三参降消胶囊联合二甲双胍在2型糖尿病合并非酒精性脂肪性肝病中的治疗效果

Effect of Sanshen Jiangxiao capsules combined with metformin in treatment of patients with type 2 diabetes mellitus and nonalcoholic fatty liver disease

目的探讨三参降消胶囊联合二甲双胍治疗对2型糖尿病合并非酒精性脂肪性肝病(nonalcoholic fatty liver disease,NAFLD)患者糖脂代谢及肝功能的影响。方法选取2022年10月至2023年10月在陕西省中医医院接受治疗的94例2型糖尿病合并NAFLD患者为研究对象,采用随机数字表法分为对照组与研究组,各47例。对照组男27例、女20例,年龄(49.04±3.63)岁,糖尿病病程(5.35±0.74)年,脂肪肝轻度12例、中度35例;研究组男23例、女24例,年龄(50.41±3.04)岁,糖尿病病程(5.14±0.75)年,脂肪肝轻度17例、中度30例。对照组患者予以二甲双胍治疗,初次口服0.5 g,每天1次;每周对血糖进行评估,血糖仍高者可逐步增加剂量,最高剂量为每次1.0 g,每天2次;血糖控制正常后下调至0.5 g/次,每天2次,并以此剂量维持治疗。研究组在对照组基础上联合三参降消胶囊治疗,口服,每次6粒,3次/d。两组均治疗3个月,对比两组患者临床疗效,治疗前后血糖指标(糖化血红蛋白、空腹血糖、餐后2h血糖)、血脂(高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、三酰甘油、总胆固醇)、肝功能(谷草转氨酶、谷丙转氨酶)、肝脏超声定量参数(肝脏回声衰竭系数、肝肾回声比值)变化情况和安全性。采用t检验、χ^(2)检验进行统计分析。结果研究组总有效率为85.11%(40/47),高于对照组的69.96%(31/47),差异有统计学意义(χ^(2)=4.663,P=0.031)。治疗前后两组患者糖脂代谢、肝功能、肝脏超声定量参数比较,差异均有统计学意义(均P<0.05)。治疗后,糖脂代谢:研究组糖化血红蛋白、空腹血糖、餐后2 h血糖、低密度脂蛋白胆固醇、三酰甘油、总胆固醇均低于对照组[(7.02±0.73)%比(7.64±0.78)%、(5.49±0.81)mmol/L比(6.08±0.73)mmol/L、(8.04±1.14)mmol/L比(9.28±1.17)mmol/L、(1.37±0.16)mmol/L比(2.41±0.36)mmol/L、(1.24±0.27)mmol/L比(1.86±0.35)mmol/L、(4.10±0.63)mmol/L比(5.17±0.74)mmol/L],高密度脂蛋白胆固醇高于对照组[(1.18±0.24)mmol/L比(1.03±0.21)mmol/L],差异均有统计学意义(均P<0.05);肝功能:研究组谷草转氨酶、谷丙转氨酶水平均低于对照组[(33.42±4.12)U/L比(40.87±5.14)U/L、(34.18±4.05)U/L比(38.56±5.73)U/L],差异均有统计学意义(均P<0.05);肝脏超声定量参数:研究组肝脏回声衰减系数、肝肾回声比值均低于对照组[(1.01±0.11)dB比(1.20±0.17)dB、1.14±0.15比1.29±0.27],差异有统计学意义(均P<0.05)。两组患者治疗期间均无不良反应发生。结论三参降消胶囊联合二甲双胍治疗2型糖尿病合并NAFLD效果显著,具有降血糖、降血脂、保护肝功能作用,且安全性高。

Objective To study the effects of Sanshen Jiangxiao capsules combined with metformin on glucose and lipid metabolism and liver function in patients with type 2 diabetes and nonalcoholic fatty liver disease(NAFLD).Methods Ninety-four patients with type 2 diabetes mellitus and NAFLD treated at Shaanxi Provincial Hospital of Traditional Chinese Medicine from October 2022 to October 2023 were selected as the study objects,and were divided into a control group and a study group by the random number table method,with 47 cases in each group.There were 27 males and 20 females in the control group;they were(49.04±3.63)years old;their diabetic course was(5.35±0.74)years;there were 12 cases of mild fatty liver and 35 cases of moderate fatty liver.There were 23 males and 24 females in the study group;they were(50.41±3.04)years old;their diabetic course was(5.14±0.75)years;there were 17 cases of mild fatty liver and 30 cases of moderate fatty liver.The control group took metformin,once a day;the initial oral dose was 0.5 g;the blood glucose was detected every week;if the blood glucose was still high,the dose could be gradually increased;the highest dose was 1.0 g per time,twice a day;after the blood glucose was under control,the dose was reduced to 0.5 g per time,twice a day and maintained.On the basis of the control group,the study group orally took 6 Sanshen Jiangxiao capsules per time,3 times/d.Both groups were treated for 3 months.The clinical efficacies,changes of blood glucose indicators(glycosylated hemoglobin,fasting blood glucose,and 2-hour postprandial blood glucose),blood lipids(high density lipoprotein cholesterol,low density lipoprotein cholesterol,triacylglycerol,and total cholesterol),liver function(aspartate aminotransferase,alanine aminotransferase),and quantitative parameters of liver ultrasound(liver echo failure coefficient and liver-kidney echo ratio)before and after the treatment,and safety were compared between the two groups.t and χ^(2) tests were used for the statistical analysis.Results The total effective rate of the study group was higher than that of the control group[85.11%(40/47)vs.69.96%(31/47)],with a statistical difference(χ^(2)=4.663;P=0.031).There were statistical differences in glucose and lipid metabolism,liver function,and quantitative parameters of liver ultrasound in both groups between before and after the treatment(all P<0.05).After the treatment,the levels of the glycated hemoglobin,fasting blood glucose,2-hour postprandial blood glucose,low-density lipoprotein cholesterol,triglyceride,total cholesterol,and high density lipoprotein in the study group were better than those in the control group[(7.02±0.73)%vs.(7.64±0.78)%,(5.49±0.81)mmol/L vs.(6.08±0.73)mmol/L,(8.04±1.14)mmol/L vs.(9.28±1.17)mmol/L,(1.37±0.16)mmol/L vs.(2.41±0.36)mmol/L,(1.24±0.27)mmol/L vs.(1.86±0.35)mmol/L,(4.10±0.63)mmol/L vs.(5.17±0.74)mmol/L,and(1.18±0.24)mmol/L vs.(1.03±0.21)mmol/L],with statistical differences(all P<0.05);the levels of aspartate aminotransferase,alanine aminotransferase in the study group were lower than those in the control group[(33.42±4.12)U/L vs.(40.87±5.14)U/L,(34.18±4.05)U/L vs.(38.56±5.73)U/L],with statistical differences(all P<0.05);the attenuation coefficient of liver echo and the ratio of liver and kidney echo in the study group were lower than those in the control group[(1.01±0.11)dB vs.(1.20±0.17)dB and 1.14±0.15 vs.1.29±0.27],with statistical differences(both P<0.05).No adverse reactions occurred in both groups during the treatment.Conclusion Sanshen Jiangxiao capsules combined with metformin for patients with type 2 diabetes mellitus and NAFLD is effective and safe,and can reduce blood glucose and lipids and protect liver function.