康柏西普不同给药方案治疗DME的安全性和疗效评估

Safety and efficacy of different loading doses followed by pro re nata regimens of Conbercept in the treatment of diabetic macular edema

摘要:

目的：评估康柏西普采用连续3次每月注射后改用按需治疗方案(3+PRN)和连续5次每月注射后改用按需治疗方案(5+PRN)治疗糖尿病性黄斑水肿(DME)的安全性和疗效。

方法：回顾性病例对照研究。选取2019-12/2020-06期间于我院就诊的DME患者51例92眼纳入研究，据治疗方案分为3+PRN组(26例48眼)和5+PRN组(25例44眼)。治疗后至少随访12mo，观察两组患者最佳矫正视力(BCVA)和中心凹视网膜厚度(CMT)的变化情况，玻璃体腔注药次数及眼部不良事件发生率。

结果：随访12mo，3+PRN组、5+PRN组患者平均注药次数无差异(7.24±0.91次 vs 7.56±1.04次，P=0.117)。治疗后3、6、9、12mo，两组患者BCVA和CMT均较治疗前改善(均P<0.05)，且治疗后6、9、12mo，5+PRN组患者BCVA和CMT均优于3+PRN组(均P<0.05)。随访期间，两组患者均未发生严重不良事件，两组患者眼部不良事件总发生率均为27%，所有不良事件给予对症处理后均好转。

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，总注射次数相当，但5+PRN治疗方案较3+PRN治疗方案视力改善更佳，CMT下降更明显。

Abstract:

AIM: To evaluate the efficacy and safety of different Conbercept treatment on diabetic macular edema(DME)with 3+PRN and 5+PRN.

METHODS: Retrospective case-control study. A total of 51 patients(92 eyes)with DME who were treated in our hospital during December 2019 and June 2020 were included, and they were divided into 3+PRN group with 26 cases(48 eyes)and 5+PRN group with 25 cases(44 eyes). All patients received monthly follow-up for 12mo and the changes of best-corrected visual acuity(BCVA)and central macular thickness(CMT), the number of intravitreal injections and the occurrence of complications were compared and observed in the two groups.

RESULTS:After follow-up for 12mo, there was no difference in the average injection times between the 3+PRN group and the 5+PRN group(7.24±0.91 times vs. 7.56±1.04 times, P=0.117). The BCVA and CMT of the two groups improved at 3, 6, 9, and 12mo after treatment compared with those before treatment(all P<0.05), and the BCVA and CMT of the 5+PRN group were better than those of the 3+PRN group at 6, 9, and 12mo after treatment(all P<0.05). During the follow-up period, no serious adverse events occurred in the two groups of patients, and the total incidence of ocular adverse events in the two groups was 27%. All adverse events were improved after symptomatic treatment.

CONCLUSION: Both the 3+PRN and 5+PRN treatment strategy of Conbercept can treat DME safely and effectively, the total times of injection were comparable. However, the BCVA and CMT improved more in the 5+PRN group than that in 3+PRN group.