目的 探讨复方苦参注射液对丙型肝炎肝硬化患者的临床疗效及其机制。方法 将56例丙型肝炎肝硬化患者随机分为治疗组和对照组，每组28例，对照组根据病情采用一般保肝护肝处理，如使用维生素C、门冬氨酸钾镁等，治疗组在对照组治疗基础上加用复方苦参注射液静脉滴注，600 mg/次，1次/d。两组3个月为1个疗程，连续治疗2个疗程后评价疗效、肝纤维化4项指标和外周单核细胞分泌细胞因子变化情况，并对IL-10进行mRNA检测。结果 治疗后治疗组ALT复常率34.56%，HCV RNA阴转率9.34%，与对照组（21.54%、6.53%）相比差异有统计学意义（P<0.01、0.05）。两组治疗后血清中透明质酸（HA）水平均低于治疗前，治疗前后差异均有统计学意义（P<0.01），治疗后两组差异无统计学意义；PC-Ⅲ、IV-C治疗前后差异均无统计学意义；治疗后两组层黏连蛋白（LN）均低于治疗前，治疗前后差异均有统计学意义（P<0.01），治疗后，治疗组LN下降程度更为明显，与对照组相比差异有统计学意义（P<0.01）。治疗后，治疗组IL-10 mRNA水平上升，与治疗前相比差异有统计学意义（P<0.01）；治疗后治疗组IL-10 mRNA显著高于对照组，两组比较差异有统计学意义（P<0.05）。对照组治疗前后IL-10 mRNA差异无统计学意义。结论 在常规治疗基础上加用复方苦参注射液对丙型肝炎肝硬化患者有较好的临床疗效，其机制可能是通过影响外周单核细胞IL-10表达，调节机体促炎/抗炎平衡实现的。

Objective To explore the clinical efficacy of Compound Matrine Injection in patients with hepatitis C cirrhosis and mechanism. Methods Patients with hepatitis C cirrhosis (56 cases) were randomly divided into treatment group and control group, 28 cases in each group. The control group used general protecting liver according to the condition of disease, such as vitamin C, potassium aspartate magnesium, and the treatment group added Compound Matrine Injection, id, 600 mg/d. One treatment course was for 3 months, then the efficacy, liver fibrosis, peripheral mononuclear cells secreting cytokines, and mRNA of IL-10 were evaluated after continuous treatment for two courses. Results The recovery rate of ALT in the treatment group was 34.56%, and negative rate of HCV RNA was 9.34%, and those of the control group were 21.54% and 6.53%. There was statistically significant difference between two groups (P < 0.01, 0.05). The levels of HA of the two groups after treatment were lower than those before treatment. The difference between the two groups was statistically significant (P < 0.01), but there was no statistically significant difference after treatment. PC-Ⅲ and IV-C had no significant difference before and after treatment; The LN levels in the two groups after treatment were obviously lower than those before treatment, and the differences were statistically significant (P < 0.01). The LN level of the treatment group decreased more significantly after treatment. Compared to the control group, the difference was statistically significant (P < 0.01). IL-10 mRNA levels of the treatment group after treatment raised. Compared with that before treatment, the difference was statistically significant (P < 0.01). IL-10 mRNA of treatment group after treatment was significantly higher than that in control group, and there was significant difference between two groups (P < 0.05). IL-10 mRNA of the control group had no significant difference before and after treatment. Conclusion There is a better clinical effect of Compound Matrine Injection within the basis of conventional therapy on patients with hepatitis C cirrhosis, and its mechanism may be related to the influence of peripheral mononuclear cell IL-10 and regulating the body's inflammatory balanced realization.