| Objective:1.It observes the correlation between MMP-9 and diabetes-related indicators such as pancreatic islet function,dry eye indicators and the correlation of related pathogenesis in patients with Type 2 diabetic dry eye,and explores the related mechanism of its occurrence2.It observes the clinical efficacy of Erdong Xiaoke Prescription in the treatment of patients with Type 2 diabetic dry eye for Yin-deficiency and heat-rich type,and its effect on MMP-9,moreover,it evaluates the safenessMethods:1.Observe the correlation of diabetes-related indicators such as pancreatic islet function,dry eye indicators,MMP-9,and pathogenesis in Type 2 diabetic patients with dry eyeA total of 111 cases of Type 2 diabetic patients with dry eye were selected,the basic data such as gender,age,course of disease,body mass index,four diagnosis information and others were collected,and laboratory indicators such as MMP-9,glucose metabolism and other dry eye related indicators were determined.It was divided into low pancreatic islet function group(C peptide≤1ng/ml)and non-low pancreatic islet function group(C peptide>1ng/ml)according to the value of C peptide.The differences between MMP-9 and glucose metabolism,dry eye indicators and other related indicators were compared.Moreover,the correlation was analyzed.In addition,38 healthy volunteers(only measuring the level of MMP-9 in venous blood)who voluntarily participated in the study were the healthy control group.2.Observe the clinical efficacy of Erdong Xiaoke Prescription in the treatment of patients with Type 2 diabetic dry eye for extreme heat due to deficiency of Yin,and its effect on MMP-9Eighty patients with Type 2 diabetic dry eye were randomly divided into treatment group and control group.The control group was treated with sodium hyaluronate eye drops,and the treatment group was treated with Erdong Xiaoke Prescription on the basis of the treatment in the control group,which is lasting for a total of 4 weeks.The clinical efficacy,including Fasting C peptide(FCP),Fasting insulin(FINS),Fasting blood glucose(FBG),Postprandial blood glucose(PBG),Large amplitude of glycemic excursions(LAGE),Schirmer I test(SIt),Break up time(BUT),Fluorescein(Fl),MMP-9,symptom scores and other indicators were observed before and after treatment,and the overall clinical efficacy was analyzed according to the efficacy standard of TCM syndromes and clinical efficacy evaluation.Results:1.Correlation on diabetes related indicators such as pancreatic islet function,dry eye indicators,MMP-9 and pathogenesis of patients with Type 2 diabetic dry eye①The serum MMP-9 of patients with Type 2 diabetic dry eye was greater than that of the healthy blank control group,which was significantly different(P<0.05).②There were no significant differences in age,disease duration,BMI,FBG,PBG,LAGE,SIt,BUT,and MMP-9 in the low pancreatic islet function group and non-low pancreatic islet function group(P>0.05);FINS,Fl in the low pancreatic islet function group were all higher than the non-low pancreatic islet function group,with the statistically significant difference(P<0.05).③MMP-9 was positively correlated with Fl(P<0.01),and had no significant correlation with age,course of disease,BMI,FCP,FINS,FBG,PBG,LAGE,BUT(P>0.05);Fasting C peptide was positively correlated with SIt(P<0.01),which was negatively correlated with Fl(P<0.01).2.Clinical efficacy of Erdong Xiaoke Prescription in the treatment of patients with Type 2 diabetic dry eye①Total symptom score:After treatment,the total symptom score of two groups was both significantly declined(P<0.01);The symptoms of the treatment group were significantly improved in the comparison with the control group(P<0.05).②Glucose metabolism index:FCP,FINS,and FBG were no significant difference between the two groups of patients before and after treatment(P>0.05);PBG and LAGE was significantly reduced in the treatment group(P<0.01),and no statistical difference was found on FCP,FINS,FBG,PBG,and LAGE indicators in the control group(P>0.05).Compared with the control group,there was no statistical difference in FCP,FINS,and FBG indicators between the treatment group and the control group(P>0.05);There was a statistically significant difference in LAGE comparison(P<0.01),and there was also a statistical difference in PBG comparison(P<0.05).③Dry eye related indicators:SIt and BUT was increased significantly in the treatment group,while Fl scores were decreased significantly(all of it was shown as P<0.01);In the control group,SIt and Fl was decreased(P<0.01),while BUT was increased(P<0.05).Compared with the control group,there was a significant statistical difference in SIt and BUT(P<0.01),and the difference in Fl score was shown no statistical significance(P>0.05).④MMP-9:MMP-9 was significantly decreased in the two groups of patient,with the treatment group(P<0.01)and the control group(P<0.05).The value in treatment group was lower than the control group(P<0.01).⑤Overall efficacy evaluation:The total effective rates on the improvement of TCM syndromes in the treatment group and the control group were 80.00%and 55.00%respectively,which was statistically significant difference(P<0.05);In the clinical comprehensive effect treatment group,there was significantly effective treatment for 17 eyes,effective treatment for 32 eyes,and ineffecti-ve treatment for 31 eyes,the total effective rate was shown as 62.50%;In the control group,there was significantly effective treatment for 8 eyes,effective treatment for 29 eyes,and ineffective treatment for 43 eyes.The total effective rate was shown as 46.25%,The effective rates in the two groups had no statistical significance by χ2 test(P>0.05).3.Safety observation No serious adverse reactions were found in two groups.One case had diarrhea in the treatment group,which had been self-cure in follow-up without affecting the progress of the studyConclusion:①Serum MMP-9 levels in patients with Type 2 diabetic dry eye were significantly higher than in healthy people,and MMP-9 was positively correlated with Fl.Serum MMP-9 levels may be an effective indicator of the severity and efficacy on patients with Type 2 diabetic dry eye②The SIt of patients with Type 2 diabetic dry eye was positively correlated with level of Fasting C peptide,and Fl was negatively correlated with the level of Fasting C peptide.It is suggested that serum C peptide level can affect the severity of patients with Type 2 diabetic dry eye.③Erdong Xiaoke Prescription can obviously improve SIt,BUT,Fl,reduce the level of PBG and LAGE,reduce serum MMP-9 levels,which has a good effect on improving the symptoms of dry eye,reducing blood sugar variability and maintaining the stability of blood glucose level.④Erdong Xiaoke Prescription has a good effect in the treatment of Type 2 diabetic dry eye with extreme heat due to deficiency of Yin,and it can significantly improve the clinical symptoms of patients.It is worthy to further study.⑤Erdong Xiaoke Prescription had not been found the serious adverse reactions during the treatment on Type 2 diabetic dry eye,which was demonstrated the excellent safety. |