Faghihi H, Roohipoor R, Mohammadi S-F, Hojat-Jalali K, Mirshahi A, Lashay A, Piri N, Faghihi Sh
Eye Research Center, Farabi Eye Hospital, Medical Sciences/University of Tehran and Ophthalmic Research Center, Noor Eye Hospital, Tehran - Iran.
Eur J Ophthalmol. 2008 Nov-Dec;18(6):941-8. doi: 10.1177/112067210801800614.
To evaluate the additive effect of triamcinolone to bevacizumab in comparison to standard macular laser photocoagulation versus bevacizumab in the management of diabetic macular edema (DME).
In a prospective, randomized clinical trial, 130 eyes of 110 patients with type 2 diabetes with DME were included. Eligible eyes were randomly assigned to 1.25 mg intravitreal bevacizumab (42 eyes) (IVB group) or combination of 1.25 mg bevacizumab and 2 mg triamcinolone acetonide (41 eyes) (IVB+IVT group) or macular laser photocoagulation (47 eyes) (MPC). Central macular thickness (CMT) and visual acuity changes at week 6 and 16 were assessed.
The mean age of the patients was 57 -/+7 years. Patients were followed 16 weeks. At week 6, all the three groups showed significant reduction in CMT but the reductions for IVB and IVB+IVT were significantly more than MPC (p<0.001). At week 16, the response was not stable for IVB (p<0.001), but IVB+IVT maintained its superior status to MPC (p<0.001). At week 16, visual acuities were essentially unchanged for the two groups of MPC and IVB and improvement for IVB+IVT was marginal and at most was 0.1 log MAR. No patient developed uveitis, endophthalmitis, or thromboembolic event.
Single intravitreal bevacizumab or triamcinolone plus bevacizumab injection brought about significantly greater macular thickness reduction in diabetic patients in comparison to standard laser treatment. However, the response for bevacizumab alone was short-lived. Reduction in macular thickness was only marginally associated with visual acuity improvement in the triamcinolone plus bevacizumab injection group.
评估曲安奈德联合贝伐单抗相较于标准黄斑激光光凝以及贝伐单抗单独使用在治疗糖尿病性黄斑水肿（DME）中的附加效果。
在一项前瞻性随机临床试验中，纳入了110例患有DME的2型糖尿病患者的130只眼。符合条件的眼睛被随机分配至玻璃体内注射1.25mg贝伐单抗组（42只眼）（IVB组）或1.25mg贝伐单抗与2mg曲安奈德联合注射组（41只眼）（IVB+IVT组）或黄斑激光光凝组（47只眼）（MPC）。评估第6周和第16周时的中心黄斑厚度（CMT）和视力变化。
患者的平均年龄为57±7岁。患者随访16周。在第6周时，所有三组的CMT均显著降低，但IVB组和IVB+IVT组的降低幅度显著大于MPC组（p<0.001）。在第16周时，IVB组的反应不稳定（p<0.001），但IVB+IVT组仍保持优于MPC组的状态（p<0.001）。在第16周时，MPC组和IVB组的视力基本未变，IVB+IVT组的视力改善微乎其微，最多为0.1 log MAR。没有患者发生葡萄膜炎、眼内炎或血栓栓塞事件。
与标准激光治疗相比，单次玻璃体内注射贝伐单抗或曲安奈德联合贝伐单抗可使糖尿病患者的黄斑厚度显著降低。然而，单独使用贝伐单抗的反应是短暂的。在曲安奈德联合贝伐单抗注射组中，黄斑厚度的降低与视力改善仅存在微弱关联。
