Clinical Observation on Shuangye San in the Treatment of Type 2 Diabetes Mellitus Complicated with Non-alcoholic Fatty Liver Disease of Spleen Deficiency and Phlegm Stasis Type
10.13359/j.cnki.gzxbtcm.2024.10.026
- VernacularTitle:双叶散治疗脾虚痰瘀型2型糖尿病合并非酒精性脂肪肝病的临床观察
- Author:
Dao-Cheng ZHOU
1
,
2
;
Gui-Ji RUAN
;
You-You SHUAI
;
Wen-Hua XU
;
De-Liang LIU
;
Heng-Xia ZHAO
;
Hui-Lin LI
Author Information
1. 广州中医药大学第四临床医学院,广东深圳 518033
2. 深圳市中西医结合医院,广东深圳 518104
- Keywords:
Shuangye San;
spleen deficiency and phlegm stasis type;
type 2 diabetes mellitus;
non-alcoholic fatty liver disease;
glucose and lipid metabolism;
liver function
- From:
Journal of Guangzhou University of Traditional Chinese Medicine
2024;41(10):2687-2694
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy of Shuangye San(the prescription mainly composed of Mori Folium and Nelumbinis Folium)in the treatment of type 2 diabetes mellitus(T2DM)complicated with non-alcoholic fatty liver disease(NAFLD)of spleen deficiency and phlegm stasis type.Methods A total of 80 patients with T2DM complicated with NAFLD of spleen deficiency and phlegm stasis type were randomly divided into a treatment group and a control group,with 40 cases in each group.The control group was treated with conventional western medicine for lowering blood glucose and lipid,protecting liver and lowering enzymes.The treatment group was treated with the granules of Shuangye San orally on the basis of treatment for the control group.The course of treatment lasted for three months.The changes of traditional Chinese medicine(TCM)syndrome scores,homeostasis model assessment of insulin resistance(HOMA-IR),fasting insulin(FINS),fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPG),glycosylated hemoglobin(HbA1C),total cholesterol(TC),triglyceride(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),liver function indicators and B-ultrasound grading of fatty liver in the two groups were observed before and after treatment.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)After three months of treatment,the total effective rate of the treatment group was 85.00％(34/40),and that of the control group was 70.00％(28/40).The intergroup comparison(tested by chi-square test)showed that the efficacy of the treatment group was significantly superior to that of the control group(P＜0.01).(2)After treatment,the scores of TCM symptoms of obese physique,heaviness and weakness in the limbs,shortness of breath and unwilling to talk,tightness and stabbing pain in the chest,abdominal distension and poor appetite in the two groups were decreased compared with those before treatment(P＜0.05),and the decrease of TCM syndrome scores in the treatment group was significantly superior to that in the control group(P＜0.05).(3)After treatment,the levels of glucose and lipid metabolism indicators of FINS,HOMA-IR,FBG,2hPG,HbA1C,TC,TG and LDL-C in the two groups were significantly decreased compared with those before treatment(P＜0.05),and the level of HDL-C was significantly increased compared with that before treatment(P＜0.05).The decrease of FINS,HOMA-IR,FBG,2hPG,HbA1C,TC,TG and LDL-C levels and the increase of HDL-C levels in the treatment group were significantly superior to those in the control group(P＜0.05).(4)After treatment,the levels of liver function indicators of alanine aminotransferase(ALT),aspartate aminotransferase(AST)and gamma-glutamyl transpeptidase(GGT)in the two groups were significantly decreased compared with those before treatment(P＜0.05),and the decrease of liver function indicators in the treatment group was significantly superior to that in the control group(P＜0.05).(5)After treatment,the B-ultrasound grading of fatty liver of the two groups was significantly improved compared with that before treatment(P＜0.05),and the improvement of fatty liver B-ultrasound grading in the treatment group was significantly superior to that in the control group,and the difference was statistically significant(P＜0.05).(6)During the treatment,there were no adverse reactions such as impairment of liver and kidney function and abnormalities in routine blood,urine and stool test in the two groups.Conclusion Shuangye San exerts certain effect in the treatment of T2DM complicated with NAFLD of spleen deficiency and phlegm stasis type.It can alleviate the clinical symptoms of patients,correct the disorder of glucose and lipid metabolism,and improve liver function and fatty liver B-ultrasound grading.
