Clinical Observation Of Compound Danshen Dripping Pills In The Treatment Of Diabetic Retinopathy (qi Stagnation And Blood Stasis Syndrome)

Objective:To explore the clinical safety and efficacy of compound Danshen pills in the treatment of diabetic retinopathy(Qi stagnation and blood stasis syndrome).Methods:In this study,a randomized,double-blind,multi-center clinical trial design method was used and randomly divided into experimental group and control group.The experimental group was given compound Danshen pills,27mg/pill,20 pills each time,3 times a day.The control group was a compound Danshen pill simulator,27 mg/pill,20 pills each time,3 times a day.The changes of fundus changes,fundus fluorescein angiography,macular edema,corrected visual acuity and TCM symptoms before and after treatment were evaluated,and the safety indicators and adverse reactions of patients were observed.Results:This study included 581 patients with diabetic retinopathy(Qi stagnation and blood stasis syndrome),91 patients with exfoliation,6 patients with exclusion and 484 patients with admission criteria.The total number of patients was divided into 483 cases according to PAS data analysis set,and the patients who had fallen out did not participate in the evaluation of curative effect.They were randomly divided into experimental group 362 cases and control group 121 cases.There was no significant difference in gender,age,height,weight,pregnancy test,course of diabetes mellitus and course of diabetic retinopathy between the two groups(P>0.05).1.The total effective evaluation of fundus:the total effective rate of the experimental group(77.07%)was higher than that of the control group(46.28%),according to statistical analysis,P<0.001,the difference was statistically significant.2.The subjects'FFA score before and after treatment:The total score of FFA in the experimental group decreased,but there was no significant change in the control group,and P<0.001.The FFA score in the experimental group after 24 weeks of treatment was significantly lower than that in the baseline.3.The improvement of visual acuity of the subjects before and after treatment:The visual acuity level of the experimental group and the control group were improved,but there was significant difference between the two groups(P<0.001),that is,the visual acuity of the experimental group after 24 weeks of treatment was significantly higher than that of the baseline.4.The experimental group decreased by 5.80%,unchanged by 93.09%,increased by 1.10%;the control group by 3.31%,unchanged by 92.56%,increased by 4.13%;the experimental group was better than the control group;that of the experimental group was better than that of the control group;the difference was statistically significant(P<0.05)5.Before and after treatment,macular edema in the experimental group was better than that in the control group(P<0.05).6.The score of TCM symptoms change in subjects:Compared with the control group,the scores of TCM symptoms in the experimental group were all lower,P<0.05,and the difference was statistically significant.7.Adverse events occurred in the course of each group:according to statistical analysis,P>0.05,there was no significant difference,that is,safe and reliable.Conclusion:1.Compound Danshen Pills can significantly improve the visual acuity of DR(Qi stagnation and blood stasis syndrome);2.Compound Danshen Pills can alleviate the severity of DR(Qi stagnation and blood stasis syndrome)and macular edema.3.Compound Danshen Pills can shorten the total retinal circulation time of DR(Qi stagnation and blood stasis syndrome),reduce the non-perfusion area of retina and vascular leakage.4.Compound Danshen Pills have obvious curative effect on DR symptoms in traditional Chinese medicine.5.Compound Danshen Pill is safe and reliable in the treatment of DR(Qi stagnation and blood stasis syndrome).