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.