康柏西普联合止血祛瘀明目片治疗DME的临床观察  

Clinical observation of Conbercept combined with Zhixue Quyu Mingmu Tablets in the treatment of diabetic macular edema

作　　者：崔文轩 陶远[2] 王红[1] 杨梦瑶 司明威 CUI Wenxuan;TAO Yuan;WANG Hong;YANG Mengyao;SI Ming-wei(Qilu Hospital of Shandong University,Jinan 250012,China)

机构地区：[1]山东大学齐鲁医院,济南250012 [2]济南市第二人民医院,济南250022

出　　处：《中国中医眼科杂志》2024年第2期122-127,138,共7页China Journal of Chinese Ophthalmology

基　　金：国家自然科学基金项目(72274110);山东省医药卫生科技项目(202307020900)。

摘　　要：目的观察康柏西普联合止血祛瘀明目片治疗DME的临床疗效。方法纳入2020年12月—2022年1月在山东大学齐鲁医院接受治疗的DME患者191例(191只眼),随机分为对照组95例(95只眼)和治疗组96例(96只眼)。对照组予玻璃体内注射康柏西普注射液治疗,治疗组予在对照组基础上联合口服止血祛瘀明目片治疗。2组均观察12个月,分别于治疗前和治疗后1、3、6、9、12个月时测量最佳矫正视力(BCVA)、黄斑中心凹厚度(CMT)、微血管瘤(MAs)数量、硬性渗出(HE)面积、眼底视网膜出血(RH)面积。结果2组治疗前BCVA、CMT、MAs、HE及眼底出血面积比较,差异均无统计学意义(P>0.05)。(1)BCVA:治疗后2组各治疗时间点的视力水平均较治疗前改善,差异均有统计学意义(对照组:t_(1个月)=11.668、t_(3个月)=12.688、t_(6个月)=12.496、t_(9个月)=12.246、t_(12个月)=13.125,均P=0.000;治疗组:t_(1个月)=10.590、t_(3个月)=12.922、t_(6个月)=11.691、t_(9个月)=13.352、t_(12个月)=12.579,均P=0.000);但同一时间点2组间比较差异均无统计学意义(P>0.05)。(2)CMT:治疗后2组各时间点CMT均较治疗前改善(对照组:t_(1个月)=29.301、t_(3个月)=30.268、t_(6个月)=32.781、t_(9个月)=31.627、t_(12个月)=32.379,均P=0.000;治疗组:t_(1个月)=26.602、t_(3个月)=27.765、t_(6个月)=27.919、t_(9个月)=28.859、t_(12个月)=26.593,均P=0.000),但同一时间点2组间比较差异均无统计学意义(P>0.05)。(3)MAs:治疗后2组各治疗时间点MAs数量均较治疗前减少,差异均有统计学意义(对照组:t_(1个月)=6.089、t_(3个月)=14.099、t_(6个月)=12.171、t_(9个月)=14.839、t_(12个月)=15.536,均P=0.000;治疗组:t_(1个月)=7.521、t_(3个月)=16.310、t_(6个月)=16.650、t_(9个月)=16.894、t_(12个月)=16.468,均P=0.000)。2组间比较,治疗6个月后治疗组MAs数量少于对照组,差异具有统计学意义(t=2.186,P=0.030)。余组间比较差异无统计学意义(P>0.05)。(4)HE和RH面积:治�OBJECTIVE To observe the clinical efficacy of the combined use of conbercept injection and Zhixue Quyu Mingmu Tablets in the treatment of diabetic macular edema(DME).METHODS A total of 191 DME patients(191 eyes)treated at Qilu Hospital of Shandong University from December 2020 to January 2022 were included in this study.They were randomly divided into a control group(CG)of 95 cases(95 eyes)and a treatment group(TG)of 96 cases(96 eyes).The control group received intravitreal injection of conbercept,while the treatment group received combined oral hemostatic and Zhixue Quyu Mingmu Tablets based on the control group.Both groups were observed for 12 months.Best-corrected visual acuity(BCVA),central macular thickness(CMT),the number of microaneurysms(MAs),the area of hard exudates(HE),and the area of retinal hemorrhage(RH)were measured before treatment and at one,three,six,nine,and 12 months after treatment.RESULTS There were no statistically significant differences in BCVA,CMT,MAs,HE,and RH area between the two groups at baseline(P>0.05).(1)BCVA:The visual acuity of both groups significantly improved at each treatment time point compared to baseline(CG:t_(1 mon)=11.668,t_(3 mon)=12.688,t_(6 mon)=12.496,t_(9 mon)=12.246,t_(12 mon)=13.125,all P=0.000;TG:t_(1 mon)=10.590,t_(3 mon)=12.922,t_(6 mon)=11.691,t_(9 mon)=13.352,t_(12 mon)=12.579,all P=0.000).However,there was no statistically significant difference between the two groups at the same time points(P>0.05).(2)CMT:CMT in both groups significantly improved at each time point compared to baseline(CG:t_(1 mon)=29.301,t_(3 mon)=30.268,t_(6 mon)=32.781,t_(9 mon)=31.627,t_(12 mon)=32.379,all P=0.000;TG:t_(1 mon)=26.602,t_(3 mon)=27.765,t_(6 mon)=27.919,t_(9 mon)=28.859,t_(12 mon)=26.593,all P=0.000).However,there was no statistically significant difference between the two groups at the same time points(P>0.05).(3)MAs:The number of MAs in both groups significantly decreased at each treatment time point compared to baseline(CG:t_(1 mon)=6.089,t_(3 mon)=14.099,t_(6 mon)=12.

关 键 词：止血祛瘀明目片 康柏西普 糖尿病性黄斑水肿 临床疗效 视力 眼底出血 硬性渗出 

分 类 号：R276.7[医药卫生—中医五官科学]