不同剂量丹参注射液抗肝纤维化临床研究

Clinical Study on Treatment of Liver Fibrosis by Different Dosages of Salvia Injection

目的 :探讨何种剂量丹参注射液治疗慢性乙型肝炎肝纤维化可取得最佳疗效。方法 :选用诊断为慢性乙型肝炎肝纤维化且中医辨证为血瘀阻络证的患者 6 4例 ,采用抽签法随机分为丹参高、中、低剂量治疗组及对照组。各组均给予中药膈下逐瘀汤加减。丹参高、中、低剂量组分别加丹参注射液 2 4ml、16ml、8ml静脉滴注治疗。 4 5天为 1个疗程 ,观察各组治疗前后的临床症状、体征、肝功能指标 :丙氨酸氨基转移酶(ALT)、天门冬酸氨基转移酶 (AST)、白蛋白 (ALB) ,肝纤维化指标 :Ⅲ型前胶原 (PCⅢ )、Ⅳ型胶原 (ⅣC)、透明质酸 (HA)。结果 :高、中、低剂量丹参注射液均有改善临床症状 ,降低ALT、AST的作用 ,并有显著降低HA、PCⅢ、ⅣC的作用。其中高剂量组的疗效优于中、低剂量组 (均P <0 0 5 ) ,而中、低剂量组两者之间差异无显著性。结论 :丹参高剂量组防治肝纤维化的作用优于中、低剂量组。

Objective:To find the optimal dosage of Salvia injection in treating chronic hepatitis B caused liver fibrosis. Methods:Sixty-four patients, whose diagnosis was confirmed as chronic hepatitis B caused liver fibrosis and differentiated by TCM typing as blood stasis blocking Collaterals type, were selected and randomly divided by lottery method into the large, middle and small dose of SI treated groups and the control group. All the patients were treated with modified Gexia Zhuyu Decoction, to the patients in the SI groups, 24 ml, 16 ml and 8 ml of SI were additionally administered by intravenous dripping respectively. The therapeutic course was 45 days. The clinical symptoms and signs; liver functional indexes as alanine transaminase (ALT), aspartate aminotransferase (AST) and albumin (ALB); and liver fibrosis indexes as procollagen type Ⅲ (PC-Ⅲ), collagen type Ⅳ (C-Ⅳ) and hyaluronic acid (HA), were measured before and after treatment. Results:Different dosages of SI all could improve the clinical symptoms, and lower levels of ALT, AST, HA, PC-Ⅲ and C-Ⅳ. Treatment of large dosage SI showed the best efficacy, superior to that of middle and small dosge SI, but no significant difference was found between the efficacy of the latter two. Conclusion:Anti-liver fibrosis effect of large dosage SI is better than that of middle or small dosage SI.