Clinical Study On The Treatment Of Diabetic Macular Edema By Xiaozhong Granule Combined With Aflibercept

Objective:To investigate the preventive and therapeutic effects of Aflibercept combined with Xiaozhong granule on diabetic macular edema.To verify the efficacy and safety of TCM combined with Aflibercept,and the effect of TCM on improving best corrected visual acuity(BCVA)and eliminating macular edema.Methods:Seventy patients(81 eyes)with DME who underwent vitreous infusion in Zaozhuang Hospital of Traditional Chinese Medicine from December2019 to December 2021 were selected.Random number table method was used to randomly divide into experimental group and control group,35 patients(39eyes)in experimental group,35 patients(42 eyes)in control group.All patients in group 2 were given intravitreal albecercept(once per month,3 times in total).The control group was treated with tobramycin/dexamethasone eye drops and pralprofen eye drops,4 times a day,and the dosage was reduced once every7 days.The experimental group was given Xiaozhong granule orally on the same treatment basis(once/package,2 times/day,continuous oral administration for 21 days as a course of treatment for 3 courses).Both groups will be treated for 3 months.The BCVA,central macular thickness(CMT)and TCM syndrome score before and after treatment were observed.BCVA,CMT and TCM syndrome score were analyzed and compared between the two groups.Results:Before treatment,there were no significant differences in gender,age,Number of single and double eye,eye type,IOP,BCVA,CMT and TCM syndrome score between the two groups(P>0.05);After 1,2 and 3 months of treatment,there were significant differences in BCVA between the experimental group and the control group(P=0.041,0.005,0.000;P<0.05).After 3 months of treatment,the effective rate of BCVA was 89.7% in the experimental group and 68.3% in the control group.There was a significant difference in effective rate between the two groups(P<0.05);After 1,2 and 3 months of treatment,there were significant differences in CMT between the experimental group and the control group(P=0.001,0.000,0.000;P<0.05);After 3 months of treatment,there were significant differences in TCM syndrome scores between the two groups(P< 0.05),the effective rate of the experimental group was 91.4%,and the effective rate of the control group was 64.7%,The efficiency of TCM syndrome score was significantly different between the two groups(P<0.05);The BCVA before and after 3 months was significantly different in the experimental and control groups(P<0.05).The CMT before and after 3 months of treatment was significant between the two groups(P<0.05).There were significant differences in the TCM syndrome scores before and after treatment between the two groups(P<0.05).Conclusions:In the treatment of DME,pure vitreous injection of Aflibercept and Xiaozhong granule combined with vitreous injection of Aflibercept were effective,but the latter was better.The application of Xiaozhong granules can effectively reduce retinal leakage,promote the regression of macular edema,better and effectively improve patients’ BCVA,protect the visual function,improve the systemic symptoms,and have good safety.