柔肝补肾汤结合熊去氧胆酸对原发性胆汁性肝硬化疗效、肝功能影响研究

Effect of Rougan Bushen Decoction(柔肝补肾汤)Combined with Ursodeoxycholic Acid on Primary Biliary Cirrhosis and Liver Function

目的评估原发性胆汁性肝硬化患者采取柔肝补肾汤与熊去氧胆酸结合治疗的疗效及对肝功能影响。方法纳入119例原发性胆汁性肝硬化患者(2017年3月—2020年7月)随机分为对照组(59例)与观察组(60例),对照组患者给予熊去氧胆酸药物治疗,观察组患者给予熊去氧胆酸+柔肝补肾汤治疗,比较两组患者疗效、治疗前后肝功能指标及肝纤维化指标变化、中医症状(黄疸、肝脾肿大、皮肤瘙痒、乏力口干、纳差胁痛等)积分变化及肝脏硬度值、免疫功能指标变化、不良反应。结果观察组疗效(95.00%,51/60)优于对照组(83.05%,49/59)(P<0.05);两组患者治疗前总胆汁酸(total bile acids,TBA)与总胆红素(total bilirubin,TB)、γ-谷氨酰转肽酶(γ-glutamyl transpeptadase,GGT)及碱性磷酸酶(alkaline phosphatase,ALP)、天冬氨酸氨基转移酶(aspartate transaminase,AST)及丙氨酸氨基转移酶(alanine aminotransfease,ALT)等肝功能指标、层粘连蛋白(lymph node,LN)、透明质酸(hyaluronic acid,HA)、Ⅲ型前胶原(N-terminal procollagenⅢpropeptide,PⅢNP)及Ⅳ型胶原(collage typeⅣ,C-Ⅳ)等肝纤维化指标,黄疸、肝脾肿大、皮肤瘙痒、乏力口干、纳差胁痛等中医症状积分,肝脏硬度值,免疫球蛋白A、G、M(IgA、IgG、IgM)水平比较,P>0.05,各组患者治疗后中医症状积分、肝功能、肝纤维化指标、肝脏硬度值、免疫功能等指标均好转,而观察组中医症状积分、肝功能、肝纤维化、肝脏硬度值及免疫功能等指标优于对照组(P<0.05);观察组与对照组不良反应比较(1.67%vs 3.39%),P>0.05。结论原发性胆汁性肝硬化采取柔肝补肾汤与熊去氧胆酸两种药物结合治疗效果显著,且安全可靠。

Objective To evaluate the effect of Rougan Bushen Decoction(柔肝补肾汤)combined with ursodeoxycholic acid on liver function in patients with onset biliary cirrhosis.Methods A total of 119 patients with primary biliary cirrhosis(from March 2017 to July 2020)were randomly divided into control group(59 cases)and observation group(60 cases).Patients in the control group were treated with ursodeoxycholic acid,while those in observation group were treated with ursodeoxycholic acid+Rougan Bushen Decoction.The curative effect,changes of liver function indexes and liver fibrosis indexes before and after treatment,changes of TCM symptom scores(jaundice,hepatosplenomegilia,pruritus,fatigue and dry mouth,hypoxic pain,etc.),liver hardness value,changes of immune function indexes and adverse reactions were compared between the two groups.Results The curative effect of the observation group(95.00%,57/60)was better than that of the control group(83.05%,49/59)(P<0.05).Total bile acids(TBA),total bilirubin(TB),γ-glutamyl transpeptadase,alkaline phosphatase(ALP),aspartate transaminase(AST),alanine aminotransfease(ALT)and other liver function indicators,lymph node(LN),hyaluronic acid(HA),N-terminal procollagenⅢpropeptide(PⅢNP),lymph node and Collage TypeⅣ(C-Ⅳ),TCM symptom scores(jaundice,hepatosplenomegalysis,skin pruritis,fatigue,dry mouth,and hypochigalgia),liver hardness value,immunoglobulin A,G,M(IgA,IgG,IgM)levels of two groups were not significant(P>0.05),After treatment,TCM symptom scores,liver function,liver fibrosis indexes,liver hardness value,immune function and other indicators were improved in both groups,while TCM symptom scores,liver function,liver fibrosis,liver hardness value,immune function and other indicators in the observation group were better than those in the control group(P<0.05).The adverse reactions of observation group and control group(1.67%vs 3.39%)was not significant(P>0.05).Conclusion Rougan Bushen Decoction combined with ursodeoxycholic acid in the treatment of primary biliary cirrhosis is effective and safe.