背景:评估局部或Tenon下注射干扰素(IFN)-α2b治疗难治性糖尿病性黄斑水肿的累加作用。
方法:在这项前瞻性研究中,招募了对3个月连续IVB注射无反应的中心参与DME患者。患者分为三组:第1组,每天四次以1mIU/ml的剂量接受IFN-α2b局部滴剂,持续3个月。第2组,在招募时接受了1mIU/mlIFN-α2b的单次腱注射。第3组接受人工泪液,每天四次,持续3个月(对照组)。所有组均接受三次连续每月IVB注射,并在最后一次IVB注射后每月直至1个月进行评估。
结果:在这项研究中,对35例难治性DME患者的59只眼进行了评估。最后的随访显示,尽管所有组的CMT都下降了,与基线值相比,只有第2组患者的CMT显著降低(CMT变化:-117±213µm;p值=0.025).3组间CMT变化比较差异无统计学意义,尽管在第2组中较高(CMT的变化:-117±213µm(组2)与-49±173(第1组)vs.-36±86(第3组);p值=0.085)。考虑到基线CMT>400µm的眼睛,Tenon下注射IFNα2b导致第一个月和最后一次随访时CMT显著减少(CMT变化:-166±210,-145±231µm;p值分别=0.018和0.035).在这个子群中,与对照组相比,第2组的眼睛在治疗后第一个月的CMT较低(CMT:444±123µmvs.544±96微米,p值=0.042)。CDVA的改变在组间没有统计学意义,尽管第1组患者在第二次和最后一次随访时视力显著改善(CDVA变化:-0.23±0.39,-0.20±0.43logMAR;p值分别=0.030和0.010).
结论:在短期内,Tenon下注射IFN可能对难治性DME的眼睛具有附加的解剖作用。这一观察结果的验证需要进一步的前瞻性对照研究。
BACKGROUND: To evaluate the additive effect of topical or sub-tenon injection of interferon (IFN)-α 2b in the treatment of refractory diabetic macular edema.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.