益气健脾汤治疗初发2型糖尿病合并非酒精性脂肪性肝病患者的临床疗效及其对肠道菌群多样性的影响

Curative Effects of Yiqi Jianpi Decoction(益气健脾汤)in Treatment of Incipient Type 2 Diabetes Mellitus and Non-Alcoholic Fatty Liver Disease and Influence on Intestinal Microbiota Diversity

目的:观察益气健脾汤对初发2型糖尿病合并非酒精性脂肪性肝病患者的临床疗效及其对肠道菌群多样性的影响。方法:选取符合诊断与纳入标准的脾虚湿困证型初发2型糖尿病并非酒精性脂肪性肝病患者68例,随机分为对照组与观察组,每组各34例。对照组采用吡格列酮二甲双胍片口服治疗,观察组在对照组的基础上给予益气健脾汤口服治疗,两组患者疗程均为12周。分别观察两组患者治疗前后中医证候评分、生化指标(FPG、FINS、HBA1c、AST、ALT、GGT)、胰岛素抵抗指数的变化,并评估其临床疗效。采用16S rRNA高通量测序检测各组患者肠道菌群多样性。结果:治疗后两组患者临床疗效比较,观察组优于对照组(P<0.05)。与对照组相比,观察组患者治疗后FPG、FINS、HBA1c、AST、ALT、GGT及HOMA-IR的水平均明显降低(P<0.05)。与对照组相比,治疗后观察组Simpon指数明显的降低,Ace、Chao1与Shannon的指数明显的升高(P<0.05)。结论:益气健脾汤能改善初发2型糖尿病合并非酒精性脂肪性肝病患者胰岛素抵抗,具有降糖和保肝作用,恢复肠道菌群的多样性是其作用机制之一。

Objective:To confirm the therapeutic effect of Yiqi Jianpi Decoction in treating incipient type 2 diabetes accompanied by non-alcoholic fatty liver disease and its influence on intestinal microbiota diversity.Methods:68 patients with spleen deficiency and dampness trapped syndrome with incipient type 2 diabetes me-llitus and non-alcoholic fatty liver disease were divided to the control group and the observation group randomly,with 34 patients in each group.The control group was given Pioglitazone metformin tablets,the observation group was treated with Yiqi Jianpi Decoction based on the control group for oral treatment,and the course of treatment for both groups was 12 weeks.The changes in TCM syndrome scores,biochemical indexes(FPG,FINS,HBA1c,AST,ALT,GGT),insulin resistance index were observed respectively before and after treatment,and their curative effect was evaluated.16S rRNA high-throughput sequencing was used to detect the intestinal microbiota diversity in each group.Results:The clinical efficacy of the observation group was superior to that of the control group,and there was significant difference(P<0.05).To compare with the control group,the levels of FPG,FINS,HBA1c,AST,ALT,GGT,and HOMA-IR in observation group were significantly reduced after treatment,and these differences were found to be significant(P<0.05).Additionally,to compare with the control group,the Simpon index was significantly lower and Ace,Chao1,and Shannon index were greater for the observation group,and all of the differences were found to be significant(P<0.05).Conclusion:Yiqi Jianpi Decoction can improve insulin resistance of patients with incipient type 2 diabetes mellitus with non-alcoholic fatty liver disease,lower blood glucose and protect liver function,restoring the intestinal microbiota diversity in one of its mechanism.