| Objective:1、Clinical study To discuss the clinical effect of Yiqi Yangyin Tongluo Formula on non-proliferative diabetic retinopathy.2、Experimental study To investigate the effect of Yiqi Yangyin Tongluo Formula on the expression of PDGF-B and PDGF-D in diabetic retinopathy model SD rats.Methods:1、Clinical study Clinical observation was carried out in 120 patients with non-proliferative diabetic retinopathy.They were randomly divided into TCM group,western medicine group and blank group.During the study,11 patients were lost.A total of 109 patients completed the experiment,including 36 patients in traditional Chinese medicine(TCM)group,38 patients in western medicine group and 35 patients in blank group.The TCM group was treated with Yiqi Yangyin Tongluo Formula+routine glycemic control therapy,the western medicine group was treated with calcium oxybenzene sulfonic capsule+routine glycemic control therapy.The blank group was treated with simple routine glycemic control therapy.The clinical efficacy of the three groups was summarized and evaluated by comparing the best corrected visual acuity,fundus lesions and macular central foveal thickness before and after treatment.2、Experimental study Among 40 SD rats,9 were randomly divided into blank group,and the other 31 rats were selected as model group.The diabetic retinopathy model of SD rats was induced by STZ,and intraperitoneal STZ injection was performed at 40mg/kg.When the blood glucose of SD rats reached 16.7mmol/L,the diabetic model was confirmed to be established.One month after the diabetic model was established,the blank group and model group SD rats were selected for retinal digestion smear examination.The successful establishment of diabetic retinopathy model was confirmed.The blank and model control group were intragastric fed with normal saline,model Chinese medicine group was intragastric fed with traditional Chinese medicine compound liquid Yiqi Yangyin Tongluo Formula,model Western medicine group was intragastric fed with calcium hydroxybenzoate suspension,all groups were intragastric fed continuously for 8 weeks.After 8 weeks,retinal HE staining and expression of PDGF-B and PDGF-D in SD rats were observed.Results1、Clinical study Visual acuity:after treatment,compared with blank group,visual acuity of TCM group and western medicine group was improved(P<0.05);Compared with before treatment,visual acuity of blank group had no significant change after treatment(P>0.05),visual acuity of TCM group and western medicine group was improved(P<0.05),and the curative effect of TCM group was better than western medicine group(P<0.05).Comparison of TCM syndrome score and TCM syndrome efficacy:Compared with before treatment,TCM syndrome score of blank group had no significant change after treatment(P>0.05);After treatment,the TCM syndrome score of the TCM group and the western medicine group was significantly lower than that before treatment(P<0.05),the decrease value of TCM group was significantly greater than that of western medicine group(P<0.05).Compared with blank group,the decrease values of the others were statistically significant(P<0.05).Compared with the blank group,there were both statistically significant differences in the distribution of TCM syndrome efficacy after treatment of the TCM group and the western medicine group(P<0.05).There were statistically significant differences between the TCM group and the western medicine group(P<0.05).The results indicate that two drug administration groups can reduce the TCM syndrome score of patients with non-proliferative diabetic retinopathy,and the efficacy of TCM group is better than western medicine group.Changes in serum PDGF-B levels:There was no significant difference in serum PDGF-B levels between the three groups before treatment(P>0.05);The expression of PDGF-B in serum of NPDR patients was down-regulated in both the TCM group and western medicine group(P<0.05),and the TCM group had an advantage compared with the western medicine group(P<0.05).Efficacy of fundus lesions:There were statistically significant differences between the two administration groups and the blank group(P<0.01).There were statistically significant differences between the TCM and western medicine group(P<0.05).The results indicate that both TCM group and western medicine group can effectively reduce the fundus lesions of NPDR patients,and the efficacy of TCM group is better than western medicine group.The change of macular central fovea thickness:There was no significant difference in the macular central fovea thickness(CFT)among three groups before treatment(P>0.05).After treatment,compared with blank group,the CFT was decreased in both TCM and western medicine groups(P<0.05).The CFT in blank group had no outstanding change after treatment(P>0.05),and the CFT in TCM group and western medicine group was lower than before treatment(P<0.05).The efficacy of TCM group was better than western medicine group(P<0.05).2、Experimental studyRetinal HE staining of SD rats showed that clear tissue structure and orderly arrangement of cells in blank group.The structure of the retinal layers was loose and the cells were disordered,with vacuole-like changes in model control group.And the cells in the inner and outer nuclear layers were sparse and decreased,and the cells in the photoreceptor layer were disordered.The retinal layers of SD rats in model Chinese medicine group and model western medicine group were loose,the inner core layer,outer nucleus layer and photoreceptor layer were disordered,and the tissue edema was less than that in model group.Both PDGF-B and PDGF-D were expressed in cytoplasm,and the immune-positive reaction was brown-yellow or brown-brown.In blank group,the positive expression of PDGF-B and PDGF-D was mainly found in ganglion cell layer and inner plexus layer cells,and a little expression was found in inner core layer.In model control group,the positive reactions of PDGF-B and PDGF-D were significantly increased in the retina of SD rats.The positive reactions were mainly found in the inner boundary membrane layer,ganglion cell layer,inner plexus layer,inner kernel layer and outer nuclear layer,and a little expression was found in the outer plexus layer.The positive expression of PDGF-B and PDGF-D in model Chinese medicine group and model western medicine group was weaker than that in model control group.The expression of PDGF-B and PDGF-D in model control group was observably increased(P<0.01);The protein expression of PDGF-B and PDGF-D in two drug administration groups were significantly decreased compared with model control group(P<0.01);The decrease degree of PDGF-B in model Chinese medicine group was significantly higher than that in model western medicine group(P<0.05).There was no significant difference in PDGF-D protein expression between the two drug administration groups(P>0.05).ConclusionsYiqi Yangyin Tongluo Formula has satisfactory clinical effect on patients with Qi-Yin deficiency and vein stasis syndrome of NPDR.It can improve TCM syndromes,improve visual acuity,alleviate clinical symptoms,reduce fundus lesionsand macular edema.It can down-regulate the expression of PDGF-B in serum of NPDR patients,which has advantages compared with western medicine group.The expression of PDGF-B and PDGF-D in the retina of SD rats in diabetic retinopathy model can be down-regulated by the Yiqi Yangyin Tongluo Formula. |
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