康柏西普不同玻璃体腔注射方案治疗湿性年龄相关性黄斑变性的疗效及安全性比较

doi:10.3760/cma.j.cn115909-20201114-00439

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摘要目的：比较康柏西普3+PRN和3+Q3M注射方案治疗湿性年龄相关性黄斑变性（AMD）的疗效及安全性。方法：前瞻性临床研究。选取2018年8月至2019年8月在山东大学齐鲁医院眼科确诊的湿性 AMD患者106例（106眼），所有患眼均可见黄斑区脉络膜新生血管（CNV）渗漏病灶。采用国际标准小数视力表检查最佳矫正视力（BCVA），统计时换算为最小分辨角对数视力（LogMAR），应用光学相干断层扫描（OCT）测量中心视网膜厚度（CRT）。所有患眼玻璃体腔注射康柏西普0.5 mg，其中 55只眼每个月注射1针，连续3针后，延长期按需给药（3+PRN）；51只眼每个月注射1针，连续3针后，延长期每3个月注射1次（3+Q3M）。开始治疗后第1、2周以及每个月行常规视力、眼压和OCT检查，每3个月行荧光素眼底血管造影检查，观察所有患者治疗前后患眼BCVA、CRT及CNV病灶渗漏面积的变化及术后不良反应。采用重复测量方差分析、卡方检验进行数据比较。结果：治疗1、3、6、9、 12个月后，3+PRN组和3+Q3M组患眼平均BCVA均较治疗前改善（3+PRN组：t=7.202、11.178、9.914、 9.869、10.587，均P<0.001；3+Q3M组：t=5.548、9.780、9.358、11.884、11.622，均P<0.001），平均 CRT均较治疗前降低（3+PRN组：t=12.28、17.041、17.615、15.739、16.171，均P<0.001；3+Q3M 组：t=10.221、15.598、16.297、16.984、17.275，均P<0.001），差异均有统计学意义。其中治疗9、 12个月后3+Q3M组患眼BCVA明显高于3+PRN组，差异有统计学意义（t=2.304，P=0.023；t=2.058， P=0.042）；治疗9、12个月后3+Q3M组患眼平均CRT明显低于3+PRN组，差异有统计学意义（t=2.032， P=0.045；t=2.092，P=0.039）。治疗12个月时，FFA、ICGA检查发现3+PRN组31眼（56%）、3+Q3M 组32眼（63%）渗漏完全消失，3+PRN组18眼（33%）、3+Q3M组15眼（29%）渗漏减轻，3+PRN组 6眼（11%）、3+Q3M组4眼（8%）渗漏面积不变或扩大，2组比较差异无统计学意义。随访期间均未见与治疗相关的严重眼部并发症及全身严重不良反应发生。结论：康柏西普3+PRN与3+Q3M治疗方案均为治疗湿性AMD的有效方法，但在视力提高、降低黄斑CRT厚度方面，3+Q3M治疗方案更为有效。

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关键词 ： , 康柏西普, 湿性年龄相关性黄斑变性, 最佳矫正视力, 中心视网膜厚度

Abstract： Objective: To assess the clinical effectiveness of an intravitreal injection of conbercept using two different strategies, the 3+PRN and 3+Q3M strategies, for the treatment of wet age-related macular degeneration (AMD). Methods: Prospective clinical study. Patients at Qilu Hospital, Shandong University who were confirmed to have exudative AMD from August 2018 to August 2019 were included. Exudative lesions of choroidal neovascularization (CNV) in the macular area were found in all 106 eyes of these patients. The international standard decimal visual acuity chart was used to measure best corrected visual acuity (BCVA). This was converted to the logarithm of the minimum angle of resolution (LogMAR) for the analysis. Optical coherence tomography (OCT) was used to measure central retinal thickness (CRT). For all eyes, an intravitreal injection of 0.5 mg of conbercept was administered with one of two strategies: 55 eyes received once monthly injections for the first 3 months, then 3+prore nata (3+PRN), and 51 eyes received once monthly injections for the first 3 months, followed by one injection every 3 months (3+Q3M). The patients were followed up for 12 months after the treatment. Routine examinations of BCVA, intraocular pressure (IOP), and OCT were conducted at 1 and 2 weeks after the operation, then these examinations were conducted every month. FFA examination was conducted every 3 months after the operation.The changes in BCVA, CRT and exudation of CNV lesions of the eyes were measured before and after treatment. Repeated measures analysis of variance was used to compare the groups and show the time effect, while the LSD t-test was used for comparisons among different time points within the same group. Results: The mean BCVA in both groups improved significantly at 1, 3, 6, 9 and 12 months after the operation, compared to the levels before treatment (3+PRN: t=7.202, 11.178, 9.914, 9.869, 10.587, respectively, P<0.001; 3+Q3M: t=5.548, 9.780, 9.358, 11.884, 11.622, respectively, P<0.001). In addition, the BCVA of the eyes was also significantly better in the 3+Q3M group than in the 3+PRN group at 9 and 12 months after the operation (t=2.304, P=0.023; t=2.058, P=0.042). The mean CRT of the eyes was significantly lower at 1, 3, 6, 9 and 12 months after treatment, compared to the level before treatment (3+PRN: t=12.28, 17.041, 17.615, 15.739, 16.171, P<0.001; 3+Q3M: t=10.221, 15.598, 16.297, 16.984, 17.275, P<0.001). In addition, the CRT of the eyes was significantly lower in the 3+Q3M group than in the 3+PRN group at 9 and 12 months after the operation (t=2.032, P=0.045; t=2.092, P=0.039). The FFA and ICGA examinations at the last follow-up showed that the exudation of CNV lesions in the macular area disappeared, reduced, or increased in 31(56%), 18(33%), and 6(11%) eyes in the 3+PRN group, and in 32(63%), 15(29%), and 4(8%) eyes in the 3+Q3M group, respectively. The Chi-square test shows the difference has no significance. There were no serious treatment-related ocular complications, such as retinal detachment, retinal tear, persistent intraocular pressure increase, or endophthalmitis, as well as serious systemic adverse responses found during the follow-up. Conclusions: Both strategies, namely the 3+PRN and 3+Q3M strategies, of intravitreal injection of conbercept are effective in treating wet AMD. However, the 3+Q3M strategy needs more injections but is more effective for improving visual acuity, reducing macular CRT thickness, and decreasing the exudation area of CNV, than the 3+PRN strategy.

Key words： conbercept wet age-related macular degeneration best corrected visual acuity central retinal thickness

收稿日期: 2020-11-14

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通讯作者: 王红（ORCID：0000-0001-8484-0231），Email：dr.wanghong@163.com

引用本文:

张鹏1 高蕾1 王淑静2 李一啸3 王红4. 康柏西普不同玻璃体腔注射方案治疗湿性年龄相关性黄斑变性的疗效及安全性比较[J]. 中华眼视光学与视觉科学杂志, 2021, 23(4): 260-266. Peng Zhang1,Lei Gao1,Shujing Wang2,Yixiao Li3,Hong Wang4. Comparison of the Efficacy and Safety of Different Regimens of Intravitreal Conbercept Injections for Wet Age-Related Macular Degeneration. Chinese Journal of Optometry Ophthalmology and Visual science, 2021, 23(4): 260-266. DOI: 10.3760/cma.j.cn115909-20201114-00439

链接本文:

https://www.cjoovs.com/CN/ 10.3760/cma.j.cn115909-20201114-00439 或 https://www.cjoovs.com/CN/Y2021/V23/I4/260

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