Objective

2

To analyze the clinical characteristics of real-world patients with type 2 diabetes mellitus （T2DM） treated with pure Chinese medicine based on “disease-syndrome-constitution differentiation and treatment mode”， thereby providing reference for clinical practice.

Methods

2

A total of 546 T2DM patients were collected from five hospitals in China who were treated with pure traditional Chinese medicine （TCM） based on “disease-syndrome-constitution differentiation and treatment mode” from August 2018 to August 2020. The basic characteristics， TCM disease name， TCM syndrome diagnosis， western medicine diagnosis， disease course and other information of the patients were collected， and the age， disease course， comorbid diseases， disease differentiation， syndrome differentiation and constitution differentiation were analyzed. In addition， the gender and age characteristics among patients with different TCM syndrome types， as well as the TCM syndrome characteristics among patients with different gender and age， different TCM diagnosis， and different disease course were analyzed.

Results

2

The 546 patients ranged from 18 to 85 years old， and 425 patients （77.84%） were aged 18 to ＜60 years old. The disease course was from the initial diagnosis to 25 years long， of which 188 cases were at the initial diagnosis and 233 cases at the early stage of the disease， accounting for 77.11% of the total. The most common comorbid diseases were hyperlipidemia （293 cases， 54.58%）， hypertension （195 cases， 22.71%）， atherosclerosis （122 cases， 22.34%）， fatty liver （118 cases， 21.61%）， and coronary heart disease （74 cases， 13.55%）. In terms of TCM diagnosis， there were 298 cases of

xiao ke

（消渴）（54.58%）， followed by 124 cases of

xiao ke

of the upper

jiao

（焦） （22.71%）， 83 cases of splenic pure heat （15.20%）， 26 cases of

xiao ke

of the lower

jiao

（4.76%）， and 15 cases of

xiao ke

of the middle

jiao

（2.75%）. Except for 83 patients with splenic pure heat who had no obvious TCM syndromes， the rest 463 patients were involved with six types， including deficiency of both

qi

and

yin

syndrome （216 cases， 39.56%）， turbid phlegm obstructing the middle

jiao

syndrome （128 cases， 23.44%）， liver constraint and spleen deficiency syndrome （73 cases， 13.37%）， spleen-kidney

qi

deficiency syndrome （22 cases， 4.03%）， damp-heat internal accumulation syndrome （13 cases， 2.38%）， and excessive heat injuring fluid syndrome （11 cases， 2.02%）. Of the 83 splenic pure heat cases， there were 56 phlegm-damp constitution （10.26%）， 19

qi

constraint constitution （3.48%）， 5

yin

deficiency constitution （0.91%） and 3

qi

deficiency constitution （0.55%）. There were statistically significant differences in TCM syndromes in terms of different genders and ages （

P

＜0.01）. Turbid phlegm obstructing the middel

jiao

syndrome was more common in male than female， while the liver constraint and spleen deficiency syndrome was more frequent in female. The average age of patients with spleen-kidney

qi

deficiency syndrome was greater than that of patients with damp-heat internal accumulation syndrome （

P

＜0.01）.

Conclusion

2

The T2DM patients treated with pure Chinese medicine based on "disease-syndrome-constitution differentiation and treatment mode” are mainly at the initial diagnosis stage and early stage with less than 5 years of the disease course， and most of them are aged 18 to ＜60 years old. Deficiency of both

qi

and

yin

syndrome， turbid phlegm obstructing the middle jiao syndrome， and liver constraint and spleen deficiency syndrome are commonly seen， while the phlegm damp constitution is the most frequent.