Objective

2

To observe the efficacy of modified Huanglian Wendantang in treating newly diagnosed type 2 diabetes mellitus （T2DM） with phlegm （dampness）-heat syndrome， in order to study the effect on islet

β

cell function and adipocytokines.

Method

2

A total of 130 patients were randomly divided into two groups by random number table （65 cases in each group）. The 60 patients in control group completed the treatment （4 patients fell off or lost visit， 2 were eliminated because of breach of plan）， and the 61 patients in observation group completed the treatment （3 patients fell off， 1 were eliminated）. And 20 healthy volunteers were taken as normal control group. Both groups′ patients got lifestyle interventions and metformin hydrochloride tablets （1 tablet/time， 1 time/day during the meal）. In addition， patients in control group got Huazhuo Qingshen Keli in the morning and at night， 5 g/time， 2 times/day， and patients in observation group got modified Huanglian Wendantang， 1 dose/day. And the treatment was lasted for 3 months. Before and after treatment， levels of fasting blood glucose （FBG）， postprandial 2 blood glucose （PBG）， HbA1c and fasting insulin （FINS）， insulin resistance index （HOMA-IR）， insulin sensitivity index （InISI）， islet β cell function index （HOMA-

β

）， early insulin secretion index （I

30

/

△

G

30

） and late insulin secretion index （AUC

I30~I120/G30~G120

）， total cholesterol （TC） and triglycerides （TG）， high-density lipoprotein （HDL-C）， low-density lipoprotein （LDL-C）， adiponectin， TNF -

α

（TNF-

α

）， resistin and leptin were detected. And syndrome of phlegm （dampness） combined with heat were scored， and the safety was discussed.

Result

2

The total effective rate in observation group was 91.80% （56/61）， which was higher than 78.33% （47/60） in control group （

χ

2

=4.333，

P

<

0.05）. And the score of phlegm （dampness）-heat syndrome was lower than that in control group （

P

<

0.01）， levels of FBG， PBG， HbA1c， HOMA-IR， AUC

I30~I120/G30~G120

， TC， TG， LDL-C， TNF-

α

， leptin and resistin were lower than those in control group （

P

<

0.01）， while levels of I

30

/△G

30

， HOMA-

β

， InISI， HDL-C and adiponectin were higher than those in control group （

P

<

0.01）. There was no adverse reaction related to modified Huanglian Wendantang.

Conclusion

2

In addition to treatment with metformin， modified Huanglian Wendantang can effectively control blood glucose and lipid， regulate adipocyte factor， improve early and late phase insulin secretion， improve the function of

β

cell and insulin sensitivity of islet， improve IR， with a better comprehensive efficacy and a safety in clinical use.