半夏泻心汤加减对非酒精性脂肪肝的临床疗效及对胰岛素抵抗的调节效果观察

Regulatory Effect of Modified Banxia Xiexintang on Insulin Resistance of Patients with Nonalcoholic Fatty Liver

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.