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康柏西普联合止血祛瘀明目片治疗DME的临床观察

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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:t1个月=11.668、t3个月=12.688、t6个月=12.496、t9个月=12.246、t12个月=13.125,均P=0.000;治疗组:t1个月=10.590、t3个月=12.922、t6个月=11.691、t9个月=13.352、t12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:t1个月=29.301、t3个月=30.268、t6个月=32.781、t9个月=31.627、t12个月=32.379,均P=0.000;治疗组:t1个月=26.602、t3个月=27.765、t6个月=27.919、t9个月=28.859、t12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:t1 个月=6.089、t3 个月= 14.099、t6 个月=12.171、t9 个月=14.839、t12 个月=15.536,均P=0.000;治疗组:t1个月=7.521、t3个月= 16.310、t6个月=16.650、t9个月=16.894、t12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:治疗12个月后2组HE(χ2对照组=15.656、χ2治疗组= 34.173,均P=0.000)及RH面积(χ2对照组=22.579、χ2治疗组=52.191,均P=0.000)均较治疗前减少,差异均有统计学意义.2组间比较,治疗组HE面积及RH吸收面积优于对照组,特别是在面积较大的情况下,差异均有统计学意义(χ2HE=7.343,P=0.025;χ2RH=7.353,P=0.025).(5)注射次数:治疗期间,对照组平均注射次数6.36次多于治疗组4.92次,差异有统计学意义(t=9.3775,P=0.000).(6)安全性评价:对照组和治疗组患者在用药和观察过程中均未出现任何严重不良反应和不良事件,治疗前后肝、肾功能及血、尿、便常规及心电图检查未出现明显异常.结论 止血祛瘀明目片联合康柏西普治疗效果显著,可有效消退黄斑水肿、提高患者视力,促进眼底HE及出血的吸收,并通过减少康柏西普注射频率减轻患者的经济负担,具有一定的临床推广应用价值.
Clinical observation of Conbercept combined with Zhixue Quyu Mingmu Tablets in the treatment of diabetic macular edema
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:t1 mon=11.668,t3 mon= 12.688,t6 mon=12.496,t9 mon=12.246,t12 mon=13.125,all P=0.000;TG:t1 mon=10.590,t3 mon=12.922,t6 mon= 11.691,t9 mon=13.352,t12 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:t1 mon=29.301,t3 mon=30.268,t6 mon=32.781,t9 mon=31.627,t12 mon=32.379,all P=0.000;TG:t1 mon=26.602,t3 mon=27.765,t6 mon=27.919,t9 mon=28.859,t12 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:t1 mon=6.089,t3 mon=14.099,t6 mon=12.171,t9 mon=14.839,t12 mon=15.536,all P=0.000;TG:t1 mon=7.521,t3 mon=16.310,t6 mon=16.650,t9 mon=16.894,t12 mon=16.468,all P=0.000).When comparing between the two groups,the number of MAs in the treatment group was significantly less than that in the control group after 6 months of treatment,with a statistically significant difference(t=2.186,P=0.030).There were no statistically significant differences between the groups at other time points(P>0.05).(4)HE and RH area:After 12 months of treatment,both groups showed a significant reduction in HE(χ2CG = 15.656,χ2TG =34.173,both P=0.000)and retinal hemorrhage area(χ2CG =22.579,χ2TG =52.191,both P=0.000)compared to baseline,and the differences were statistically significant.When comparing between the two groups,the absorption of HE and RH(χ2HE=7.343,P=0.025;χ2RH = 7.353,P=0.025)in the treatment group was better than that in the control group,especially in cases with larger areas,and the differences were statistically significant.(5)Number of injections:During the treatment period,the average number of injections in the control group was 6.36 times,while in the treatment group,it was 4.92 times.The number of injections in the treatment group was significantly less than that in the control group,with a statistically significant difference(t= 9.3775,P=0.000).(6)Safety evaluation:There were no serious adverse reactions or events during the medication and observation processes for patients in both the control and treatment groups.There were no significant abnormalities in liver and kidney function,as well as blood,urine,and stool routine tests and electrocardiograms before and after treatment.CONCLUSIONS The combined treatment of Zhixue Quyu Mingmu tablets with conbercept injection shows significant efficacy in the treatment of DME.It can effectively reduce macular edema,improve visual acuity in patients,promote the absorption of RH and HE,and reduce the economic burden on patients by reducing the frequency of conbercept injection s.It has certain clinical application value and deserves further promotion.

Zhixue Quyu Mingmu Tabletsconberceptdiabetic macular edemaclinical ef-fectvisual acuityfundus hemorrhagehard exudation

崔文轩、陶远、王红、杨梦瑶、司明威

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山东大学齐鲁医院,济南 250012

济南市第二人民医院,济南 250022

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

国家自然科学基金项目山东省医药卫生科技项目

72274110202307020900

2024

中国中医眼科杂志
中国中医科学院

中国中医眼科杂志

CSTPCD
影响因子:0.476
ISSN:1002-4379
年,卷(期):2024.34(2)
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