Clinical Observation on the Treatment of PDR by Aflibercept Combined with Zhixue Quyu Min-gmu Tablets
OBJECTIVE To observe the clinical efficacy of combined use of aflibercept and Zhixue Quyu Mingmu Tablets in the treatment of proliferative diabetic retinopathy(PDR)through a controlled observation.METHODS Fifty patients(100 eyes)diagnosed with PDR of Yin deficiency and Liver hyperactivity at Shandong province eye hospital from January 2020 to January 2021 were collected and randomly divided into a control group(25 cases,50 eyes)and a treatment group(25 cases,50 eyes),12 eyes dropped out from the control group and five eyes dropped out from the treatment group.Finally,20 cases(38 eyes)in the control group and 23 cases(45 eyes)in the treatment group were included.The control group received intravitreal injection of aflibercept,while the treatment group received Zhixue Quyu Mingmu Tablets on the basis of the control group's treatment.Best corrected visual acuity(BCVA),OCTA parameters,including central macular thickness(CMT)central,parafoveal macular thickness(CPFT),area,perimeter,and circularity index(AI)of foveal avascular zone(FAZ),and Traditional Chinese Medicine(TCM)syndrome scores were measured before treatment and at one,three,and six months after treatment.RESULTS There were no statistically significant differences in BCVA,CMT,CPFT,parameters of macular capillaries and TCM syndrome scores in the two groups before treatment(P>0.05).(1)BCVA:The BCVA in the control group after three months treatment and in the treatment group after three,six months treatment improved compared to before treatment with statistically significance(control group:t=2.197,P=0.031.treatment group:t3 mon=2.148,P=0.034;t6 mon= 4.045,P=0.000).Comparing the two groups,BCVA improvement in the treatment group was superior to that in the control group at the sixth month after treatment,with statistical significance(t=-2.239,P=0.027).There were no statistically significant differences at other time points or between the two groups(P>0.05).(2)OCTA parameters:CMT in the control group after one,three months treatment,and in the treatment group after one,three,six months treatment decreased significantly compared to before treatment with statistically significance(control group:t1 mon=2.330,P=0.023;t3 mon =5.940,P=0.000.treatment group:t1 mon=2.955,P=0.004;t3 mon=7.279,P=0.000;t6 mon = 4.952,P=0.000).There were no statistically significant differences at other time points or between the two groups(P>0.05).CPFT in control group after three months treatment and the treatment group after three,six months treatment decreased significantly compared to before treatment with statistically significance(control group:t3 mon =3.117,P=0.003.treatment group:t3 mon= 3.354,P=0.001;t6 mon= 2.343,P=0.022).There were no statistically significant differences at other time points or between the two groups(P>0.05).At six months after treatment,the improvement of DCP central foveal vessel density in the treatment group was superior to that in the control group,with statistical significance(t=-2.028,P=0.045).There were no statistically significant differences at other time points or between the two groups(P>0.05).There were also no statistically significant differences in FAZ area,perimeter,AI,or mean blood flow density at other time points after treatment or between the two groups(P>0.05).(3)TCM syndrome scores:At six months after treatment,the TCM syndrome scores in the treatment group decreased significantly compared to before treatment(t=4.828,P=0.000).Comparing the two groups,the TCM syndrome scores in the treatment group were lower than those in the control group,with statistical significance(t=-6.273,P=0.000).There were no statistically significant differences in other time points or between the two groups(P>0.05).CONCLUSIONS Zhixue Quyu Mingmu Tablets did not cause obvious ischemia or adverse reactions.Its composition of promoting blood circulation and stopping bleeding can promote absorption of vitreous hemorrhage.Combined use of aflibercept and Zhixue Quyu Mingmu Tablets can significantly improve the vision of patients with PDR of Yin deficiency and Liver hyperactivity,have no significant effect on blood flow,and can improve visual function and microcirculation to a certain extent,providing a certain basis for the integrated treatment of this disease with TCM and Western Medicine.