参泽舒肝胶囊对非酒精性脂肪性肝炎湿热瘀结证作用研究

Clinical Evaluation of Shen Ze Shugan Capsule in the Treatment of Non-alcoholic Steatohepatitis(Damp-heat Stagnation Syndrome)

目的评价参泽舒肝胶囊治疗非酒精性脂肪性肝炎(湿热瘀结证)的临床疗效。方法将120例患者按随机数字表法分为对照组60例及观察组60例。对照组予多烯磷脂酰胆碱胶囊,每次2粒,每天3次,口服;维生素E软胶囊,每次0.1 g,每天3次,口服;合并高胆固醇血症,加用阿托伐他汀钙片,每次10 mg,每天1次,口服。观察组西医治疗措施同对照组,并加用参泽舒肝胶囊,每次5粒,每天3次,口服。疗程:3个月。检测治疗前后谷丙转氨酶(ALT)、谷草转氨酶(AST)、血脂4项、空腹血糖(FGP)、空腹胰岛素(FINS),并计算胰岛素敏感指数(ISI)和胰岛素抵抗指数(HOMA-IR),进行腹部CT检查,测量肝/脾CT比值;进行腹部彩超检查,测定Fibroscan肝脏脂肪含量;进行主要症状评分。结果治疗后观察组ALT、AST水平低于对照组,HOMA-IR低于对照组,ISI高于对照组(P<0.01);观察组肝/脾CT比值高于对照组,CAP值和主要症状积分低于对照组(P<0.01);经秩和检验,观察组患者肝脏脂肪含量测定疗效优于对照组(P<0.05),观察组实验室指标疗效优于对照组(P<0.05);观察组患者腹部B超疗效优于对照组(P<0.05);观察组患者腹部CT疗效优于对照组(P<0.05)。结论参泽舒肝胶囊可降低NASH患者的肝/脾CT比值、CAP值,减轻中医症状,具有保肝、降酶功能,能提高ISI,改善胰岛素抵抗,起到减轻脂肪肝程度和促进肝脏形态及实质恢复的作用。

Objective To evaluate the clinical efficacy of Shen Ze Shugan capsule in treatment of non-alcoholic steatohepatitis(damp-heat stagnation syndrome).Methods One hundred and twenty patients were divided into control group with 60 cases and observation group with 60 cases according to random number table.Patients in control group were treated with polyene phosphatidylcholine capsules(2 capsules per time,3 times per day),plus vitamin E soft capsules(0.1 g per time,3 times per day,orally);patients with hypercholesterolemia,were additionally given atorvastatin calcium tablets(10 mg per time,1 times per day).In the observation group,the western medicine treatment measures were the same as those in the control group,and given Shen Ze Shugan capsule additionally(5 capsules per time,3 times per day).Treatments were last for 3 months.The alanine aminotransferase(ALT),aspartate aminotransferase(AST),blood lipids,fasting plasma glucose(FGP)and fasting insulin(FINS)were measured before and after treatment,and the insulin sensitivity index(ISI)and insulin resistance index(HOMA-IR)were calculated,abdominal CT examination was performed to obtain the liver/spleen CT ratio;abdominal color Doppler ultrasonography were performed.Fibroscan was used for liver fat content determination.Major symptoms of patients were scored.Results The levels of ALT and AST in the observation group were lower than those in the control group;HOMA-IR was lower than that of control group,ISI was higher than that of control group(P<0.01);the ratio of liver/spleen by CT in the observation group was higher than that in the control group,and the CAP value and main symptom score were lower than those in the control group(P<0.01).Rank sum test result showed that the curative effect of the observation group was better than that of the control group(P<0.05).The laboratory indexes in the observation group was better than that in the control group with significant difference(P<0.05);the effect showed by abdominal B-mode ultrasonography in the observation group was better than that in the control group(P<0.05);the effect showed by abdominal CT in the observation group was better than that in the control group(P<0.05).Conclusion Shen Ze Shugan capsule can reduce the CT ratio of liver/spleen and CAP ratio in NASH patients,alleviate traditional Chinese medical syndromes,has the functions of protecting liver and lowering enzymes,which can improve ISI,improve insulin resistance;it also has the function of reducing the degree of fatty liver and promoting recovery of liver morphology and substance.