Abstract:

Objective　Non-alcoholic fatty liver disease (NAFLD) is often accompanied by type 2 diabetes mellitus (T2DM). The current study was to evaluate the effect of canagliflozin, in addition to lifestyle modification and metformin, on T2DM patients with NAFLD. Methods　This was a randomized clinical trail and 120 patients diagnosed as T2DM with NAFLD in Huizhou Third People's Hospital from October 2021 to September 2022 were randomly divided into a control group and an intervention group. In the intervention group, there were 38 males and 22 females, aged (50.5±7.0) years. In the control group, there were 37 males and 23 females, aged (51.3±8.2) years. The control group received lifestyle intervention combined with metformin 1.0 g bid, and the intervention group was additionally treated with 100 mg qd of canagliflozin in addition to the control group. Both groups were treated for 12 weeks. Serum biochemical indexes and fatty liver related indexes in the two groups were measured before and after treatment for 12 weeks, and the rates of genitourinary system infection and hypoglycemia in the two groups during treatment were also compared. Student t test, rank sum test, and χ² test were used. Results　After 12 weeks of treatment, the levels of fasting blood glucose and glycosylated hemoglobin in the intervention group were lower than those in the control group [(6.7±0.5) mmol/L vs. (7.0±0.6) mmol/L, (7.0±0.5)% vs. (7.3±0.6)%], the level of triacylglycerol was lower and the level of high-density lipoprotein cholesterol was higher [1.87 (0.54, 2.21) mmol/L vs. 2.02 (0.60, 2.39) mmol/L, (1.00±0.09) mmol/L vs. (0.92±0.11) mmol/L], with statistically significant differences (all P<0.05). The plasma transaminase levels in the intervention group were lower than those in the control group, with statistically significant differences (all P<0.05). Compared with those in the control group, the liver fibrosis indexes, liver stiffness [(7.1±3.0) kPa vs. (9.5±3.3) kPa], and liver fat content [(10.8±5.6)% vs. (13.7±5.2)%] in the intervention group were significantly lower, with statistically significant differences (all P<0.05). There were no statistically significant differences in the incidences of adverse reactions between the two groups (all P>0.05). Conclusion　For T2DM patients with NAFLD, the addition of 12 weeks' treatment of canagliflozin can significantly improve the blood glucose and lipid metabolism disorders and can also improve NAFLD in addition to lifestyle intervention and metformin treatment. This study can provide some reference for clinicians in the treatment of T2DM patients with NAFLD.

Key words:

Diabetes mellitus, Non-alcoholic fatty liver disease, Canagliflozin, Metformin

摘要：

目的　2型糖尿病（T2DM）患者经常伴发非酒精性脂肪性肝病（NAFLD）。本研究拟分析在生活方式和二甲双胍治疗基础上，加用卡格列净是否能够改善T2DM患者的NAFLD。方法　采用前瞻性干预性研究，将2021年10月至2022年9月惠州市第三人民医院确诊T2DM合并NAFLD患者120例随机分为对照组和干预组。干预组男38例，女22例，年龄（50.5±7.0）岁；对照组男37例，女23例，年龄（51.3±8.2）岁。对照组使用生活方式干预联合二甲双胍1.0 g bid治疗，干预组在对照组基础上加用卡格列净100 mg qd治疗，两组均治疗12周。两组患者在治疗前及治疗12周后分别测定血清生化指标及脂肪肝相关指标。同时比较治疗期间两组患者发生泌尿生殖系统感染和低血糖比例。使用student t检验、秩和检验、χ²检验。结果　治疗12周后，与对照组相比，干预组患者空腹血糖和糖化血红蛋白水平较低［（6.7±0.5）mmol/L比（7.0±0.6）mmol/L、（7.0±0.5）%比（7.3±0.6）%］，三酰甘油水平较低而高密度脂蛋白胆固醇水平较高［1.87（0.54，2.21）mmol/L比2.02（0.60，2.39）mmol/L、（1.00±0.09）mmol/L比（0.92±0.11）mmol/L］，差异均有统计学意义（均P<0.05）。干预组患者血浆转氨酶水平较对照组低，差异均有统计学意义（均P<0.05）。与对照组相比，干预组患者肝脏纤维化指标、肝脏硬度［（7.1±3.0）kPa比（9.5±3.3）kPa］和肝脂肪含量［（10.8±5.6）%比（13.7±5.2）%］明显较低，差异均有统计学意义（均P<0.05）。两组不良反应发生率组间比较差异均无统计学意义（均P>0.05）。结论　对于T2DM合并NAFLD患者，在生活方式干预和二甲双胍治疗的基础上，加用卡格列净治疗能够明显改善患者血糖和血脂代谢紊乱，同时还能够改善NAFLD。本研究可为临床医生对合并NAFLD的T2DM患者的治疗提供参考。

关键词:

糖尿病, 非酒精性脂肪性肝病, 卡格列净, 二甲双胍