Abstract:

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 χ² 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 (χ²=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.

Key words:

Type 2 diabetes mellitus, Nonalcoholic fatty liver, Sanshen Jiangxiao capsules, Metformin, Blood glucose, Blood lipids, Liver function

摘要：

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、χ²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（χ²=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。

关键词:

2型糖尿病, 非酒精性脂肪性肝病, 三参降消胶囊, 二甲双胍, 血糖, 血脂, 肝功能