复方牛胎肝提取物片治疗肝纤维化的多中心研究

目的观察研究复方牛胎肝提取物片治疗肝纤维化在扩大人群中的临床疗效。方法采用多中心、自身对照的研究设计。筛选肝纤维化患者共115例,所有病例给予口服复方牛胎肝提取物片治疗24周,治疗前均行肝穿刺做肝活体组织检查,其中有38例患者住治疗后再次做肝活体组织检查。患者均在治疗前、治疗后12、24周和36周,应用放射免疫法检测患者血清肝纤维化标志物HA、LN、Ⅳ型胶原（Ⅳ-C）,观察用药前后各项指标及肝组织病理学变化。结果口服复方牛胎肝提取物片治疗前（0周）,治疗后24周和36周,患者血清肝纤维化标志物HA值分别为（279.2±81.4）ng/ml、（136.8±56.7）ng/ml、（86.9±40.7）ng/ml,LN值分别为（170.8±73.0）ng/ml、（112.5±39.5）ng/ml、（60.8±31.8）ng/ml;Ⅳ-C值分别为（153.7±60.1）ng/ml、（112.4±43.1）ng/ml、（96.3±44.1）ng/ml,治疗后血清肝纤维化标志物较治疗前显著降低（P〈0.05）。肝活体组织病理检查显示,治疗后肝组织纤维化分期比治疗前有明显降低（P〈0.01）。结论复方牛胎肝提取物片具有改善肝纤维化的作用,对于治疗慢性肝病肝纤维化具有较好的疗效。

A multicenter clinical study of Anfate for treatment of hepatic fibrosis in patients with chronic liver diseases

OBJECTIVES: To investigate the effect of Anfate (compound fetal cow liver extract tablets) in hepatic fibrosis patients with chronic liver diseases. METHODS: One hundred fifteen hepatic fibrosis patients with chronic liver diseases from 3 medical centers were included in this study. All patients were given Anfate orally for twenty-four weeks. Before treatment and 12, 24 and 36 weeks after the treatment, serum levels of hyaluronic acid (HA), laminin (LN) and type IV collagen (IV-C) of the patients were measured by radioimmunoassay and their liver biopsy specimens were also assessed. RESULTS: Before treatment and 24 and 36 weeks after the Anfate treatment, serum levels of HA were (279.2+/-81.4) ng/ml, (136.8+/-56.7) ng/ml and (86.9+/-40.7) ng/ml respectively, serum levels of LN were (170.8+/-73.0) ng/ml, (112.5+/-39.5) ng/ml, and (60.8+/-31.8) ng/ml respectively, and IV-C levels were (153.7+/-60.1) ng/ml, (112.4+/-43.1) ng/ml, and (96.3+/-44.1) ng/ml respectively. There was a significant reduction in these serum values after the treatments. Histopathological examinations of the liver biopsies showed that the degree of hepatic fibrosis obviously declined by one or two degrees after the treatments. CONCLUSIONS: Anfate has positive effects in treating hepatic fibrosis.