have an additive anatomical effect in eyes with refractory DME. Validation of this observation requires further prospective controlled studies.
评估局部或Tenon囊下注射干扰素（IFN）-α 2b在治疗难治性糖尿病性黄斑水肿中的附加效果。
在这项前瞻性研究中，招募了对连续3个月每月一次玻璃体腔注射雷珠单抗无反应、黄斑中心凹受累的糖尿病性黄斑水肿患者。患者被分为三组：第1组，接受剂量为1mIU/ml的IFN-α 2b滴眼液，每日4次，共3个月。第2组，在入组时接受一次1mIU/ml的IFN-α 2b Tenon囊下注射。第3组，每日4次人工泪液，共3个月（对照组）。所有组均连续3个月每月进行一次玻璃体腔注射雷珠单抗，并在最后一次玻璃体腔注射后直至1个月每月进行评估。
在本研究中，评估了35例难治性糖尿病性黄斑水肿患者的59只眼。最终随访显示，尽管所有组的中心凹视网膜厚度（CMT）均下降，但仅第2组患者的CMT与基线值相比有统计学意义的降低（CMT变化：-117±213μm；p值=0.025）。三组之间CMT变化的比较无统计学意义，尽管第2组较高（CMT变化：第2组为-117±213μm，第1组为-49±173μm，第3组为-36±86μm；p值=0.085）。对于基线CMT>400μm的眼，Tenon囊下注射IFNα2b在第一个月和最终随访时导致CMT显著降低（CMT变化：分别为-166±210、-145±231μm；p值分别为0.018和0.035）。在该亚组中，治疗后第一个月第2组的眼与对照组相比CMT较低（CMT：444±123μm对544±96μm，p值=0.042）。组间最佳矫正视力（CDVA）的改变无统计学意义，尽管第1组患者在第二次和最后一次随访时视力有显著改善（CDVA变化：分别为-0.23±0.39、-0.20±0.43 logMAR；p值分别为0.030和0.010）。
短期内，Tenon囊下注射IFN可能对难治性糖尿病性黄斑水肿的眼有附加的解剖学效果。这一观察结果的验证需要进一步的前瞻性对照研究。
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