上海中医药杂志2026，Vol.60Issue(6)：56-62,7.DOI:10.16305/j.1007-1334.2026.z20260120004
柔肝散结方治疗乙型肝炎后肝硬化代偿期伏邪瘀结证的临床疗效观察
Clinical observation on efficacy of Rougan Sanjie Formula in treating compensated HBV-related cirrhosis with latent pathogen and blood stasis syndrome
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of adding Rougan Sanjie Formula to tenofovir alafenamide(TAF)in treating patients with compensated hepatitis B-related cirrhosis presenting a latent pathogen and blood stasis syndrome.Methods Seventy-five patients diagnosed with compensated HBV-related liver cirrhosis and differentiated as latent pathogen and blood stasis syndrome were randomly assigned to either the treatment group(n=38)or the control group(n=37).The treatment group received Rougan Sanjie Formula plus TAF,whereas the control group received a mimicked placebo Rougan Sanjie Formula plus TAF.Both interventions lasted 24 weeks.Liver stiffness measurement(LSM),traditional Chinese medicine(TCM)syndrome scores and efficacy,biochemical parameters,and safety outcomes were compared between groups.Results ①A total of 72 patients completed the full treatment and efficacy evaluation,including 36 in each group.②LSM decreased significantly after treatment in both groups(P<0.05);post-treatment LSM was lower in the treatment group than that in the control group(P<0.05).③Post-treatment TCM syndrome scores in the treatment group were significantly lower than those in the control group(P<0.05).The difference in TCM syndrome efficacy between the two groups was statistically significant,and the treatment group showed superior efficacy to the control group(P<0.05).④Serum alanine amino-transferase(ALT),aspartate transferase(AST),gamma glutamyl transferase(GGT),total bilirubin(TBil)decreased significantly after treatment in both groups(P<0.05);the treatment group had lower post-treatment GGT than the control group(P<0.05).⑤Serum laminin(LN)decreased in the treatment group and type Ⅳ collagen(Ⅳ-C)decreased in the control group after treatment(P<0.05);the treatment group had lower post-treatment LN than the control group(P<0.05).⑥No obvious adverse events or abnormal safety parameters occurred during the trial.Conclusion Rougan Sanjie Formula combined with TAF shows favorable efficacy and safety in compensated HBV-related liver cirrhosis with latent pathogen and blood stasis syndrome,and can significantly improve clinical indicators and TCM syndrome manifestations.关键词
乙型肝炎/肝硬化/肝纤维化/柔肝散结方/辨证论治/中西医结合/临床试验Key words
hepatitis B/liver cirrhosis/liver fibrosis/Rougan Sanjie Formula/syndrome differentiation and treatment/integrated traditional Chinese and Western medicine/clinical trial引用本文复制引用
王婷婷,马奕中,王玉洁,王思宇,王一凤,韩向晖,王见义..柔肝散结方治疗乙型肝炎后肝硬化代偿期伏邪瘀结证的临床疗效观察[J].上海中医药杂志,2026,60(6):56-62,7.基金项目
国家自然科学基金项目(82174016) （82174016）
上海中医药大学附属岳阳中西医结合医院"青苗人才"培养项目(RY411.07.02.09) （RY411.07.02.09）
上海中医药大学第十八批大学生创新创业项目(202510268332) （202510268332）
