摘要
目的:观察半夏泻心汤加减治疗非酒精性脂肪肝(NAFLD)的临床疗效及对胰岛素抵抗(IR)调节效果。方法:将140例患者按1∶1随机按数字表法分为对照组和观察组。对照组脱落/失访4例,违背方案剔除3例,完成63例;观察组脱落/失访5例,完成65例。两组均给予生活方式干预、保肝和调脂等处理。对照组口服化滞柔肝颗粒,1袋/次,3次/d;观察组内服半夏泻心汤加减,1剂/d;两组疗程均为治疗12周,并随访12周。采用瞬时弹性记录仪测量肝脏脂肪含量,测量空腹血糖(FGP)和空腹胰岛素(FINS),并计算胰岛素敏感指数(ISI),胰岛素抵抗指数(HOMA-IR)和胰岛β细胞功能指数(HOMA-β),治疗前、治疗后和随访时各评价1次;进行治疗前后腹部B超检查;测量肝/脾CT;检测治疗前后丙氨酸氨基转移酶(ALT),天冬氨酸氨基转移酶(AST),总胆固醇(TC),甘油三酯(TG),高密度脂蛋白胆固醇(HDL-C),低密度脂蛋白胆固醇(LDL-C),脂联素、瘦素、丝氨酸蛋白酶抑制剂(Vaspin),肿瘤坏死因子(TNF-α)和白细胞介素-6(IL-6)水平;进行治疗前后中医证候评分;进行安全性评价。结果:观察组患者治疗后和随访期CAP和HOMA-IR均低于对照组(P<0.01),ISI和HOMA-β均高于对照组(P<0.01);观察组患者血脂各指标的改善均高于对照组(P<0.01);观察组ALT,AST,FBG和FINS均低于对照组(P<0.01);观察组中医证候评分低于对照组(P<0.01),肝/脾CT高于对照组(P<0.01);观察组TNF-α,IL-6,Vaspin和瘦素水平均低于对照组(P<0.01),脂联素水平高于对照组(P<0.01);观察组腹部B超疗效和肝脏脂肪含量测定疗效均高于对照组(P<0.05)。两组试验期间均无严重不良事件,没有发现与药物相关不良反应。结论:半夏泻心汤加减治疗NAFLD肝胃不和、湿浊内停型患者,可调节糖、脂代谢,提高了胰岛素敏感性和HOMA-β细胞功能,改善了IR,并能调节脂肪细胞因子、炎症因子,减轻了临床症状和肝脏脂肪含量,提高了肝/脾CT,有着较好的临床疗效和安全性。
Objective:To observe the clinical efficacy of modified Banxia Xiexintang on nonalcoholic fatty liver(NAFLD)and the regulatory effect on insulin resistance(IR). Method: One hundred and forty patients were randomly divided into control group and observation group. A total of 63 patients in control group completed the therapy(4 patients fell off or were lost to follow-up,3 were eliminated),while 65 patients in observation group completed the therapy(5 patients fell off or were lost to follow-up,none was eliminated).Both groups’ patients got lifestyle intervention,liver protection and lipid regulation. Patients in control group got Huazhi Rougan granule, 1 pack/time, 3 times/day. Patients in observation group got modified Banxia Xiexintang,1 dose/day. And the course of treatment for the two groups was 12 weeks,and a 12 week follow-up was recorded. Before and after treatment and during the follow-up, fat content of liver was recorded by instantaneous elastic recorder,fasting blood glucose(FBG)and fasting insulin(FINS)were detected,and insulin sensitivity index(ISI),insulin resistance index(HOMA-IR)and islet β cell function index(HOMA-β)were detected. After treatment,B-mode ultrasonography and ratio of liver/spleen CT were detected. And levels of alanine transaminase(ALT),aspartate transaminase(AST),total cholesterol(TC),triglyceride(TG),highdensity lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),adiponectin,leptin,serine protease inhibitor(Vaspin),tumor necrosis factor(TNF)-α and interleukin-6(IL-6)were detected. And the safety was evaluated. Result: CAP and HOMA-IR in observation group were lower than those in control group after treatment and during the follow-up(P<0.01),and ISI and HOMA-β were higher than those in control group(P<0.01). Amelioration of indexes of blood lipid was better than those in control group(P<0.01).Levels of ALT,AST,FBG and FINS were lower than those in control group(P<0.01). Scores of traditional Chinese medicine(TCM)syndromes were lower than those in control group(P<0.01),ratio of liver/spleen CT and adiponectin was higher than that in control group(P<0.01). Levels of TNF-α,IL-6,vaspin and leptin were lower than those in control group(P<0.01). B-ultrasound efficacy and fat content of liver were superior to those of control group(P<0.05). There were no serious adverse events and drug-related adverse reactions. Conclusion:Modified Banxia Xiexintang can regulate glucose and lipid metabolism,improve insulin sensitivity and HOMA-β cell function,improve IR,regulate adipocytokines and inflammatory factors,relieve clinical symptoms and liver fat content,and improve CT ratio of liver/spleen,with a better clinical efficacy and safety.
作者
绽永华
王学红
王芳
ZHAN Yong-hua;WANG Xue-hong;WANG Fang(Affiliated Hospital of Qinghai University,Xining 810001,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2021年第3期117-122,共6页
Chinese Journal of Experimental Traditional Medical Formulae
基金
青海省临床医学研究中心项目(2019-SF-L3)。
关键词
非酒精性脂肪性肝炎
肝胃不和、湿浊内停证
半夏泻心汤
胰岛素抵抗
胰岛β细胞功能指数
脂肪细胞因子
炎症因子
nonalcoholic steatohepatitis
disharmony of liver and stomach
stagnation of dampness and turbidity
Banxia Xiexintang
insulin resistance
HOMA-βcell
adipocyte factor
inflammatory factor
