Objective

2

To observe the clinical efficacy of Danzhi Jiangtang capsules with the functions of replenishing Qi， nourishing Yin， and dredging collaterals on patients with type 2 diabetes mellitus （T2DM） combined with lower-extremity macroangiopathy and serum levels of homocysteine （Hcy） and cystatin C （Cys C）.

Method

2

A total of 80 eligible patients who were treated in the department of endocrinology of the First Affiliated Hospital of Anhui University of Chinese Medicine from May 2017 to December 2019 were randomized into the treatment group （40 cases） and control group （40 cases）. Both groups received the basic therapies for diabetes and Danzhi Jiangtang capsules （oral） was added to the treatment group. The levels of glycosylated hemoglobin A1c （HbA1c）， fasting plasma glucose （FPG）， 2-hour postprandial glucose （2 hPG）， fasting C-peptide （C-P）， and 2-hour postprandial C-peptide （2 hC-P）， triglycerides （TG）， total cholesterol （TC）， high density lipoprotein cholesterol （HDL-C）， and low density lipoprotein cholesterol （LDL-C） and serum levels of Hcy and Cys C were measured and the traditional Chinese medicine（TCM） syndrome scores were calculated before and after treatment in the two groups.

Result

2

After 12 weeks of treatment， levels of HbA1c， FPG， and 2 hPG were lower than those before treatment in the two groups （

P

<

0.05）. Levels of C-P （

P

<

0.05） and 2 hC-P were higher than those before treatment in the two groups. After treatment， levels of HbA1c， FPG， and 2 hPG in the treatment group were lower than those in the control group （

P

<

0.05）， while levels of C-P and 2 hC-P showed no significant difference between two groups. After treatment， the levels of TG， TC， and LDL-C were lower than those before treatment （

P

<

0.05） and HDL-C level was higher than that before treatment （

P

<

0.05） in both groups. After treatment， levels of TG and LDL-C in the treatment group were lower than those in the control group （

P

<

0.05）， and levels of TC and HDL-C demonstrated no significant difference between two groups. After the treatment， the TCM syndrome score was lower than that before the treatment in both groups （

P

<

0.05） and lower in the treatment group than in the control group （

P

<

0.05）. The overall effective rate of the treatment group was higher than that of the control group （

χ

２

=7.585，

P

<

0.05）. The levels of Cys C and Hcy were lower than those before treatment in the two groups （

P

<

0.05） and lower in the treatment group than in the control group （

P

<

0.05）. Doppler echocardiography of the lower limbs showed no obvious improvement in the control group after treatment. However， for the treatment group， slight decrease in intima-media thickness of the lower limb arteries and a slight reduction in the plaque area were observed， but the difference was not statistically significant.

Conclusion

2

Danzhi Jiangtang capsules has definite therapeutic effect on T2DM combined with lower-extremity macroangiopathy， which can improve glucolipid metabolism and reduce serum levels of Hcy and Cys C. This study can serve a reference for the prevention and treatment of T2DM combined with macroangiopathy.