基于临床药效剂量下的栀子大黄汤抗酒精性肝损伤的临床研究OA
A Clinical Study on the Anti-Alcoholic Liver Injury Effect of Gardeniae Fructus and Rhei Radix et Rhizoma Decoction Based on Clinically Effective Dosage
[目的]探究基于临床药效剂量下栀子大黄汤抗酒精性肝损伤的临床疗效.[方法]选取2023年2月至2025年4月期间同济大学附属第十人民医院收治的98例湿热内蕴型酒精性肝损伤患者作为研究对象,依据患者意愿和治疗方式的不同,将98例患者分为对照组47例和研究组51例.对照组给予常规西医治疗,研究组在对照组的基础上给予基于临床药效剂量的栀子大黄汤治疗,疗程均为4周.观察2组患者治疗前后中医证候积分、肝功能指标、肝纤维化指标、FibroScan肝硬度值、糖脂代谢指标、T细胞亚群及欧洲癌症研究与治疗组织生命质量测定量表(EORTC-QLQ-C30)评分的变化情况,并评价2组患者的临床疗效.[结果](1)疗效方面,治疗4周后,研究组的总有效率为90.20%(46/51),对照组为72.34%(34/47),组间比较(χ2检验),研究组的疗效明显优于对照组(P<0.05).(2)中医证候积分方面,治疗后,2组患者的胁肋胀痛、纳差、恶心呕吐、尿黄、身目发黄评分均较治疗前降低(P<0.05),且研究组的降低幅度均明显优于对照组(P<0.01).(3)肝功能指标方面,治疗后,2组患者血清总胆红素(TBil)、胆汁酸(BA)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、γ-谷氨酰转肽酶(GGT)水平均较治疗前降低(P<0.05),且研究组的降低幅度均明显优于对照组(P<0.01).(4)肝纤维化指标方面,治疗后,2组患者血清层黏连蛋白(LN)、I型前胶原氨基端肽原(PINP)、Ⅲ型前胶原肽(Ⅲ-PC)、脯氨酸肽酶(PLD)、透明质酸(HA)水平均较治疗前降低(P<0.05),且研究组的降低幅度均明显优于对照组(P<0.01).(5)肝硬度方面,治疗后,2组患者的肝硬度值(LSM)、受控衰减参数(CAP)值均较治疗前降低(P<0.05),且研究组的降低幅度均明显优于对照组(P<0.01).(6)糖脂代谢方面,治疗后,2组患者的总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、空腹血糖(FBG)、胰岛素抵抗指数(HOMA-IR)水平均较治疗前降低(P<0.05),且研究组的降低幅度均明显优于对照组(P<0.01).(7)T细胞亚群方面,治疗后,2组患者T细胞亚群CD3+、CD4+、CD4+/CD8+水平均较治疗前升高(P<0.05),CD8+水平均较治疗前下降(P<0.05),且研究组对T细胞亚群CD3+、CD4+、CD4+/CD8+水平的升高幅度及对CD8+水平的下降幅度均明显优于对照组(P<0.05或P<0.01).(8)生活质量方面,治疗后,2组患者EORTC-QLQ-C30量表的认知功能、社会功能、身体功能、角色功能等各维度评分均较治疗前升高(P<0.05),且研究组的升高幅度均明显优于对照组(P<0.01).[结论]通过既往实验研究得到的栀子大黄汤有效剂量,应用于在湿热内蕴型酒精性肝损伤患者中,可显著改善肝纤维化,降低肝硬度值,提高肝功能,调节糖脂代谢,改善免疫功能,减轻临床症状,提升临床疗效和生活质量,具备一定抗酒精性肝损伤的活性.
Objective To investigate the clinical efficacy of Gardeniae Fructus and Rhei Radix et Rhizoma(Zhizi Dahuang Decoction,ZZDH Decoction)against alcoholic liver injury when administered at a clinically effective dosage.Methods A total of 98 patients with alcoholic liver injury of internal retention of damp-heat type,admitted to the Tenth People's Hospital Affiliated to Tongji University from February 2023 to April 2025 were enrolled as study subjects.Based on patients'intention and treatment modality,they were divided into a control group(47 cases)and a study group(51 cases).The control group received conventional western medicine treatment,while the study group received additional ZZDH Decoction at a clinically effective dosage for 4 weeks.Before and after treatment,both groups were evaluated for traditional Chinese medicine(TCM)syndrome scores,liver function markers,liver fibrosis markers,FibroScan liver stiffness measurements,glucose and lipid metabolism indicators,T lymphocyte subsets,and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC-QLQ-C30)scores.Clinical efficacy was also assessed.Results(1)Efficacy:After 4 weeks of treatment,the total effective rate in the study group was 90.20%(46/51),significantly higher than 72.34%(34/47)in the control group(by chi-square test,P<0.05).(2)TCM syndrome scores:After treatment,scores for hypochondriac distending pain,poor appetite,nausea and vomiting,yellowish urine,and scleral and cutaneous icterus were significantly decreased in both groups(P<0.05),with significantly greater reductions in the study group(P<0.01).(3)Liver function markers:Serum levels of total bilirubin(TBil),bile acid(BA),alanine aminotransferase(ALT),aspartate aminotransferase(AST),and γ-glutamyl transferase(GGT)were significantly reduced in both groups after treatment(P<0.05),with significantly greater reductions in the study group(P<0.01).(4)Liver fibrosis markers:Serum levels of laminin(LN),procollagen I N-terminal peptide(PINP),procollagen Ⅲ peptide(Ⅲ-PC),prolyl endopeptidase(PLD),and hyaluronic acid(HA)were significantly decreased in both groups after treatment(P<0.05),with significantly greater decreases in the study group(P<0.01).(5)Liver stiffness:Liver stiffness measurement(LSM)and controlled attenuation parameter(CAP)values were significantly reduced in both groups after treatment(P<0.05),with significantly greater reductions in the study group(P<0.01).(6)Glucose and lipid metabolism:After treatment,levels of total cholesterol(TC),triglycerides(TG),low-density lipoprotein cholesterol(LDL-C),fasting blood glucose(FBG),and homeostatic model assessment of insulin resistance(HOMA-IR)were significantly decreased in both groups(P<0.05),with significantly greater decreases in the study group(P<0.01).(7)T lymphocyte subsets:After treatment,the percentages of CD3+,CD4+,and CD4+/CD8+ratio were significantly increased,while CD8+percentage was significantly decreased in both groups(P<0.05).The study group showed significantly greater improvements in these parameters compared to the control group(P<0.05 or P<0.01).(8)Quality of life:After treatment,scores for cognitive function,social function,physical function,and role function dimensions of the EORTC-QLQ-C30 scale were significantly increased in both groups(P<0.05),with significantly greater increases in the study group(P<0.01).Conclusion The ZZDH Decoction at clinically effective dosage determined by prior experimental studies significantly alleviates liver fibrosis,reduces liver stiffness,improves liver function,regulates glucose and lipid metabolism,enhances immune function,alleviates clinical symptoms,and improves clinical efficacy and quality of life in patients with alcoholic liver injury of internal retention of damp-heat type,demonstrating promising anti-alcoholic liver injury effect.
颜姝雯;果卉;金哲明
同济大学附属第十人民医院,上海 201821同济大学附属第十人民医院,上海 201821同济大学附属第十人民医院,上海 201821
医药卫生
临床药效剂量栀子大黄汤酒精性肝损伤湿热内蕴型肝功能肝纤维化糖脂代谢免疫功能生活质量
clinically effective dosageGardeniae Fructus and Rhei Radix et Rhizoma Decoctionalcoholic liver injuryinternal retention of damp-heat typeliver functionliver fibrosisglucose and lipid metabolismimmune functionquality of life
《广州中医药大学学报》 2026 (6)
1464-1472,9
国家自然科学基金资助项目(编号:82304687)
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