Objective

2

To observe the clinical efficacy and safety of Tangfukang Formula in the treatment of type 2 diabetes mellitus with deficiency of both qi and yin.

Method

2

A prospective cohort study was conducted on patients with type 2 diabetes mellitus with deficiency of both qi and yin treated at Beijing Chaoyang Hospital of Capital Medical University and Dongfang Hospital of Beijing University of Chinese Medicine from January 2022 to August 2023. The sample size in the observation group and control group was allocated in a 1：1 ratio. The control group received conventional Western medicine treatment， while the observation group received conventional Western medicine treatment combined with oral Tangfukang Formula. Both groups were treated for 3 months. The efficacy of traditional Chinese medicine （TCM） syndrome and blood glucose control were compared between the two groups， including TCM syndrome scores before and after treatment， glucose metabolism indicators （fasting blood glucose， 2-hour postprandial blood glucose， glycated hemoglobin， insulin， insulin resistance index）， adiponectin， branched-chain amino acids， body mass index， and lipid metabolism indicators （total cholesterol， triglycerides， high-density lipoprotein， low-density lipoprotein）， as well as safety indicators. Follow-up observation was conducted 6 months after treatment to compare these indicators and safety.

Result

2

The total effective rate

of TCM syndrome treatment in the observation group was higher than that in the control group （

P

<

0.05）. After treatment， both groups showed a significant reduction in TCM syndrome scores compared with those before treatment （

P

<

0.05）， with the observation group showing a lower score than the control group （

P

<

0.05）. The total effective rate for blood glucose control in the observation group was higher than that in the control group （

P

<

0.05）. After treatment， fasting blood glucose， 2-hour postprandial blood glucose， glycated hemoglobin， insulin， and insulin resistance index decreased significantly in both groups （

P

<

0.05）， with the observation group showing lower levels than the control group （

P

<

0.05）. After treatment， adiponectin levels increased and branched-chain amino acids decreased in both groups （both

P

<

0.05）， with the observation group showing higher levels of adiponectin and lower levels of branched-chain amino acids than the control group （

P

<

0.05）. After treatment， body mass index， total cholesterol， triglycerides， and low-density lipoprotein decreased significantly in both groups （

P

<

0.05）， while high-density lipoprotein increased （

P

<

0.05）. The improvement in body mass index and lipid profile in the observation group was superior to that in the control group （

P

<

0.05）. No serious adverse events were observed in either group during the study period. No significant abnormalities were found in blood routine， liver function， or kidney function tests before and after treatment in either group. After 6 months of follow-up， the observation group showed better improvement in the observed indicators than the control group （

P

<

0.05）， with no significant abnormalities in safety indicators in either group.

Conclusion

2

Tangfukang Formula is safe and effective in the treatment of type 2 diabetes mellitus with deficiency of both qi and yin. Its mechanism may involve regulating adiponectin and branched-chain amino acids.