四逆软肝方干预肝郁脾虚型肝硬化的临床研究

Clinical Study on Sini Ruangan Prescription in the Intervention of Liver Depression and Spleen Deficiency Type Liver Cirrhosis

目的:探讨四逆软肝方治疗肝郁脾虚型肝硬化的临床疗效及安全性。方法:选择2018年9月至2019年12月期间湖南中医药大学第一附属医院收治的29例肝郁脾虚型肝硬化患者,根据随机信封抽签原则分为观察组(14例)与对照组(15例)。对照组患者给予常规病因治疗加扶正化瘀片,观察组患者给予常规病因治疗加四逆软肝方,观察比较两组患者疗效。结果:观察组患者治疗总有效率为100.00%,高于对照组的86.67%,差异具有统计学意义(P <0.01)。治疗后1个月、2个月、3个月两组患者的中医病症主症积分均较治疗前降低,差异具有统计学意义(P <0.01)。治疗前、治疗后1个月、2个月两组患者的同期中医病症主症积分比较,差异无统计学意义(P> 0.05)。治疗3个月观察组患者的中医病症主症积分低于对照组,差异具有统计学意义(P <0.01)。治疗后两组患者的谷丙转氨酶(ALT)水平均有不同程度下降,差异具有统计学意义(P <0.01)。治疗后两组患者的谷草转氨酶(AST)比较有所降低,但差异无统计学意义(P> 0.05)。治疗后两组患者的ALT、AST分别比较,差异无统计学意义(P> 0.05)。治疗后观察组患者的IV型胶原(IV–C)、透明质酸(HA)、Ⅲ型前胶原肽(PⅢP)水平均较治疗前下降,差异具有统计学意义(P <0.05),治疗后对照组患者的IV–C、HA、PⅢP水平均较治疗前有所下降,但差异无统计学意义(P> 0.05)。治疗后两组患者的层粘连蛋白(LN)与治疗前比较,差异均无统计学意义(P> 0.05)。治疗前、治疗后两组患者的同期IV–C、HA、PⅢP、LN水平分别比较,差异无统计学意义(P> 0.05)。治疗后两组患者的肝脏瞬间弹性均有不同程度下降,差异具有统计学意义(P <0.01),治疗后两组患者的肝脏瞬间弹性结果比较,差异无统计学意义(P> 0.05)。结论:四逆软肝方治疗肝郁脾虚型肝硬化效果显著,能够有效改善患者症状体征、肝功能转氨酶以及肝纤维化水平,从而抑制肝硬化发展。且不良反应少。

Objective To investigate the clinical efficacy and safety of Sini ruangan prescription(SNRG)in the treatment of liver depression and spleen deficiency type liver cirrhosis.Methods A total of 29 patients with liver depression and spleen deficiency type liver cirrhosis admitted to the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine from September 2018 to December 2019 were selected and divided into an observation group(14 cases)and a ncontrol group(15 cases)according to the principle of random envelope lottery.The control group was given conventional etiological treatment plus fuzheng huayu tablet,and the observation group was given conventional etiological treatment plus Sini ruangan prescription,and the efficacy of the two groups was observed and compared.Results The total effective rate of the observation group was 100.00%,higher than 86.67%of the control group,the difference was statistically significant(P<0.01).After 1 month,2 months and 3 months,the scores of traditional Chinese medicine(TCM)symptoms in the two groups were lower than those before treatment,the differences were statistically significant(P<0.01).There was no significant difference in the scores of TCM symptoms before treatment,1 month and 2 months after treatment between the two groups(P>0.05).After 3 months of treatment,the scores of TCM symptoms in the observation group were lower than those in the control group,and the differences were statistically significant(P<0.01).After treatment,the level of alanine aminotransferase(ALT)in the two groups decreased to different degrees,the differences were statistically significant(P<0.01).After treatment,the level of aspartate aminotransferase(AST)in the two groups was decreased,but the difference was not statistically significant(P>0.05).After treatment,there was no statistical significance in the levels of ALT and AST between the two groups(P>0.05).After treatment,the levels of type IV collagen(IV-C),hyaluronic acid(HA)and typeⅢprocollagen peptide(PⅢP)in the observation group were decreased compared with those before treatment,the differences were statistically significant(P<0.05),while the levels of type IV-C,HA and PⅢP in the control group were decreased after treatment,but the differences were not statistically significant(P>0.05).There was no significant difference in laminin(LN)between the two groups after treatment and before treatment(P>0.05).The the levels ofⅣ-C,HA,PⅢP and LN of the two groups were compared before and after treatment,but there was no significant difference(P>0.05).After treatment,the transient elasticity of liver in the two groups decreased to varying degrees,and the difference was statistically significant(P<0.01),while there was no statistically significant difference between the two groups after treatment(P>0.05).Conclusion Sini ruangan prescription has a significant effect on liver depression and spleen deficiency type liver cirrhosis cirrhosis,which can effectively improve the patient's symptoms and signs,liver function transaminase and liver fibrosis levels,thus inhibiting the development of liver cirrhosis.And less adverse reactions.