利拉鲁肽联合健脾化痰方治疗2型糖尿病合并非酒精性脂肪肝临床疗效

The clinical efficacy of liraglutide combined with Jianpi Huatan Formula in the treatment of type 2 diabetes(T2DM)complicated with non-alcoholic fatty liver disease

目的:探讨利拉鲁肽联合健脾化痰方治疗2型糖尿病(T2DM)合并非酒精性脂肪肝(NAFLD)的疗效。方法:选取90例T2DM合并NAFLD患者,随机分为利拉鲁肽组和联合组,各45例,利拉鲁肽组均给予利拉鲁肽治疗,联合组在此基础上给予健脾化痰方,治疗12周后比较两组患者治疗前后体重(W)、体质指数(BMI)、血糖(FPG,2h PG)、糖化血红蛋白(HbA1c)、血脂(TC,TG,LDL-c)、肝功能(ALT,AST,GGT)、胰岛素抵抗指数(HOMA-IR)、中医证候评分及脂肪肝分级(通过肝脏CT诊断)。结果:治疗前两组患者各项指标无明显统计学差异(P>0.05),治疗后两组指标均较治疗前改善,联合组改善血脂、肝功能及中医证候评分较利拉鲁肽组更显著(P<0.05),而对W、BMI、血糖、HbA1c、HOMA-IR及脂肪肝分级的改善与利拉鲁肽组无显著差异(P>0.05)。利拉鲁肽组有3例恶心伴腹泻,2例厌食,短期减量后好转,均可耐受并在治疗4周后缓解,联合组无显著不良反应,组间不良反应有统计学差异(P<0.05)。结论:利拉鲁肽联合健脾化痰方对T2DM合并NAFLD患者降低体重、体质指数、稳定血糖、改善胰岛素抵抗以及降低脂肪肝等级作用与利拉鲁肽相当,但对于血脂、肝功能和中医证候评分的改善优于利拉鲁肽组,而且联合用药组不良反应显著低于利拉鲁肽组,由此推测健脾化痰方缓解利拉鲁肽引起的胃肠道反应,使患者依从性更佳,值得临床推广。

Objective:To investigate the efficacy of liraglutide combined with Jianpi Huatan Formula in the treatment of type 2 diabetes(T2DM)complicated with non-alcoholic fatty liver disease(NAFLD).Methods:A total of 90 T2DM patients with NAFLD were selected and divided into 2 groups randomly,with 45 cases in each group.Then the liraglutide group received liraglutide,while the combination group received Jianpi Huatan Formula on the basis of the treatment of liraglutide,both groups were treated for 12 weeks.Before and after the treatment,the body weight(W),body mass index(BMI),blood glucose(FPG,2h PG),glycosylated hemoglobin(HbA1c),blood lipid(TC,TG,LDL-c),liver function(ALT,AST,GGT),hemeostasis model assessment of insulin resistance(HOMA-IR),the TCM symptom scores and the classification of NAFLD(classified by liver CT scan)were monitored and compared.Results:Before the treatment,there were no significant differences between groups in the above indexes,after the treatment of 12 weeks,all the indexes were superior compared with those before treatment,while the blood lipid,liver function and TCM symptom scores of the combination group were better than those of the liraglutide group;meantime,the differences of the W,BMI,blood glucose,HbA1c,HOMA-IR and the alliviation of NAFLD grade between the groups were not significant(P>0.05).There were three patients suffered from nausea accompanied with diarrhoea and two with anorexia in the liraglutide group,while no obvious side effect was discovered in the combination group,the difference was significant(P<0.05).Conclusion:Liraglutide combined with Jianpi Huatan Formula has equivalent effect to liraglutide in the amelioration of the W,BMI,blood glucose,insulin resistance,and the alleviation of NAFLD grade in T2DM with NAFLD,while the blood lipid,liver function and TCM syptom scores of the combination group were superior to those of the liraglutide group.Furthermore,the side effects of the combination group is less than that of the liraglutide group,therefore,Jianpi Huatan Forlula may relieve the gastrointestinal disturbances caused by liraglutide,make patients be more adherent to therapy and is worthy of clinical recommending.