【目的】 观察降脂护肝膏方（由炒山药、茯苓、人参、北柴胡、佛手、桃仁、虎杖等组成）治疗湿浊内停型非酒精性脂 肪性肝病（NAFLD）的临床疗效和安全性。【方法】 选取2023年11月至2024年12月期间在广州中医药大学茂名医院（茂名市中 医院）消化科门诊及住院部接受治疗的60例湿浊内停型NAFLD患者为研究对象，采用分层随机方法将患者随机分为试验组 和对照组，每组各30例。2组患者均给予生活方式干预治疗（包括饮食控制和运动等），试验组在上述治疗的基础上给予降脂 护肝膏方治疗，疗程为4周。观察2组患者治疗前后的体质量指数（BMI）、肝功能指标[丙氨酸氨基转移酶（ALT）、天冬氨酸 氨基转移酶（AST）、γ-谷氨酰转肽酶（GGT）]、血脂指标[总胆固醇（TC）、甘油三酯（TG）]及中医证候积分的变化情况，并评估 2 组患者的中医证候疗效及用药安全性。【结果】（1）疗效方面，治疗4周后，试验组的总有效率为93.33%（28/30），对照组为 60.00%（18/30）；组间比较（秩和检验），试验组的中医证候疗效明显优于对照组，差异有统计学意义（P＜0.01）。（2）BMI 方 面，治疗后，2组患者的BMI均较治疗前明显改善（P＜0.01），且试验组对BMI的改善幅度明显优于对照组，组间治疗前后差 值比较，差异有统计学意义（P＜0.05）。（3）肝功能方面，治疗后，2 组患者的 ALT、AST、GGT 水平均较治疗前降低（P＜ 0.01），且试验组对 ALT、AST、GGT 水平的降低幅度均明显优于对照组，组间治疗前后差值比较，差异均有统计学意义 （P＜0.05）。（4）血脂方面，治疗后，2组患者的TC、TG水平均较治疗前降低（P＜0.05），且试验组对TC水平的降低幅度明显 优于对照组，组间治疗前后差值比较，差异有统计学意义（P＜0.05）。（5）安全性方面，治疗过程中，2组患者均未发现明显 的不良反应，具有较高的安全性。【结论】 降脂护肝膏方可以有效改善湿浊内停型NAFLD患者BMI、肝功能及血脂水平，缓 解患者临床症状，并且不良反应少，安全性较高。

Objective To evaluate the clinical efficacy and safety of Jiangzhi Hugan Soft Extract （composed of stirfried Dioscoreae Rhizoma， Poria， Ginseng Radix et Rhizoma， Bupleuri Radix， Citri Sarcodactylis Fructus， Persicae Semen，Polygoni Cuspidati Rhizoma，etc.） in treating non-alcoholic fatty liver disease （NAFLD） with internal dampness-turbidity accumulation syndrome. Methods Sixty patients with NAFLD of dampness-turbidity accumulation syndrome treated at the Gastroenterology Department of Maoming Hospital of Guangzhou University of Chinese Medicine （Maoming Hospital of Traditional Chinese Medicine） from November 2023 to December 2024 were enrolled. The patients were divided into trial group and control group using stratified randomization， with 30 patients in each group. Both groups received lifestyle interventions （diet control and exercise），with the trial group additionally receiving Jiangzhi Hugan Soft Extract for 4 weeks. Outcomes included body mass index （BMI）， liver function indicators [alanine aminotransferase （ALT），aspartate aminotransferase （AST），gamma-glutamyl transferase （GGT）]， lipid profiles [total cholesterol （TC）， triglycerides （TG）]， traditional Chinese medicine （TCM） syndrome scores，efficacy evaluation，and safety assessment. Results （1） After 4 weeks of treatment，the overall response rate in the trial group was 93.33% （28/30），while that in the control group was 60.00% （18/30）. The intergroup comparison （by rank sum test） showed that the efficacy of TCM syndrome in the trial group was significantly superior to that in the control group，with a statistically significant difference （P＜0.01）.（2）After treatment，the BMI of patients in both groups was improved significantly compared to before treatment （P＜0.01）. The improvement in BMI was significantly greater in the trial group than in the control group. The difference in the change of BMI between the two groups was statistically significant before and after treatment （P＜0.05）.（3） After treatment，the levels of ALT，AST，and GGT in both groups decreased compared to before treatment （P＜0.01）. The trial group showed a significantly greater reduction in ALT，AST，and GGT levels than the control group. The difference between the two groups was statistically significant before and after treatment （P＜0.05）.（4） After treatment，both groups showed a significant decrease in TC and TG levels compared to pre-treatment levels （P＜ 0.05）. The trial group demonstrated a more pronounced reduction in TC levels than the control group. The difference between the two groups was statistically significant before and after treatment （P＜0.05）.（5） There were no significant adverse reactions occurring in either group during treatment， indicating a high level of safety. Conclusion Jiangzhi Hugan Soft Extract effectively improves BMI，liver function，and lipid profile in NAFLD patients with dampness-turbidity accumulation syndrome，demonstrating good clinical efficacy and high safety， warranting further clinical application.

R259.755

广东省中医药局科研项目（编号：20242121）；第五批全国中医临床优秀人才研修项目（编号：国中医药人教函[2022]1号）