阈值下微脉冲激光联合雷珠单克隆抗体治疗糖尿病性黄斑水肿的临床疗效观察  

Clinical observation of the subthreshold micropulse laser combined with ranibizumab for treatment of diabetic macular edema

作　　者：谷潇雅 宋爽[1] 戴虹[1] 喻晓兵[1] Gu Xiaoya;Song Shuang;Dai Hong;Yu Xiaobing(Department of Ophthalmology,Beijing Hospital,National Center of Gerontology Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院眼科、国家老年医学中心、中国医学科学院老年医学研究院,北京100730

出　　处：《中华眼科杂志》2024年第7期570-579,共10页Chinese Journal of Ophthalmology

基　　金：中国医学科学院临床与转化医学研究专项(2021-I2M-C&T-B-093);北京医院院级科研课题(BJ-2019-154)。

摘　　要：目的探讨阈值下微脉冲激光(SMPL)联合雷珠单克隆抗体治疗糖尿病性黄斑水肿(DME)的有效性、安全性及特点。方法前瞻性随机对照研究。连续收集2020年1月至2022年12月在北京医院眼科确诊为DME的患者,使用随机数字表按照1∶1比例随机分为SMPL联合雷珠单克隆抗体治疗组(联合组)和单纯雷珠单克隆抗体治疗组(单纯组)。记录并比较两组治疗前(基线)和治疗6和12个月随访时的最佳矫正视力(BCVA)、黄斑中心凹视网膜厚度(CMT)以及相干光层析血管成像术参数,包括浅层毛细血管丛血管密度(SCP-VD)、深层毛细血管丛血管密度(DCP-VD)、黄斑中心凹无血管区(FAZ)面积、视盘旁血管密度(P-VD);治疗前和治疗12个月随访时的荧光素眼底血管造影术(FFA)检查结果,治疗12个月随访时玻璃体腔注射药物次数、SMPL治疗次数和不良反应。采用Fisher精确概率法和成组t检验进行统计学分析。结果共纳入符合标准DME患者72例(72只眼),年龄为(61.1±8.2)岁;联合组36例(36只眼),男性19例(19只眼),女性17例(17只眼);单纯组36例(36只眼),男性17例(17只眼),女性19例(19只眼),两组基线特征比较差异均无统计学意义(均P>0.05)。治疗6和12个月随访时,两组BCVA均明显改善[联合组提升至(58.5±12.9)和(58.2±12.2)个早期治疗糖尿病视网膜病变研究(ETDRS)字母;单纯组提升至(63.3±13.1)和(63.8±12.5)个ETDRS字母];CMT均显著下降[联合组降低至(451.0±185.5)和(380.4±159.3)μm;单纯组降低至(387.5±135.5)和(372.8±146.1)μm],差异均有统计学意义(均P<0.05),但是组间比较的差异均无统计学意义(均P>0.05)。治疗12个月随访时,单纯组(42.6%±5.9%)和联合组(42.2%±5.5%)SCP-VD与基线比较的差异和组间比较的差异均无统计学意义(均P>0.05);联合组DCP-VD增加至47.5%±5.6%,与单纯组比较(43.4%±5.1%)的差异有统计学意义(P<0.05);单纯组FAZ面积缩小至(0.32±0.13)mm2,联合组FAZ面积缩小�Objective To evaluate the efficacy and safety of the subthreshold micropulse laser(SMPL)combined with ranibizumab in treating diabetic macular edema(DME).Methods This was a prospective randomized controlled study.Patients diagnosed with DME in the Ophthalmology Department of Beijing Hospital were enrolled from January 2020 to December 2022.Patients were randomized in a ratio of 1∶1 using a table of random numbers into the ranibizumab monotherapy group and the SMPL combined with ranibizumab therapy group.We compared the changes of best-corrected visual acuity,central macular thickness measured by optical coherence tomography and optical coherence tomography angiography parameters,including the vessel density of the superficial and deep capillary plexus(DCP),foveal avascular zone size and peripapillary vessel density,at baseline,6 and 12 months after the treatment.After 12 months of follow-up,fundus fluorescein angiography results,adverse events,and the number of injections or laser therapies were recorded.The Fisher′s exact test and group t-test were used for statistical analysis.Results Seventy-two patients(72 eyes)were enrolled,with a mean age of(61.1±8.2)years.Patients in the combination therapy group included 19 males and 17 females,while patients in the ranibizumab monotherapy group were 17 males and 19 females.There was no statistically significant difference in baseline characteristics between the two groups(P>0.05).A significant improvement in best-corrected visual acuity was shown in both groups at 6 and 12 months[(58.5±12.9)and(58.2±12.2)ETDRS letters in the combination therapy group,and(63.3±13.1)and(63.8±12.5)ETDRS letters in the ranibizumab monotherapy group].A significant reduction in central macular thickness was shown in both groups at 6 and 12 months[(451.0±185.5)and(380.4±159.3)μm in the combination therapy group,and(387.5±135.5)and(372.8±146.1)μm in the ranibizumab monotherapy group].However,there was no significant difference between groups at each timepoint(all P>0.05).At 12 mon

关 键 词：糖尿病视网膜病变 黄斑水肿 激光凝固术 兰尼单抗 体层摄影术 光学相干 血管造影术 治疗结果 

分 类 号：R587.2[医药卫生—内分泌] R774.5[医药卫生—内科学]