摘要目的:明确益气活血方治疗慢性病毒性肝炎肝纤维化的临床疗效。方法:采用开放、阳性药平行对照研究的方法，选取经肝穿活组织学及肝脏瞬时弹性成像技术检查确诊的慢性乙型及丙型肝炎肝纤维化患者207例，根据中医辨证施治的原则，分别采用自拟益气活血方（ n = 127）和扶正化瘀胶囊（ n = 80）治疗，疗程均为24～48周。对比分析两组患者中医症候积分、肝脏生化学、肝脏硬度值（LSM）、无创性肝纤维化指数[天冬氨酸转氨酶与血小板比值指数（APRI）、基于4因子的肝纤维化指标（FIB-4）]的变化，评估益气活血方抗肝纤维化疗效。 结果:益气活血方组和扶正化瘀胶囊组患者基线LSM、APRI、FIB-4比较， P值均> 0.05，差异均无统计学意义。应用益气活血方和扶正化瘀胶囊患者症候积分均有一定程度改善，益气活血方在改善肝病面容、肝区不适及腰膝酸软方面优于扶正化瘀胶囊（ P < 0.05）；肝脏生物化学指标（丙氨酸转氨酶、天冬氨酸转氨酶、γ-谷氨酰转移酶、碱性磷酸酶）随疗程延长逐渐复常，治疗24～48周复常率两组分别为100%对比100%、100%对比93.8%、96.8%对比92.3%及87.5%对比81.8%。治疗12周后两组APRI值均显著降低；治疗48周，两组LSM显著改善；而FIB-4显著改善仅见于益气活血方治疗48周，与扶正化瘀治疗组比较差异有统计学意义， P < 0.05。两组治疗后LSM、APRI、FIB-4的总有效率分别为80.0%对比63.6%， P = 0.046；68.4%对比52.0%， P = 0.052；68.4%对比62.0%， P = 0.437；益气活血方治疗患者LSM总有效率显著高于扶正化瘀胶囊治疗组。 结论:中药益气活血方可作为治疗慢性病毒性肝炎肝纤维化的优选方案。

abstractsObjective:To clarify the clinical efficacy of Yiqi Huoxue recipe in the treatment of liver fibrosis of chronic viral hepatitis.Methods:An open, positive-drug, parallel-controlled study method was applied. A total of 207 cases of liver fibrosis with chronic hepatitis B and C diagnosed with liver biopsy and transient elastography were selected. According to the principle of syndrome differentiation in traditional Chinese medicine, self-made Yiqi Huoxue recipe ( n = 127) and Fuzheng Huayu capsule ( n = 80) were used for the treatment course of 24-48 weeks. Change score of TCM symptom, liver biochemistry, liver stiffness measurement (LSM), and noninvasive liver fibrosis index [aspartate transaminase to platelet ratio index (APRI), and fibrosis-4 score (FIB-4)] were compared between the two groups to evaluate the therapeutic effect of Yiqi Huoxue recipe on liver fibrosis. Results:Yiqi Huoxue recipe group and Fuzheng Huayu capsule group baseline LSM, APRI and FIB-4 was compared, and there was no statistically significant difference between them ( P > 0.05). Yiqi Huoxue recipe and Fuzheng Huayu capsule received patients had improved symptom scores to a certain extent. Hepatic facies, discomfort over liver area, and soreness and weakness of waist and knees ( P < 0.05) was significantly improved in Yiqi Huoxue recipe than Fuzheng Huayu capsule. Liver biochemical indicators (ALT, AST, GGT, ALP) had gradually relapsed with the extension of treatment duration and the normalization rate between the two groups after 24 to 48 weeks had reached 100% vs. 100%, 100% vs. 93.8%, 96.8% vs. 92.3% and 87.5% vs. 81.8%. After 12 weeks of treatment, APRI values ??of both groups had significantly reduced, and after 48 weeks of treatment, LSM values of both groups had significantly improved. Moreover, Yiqi Huoxue recipe FIB-4 score was significantly improved after 48 weeks of treatment, and the difference was statistically significant compared to Fuzheng Huayu capsule group ( P < 0.05). After treatment, LSM, APRI, and FIB-4 total effectiveness in the two groups were 80.0% vs. 63.6%, P = 0.046; 68.4% vs. 52.0%, P = 0.052; 68.4% vs. 62.0%, P = 0.437, respectively. LSM total effectiveness was significantly higher in Yiqi Huoxue recipe treated group than Fuzheng Huayu capsule group. Conclusion:Traditional Chinese medicine Yiqi Huoxue decoction can be used as an optimal treatment for liver fibrosis of chronic viral hepatitis.