降脂通脉胶囊联合常规疗法治疗非酒精性脂肪性肝炎临床研究

Clinical Study on Jiangzhi Tongmai Capsules Combined with Routine Therapy for Non-Alcoholic Steatohepatitis

目的:观察降脂通脉胶囊联合常规疗法治疗非酒精性脂肪性肝炎(NASH)痰瘀互结证的临床疗效。方法:将120例NASH痰瘀互结证患者随机分为对照组和观察组各60例。2组均在改变不良生活方式的基础上口服甘草酸二铵肠溶胶囊、维生素E软胶囊治疗,观察组加服降脂通脉胶囊。2组疗程均为3个月。治疗前、治疗3个月后检测谷丙转氨酶(ALT)、谷草转氨酶(AST)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)及低密度脂蛋白胆固醇(LDL-C)水平,行腹部CT和B超检查,评定痰瘀互结证评分,评价中医证候疗效、腹部CT疗效及腹部B超疗效。结果:治疗3个月后,观察组中医证候疗效、腹部CT疗效、腹部B超疗效均优于对照组(P<0.05)。2组TC、TG、LDL-C均较治疗前下降(P<0.01),HDL-C水平均较治疗前升高(P<0.01);观察组TC、TG、LDL-C水平均低于对照组(P<0.05),HDL-C水平高于对照组(P<0.05)。2组ALT、AST水平均较治疗前下降(P<0.01);观察组ALT、AST水平均低于对照组(P<0.01)。结论:降脂通脉胶囊联合常规疗法治疗NASH可更好地调节患者的血脂水平,保护肝功能,减轻脂肪肝程度,促进肝脏形态及实质恢复。

Objective:To observe the clinical effect of Jiangzhi Tongmai capsules combined with routine therapy for nonalcoholic steatohepatitis(NASH)with binding of phlegm and stasis syndrome.Methods:A total of 120 cases of NASH patients with binding of phlegm and stasis syndrome were randomly divided into the control group and the observation group,60 cases in each group.Both groups were given oral administration of Jiangzhi Tongmai capsules and vitamin E soft capsules based on the change of unhealthy lifestyles;the observation group was additionally treated with Jiangzhi Tongmai capsules.Both groups were treated for three months.Before treatment and after three-month treatment,the levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C)and low-density lipoprotein cholesterol(LDL-C)in the two groups were detected;abdominal CT scan and abdominal ultrasound were performed;the scores of binding of phlegm and stasis syndrome,the curative effect of Chinese medicine syndrome,abdominal CT scan and abdominal ultrasound were evaluated.Results:After three-month treatment,the curative effect of Chinese medicine syndrome,abdominal CT scan and abdominal ultrasound in the observation group was better than that in the control group(P<0.05).The levels of TC,TG and LDL-C in the two groups were decreased when compared with those before treatment(P<0.01),and the HDL-C levels were increased(P<0.01).The levels of TC,TG and LDL-C in the observation group were lower than those in the control group(P<0.05),and the HDL-C level was higher(P<0.05).The levels of ALT and AST in the two groups were decreased when compared with those before treatment(P<0.01).The levels in the observation group were lower than those in the control group(P<0.01).Conclusion:Jiangzhi Tongmai capsules combined with routine therapy for NASH can better regulate the blood lipid levels of patients,protect their liver function,relieve the degree of fatty liver and promote the recovery of liver histolomorph and essence.