丹瓜护脉口服液对痰瘀型2型糖尿病合并NAFLD患者糖脂代谢、胰岛素抵抗及肝纤维化程度的疗效观察

Effect of Dangua Humai Oral Liquid on Glucose and Lipid Metabolism,Insulin Resistance and Liver Fibrosis in Patients with Type 2 Diabetes Mellitus of Phlegm and Blood Stasis Type Complicated with NAFLD

目的:以中成药丹瓜护脉口服液干预痰瘀型2型糖尿病合并非酒精性脂肪性肝病(NAFLD)患者,观察其临床疗效。方法:选取2018年6月1日-12月31日在本科住院的105例痰瘀型T2DM合并NAFLD患者,随机分为对照组50例及治疗组55例。对照组按指南规范给予降糖、降压、降脂及抗血小板等西医治疗;治疗组在此基础上加用丹瓜护脉口服液,疗程6个月。观察两组治疗前后糖代谢(FPG、HbA1c、FINS)、脂代谢(TC、TG、HDL-C、LDL-C)、肝酶学指标(ALT、AST),计算HOMA-IR与NAFLD纤维化评分(NFS)的变化,以及脂肪肝程度的变化。结果:(1)治疗前,两组血糖、血脂、HOMA-IR、肝酶学指标等差异无统计学意义(P>0.05)。(2)治疗组治疗6个月后,组内治疗前后比较显示,糖脂代谢、肝酶指标及计算HOMA-IR、NFS也较治疗前明显下降(P<0.05),而FINS、HDL-C水平无明显变化(P>0.05)。对照组治疗6个月后,上述糖脂代谢、肝酶指标等实验室检查指标较治疗前亦有下降(P<0.05),但HOMA-IR、NFS下降并不明显(P>0.05)。(3)组间治疗后比较,治疗6个月后治疗组不仅糖脂代谢及肝酶指标低于对照组,HOMA-IR、NFS也显著低于对照组(P<0.05)。(4)治疗组脂肪肝治疗的总有效率显著高于对照组(P<0.05)。结论:丹瓜护脉口服液用于痰瘀型T2DM合并NAFLD患者在有效改善糖脂代谢的基础上,可改善胰岛素抵抗,同时降低肝损伤并显著改善脂肪肝程度,从而延缓肝纤维化进展。

Objective:To observe the clinical therapeutic effect of a Chinese patent medicine called Dangua Humai Oral Liquid on type 2 diabetes patients with non-alcoholic fatty liver disease(NAFLD)of phlegm and blood stasis type.Method:A total of 105 patients with NAFLD of phlegm and blood stasis type hospitalized in our Department from June 1 to December 31,2018 were enrolled and randomly divided into control group(50 cases)and treatment group(55 cases).The patients in control group were treated with western medicine according to the guidelines and that in the treatment group were treated with Dangua Humai Oral Liquid on the basis of the same routine therapy with the control group.The course of treatment was 6 months for both groups.The statistical analysis was applied to investigate the changes of glycometabolism(FPG,HbA1c,FINS),lipid metabolism(TC,TG,HDL-C,LDL-C),liver enzymes(ALT,AST),homeostasis model assessment of insulin resistance(HOMA-IR)and NAFLD fibrosis score(NFS)after treatment,and the degree of NAFLD was also evaluated in both groups.Result:(1)Before treatment,the data between both groups in terms of blood glucose,blood lipid,HOMA-IR,liver enzymes were no statistical differences(P>0.05).(2)After 6 months of treatment in the treatment group,pre-and post-treatment comparisons of intra-group showed a significant decline in the levels of FPG,HbA1c,TC,TG,LDL,AST and ALT,HOMA-IR and NFS also decreased significantly(P<0.05),while FINS and HDL-C levels did not change significantly(P>0.05).After 6 months of treatment in the control group,the level of FPG,HbA1c,TC,TG,LDL-C,AST and ALT also decreased compared with those before treatment(P<0.05),but HOMA-IR and NFS did not decrease significantly(P>0.05).(3)After 6 months of treatment,the levels of FPG,HbA1c,TC,TG,LDL-C,AST and ALT in the treatment group were significantly lower than those in the control group,the levels of HOMA-IR and NFS also lower than those in the control group(P<0.05).(4)The total effective rate of treatment for NAFLD in the treatment group was significantly higher than that in control group(P<0.05).Conclusion:On the basis of effectively improving glucose and lipid metabolism,Dangua Humai Oral Liquid can improve insulin resistance,reduce liver injury and significantly improve degree of fatty liver,thus delay the progress of liver fibrosis in T2DM patients with NAFLD of phlegm and blood stasis type.