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连荷消脂膏联合司美格鲁肽治疗痰热互结型代谢相关脂肪性肝病合并2型糖尿病的临床研究

Clinical Study of Lianhe Xiaozhi Ointment Combined with Semaglutide in the Treatment of Metabolic Associated Fatty Liver Disease with Type 2 Diabetes Mellitus of Phlegm-Heat Interconnection Syndrome
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摘要 目的观察连荷消脂膏联合司美格鲁肽对痰热互结型代谢相关脂肪性肝病(MAFLD)合并2型糖尿病(T2DM)的临床疗效。方法选取2022年8月至2023年12月于南京中医药大学附属医院内分泌科就诊的痰热互结型MAFLD合并T2DM患者80例作为研究对象,按照简单随机法分为对照组和观察组各40例。对照组予生活方式干预联合司美格鲁肽治疗,观察组在对照组基础上加用连荷消脂膏口服治疗,疗程均为12周。观察2组治疗前后受控衰减参数(CAP),肝脏硬度值(LSM),人体测量学指标[体质量、体质量指数(BMI)、腰围(WC)、内脏脂肪面积(VFA)、体脂百分比(PBF)],代谢相关指标[空腹血糖(FPG)、糖化血化蛋白A1c(HbA1c)、空腹胰岛素(FINS)、空腹C肽(FC-P)、胰岛素抵抗指数(HOMA-IR)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、尿酸(UA)],肝功能相关指标[丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷氨酰转移酶(GGT)、碱性磷酸酶(ALP)],肝纤维化-4(FIB-4)指数、中医证候积分和临床疗效等变化情况。结果治疗后,2组CAP、LSM、FIB-4指数、VFA、PBF、体质量、BMI、WC均明显降低(P<0.05,P<0.01),观察组优于对照组(P<0.05,P<0.01);2组FPG、HbA1c、FC-P、FINS、HOMA-IR、TC、TG、LDL-C、ALT、AST、ALP、GGT水平均明显下降(P<0.05,P<0.01),观察组在FPG、HbA1c、FINS、HOMA-IR、TC、TG、ALT、AST、GGT的改善方面优于对照组(P<0.05,P<0.01);2组中医证候积分均显著降低(P<0.05),观察组优于对照组(P<0.05);观察组临床有效率明显优于对照组(P<0.05)。结论连荷消脂膏联合司美格鲁肽治疗痰热互结型MAFLD合并T2DM疗效确切,可有效减少肝脏脂肪含量,改善肝纤维化,调控代谢紊乱,恢复肝功能状态,且安全性良好,具有较好的临床应用价值。 To evaluate the clinical efficacy of Lianhe Xiaozhi Ointment combined with semaglutide in treating metabolic associated fatty liver disease(MAFLD)combined with Type 2 Diabetes Mellitus(T2DM)characterized by the phlegm-heat interconnection syndrome.METHODS A total of 80 patients were enrolled in this study.They were recruited from the Department of Endocrinology at the Affiliated Hospital of Nanjing University of Chinese Medicine between August 2022 and December 2023,with a diagnosis of both MAFLD and T2DM characterized by the phlegm-heat interconnection syndrome.Patients were randomized into a control group and an observation group(n=40 per group).The control group received lifestyle interventions combined with semaglutide.The observation group received oral Lianhe Xiaozhi Ointment in addition to the control regimen.The treatment course for both groups was 12 weeks.The following outcome measures were assessed before and after treatment:controlled attenuation parameter(CAP),liver stiffness measurement(LSM),anthropometric indicators[body weight,body mass index(BMI),waist circumference(WC),visceral fat area(VFA),percentage of body fat(PBF)],metabolism-related indicators[fasting plasma glucose(FPG),glycated hemoglobin A1c(HbA1c),fasting insulin(FINS),fasting C-peptide(FC-P),homeostasis model assessment of insulin resistance index(HOMA-IR),total cholesterol(TC),triglycerides(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),uric acid(UA)],liver function-related indicators[alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl transferase(GGT),alkaline phosphatase(ALP)],liver fibrosis-4(FIB-4)index,traditional Chinese medicine(TCM)syndrome scores,and clinical efficacy.RESULTS After treatment,both groups exhibited significant reductions in CAP,LSM,FIB-4 index,VFA,PBF,body weight,BMI,and WC(P<0.05,P<0.01),with the observation group showing significantly superior improvements compared to the control group(P<0.05,P<0.01).Levels of FPG,HbA1c,FC-P,FINS,HOMA-IR,TC,TG,LDL-C,ALT,AST,ALP,and GGT significantly decreased in both groups(P<0.05,P<0.01).Notably,the observation group outperformed the control group in improving FPG,HbA1c,FINS,HOMA-IR,TC,TG,ALT,AST,and GGT(P<0.05,P<0.01).Furthermore,TCM syndrome scores decreased significantly in both groups(P<0.05),with greater reductions observed in the observation group(P<0.05).The total clinical effective rate was significantly higher in the observation group than in the control group(P<0.05).CONCLUSION Combination therapy comprising Lianhe Xiaozhi Ointment and semaglutide demonstrates definitive efficacy in treating MAFLD with T2DM of phlegm-heat interconnection type.The regimen effectively reduces hepatic fat content,alleviates liver fibrosis,regulates metabolic disorders,and improves liver function with a favorable safety profile,suggesting significant clinical value.
作者 张瑜娟 杨欣懿 聂丽娟 王高翔 张舒 张文辉 怀家轩 吕天溯 娄妍 周希乔 ZHANG Y ujuan;YANG Xinyi;NIE Lijuan;WANG Gaoxiang;ZHANG Shu;ZHANG Wenhui;HUAI Jiaxuan;LYU T iansu;LOU Y an;ZHOU Xiqiao(Affiliated Hospital of Nanjing University of Chinese Medicine,Nanjing 210029,China;The First Clinical Medical College,Nanjing University of Chinese Medicine,Nanjing 210023,China)
出处 《南京中医药大学学报》 北大核心 2026年第2期173-181,共9页 Journal of Nanjing University of Traditional Chinese Medicine
基金 江苏省中医药管理局项目(ZT202105)。
关键词 连荷消脂膏 代谢相关脂肪性肝病 2型糖尿病 痰热互结证 临床疗效 减重 糖脂代谢 Lianhe Xiaozhi Ointment metabolic associated fatty liver disease type 2 diabetes mellitus phlegm-heat interconnection syndrome clinical efficacy weight loss glucose and lipid metabolism
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