自拟莓茶化脂方联合双歧杆菌三联活菌胶囊 治疗代谢相关脂肪性肝病合并糖尿病前期(湿热蕴结证)的疗效观察

Observation on the Efficacy of a Self-Formulated Berry Tea Fat-Metabolizing Formula Combined with Bifidobacterium Triple Live Bacteria Capsules in Treating Metabolic-Associated Fatty Liver Disease with Prediabetes (Pattern of Damp-Heat Accumulation)

摘要: 目的：观察自拟莓茶化脂方联合双歧杆菌三联活菌胶囊治疗代谢相关脂肪性肝病(MAFLD)合并糖尿病前期(湿热蕴结证)的临床效果。方法：将2025年1月~2025年12月张家界市中医医院收治的120例MAFLD合并糖尿病前期(湿热蕴结证)患者，随机分为治疗组、对照组1、对照组2，每组各40例。对照组1仅给予常规生活方式干预，对照组2在对照组1的基础上加用双歧杆菌三联活菌胶囊，治疗组在对照组1的基础上加用自拟莓茶化脂方联合双歧杆菌三联活菌胶囊，疗程均为8周。比较3组治疗前后总有效率、肝脏脂肪受控衰减参数(CAP)，肝功能酶学指标[谷丙转氨酶(ALT)、谷草转氨酶(AST)、谷氨酰转肽酶(GGT)]，糖代谢指标[空腹血糖(FPG)、口服葡萄糖耐量试验(OGTT) 2 h血糖(2hPG)、糖化血红蛋白(HbA1c)]，脂代谢指标[甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)]，中医证候疗效指标(中医证候积分、疗效指数)并观察不良事件发生情况。结果：总有效率治疗组为92.5% (37/40)，对照组1为77.5% (31/40)，对照组2为80% (32/40)，3组比较，差异有统计学意义(P < 0.05)。3组治疗后CAP、ALT、AST、GGT、FPG、OGTT 2hPG、HbA1c、TG、TC、HDL-C、LDL-C及中医证候积分、疗效指数组内比较有统计学差异(P < 0.01)，且治疗组上述指标的改善幅度显著优于对照组1和对照组2 (P < 0.05)；3组不良事件总发生率比较差异无统计学意义(P > 0.05)。结论：自拟莓茶化脂方联合双歧杆菌三联活菌胶囊应用可有效改善MAFLD合并糖尿病前期(湿热蕴结证)患者的脂肪肝程度，促进肝功能恢复，调节糖脂代谢水平，缓解临床症状且安全性良好。

Abstract: Objective: To evaluate the clinical efficacy of a proprietary berry tea formula combined with Bifidobacterium triple-strain live bacteria capsules in treating metabolic-associated fatty liver disease (MAFLD) complicated by prediabetes (pattern of damp-heat accumulation). Methods: From January to December 2025, 120 patients with MAFLD and prediabetes (damp-heat accumulation pattern) admitted to Zhangjiajie Traditional Chinese Medicine Hospital were randomly assigned to the treatment group, control group 1, and control group 2, with 40 patients in each group. Control Group 1 received only conventional lifestyle intervention. Control Group 2 received the same intervention plus Bifidobacterium Triple Live Bacteria Capsules. The Treatment Group received the same intervention as Control Group 1 plus a proprietary berry tea formula for fat reduction combined with Bifidobacterium Triple Live Bacteria Capsules. All groups underwent an 8-week treatment course. The following parameters were compared among the three groups before and after treatment: overall response rate, controlled attenuation parameter (CAP) for hepatic fat, liver enzyme levels [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)], glucose metabolism indicators [fasting plasma glucose (FPG), 2-hour post-oral glucose tolerance test (OGTT) glucose (2hPG), glycated hemoglobin (HbA1c)], lipid metabolism indicators [triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)], and Traditional Chinese Medicine (TCM) syndrome efficacy indicators (TCM syndrome scores, efficacy index), while monitoring adverse events. Results: The total effective rate was 92.5% (37/40) in the treatment group, 77.5% (31/40) in control group 1, and 80% (32/40) in control group 2. Comparisons among the three groups showed statistically significant differences (P < 0.05). Post-treatment comparisons within each group showed statistically significant differences (P < 0.01) for CAP, ALT, AST, GGT, FPG, OGTT 2hPG, HbA1c, TG, TC, HDL-C, LDL-C, TCM syndrome scores, and efficacy indices. The treatment group demonstrated significantly greater improvement in these parameters compared to Control Groups 1 and 2 (P < 0.05). The overall incidence of adverse events showed no statistically significant difference among the three groups (P > 0.05). Conclusion: The combination of the proprietary Berry Tea Fat-Reducing Formula and Bifidobacterium Triple Live Bacteria Capsules effectively improves the severity of fatty liver in patients with MAFLD complicated by prediabetes (damp-heat accumulation pattern), promotes liver function recovery, regulates glucose and lipid metabolism levels, alleviates clinical symptoms, and demonstrates good safety.