Riazi-Esfahani Mohammad, Riazi-Esfahani Hamid, Ahmadraji Aliasghar, Karkhaneh Reza, Mahmoudi Alireza, Roohipoor Ramak, Ghasemi Fariba, Yaseri Mehdi
Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Science, Qazvin Square, South Karegar Street, Tehran, 1336616351, Iran.
Int Ophthalmol. 2018 Apr;38(2):585-598. doi: 10.1007/s10792-017-0496-4. Epub 2017 Mar 27.
To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal 1 mg triamcinolone acetonide (IVT) in center-involved diabetic macular edema.
In this randomized clinical trial study, ninety-two eyes of 46 patients with bilateral center-involved diabetic macular edema and no previous treatment were included in the study. One eye of each patient was randomly assigned to 1.25 mg of IVB injection or combination of 1.25 IVB and 1 mg IVT. Evaluation of best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and grading of lens opacity was conducted at baseline, and weeks 2, 4, 6, 8, 12 and 24 after treatment. Retreatment was performed at a 6-week interval whenever indicated based on CMT.
Between the groups, BCVA changes were not statistically different until 24-week follow-up (P > 0.05), but at 24 weeks after treatment, BCVA improvement was significantly better in IVB group (P = 0.049). Significant CMT reduction was observed in each group along the follow-up period (P = 0.001). The mean CMT reduction was more significant in combination (IVB + IVT) group at 2 weeks of follow-up (P < 0.001), but CMT changes were not significant between the groups at weeks 12th and 24th after injection. Overall, retreatment was applied for 59 eyes up to 24 weeks (33 in the IVB group, 26 in the IVB + IVT group). Among patients with 2 or more injections, number of injections was significantly lower in IVB + IVT group (P = 0.043). Three eyes within IVB + IVT group developed IOP rise beyond 21 mmHg, which were controlled with topical anti-glaucoma medications within 1 week. Changes in lens opacity were not significant between two groups.
Eyes treated with IVB plus 1 mg IVT injections had more significant reduction in CMT in early post-injection, but this effect was transient. Although after 24 weeks visual acuity improvement was better in IVB group, combination therapy may decrease the number of injections. Combining 1 mg of intravitreal triamcinolone with bevacizumab was not accompanied with significant side effects.
比较单纯玻璃体内注射贝伐单抗（IVB）或联合玻璃体内注射1mg曲安奈德（IVT）治疗累及黄斑中心的糖尿病性黄斑水肿的效果。
在这项随机临床试验研究中，纳入46例双侧累及黄斑中心的糖尿病性黄斑水肿且未接受过治疗的患者的92只眼。将每位患者的一只眼随机分配至接受1.25mg IVB注射或1.25mg IVB与1mg IVT联合注射。在基线以及治疗后第2、4、6、8、12和24周评估最佳矫正视力（BCVA）、黄斑中心厚度（CMT）、眼压（IOP）以及晶状体混浊分级。根据CMT情况，必要时每隔6周进行再次治疗。
两组间，直至24周随访时BCVA变化无统计学差异（P>0.05），但在治疗后24周，IVB组的BCVA改善明显更好（P=0.049）。在整个随访期间每组均观察到CMT显著降低（P=0.001）。在随访2周时联合治疗组（IVB+IVT）的平均CMT降低更显著（P<0.001），但在注射后第12周和第24周两组间CMT变化无显著差异。总体而言，至24周时共59只眼接受了再次治疗（IVB组33只，IVB+IVT组26只）。在接受2次或更多次注射的患者中，IVB+IVT组的注射次数显著更低（P=0.043）。IVB+IVT组有3只眼眼压升高超过21mmHg，在1周内通过局部抗青光眼药物得到控制。两组间晶状体混浊变化无显著差异。
接受IVB加1mg IVT注射治疗的眼在注射后早期CMT降低更显著，但这种效果是短暂的。虽然24周后IVB组视力改善更好，但联合治疗可能减少注射次数。玻璃体内注射1mg曲安奈德与贝伐单抗联合应用未伴随明显副作用。
