摘要目的:对比观察康柏西普不同给药方案治疗糖尿病黄斑水肿（DME）的疗效和安全性。方法:回顾性临床研究。2016年11月至2020年11月于解放军中部战区总医院眼科检查确诊并接受康柏西普治疗的累及中心凹DME患者92例135只眼纳入研究。患者均行最佳矫正视力（BCVA）、光相干断层扫描（OCT）检查。患眼均接受起始每月玻璃体腔注射康柏西普1次，连续3个月或5个月，其后根据患者视力和OCT检查结果进行按需治疗（PRN），即3+PRN或5+PRN治疗方案，并据此分为3+PRN组、5+PRN组，分别为84、51只眼。两组患者基线资料比较，差异均无统计学意义（ P>0.05）。对比观察两组患眼治疗后12个月末BCVA、中心凹视网膜厚度（CRT）变化以及玻璃体腔注药次数和并发症发生情况。组间连续变量比较行独立样本Mann-Whitney检验；分类变量比较行 χ2检验。 结果:治疗后12个月末，与基线时比较，3+PRN组、5+PRN组患眼BCVA分别提高（8.8±4.4）、（9.2±6.1）个字母，CRT分别下降（145.1±50.5）、（148.5±82.5）μm；两组患眼间BCVA提高字母数、CRT下降值比较，差异均无统计学意义（ P=0.295、0.548）。3+PRN组、5+PRN组BCVA提高>10、15个字母者分别为40 （47.6%，40/84）、21 （25.0%，21/84）只眼和27 （52.9%，27/51）、16 （31.4%，16/51）只眼；两组BCVA提高>10、15个字母者所占比例比较，差异无统计学意义（ χ2=0.360、0.648， P=0.549、0.421）。PRN期间，3+PRN组、5+PRN组患眼中，视力预后不稳定者分别为22 （26.2%，22/84）、6 （11.8%，6/51）只眼；两组视力预后不稳定眼数比较，差异有统计学意义（ χ2=4.017 ， P=0.045）。两组患眼玻璃体腔注药次数分别为（4.1±2.9）、（2.4±1.8）次，差异有统计学意义（ P<0.001 ）；补救激光光凝治疗次数分别为（1.9±1.0）、（1.5±0.8）次，差异有统计学意义（ P=0.034）。随访期间，3+PRN组、5+PRN组眼部不良事件和严重不良事件总体发生率近似，分别为22.6% （19/84）、25.5% （13/51）和8.3% （7/84）、7.8% （4/51 ）。 结论:康柏西普3+PRN和5+PRN治疗方案均能安全、有效地治疗DME；5+PRN治疗方案患眼仅需较少的PRN次数即可维持更稳定的疗效。

abstractsObjective:To compare and observe the efficacy and safety of different administration methods of conbercept in the treatment of diabetic macular edema (DME).Methods:A retrospective clinical study. From November 2016 to November 2020, 135 eyes of 92 patients with foveal DME who were diagnosed in the Department of Ophthalmology of General Hospital of Central Theater Command received conbercept treatment were included in the study. All patients underwent best corrected visual acuity (BCVA) and optical coherence tomography (OCT) examinations. All the affected eyes received intravitreal injection of conbercept once a month for 3 months or 5 months, and then pro re nata (PRN) treatment based on the patient’s visual acuity and OCT examination results, namely 3+PRN or 5+PRN treatment plan, and divided into 3+PRN group (84 eyes) and 5+PRN group (51 eyes), respectively. There was no statistically significant difference in baseline information between the two groups of patients ( P>0.05). The changes of BCVA, centre retinal thickness (CRT), the number of intravitreal injections and the occurrence of complications in the two groups were compared and observed at the end of 12 months after treatment. The independent sample Mann-Whitney test was used to compare continuous variables between groups; the χ2 test was used to compare categorical variables. Results:At the end of 12 months after treatment, compared with baseline, the BCVA of 3+PRN group and 5+PRN group increased by 8.8±4.4, 9.2±6.1 letters, and CRT decreased by 145.1±50.5, 148.5±82.5 μm; there was no statistically significant difference between the two groups of eyes with BCVA increasing letter number and CRT decreasing value ( P=0.295, 0.548). In the 3+PRN group and 5+PRN group, the BCVA increased by more than 10 and 15 letters were 40 (47.6%, 40/84), 21 (25.0%, 21/84) eyes and 27 (52.9%, 27/51), 16 (31.4%, 16/51) eyes; there was no statistically significant difference in the proportion of the two groups with BCVA improvement> 10, 15 letters ( χ2=0.360, 0.648; P=0.549, 0.421). During PRN, in the eyes of 3+PRN group and 5+PRN group, the prognosis of eyesight was unstable in 22 (26.2%, 22/84) and 6 (11.8%, 6/51) eyes; the prognosis of eyes in the two groups was unstable. Compared with the number of eyes, the difference was statistically significant ( χ2=4.017, P=0.045). The number of injections into the vitreous cavity of the two groups of eyes were 4.1±2.9 and 2.4±1.8, the difference was statistically significant ( P<0.001); the times of remedial photocoagulation were 1.9±1.0, 1.5±0.8 times, the difference was statistically significant ( P=0.034). During the follow-up period, the overall incidence of ocular adverse events and serious adverse events in the 3+PRN group and 5+PRN group were similar, being 22.6% (19/84), 25.5% (13/51), and 8.3% (7/84), 7.8% (4/51), respectively. Conclusion:Both the 3+PRN and 5+PRN regimens of conbercept can treat DME safely and effectively; the 5+PRN regimen only requires fewer PRNs to maintain a more stable therapeutic effect.