【目的】观察双叶散治疗脾虚痰瘀型2型糖尿病（T2DM）合并非酒精性脂肪肝病（NAFLD）的临床疗效。【方法】将80例脾虚痰瘀型T2DM合并NAFLD患者随机分为治疗组和对照组，每组各40例。对照组给予西医常规降糖、降脂、护肝降酶治疗，治疗组在对照组的基础上给予双叶散治疗，疗程为3个月。观察2组患者治疗前后中医证候积分、胰岛素抵抗指数（HOMA-IR）、空腹胰岛素（FINS）、空腹血糖（FBG）、餐后2h血糖（2hPG）、糖化血红蛋白（HbA1C）、总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、肝功能及肝脏B超分度的变化情况，并评价2组患者的临床疗效及用药安全性。【结果】（1）疗效方面：治疗3个月后，治疗组的总有效率为85.00%（34/40），对照组为70.00%（28/40），组间比较（χ²检验），治疗组的疗效明显优于对照组（P＜0.01）。（2）中医证候积分方面：治疗后，2组患者的形体肥胖、肢体困重、气短懒言、胸闷刺痛、腹胀纳呆等中医证候积分均较治疗前降低（P＜0.05），且治疗组对各项中医证候积分的降低幅度均明显优于对照组（P＜0.05）。（3）糖脂代谢指标方面：治疗后，2组患者的FINS、HOMA-IR、FBG、2hPG、HbA1C、TC、TG、LDL-C水平均较治疗前明显降低（P＜0.05），HDL-C水平均较治疗前明显升高（P＜0.05），且治疗组对FINS、HOMA-IR、FBG、2hPG、HbA1C、TC、TG、LDL-C水平的降低幅度及对HDL-C水平的升高幅度均明显优于对照组（P＜0.05）。（4）肝功能方面：治疗后，2组患者的丙氨酸氨基转移酶（ALT）、门冬氨酸氨基转移酶（AST）、γ-谷氨酰转肽酶（GGT）水平均较治疗前明显降低（P＜0.05），且治疗组对各项肝功能指标的降低幅度均明显优于对照组（P＜0.05）。（5）脂肪肝B超分度方面：治疗后，2组患者的脂肪肝B超分度均较治疗前明显改善（P＜0.05），且治疗组对脂肪肝B超分度的改善作用明显优于对照组，差异有统计学意义（P＜0.05）。（6）安全性方面：治疗过程中，2组患者均无肝肾功能受损及血、尿、大便常规异常等不良反应。【结论】双叶散治疗脾虚痰瘀型T2DM合并NAFLD疗效显著，能减轻患者临床症状，纠正糖脂代谢紊乱，改善肝功能和脂肪肝B超分度。

Objective To observe the clinical efficacy of Shuangye San（the prescription mainly composed of Mori Folium and Nelumbinis Folium）in the treatment of type 2 diabetes mellitus（T2DM）complicated with non-alcoholic fatty liver disease（NAFLD）of spleen deficiency and phlegm stasis type. Methods A total of 80 patients with T2DM complicated with NAFLD of spleen deficiency and phlegm stasis type were randomly divided into a treatment group and a control group，with 40 cases in each group. The control group was treated with conventional western medicine for lowering blood glucose and lipid，protecting liver and lowering enzymes. The treatment group was treated with the granules of Shuangye San orally on the basis of treatment for the control group. The course of treatment lasted for three months. The changes of traditional Chinese medicine（TCM）syndrome scores，homeostasis model assessment of insulin resistance（HOMA-IR），fasting insulin（FINS），fasting blood glucose（FBG），2-hour postprandial blood glucose（2hPG），glycosylated hemoglobin（HbA1C），total cholesterol（TC），triglyceride（TG），low-density lipoprotein cholesterol（LDL-C），high-density lipoprotein cholesterol（HDL-C），liver function indicators and B-ultrasound grading of fatty liver in the two groups were observed before and after treatment. After treatment，the clinical efficacy and safety of the two groups were evaluated. Results （1）After three months of treatment，the total effective rate of the treatment group was 85.00%（34/40），and that of the control group was 70.00%（28/40）. The intergroup comparison（tested by chi-square test）showed that the efficacy of the treatment group was significantly superior to that of the control group（P＜0.01）.（2）After treatment，the scores of TCM symptoms of obese physique，heaviness and weakness in the limbs，shortness of breath and unwilling to talk，tightness and stabbing pain in the chest，abdominal distension and poor appetite in the two groups were decreased compared with those before treatment（P＜0.05），and the decrease of TCM syndrome scores in the treatment group was significantly superior to that in the control group （P＜0.05）.（3）After treatment，the levels of glucose and lipid metabolism indicators of FINS，HOMA-IR，FBG，2hPG，HbA1C，TC，TG and LDL-C in the two groups were significantly decreased compared with those before treatment（P＜0.05），and the level of HDL-C was significantly increased compared with that before treatment（P＜0.05）. The decrease of FINS，HOMA-IR， FBG，2hPG，HbA1C，TC，TG and LDL-C levels and the increase of HDL-C levels in the treatment group were significantly superior to those in the control group （P＜0.05）.（4）After treatment，the levels of liver function indicators of alanine aminotransferase（ALT），aspartate aminotransferase（AST）and gamma-glutamyl transpeptidase（GGT）in the two groups were significantly decreased compared with those before treatment（P＜0.05），and the decrease of liver function indicators in the treatment group was significantly superior to that in the control group（P＜0.05）.（5）After treatment，the B-ultrasound grading of fatty liver of the two groups was significantly improved compared with that before treatment（P＜0.05），and the improvement of fatty liver B-ultrasound grading in the treatment group was significantly superior to that in the control group，and the difference was statistically significant（P＜0.05）. （6）During the treatment， there were no adverse reactions such as impairment of liver and kidney function and abnormalities in routine blood，urine and stool test in the two groups. Conclusion Shuangye San exerts certain effect in the treatment of T2DM complicated with NAFLD of spleen deficiency and phlegm stasis type. It can alleviate the clinical symptoms of patients，correct the disorder of glucoseand lipid metabolism，and improve liver function and fatty liver B-ultrasound grading.

R259.892

国家自然科学基金面上项目 （编号：81174225）；广东省基础与应用基础研究基金企业联合基金项目 （编号：2021A1515220177）；深圳市宝安区医疗卫生科技计划项目 （编号：2022JD259）