“浙八味”煎剂治疗非酒精性脂肪性肝炎的前瞻性队列研究

Prospective Cohort Study of “Eight Zhes” Decoction in the Treatment of Non-alcoholic Steatohepatitis

关键词:  非酒精性脂肪性肝炎  浙江道地药材  “浙八味”煎剂  队列研究

Key words:  non-alcoholic steatohepatitis  genuine medicinal materials in Zhejiang  “Eight Zhes” decoction  cohort study

摘要:

目的 探讨中药复方"浙八味"煎剂治疗非酒精性脂肪性肝炎的临床疗效和安全性。方法 采用前瞻性队列研究设计，收集非酒精性脂肪性肝炎临床病例，按患者治疗意愿分为试验组和对照组。对照组纳入66例常规西医治疗，予生活方式干预及多烯磷脂酰胆碱胶囊治疗，试验组纳入63例在西医常规治疗基础上给予中药"浙八味"煎剂治疗。疗程均为12周，疗程结束后评估患者中医症候疗效、B超疗效、血肝功能及血脂变化。结果 试验组中医症候疗效总有效率显著高于对照组（P<0.01）；试验组TG、TC复常率显著高于对照组（P<0.01或P<0.05）；2组ALT、AST复常率均为90%左右，无显著性差异；试验组B超总有效率显著高于对照组（P<0.05）。结论 非酒精性脂肪性肝炎在西医常规治疗基础上，联合"浙八味"煎剂能显著提高临床疗效。

Abstract:

OBJECTIVE To explore the clinical efficacy and safety of "Eight Zhes" decoction in the treatment of non-alcoholic steatohepatitis. METHODS A prospective cohort study design was used. Clinical cases of non-alcoholic steatohepatitis were collected. Patients were divided into experimental group and control group according to their treatment intention. Sixty-six cases in the control group were treated with routine western medicine for lifestyle intervention and treatment with polyene phosphatidy-lcholine capsules. Sixty-three cases in the experimental group were treated with integrated traditional Chinese and western medicine, received "Eight Zhes" decoction treatment. The course of treatment was 12 weeks, evaluate the curative effect of TCM symptoms, B-ultrasound, blood-liver function and blood lipid changes in patients. RESULTS The total effective rate of TCM symptoms in the experimental group was significantly higher than that in the control group(P<0.01). The normalization rate of TG and TC in the experimental group was significantly higher than that in the control group(P<0.01 or P<0.05). The normalization rates of ALT and AST in both groups were about 90%, there was no significant difference between the two groups. Besides, according to the results of B-ultrasound, the total effective rate of the experimental group was significantly higher than that of the control group(P<0.05). CONCLUSION The results suggest that, the traditional Chinese medicine "Eight Zhes" decoction can significantly improve the clinical efficacy in the treatment of non-alcoholic steatohepatitis on the bases of routine western medicine.