Diaz-Llopis Manuel, Udaondo Patricia, Arevalo Fernando, Salom David, Garcia-Delpech Salvador, Quijada Arturo, Romero Francisco Javier
Department of Ophthalmology, Hospital General, Valencia, Spain.
J Ocul Pharmacol Ther. 2009 Aug;25(4):379-84. doi: 10.1089/jop.2008.0118.
To determine the effectiveness of a low-dose intravitreal injection of autologous plasmin enzyme (APE), without the performance of a vitrectomy, as a treatment for refractory diffuse diabetic macular edema (DDME).
Prospective, comparative, interventional case series.
Sixteen patients with bilateral DDME who had not responded to prior laser photocoagulation. All patients received an injection in 1 eye, while the other eye served as a control.
Intravitreal 0.2 mL APE injection under topical anesthesia. The APE was obtained using a simplified method.
Central macular thickness (CMT) at 1 and 6 months, determined by optical coherence tomography (OCT) and best corrected visual acuity (BCVA).
All patients underwent a 1-month follow-up. Prior to injection, CMT in the eye about to receive the injection was 541 +/- 79 microm (mean +/- standard deviation [SD]) versus 535 +/- 76 microm in the control eye. One month after injection, CMT was 241 +/- 47 microm in injected eyes and 530 +/- 85 microm in control eyes (P < 0.001, bilateral Wilcoxon test for paired samples). The macular edema (ME) improved in all injected eyes (100%), with complete resolution in 7 patients (44%). The mean BCVA of treated eyes was 0.618 +/- 0.27 (mean +/- SD) at baseline and 0.45 +/- 0.24 four weeks after injection (paired samples t-test, P < 0.001). No adverse effects were observed in any of the patients. BCVA and CMT were stable when evaluated at 6-month follow-up (0.43 +/- 0.242 and 244 +/- 46 microm, respectively).
Intravitreal APE injection effectively reduces macular thickening due to DDME in cases that fail to respond to conventional laser photocoagulation, and improves visual acuity in a short term, and this results remain stable in a medium term what is very important. Further investigation is warranted in order to assess long-term efficacy and safety.
确定在不进行玻璃体切割术的情况下，低剂量玻璃体内注射自体纤溶酶（APE）治疗难治性弥漫性糖尿病性黄斑水肿（DDME）的有效性。
前瞻性、比较性、干预性病例系列研究。
16例双侧DDME患者，此前对激光光凝治疗无反应。所有患者一只眼接受注射，另一只眼作为对照。
表面麻醉下玻璃体内注射0.2 mL APE。APE采用简化方法获取。
通过光学相干断层扫描（OCT）和最佳矫正视力（BCVA）测定1个月和6个月时的中心黄斑厚度（CMT）。
所有患者均接受了1个月的随访。注射前，即将接受注射的眼的CMT为541±79微米（平均值±标准差[SD]），对照眼为535±76微米。注射后1个月，注射眼的CMT为241±47微米，对照眼为530±85微米（P<0.001，配对样本双侧Wilcoxon检验）。所有注射眼的黄斑水肿（ME）均有改善（100%），7例（44%）完全消退。治疗眼的平均BCVA在基线时为0.618±0.27（平均值±SD），注射后4周为0.45±0.24（配对样本t检验，P<0.001）。所有患者均未观察到不良反应。在6个月随访时评估，BCVA和CMT保持稳定（分别为0.43±0.242和244±46微米）。
玻璃体内注射APE可有效减轻常规激光光凝治疗无效的DDME所致的黄斑增厚，并在短期内提高视力，且中期结果保持稳定，这一点非常重要。有必要进一步研究以评估长期疗效和安全性。
