| 1 ObjectiveUnder the guidance of TCM theory,the non-proliferative stage of diabetic retinopathy is a blood stasis type of patients with deficiency of qi and yin,application of combined western medicine stilbene to sugar pain ning hydroxyl benzene sulfonic acid calcium capsule treatment,observe the party NPDR disease clinical curative effect and evaluate its drug safety,analysis of stilbene sugar tong ning to patients serum VEGF and Cys-C content,the influence of and the patients’ vision,fundus,blood glucose(FPG,2 HPG,Hb A1c),degree of CMT,the improvement of TCM syndrome integral,provide reference for clinical medication.At the same time,it help to explore and give play to the advantages and characteristics of traditional Chinese medicine in the prevention and treatment of chronic diseases,bring better clinical efficacy,and provide more options for the clinical treatment of NPDR patients.2 methodsInclusion criteria based on the findings of this clinical observation,62 eligible NPDR patients were included and randomly divided into two groups according to the order of treatment,including 31 cases in the control group and 31 cases in the treatment group.On the basis of routine diet,exercise guidance and hypoglycemic treatment,the control group was given the western medicine Calcium Hydrobenzosulfonate capsule orally,and the treatment group was given Qigui Tangtongning Granules on the basis of the control group.They were observed for 6 months.During the medication,regular monitoring of patients with three indexes and liver and kidney function,electrocardiogram(ecg),four vital signs such as safety index,and observe the clinical curative effect of two groups of patients before and after treatment in improvement and TCM syndrome integral,and recorded before and after treatment the patient’s blood sugar(measured fasting blood glucose,2 h postprandial blood glucose and glycosylated hemoglobin),best corrected visual acuity,fundus and CMT,and serum VEGF and urinary inhibition C serum index value.After the treatment,they were sorted out and analyzed by statistical software.SPSS21.0 statistical software was used in this study,and the dominance level was represented as P < 0.05 or P < 0.01,indicating statistical significance.3 Results(1)A total of 62 NPDR patients meeting the inclusion criteria were randomly divided into two groups,31 cases in the control group and 31 cases in the treatment group;59 cases were followed up effectively,and 2 cases in the control group were excluded because they did not take medicine regularly.One case in the treatment group was excluded because it could not be followed up effectively.The differences of gender,age,blood glucose level and other general data between the two groups before treatment were compared,P > 0.05.(2)Comparison of the clinical efficacy: after treatment,the total effective rate of the control group and the treatment group was 65.52 and 86.67%,respectively,compared with the two groups,P < 0.05,there was a difference,the curative effect of the treatment group was improved more obviously than the control group.(3)Comparison of TCM syndrome scores: the comparison of TCM syndrome scores between the two groups before treatment showed no difference in P > 0.05,which was comparable.After treatment,the TCM syndrome scores of both groups were decreased compared with those of the two groups before treatment,and the intra-group comparison was statistically significant(P < 0.05 or P < 0.01).Compared with the control group,the improvement of TCM syndrome scores in the treatment group was more significant(P < 0.05).(4)Comparison of blood glucose levels: there was no statistical difference in FPG,2HPG and HBALC between the two groups before treatment(P > 0.05).After treatment,compared with before treatment,FPG and 2HPG of the patients were decreased(P<0.05),and intra-group comparison showed that the two groups had differences(P<0.05).Compared with inter-group comparison,FPG and 2HPG of the treatment group were decreased more obviously(P<0.05).Hb A1 c decreased slightly after treatment compared with before treatment,and intra-group comparison showed no statistically significant difference(P>0.05).There was no significant difference between the two groups(P>0.05).(5)Comparison of BCVA and fundus symptom scores: there was no difference in BCVA and fundus symptom scores between the two groups before treatment(P > 0.05),which was comparable.After treatment,the best corrected visual acuity and fundus condition of 2 groups were improved compared with before treatment,and intra-group comparison was made(P<0.05 or P< 0.01);Comparison between groups showed that the improvement of BCVA and fundus symptoms in the treatment group was better than that in the control group,with statistical significance(P<0.05).(6)Comparison of CMT : the CMT of the two groups before treatment was compared(P > 0.05),which was comparable.After treatment,the CMT in both groups was significantly decreased compared with that before treatment(P<0.05 or P<0.01).The decrease level of CMT in treatment group was better than that in control group(P<0.05).(7)Serum VEGF and cystatin C levels: there were no significant differences in serum VEGF and cystatin C levels between 2 groups before treatment(P > 0.05).After treatment,they were significantly lower than before,and it was meaningful to make intra-group comparison(P<0.05 or P< 0.01).Compared with the control group,the treatment group was significantly lower(P<0.05).(8)Safety observation before and after treatment: during the treatment process,the three routine and four vital signs of the patients monitored were normal,liver and kidney functions were normal,and electrocardiogram was normal.No allergic reaction or other physical discomfort occurred.4 conclusionWith qi,qi and remove stasis for therapeutic principles of stilbene sugar pain ning on the dialectical therapy for diabetic retinal non proliferation period is for the virtual folder stasis,qi and Yin type patients had obvious clinical curative effect,can reduce the TCM syndrome integral,control in patients with blood sugar levels and raise the level of patient BCVA,improve eye ground situation,reduce the CMT,urinary inhibition on patients serum VEGF,serum level of C index has obvious improvement effect,and there was no liver and kidney damage,good security,is worth popularizing in clinical use. |