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OA
Clinical observation on efficacy of Rougan Sanjie Formula in treating compensated HBV-related cirrhosis with latent pathogen and blood stasis syndrome
目的 评估柔肝散结方与富马酸丙酚替诺福韦(TAF)联用治疗乙型肝炎后肝硬化代偿期伏邪瘀结证患者的临床疗效及其安全性.方法 将75例符合乙型肝炎后肝硬化代偿期且辨证为伏邪瘀结证的患者随机分为试验组(38例)与对照组(37例).试验组予柔肝散结方联合TAF治疗,对照组予柔肝散结方模拟安慰剂联合TAF治疗,两组疗程均为24周.比较两组肝脏硬度值(LSM)、中医证候积分及疗效、相关生化指标变化情况,同时进行安全性评价.结果 ①最终完成试验全部治疗以及疗效评估者共72例,试验组36例,对照组36例.②试验结束与试验开始比较,两组LSM水平均明显降低(P<0.05);组间试验结束比较,试验组LSM水平低于对照组(P<0.05).③组间试验结束比较,试验组中医证候积分明显低于对照组(P<0.05);两组中医证候疗效比较,差异有统计学意义,试验组明显优于对照组(P<0.05).④试验结束与试验开始比较,两组丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、γ-谷氨酰转移酶(GGT)、总胆红素(TBil)水平均明显降低(P<0.05);组间试验结束比较,试验组GGT水平明显低于对照组(P<0.05).⑤试验结束与试验开始比较,试验组层粘连蛋白(LN)水平、对照组Ⅳ型胶原(Ⅳ-C)水平明显降低(P<0.05);组间试验结束比较,试验组LN水平明显低于对照组(P<0.05).⑥试验期间,两组受试者均未出现明显不良事件,相关安全性指标未见异常.结论 柔肝散结方联用TAF治疗乙型肝炎后肝硬化代偿期伏邪瘀结证患者的疗效较佳,能明显改善其相关指标及中医证候且安全性良好.
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.
王婷婷;马奕中;王玉洁;王思宇;王一凤;韩向晖;王见义
上海中医药大学附属岳阳中西医结合医院(上海 200437)上海中医药大学附属岳阳中西医结合医院(上海 200437)上海中医药大学附属岳阳中西医结合医院(上海 200437)上海中医药大学附属岳阳中西医结合医院(上海 200437)上海中医药大学附属岳阳中西医结合医院(上海 200437)上海中医药大学附属龙华医院(上海 200032)上海中医药大学附属岳阳中西医结合医院(上海 200437)
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
hepatitis Bliver cirrhosisliver fibrosisRougan Sanjie Formulasyndrome differentiation and treatmentintegrated traditional Chinese and Western medicineclinical trial
《上海中医药杂志》 2026 (6)
56-62,7
国家自然科学基金项目(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)上海中医药大学第十八批大学生创新创业项目(202510268332)
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