Abstract: Background　Recent years have seen considerable growth in the prevalence of type 2 diabetes mellitus （T2DM） combined with non-alcoholic fatty liver disease （NAFLD），but there is still a lack of effective targeted interventions. Traditional Chinese medicine（TCM） may have some merits in treating T2DM with NAFLD，but few studies have investigated the effects and mechanism of actions of TCM in treating the disease. Objective　To investigate the clinical efficacy of adding Gegen Qinlian Decoction（GD） to care as usual to treat T2DM with NAFLD. Methods　One hundred patients with T2DM with NAFLD who were treated in the Affiliated Hospital of Integrated Traditional Chinese and Western Medicine，Nanjing University of Chinese Medicine from January 2020 to March 2021 were selected. They were randomly allocated to either the control group（n=51） or the observation group （n=49）. The control group received usual care. The observation groupreceived usual care plus GD. The therapeutic course for all was 8 weeks. Data about the pre- and post-treatment TCM symptom score，glycemic indices〔fasting plasma glucose （FPG），two-hour postprandial glucose（2 hPG）〕，glycated hemoglobin（HbA1c），blood lipid indices〔triglyceride （TG），total cholesterol （TC），low-density lipoprotein cholesterol（LDL-C）〕，homeostatic model assessment for insulin resistance （HOMA-IR），liver function indices（ALT，AST，GGT），lymphocyte subsets，and NAFLD fibrosis score measured by color Doppler ultrasonography of two groups were obtained. Results　All patients were included for final analysis except for 10 dropouts（four cases and six controls）. After treatment，the TCM symptom score decreased more significantly in the observation group（P<0.05）. But HbA1c and TC were still similar in both groups after treatment（P>0.05）. The FPG，2 hPG，TG，LDL-C and HOMA-IR decreased more significantly in the observation group after treatment（P<0.05）. Similarly，ALT，AST and GGT were lowered more significantly in the observation group after treatment（P<0.05）. In terms of post-treatment levels of lymphocyte subsets，CD4+ T cell，CD4+/CD8+ ratio and NK cell were elevated while CD8+ T cell was lowered more significantly in the observation group（P<0.05）. The post-treatment NAFLD fibrosis score was also much lower in the observation group（P<0.05）. Conclusion　Patients with T2DM and NAFLD could be treated with GD to improve glycolipid metabolism，insulin resistance，and immune function more effectively.

Key words: Diabetes mellitus, type 2, Non-alcoholic fatty liver disease, Gegen Qinlian Decoction, Immune function, Glycolipid metabolism, Treatment outcome

摘要： 背景　近年来，2型糖尿病（T2DM）合并非酒精性脂肪性肝病（NAFLD）的患病率大幅升高，但目前针对T2DM合并NAFLD尚缺乏有效干预措施。中医药治疗本病具有一定优势，但相关研究及作用机制尚缺乏。目的　探讨葛根芩连汤治疗T2DM合并NAFLD患者的临床疗效。方法　选取2020年1月至2021年3月就诊于南京中医药大学附属中西医结合医院的T2DM合并NAFLD患者100例，采用随机数字表法将其分为观察组（n=49）和对照组（n=51）。对照组给予常规治疗，观察组在对照组治疗基础上加用葛根芩连汤，两组疗程均为8周。分别比较两组治疗前后中医证候积分、血糖〔空腹血糖（FPG）、餐后2 h血糖（2 hPG）〕、糖化血红蛋白（HbA1c）、血脂〔三酰甘油（TG）、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）〕、稳态模型评估胰岛素抵抗指数（HOMA-IR）、肝功能〔丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、谷氨酰转肽酶（GGT）〕、淋巴细胞亚群变化及肝脏彩色超声评分。结果　观察组脱落4例，共纳入45例；对照组脱落6例，共纳入45例。治疗后，观察组中医证候积分低于对照组（P<0.05）。治疗后，两组患者HbA1c、TC水平比较，差异均无统计学意义（P>0.05）。治疗后，观察组FPG、2 hPG、TG、LDL-C、HOMA-IR低于对照组（P<0.05）。治疗后，观察组ALT、AST、GGT水平低于对照组（P<0.05）。治疗后，观察组CD4+ T淋巴细胞、CD4+/CD8+、自然杀伤细胞（NK细胞）水平高于对照组，CD8+ T淋巴细胞水平低于对照组（P<0.05）。治疗后，观察组肝脏超声评分低于对照组（P<0.05）。结论　葛根芩连汤可以有效改善T2DM合并NAFLD患者的糖脂代谢，减轻胰岛素抵抗，改善机体免疫功能。

关键词: 糖尿病，2型, 非酒精性脂肪性肝病, 葛根芩连汤, 免疫功能, 糖脂代谢, 治疗结果