| Objective: In this study,through the observation and analysis of clinical data,to evaluate the clinical efficacy and safety of Shengmai Fuming Decoction in the treatment of non-proliferative diabetic retinopathy(NPDR)fundus hemorrhage with deficiency of both qi and yin and blood stasis,in order to provide new ideas for the treatment of diabetic retinopathy(DR)with traditional Chinese medicine.Methods: Seventy patients who met the inclusion criteria were randomly divided into two groups,35 cases in each group.Both groups were given basic treatment;the control group was added with calcium dobesilate tablets under the premise of basic treatment;the observation group was added with Shengmai Fuming Yin,a traditional Chinese medicine,on the treatment plan of the control group;the visual acuity level,fundus lesion score,TCM symptom score,blood glucose index(FBG,2h PG,Hb Alc),C-reactive protein(CRP),blood lipid index(TG,LDL-C)and adverse reactions before and after treatment were observed and recorded in the two groups,and the statistical software SPSS25.0 was used for analysis.Results:(1)Before treatment,the age,gender,course of disease and fundus diagnosis stage of the two groups were compared,P>0.05,the difference was not statistically significant,indicating that the two groups were comparable.(2)Before treatment,the two groups were compared in TCM symptom score,visual acuity,fundus symptom score,blood glucose,CRP,blood lipid parameters,etc.,P>0.05,the difference was not statistically significant,with comparability.(3)After treatment,TCM symptom score,visual acuity,fundus symptom score,CRP,blood glucose index,and blood lipid index were improved compared with those before treatment(P<0.05);blood lipid index and TCM symptoms of fatigue,dull complexion and dry stool symptoms were compared between the two groups P>0.05,the difference was not statistically significant,and it was considered that there was no significant difference between the two groups;the other indicators and TCM symptoms were compared between the two groups,the efficacy of the observation group was better than that of the control group(P<0.05).(4)After treatment,the total effective rate of visual acuity improvement was 85.29% and the total effective rate of fundus symptom improvement was 91.18%in the observation group;the total effective rate was 64.7% and 79.41% in the control group.Compared between the two groups,the efficacy of the observation group was better than that of the control group(P<0.05).(5)After treatment,the total effective rate of TCM syndrome efficacy was94.12% in the observation group and 70.59% in the control group,indicating that the treatment effect of the observation group was better than that of the control group(P<0.05).(6)During the treatment,1 patient in the observation group dropped out due to bitter taste of traditional Chinese medicine,no regular adherence to medication,and poor compliance;1 patient in the control group dropped out due to personal reasons after 1 week of treatment.In the remaining cases,all safety outcome measures were not significantly abnormal,and no adverse reactions occurred.Conclusion: Shengmai Fuming Yin can obviously improve the fundus hemorrhage,reduce visual impairment,reduce blood glucose,significantly reduce the inflammatory indicators of patients and improve the symptoms and signs of traditional Chinese medicine.Its efficacy is superior to that of calcium dobesilate tablets alone for hemostasis,delaying the development of NPDR to PDR,without adverse reactions.It has good safety. |