Analysis of Clinical Efficacy of Huanglian Heye Formula Combined with Insulin Aspart in Obese Patients with Type 2 Diabetes Mellitus
10.13359/j.cnki.gzxbtcm.2025.09.009
- VernacularTitle:黄连荷叶方联合门冬胰岛素在肥胖型2型糖尿病患者中的应用分析
- Author:
Shengwei ZHANG
1
;
Yalin CHEN
;
Mingyu BA
;
Zhao YAN
;
Shuxun YAN
Author Information
1. 河南中医药大学第一附属医院内分泌科,河南郑州 450000
- Keywords:
Huanglian Heye Formula;
insulin aspart;
obese type 2 diabetes mellitus;
damp-heat obstructing middle jiao syndrome;
lipid metabolism parameters;
obesity indicators;
glucose metabolism markers;
clinical efficacy;
safety
- From:
Journal of Guangzhou University of Traditional Chinese Medicine
2025;42(9):2148-2155
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical efficacy of Huanglian Heye Formula(composed of Nelumbinis Folium,Coicis Semen,Atractylodis Rhizoma,Glycyrrhizae Radix et Rhizoma,Coptidis Rhizoma,Crataegi Fructus,and Atractylodis Macrocephalae Rhizoma)combined with insulin aspart in treating obese patients with type 2 diabetes mellitus(T2DM)presenting damp-heat obstructing middle jiao syndrome.Methods A total of 94 obese T2DM patients with damp-heat obstructing middle jiao syndrome were treated at the Endocrinology Department of the First Affiliated Hospital of Henan University of Chinese Medicine from April 2022 to January 2024.The patients were randomly assigned to the control group and the observation group,with 47 patients in each group.The control group was treated with insulin aspart,and the observation group was treated with Huanglian Heye Formula plus insulin aspart,both groups were treated for 12 weeks.Changes in traditional Chinese medicine(TCM)syndrome scores,lipid metabolism parameters[total cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C)],obesity indicators[waist-to-hip ratio(WHR),body mass index(BMI),glucose metabolism markers[glycated hemoglobin(HbA1c),2-hour postprandial glucose(2hPG),fasting plasma glucose(FPG)],and serological indicators(visceral adipose tissue-derived serine protease inhibitor[VASPIN],homeostasis model assessment of[3-cell function(HOMA-β)]were observed before and after treatment.Clinical efficacy and safety were evaluated.Results(1)The observation group demonstrated significantly higher total efficacy[93.62％(44/47)]compared to the control group[78.72％(37/47);the intergroup comparison(by chi-square test)showed that the efficacy in the observation group was superior to the control group(P＜0.05).(2)Both groups showed reduced TCM syndrome scores(heaviness in head/body,epigastric fullness,sticky/foul-smelling stools,halitosis,dry/bitter mouth,heartburn/vomiting,yellowish urine,and emotional distress;all P＜0.05),with greater improvements in the observation group(P＜0.01).(3)Lipid profiles of TC,TG and LDL-C were improved in both groups(P＜0.05),with more significant reductions in the observation group(P＜0.01).(4)Obesity indicators(WHR,BMI)decreased in both groups(P＜0.05),showing superior reductions in the observation group(P＜0.05 or P＜0.01).(5)Glucose metabolism markers(HbA1c,2hPG,FPG)were significantly lowered in both groups(P＜0.05),with the observation group achieving better outcomes(P＜0.01).(6)Serological analysis revealed increased VASPIN and HOMA-[3 levels in both groups(P＜0.05),with more pronounced elevations in the observation group(P＜0.01).(7)No severe adverse events occurred.The incidence of adverse reactions was 8.51％(4/47)in the observation group versus 6.38％(3/47)in the control group(P＞0.05).Conclusion Huanglian Heye Formula combined with insulin aspart significantly improves clinical outcomes in obese T2DM patients with damp-heat obstructing middle jiao syndrome by protecting pancreatic[3-cell function,reducing body mass,ameliorating glucose/lipid metabolism,and modulating VASPIN expression,with demonstrated safety.
