摘要
目的:探讨消脂护肝胶囊治疗痰湿瘀阻型非酒精性脂肪性肝炎患者的临床疗效及对血清白细胞介素-6(IL-6)、单核细胞趋化蛋白(MCP-1)的影响。方法:选取河南中医药大学第一附属医院脾胃肝胆病科2020年7月至2022年12月收治的痰湿瘀阻型非酒精性脂肪性肝炎患者124例,按随机数字表法均分为观察组与对照组,每组各62例,疗程6个月,观察组口服消脂护肝胶囊,对照组口服多烯磷脂酰胆碱胶囊,疗效指标为丙氨酸氨基转移酶(ALT),天冬氨酸氨基转移酶(AST),肝脏瞬时弹性成像受控衰减参数(CAP值),肝脏硬度值(LSM),中医证候评分(肝区不适/隐痛/胀痛、乏力等),体质量指数(BMI),腰高比(WHtR),高密度脂蛋白胆固醇(HDL-C),总胆固醇(TC),甘油三酯(TG),胰岛素抵抗指数(HOMA-IR)[包含空腹血糖(FBG)、空腹胰岛素水平(INS)],游离脂肪酸(FFA),IL-6,MCP-1,并记录药物不良反应。结果:治疗后,观察组患者总有效率92.3%(48/52),对照组患者总有效率75.5%(39/49),观察组总有效率高于对照组(χ^(2)=5.339,P<0.05)。与本组治疗前比较,治疗后两组患者中医证候积分均明显降低(P<0.05),与对照组治疗后比较,观察组改善更优(P<0.05)。与本组治疗前比较,治疗后两组患者ALT、AST、TC、FFA、FINS、HOMA-IR、MCP-1、IL-6、CAP值、LSM、BMI、WHtR水平均明显降低(P<0.05),与对照组治疗后比较,观察组在改善上述指标水平上均优于对照组(P<0.05)。与本组治疗前比较,观察组患者治疗后TG、FBG均明显降低(P<0.05),HDL-C明显升高(P<0.05),而对照组治疗前后差异无统计学意义。与对照组治疗后比较,观察组上述指标改善更优(P<0.05)。治疗过程中两组未见严重不良反应。结论:消脂护肝胶囊治疗痰湿瘀阻型非酒精性脂肪性肝炎患者临床疗效确切,可减少肝脏脂肪变性,降低肝脏硬度值,抑制血清炎症因子的表达,可减轻肝脏炎症,未发生明显不良反应,值得临床推广。
Objective:To observe the clinical effect of Xiaozhi Hugan capsules in treating patients with non-alcoholic steatohepatitis(NASH)combined with phlegm-dampness and blood stasis syndrome and its effects on serum interleukin-6(IL-6)and monocyte chemoattractant protein-1(MCP-1).Methods:A total of 124 patients with NASH combined with phlegm-dampness and blood stasis syndrome who were admitted to the Department of Spleen,Stomach,and Hepatobiliary Diseases,the First Affiliated Hospital of Henan University of Chinese Medicine from July 2020 to December 2022 were selected.According to the random number table method,patients were randomly divided into an observation group(62 cases)and a control group(62 cases).The treatment duration was 6 months.The observation group received Xiaozhi Hugan capsules orally,while the control group received polyene phosphatidylcholine capsules.The efficacy indicators included alanine aminotransferase(ALT),aspartate aminotransferase(AST),controlled attenuation parameter(CAP),liver stiffness measurement(LSM),traditional Chinese medicine(TCM)syndrome scores(discomfort/dull pain/distending pain in liver region,fatigue,etc.),body mass index(BMI),waist-to-height ratio(WHtR),high-density lipoprotein cholesterol(HDL-C),total cholesterol(TC),triglycerides(TG),homeostatic model assessment for insulin resistance(HOMA-IR)[including fasting blood glucose(FBG)and fasting insulin level(INS)],free fatty acids(FFA),IL-6,and MCP-1.Adverse drug reactions were recorded.Results:After treatment,the total effective rate in the observation group was 92.3%(48/52),while that in the control group was 75.5%(39/49).The total effective rate in the observation group was higher than that in the control group(χ^(2)=5.339,P<0.05).After treatment,the TCM syndrome scores in both groups were significantly reduced(P<0.05),and the post-treatment scores in the observation group were better than those in the control group(P<0.05).After treatment,the levels of ALT,AST,TC,FFA,fasting insulin(FINS),HOMA-IR,MCP-1,IL-6,CAP,LSM,BMI,and WHtR were decreased(P<0.05)significantly in both groups,and the observation group showed superior improvement in the above indicators compared to the control group(P<0.05).The observation group exhibited significant reductions in TG and FBG(P<0.05)and an increase in HDL-C(P<0.05),while no significant changes were observed in the control group.The observation group was superior to the control group after treatment(P<0.05).No severe adverse reactions occurred in either group during the treatment.Conclusion:Xiaozhi Hugan capsules have significant clinical efficacy in treating patients with NASH combined with phlegm-dampness and blood stasis syndrome.It reduces hepatic steatosis,lowers liver stiffness,inhibits the expression of serum inflammatory factors,and alleviates liver inflammation.No obvious adverse reactions occur,suggesting it is suitable for clinical application.
作者
刘晓彦
马素平
马庆亮
李春晓
张丽慧
陈华鑫
赵文霞
LIU Xiaoyan;MA Suping;MA Qingliang;LI Chunxiao;ZHANG Lihui;CHEN Huaxin;ZHAO Wenxia(The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450046,China;The First Clinical Medical College,Henan University of Chinese Medicine,Zhengzhou 450003,China)
出处
《中国实验方剂学杂志》
北大核心
2025年第12期185-192,共8页
Chinese Journal of Experimental Traditional Medical Formulae
基金
河南省中医药传承与创新人才工程第二批拔尖人才项目(豫卫中医函[2021]15号)
第二届全国名中医传承工作室建设项目[国中医药办人教函(2022)245号]
国家中医药传承创新中心科研专项(2023ZXZX1061)
河南省中医学“双一流”创建科学研究专项(HSRP-DFCTCM-2023-6-02)
河南省中医药科学研究专项(2019JDZX2012)。
关键词
消脂护肝胶囊
非酒精性脂肪性肝炎
痰湿瘀阻
血清炎症因子
临床研究
Xiaozhi Hugan capsules
non-alcoholic steatohepatitis
phlegm-dampness and blood stasis syndrome
serum inflammatory factor
clinical study
