Kulikov A N, Malafeeva A Yu, Kalinicheva Y A, Maltsev D S, Zhalimova V R, Vasilyev A S
S.M. Kirov Military Medical Academy, Saint Petersburg, Russia.
Vestn Oftalmol. 2023;139(1):99-105. doi: 10.17116/oftalma202313901199.
This study examines the efficacy and safety of brolucizumab in the treatment of diabetic macular edema (DME) in real clinical practice in the Russian Federation.
The study included 14 consecutive treatment-naïve DME patients, among them 7 males and 7 females (21 eyes in total) with mean age of 65.1±8.0 years. Patients underwent standard ophthalmological examination and multimodal imaging, including optical coherence tomography. All patients received intravitreal injections of brolucizumab every 6 weeks. A total of 73 injections were performed. A data analysis was performed for 10 eyes of 10 patients 6 months after initiation of the treatment.
After 4 injections of brolucizumab, best-corrected visual acuity (BCVA) increased statistically significantly from 35.8±13.7 to 41.5±11.9 ETDRS letters (=0.03), central retinal thickness (CRT) and macular volume (MV) decreased from 411.5±107.4 to 280.2±64.6 microns (=0.014) and from 7.39±0.92 to 6.16±7.37 mm (=0.0006), respectively. The average gain of visual acuity was 5.7±7.0 letters, average decrease of CRT was -131.3±91.2, and average decrease of MV was -1.21±0.75 mm. There were no adverse events associated with intraocular inflammation.
Intravitreal injections of brolucizumab provide significant anatomical and functional improvement to DME patients in real clinical practice with results comparable to that of randomized clinical trials.
本研究在俄罗斯联邦的实际临床实践中检验了布罗鲁单抗治疗糖尿病性黄斑水肿（DME）的疗效和安全性。
该研究纳入了14例初治DME患者，其中男性7例，女性7例（共21只眼），平均年龄65.1±8.0岁。患者接受了标准眼科检查和多模态成像，包括光学相干断层扫描。所有患者每6周接受一次玻璃体内注射布罗鲁单抗。共进行了73次注射。在治疗开始6个月后，对10例患者的10只眼进行了数据分析。
注射4次布罗鲁单抗后，最佳矫正视力（BCVA）从35.8±13.7 ETDRS字母显著提高至41.5±11.9 ETDRS字母（P=0.03），中心视网膜厚度（CRT）和黄斑体积（MV）分别从411.5±107.4微米降至280.2±64.6微米（P=0.014），从7.39±0.92立方毫米降至6.16±7.37立方毫米（P=0.0006）。视力平均提高5.7±7.0个字母，CRT平均降低-131.3±91.2微米，MV平均降低-1.21±0.75立方毫米。未发生与眼内炎症相关的不良事件。
在实际临床实践中，玻璃体内注射布罗鲁单抗可使DME患者在解剖结构和功能上得到显著改善，结果与随机临床试验相当。
