清肝健脾合剂治疗2型糖尿病合并非酒精性脂肪肝临床研究

Clinical Observation on Qinggan Jianpi Mixture in the Treatment of Type 2 Diabetes Mellitus Complicated with Nonalcoholic Fatty Liver

目的观察清肝健脾合剂治疗2型糖尿病合并非酒精性脂肪肝的临床疗效。方法选取2009年9月—2014年12月在邯郸市中医院内分泌科门诊及住院的120例脾虚肝郁型2型糖尿病合并非酒精性脂肪肝患者,随机分为西药组和中药组,每组60例。2组患者均采用糖尿病常规治疗,西药组予以阿托伐他汀钙口服,中药组予以清肝健脾合剂口服,2组均治疗3个月为1个疗程,共治疗2个疗程。比较2组患者的临床疗效、中医证候积分、相关生化指标、肝脏影像学脂肪肝改善情况、血液流变学指标及不良反应发生情况。结果中药组的治疗总有效率高于西药组(P<0.05);中药组治疗后的中医证候积分、体重指数(Body mass index,BMI)、丙氨酸氨基转移酶(Alanine aminotransferase,ALT)、天门冬氨酸氨基转移酶(Aspartate aminotransferase,AST)及空腹血糖(Fasting plasma glucose,FPG)水平低于西药组(P<0.05);中药组治疗后的肝脏影像学脂肪肝改善情况优于西药组(P<0.05);中药组治疗后的全血高切黏度、全血低切黏度、血浆黏度、红细胞压积及红细胞聚集指数低于西药组(P<0.05);中药组的不良反应总发生率低于西药组(P<0.05)。结论清肝健脾合剂治疗2型糖尿病合并非酒精性脂肪肝能提高临床疗效,缓解患者的症状,降低患者的生化指标和不良反应发生率,改善患者的肝脏影像学指标和血液流变学指标,值得临床推广应用。

Objective To observe the clinical efficacy of Qinggan Jianpi mixture in type 2 diabetes with nonalcoholic fatty liver(NAFL).Methods A total of 120 patients with type 2 diabetes of spleen deficiency and liver depression complicated with NAFL were selected from the outpatient and inpatient departments of endocrinology of Handan Hospital of Traditional Chinese Medicine from September 2009 to December 2014.They were randomly divided into western medicine group and Chinese medicine group.The patients in both groups were treated by routine diabetes,the western medicine group was treated by atorvastatin caicium,and the Chinese medicine group was treated by Qinggan Jianpi mixture.Two groups were treated for 3months for a course of treatment.After 2 courses,Clinical efficacy,traditional Chinese medicine(TCM)syndrome score,related biochemical indexes,liver imaging improvement of fatty liver,hemorheology indexes and the incidence of adverse reactions in 2 groups were compared.Results The total effective rate of Chinese medicine group was higher than that of western medicine group(P<0.05).TCM syndrome score,Body mass index(BMI),Alanine aminotransferase(ALT),Amino otransferase(AST)and Fasting plasma glucose(FPG)levels of the Chinese medicine group were lower than those of western group(P<0.05).The improvement of liver imaging fatty liver in Chinese medicine group after treatment was better than that in western medicine group(P<0.05).After treatment,the whole blood high shear viscosity,whole blood low shear viscosity,plasma viscosity,hematocrit and erythrocyte aggregation index in Chinese mediicne group were lower than those in western medicine group(P<0.05).The total incidence of ADR in Chinese medicine group was lower than that in western medicine group(P<0.05).Conclusion Qinggan Jianpi mixture in the treatment of type 2 diabetes mellitus complicated with NAFL can improve the clinical efficacy,alleviate the symptoms of patients,reduce the incidence of biochemical indicators and adverse reactions,improve the liver imaging indicators and hemorheology indicators of patients,and is worthy of clinical application.