| ObjectiveTo scientifically evaluate the efficacy and safety of Anti-wart Anti-wart Zhujingwan prescriptions in the treatment of early and middle age-related macular degeneration,and to provide clinical evidence and a new treatment method for the treatment of age-related macular degeneration.MethodsThis study uses a double-blind randomized controlled clinical study.A total of 120 patients with early to mid-stage age-related macular degeneration were included according to the inclusion and exclusion criteria established in this study.Using R language software,the subjects were randomly divided into two groups according to the ratio of treatment group and control group 1:1,with 60 cases in each group.The treatment group was given Anti-wart Zhujingwan prescriptions granules,and the control group was given Anti-wart Zhujingwan prescriptions placebo.The method of administration is oral,twice a day,one sachet at a time,one course of treatment for one month,and a total of six courses of intervention.Observation for a total of twelve months.The vision and intraocular pressure of the two groups of subjects were observed monthly.Slit lamp,CFP and OCT were performed every three months,and the results were recorded.TCM syndrome score,blood routine and liver and kidney function safety indexes were tested at enrollment and 6 months.Results of visual acuity and vitreous warts at the time of enrollment,6 months and 12 months were counted.The results of TCM syndrome scores and safety indexes before and after drug intervention were counted.Statistical data is analyzed using SPSS 23.Results1.Normal information:A total of 120subjects(120 eyes)were enrolled in this study.Excluding the fall off cases,the remaining 104 cases(104 eyes),55 cases(55 eyes)in the treatment group,and 49 cases(49 eyes)in the control group.There was no statistical difference in age,gender,and course of disease between the two groups of subjects(P<0.05),and they were comparable.2.Vision:At 6 months,the effective rate of the treatment group was 78.18%,and the effective rate of the control group was 20.41%.The difference between the two groups was statistically significant(P<0.01).At 12 months,the effective rate of the treatment group was 63.64%,and the effective rate of the control group was 24.49%.The difference between the two groups was statistically significant(P<0.01).3.TCM syndrome scores:At 6 months,the effective rate of the treatment group was 81.82%,and that of the control group was 20.41%,with statistical difference between the two groups(P<0.01).Blurred vision,dizziness,tinnitus,mental fatigue,and soreness in the waist and knees of the treatment group were all improved compared with before the intervention,and the difference was statistically significant(P<0.05).4.Drusen:OCT:a.Drusen area:The area of drusen in the treatment group had a decreasing trend at 6 months and 12 months,but there was no statistical difference(P>0.05);The area of drusen in the control group showed an expanding trend.There was no significant difference in the area of drusen at 6 months compared with the baseline(P>0.05).At 12 months,there was a statistically significant difference in drusen area expansion compared with baseline(P<0.05).b.Drusen volume:The drusen volume of the treatment group at 6 months and 12 months showed a decreasing trend,but there was no statistical difference(P>0.05);The volume of drusen in the control group showed an increasing trend.The volume of drusen at 6 months was enlarged compared with the baseline(P<0.05),and the volume of drusen at 12 months was enlarged compared with the baseline(P<0.01).There were statistical differences.5.Incidence rate of terminal events:There was no choroidal neovascularization(CNV)in the treatment group,and one subject in the control group had CNV.Conclusion1.The traditional Chinese medicine Anti-wart Zhujingwan prescriptions granules has certain curative effect in the treatment of early and mid-stage AMD liver and kidney insufficiency,which can improve the eyesight of patients,improve liver and kidney insufficiency,and improve the quality of life.2.The traditional Chinese medicine Anti-wart Zhujingwan prescriptions granules can inhibit the increase of drusen area and volume to a certain extent,and have the effect of controlling the progress of drusen,stabilizing the condition of the fundus,and delaying the transformation to wet AMD,providing a new treatment method for early and mid-stage intervention of AMD.3.There are no adverse reactions in the treatment of Chinese medicine Anti-wart Zhujingwan prescriptions Granules,and the clinical application is safe. |
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