香参抗纤颗粒治疗肝郁脾虚型肝纤维化

Xiangshen Kangxian Granules in Treatment of Liver Fibrosis with Liver Depression and Spleen Deficiency Syndrome

目的:观察香参抗纤颗粒对肝郁脾虚型肝纤维化患者中医证候积分、FibroScan测量(liver hardness measurement,LSM)值、肝纤维化无创诊断模型[FIB-4评分、谷草转氨酶与血小板比率指数(glutamic oxalacetic transaminase and platelet ratio index,APRI)、Forns指数]指标、肝纤维化的影响。方法:108例肝郁脾虚型肝纤维化患者随机平均分为观察组、对照组。对照组给予常规治疗,观察组在对照组治疗基础上给予香参抗纤颗粒治疗,两组均治疗6个疗程。比较两组患者临床疗效、中医证候积分、LSM值、FIB-4评分、APRI、Forns指数、炎症因子[血清转化生长因子-β1(transforming growth factor-β1,TGF-β1)、白细胞介素-6(interleukin-6,IL-6)、白细胞介素-22(interleukin-22,IL-22)]水平、肝纤维化4项[层粘连蛋白(laminin,LN)、Ⅲ型前胶原(procollagenⅢ,PCⅢ)、Ⅳ型胶原(collagen typeⅣ,Ⅳ-C)、透明质酸酶(hyaluronidase,HA)]。结果:观察组有2例脱落(未连续服用中药,中途退出);对照组有1例病情加重剔除,1例中途退出,1例合并其他系统疾病剔除。最终治疗组52例、对照组51例完成试验。观察组有效率为90.38%,对照组有效率为66.67%,两组有效率比较,差异有统计学意义(P<0.05)。治疗后,两组患者中医证候积分均显著降低,且观察组显著低于同期对照组,差异均有统计学意义(P<0.05)。治疗后,两组患者PCⅢ、Ⅳ-C、HA、LN水平显著降低,且观察组显著低于同期对照组,差异均有统计学意义(P<0.05)。治疗后,两组患者LSM值、FIB-4评分、APRI、Forns指数显著降低,且观察组显著低于同期对照组,差异均有统计学意义(P<0.05)。治疗后,两组患者TGF-β1、IL-6、IL-22水平显著降低,且观察组显著低于同期对照组,差异均有统计学意义(P<0.05)。结论:香参抗纤颗粒治疗肝郁脾虚型肝纤维化疗效确切,可显著降低患者中医证候积分、炎症因子水平,改善患者肝纤维化状态。

Objective: To observe the effect of Xiangshen Kangxian Granule on TCM syndrome score, FibroScan measurement(liver hardness measurement, LSM) value, non-invasive diagnostic model of liver fibrosis[FIB-4 score, aspartate Acid aminotransferase and platelet ratio index(glutamic oxalacetic transaminase and platelet ratio index, APRI),Forns index]index, the effect of liver fibrosis.Methods: 108 cases of liver fibrosis patients with liver depression and spleen deficiency were randomly divided into observation group and control group.The observation group was given Xiangshen Kangxian Granules, and the control group was given routine treatment.Both groups received 6 courses of treatment.The clinical efficacy, TCM syndrome score, LSM value, FIB-4 score, APRI,Forns index, inflammatory factors(transforming growth factor β one(TGF-β1),interleukin-6(interleukin-6,IL-6),interleukin-22(interleukin-22,IL-22)]levels, liver fibrosis four items[laminin(laminin, LN),type Ⅲ procollagen(procollagen Ⅲ,PCⅢ)),type IV collagen(collagen type IV,IV-C),hyaluronidase(hyaluronidase, HA)].Results: 2 cases in the observation group dropped out(did not take traditional Chinese medicines halfway);in the control group, 1 case was excluded due to aggravation, 1 case dropped out, and 1 case was excluded with other system diseases.Finally, 52 cases in the treatment group and 51 cases in the control group completed the experiment.The effective rate of the observation group was 90.38%,and the effective rate of the control group was 66.67%,and the difference was statistically significant between the two groups(P<0.05).After treatment, the TCM syndrome scores of the two groups were significantly decreased, and the observation group was significantly lower than the control group at the same period, with statistical significance(P<0.05).After treatment, the levels of PCⅢ,Ⅳ-C,HA and LN in the two groups were significantly decreased, and the observation group was significantly lower than the control group at the same period, with statistical significance(P<0.05).After treatment, the LSM value, FIB-4 score, APRI and Forns index of the two groups of patients were significantly decreased, and the observation group was significantly lower than the control group at the same period, with statistical significance(P<0.05).After two weeks of treatment, the levels of TGF-β1,IL-6 and IL-22 in the patients were significantly decreased, and the observation group was significantly lower than the control group at the same period, with statistical significance(P<0.05).Conclusion: Xiangshen Kangxian Granules has an exact curative effect in the treatment of liver stagnation and spleen deficiency type liver fibrosis, which can significantly reduce the TCM syndrome scores and inflammatory factor levels, and improve the liver fibrosis state of patients.