Objective

2

To observe the clinical efficacy of modified Banxia Xiexintang on nonalcoholic fatty liver （NAFLD） and the regulatory effect on insulin resistance （IR）.

Method

2

One hundred and forty patients were randomly divided into control group and observation group. A total of 63 patients in control group completed the therapy （4 patients fell off or were lost to follow-up， 3 were eliminated）， while 65 patients in observation group completed the therapy （5 patients fell off or were lost to follow-up， none was eliminated）. Both groups' patients got lifestyle intervention， liver protection and lipid regulation. Patients in control group got Huazhi Rougan granule， 1 pack/time， 3 times/day. Patients in observation group got modified Banxia Xiexintang， 1 dose/day. And the course of treatment for the two groups was 12 weeks， and a 12 week follow-up was recorded. Before and after treatment and during the follow-up， fat content of liver was recorded by instantaneous elastic recorder， fasting blood glucose （FBG） and fasting insulin （FINS） were detected， and insulin sensitivity index （ISI）， insulin resistance index （HOMA-IR） and islet

β

cell function index （HOMA-

β

） were detected. After treatment， B-mode ultrasonography and ratio of liver/spleen CT were detected. And levels of alanine transaminase （ALT）， aspartate transaminase （AST）， total cholesterol （TC）， triglyceride （TG）， high-density lipoprotein cholesterol （HDL-C）， low-density lipoprotein cholesterol （LDL-C）， adiponectin， leptin， serine protease inhibitor （Vaspin）， tumor necrosis factor （TNF）-

α

and interleukin-6 （IL-6） were detected. And the safety was evaluated.

Result

2

CAP and HOMA-IR in observation group were lower than those in control group after treatment and during the follow-up （

P

<

0.01）， and ISI and HOMA-

β

were higher than those in control group （

P

<

0.01）. Amelioration of indexes of blood lipid was better than those in control group （

P

<

0.01）. Levels of ALT， AST， FBG and FINS were lower than those in control group （

P

<

0.01）. Scores of traditional Chinese medicine （TCM） syndromes were lower than those in control group （

P

<

0.01）， ratio of liver/spleen CT and adiponectin was higher than that in control group （

P

<

0.01）. Levels of TNF-

α

， IL-6， vaspin and leptin were lower than those in control group （

P

<

0.01）. B-ultrasound efficacy and fat content of liver were superior to those of control group （

P

<

0.05）. There were no serious adverse events and drug-related adverse reactions.

Conclusion

2

Modified Banxia Xiexintang can regulate glucose and lipid metabolism， improve insulin sensitivity and HOMA-

β

cell function， improve IR， regulate adipocytokines and inflammatory factors， relieve clinical symptoms and liver fat content， and improve CT ratio of liver/spleen， with a better clinical efficacy and safety.