中药联合熊脱氧胆酸治疗老年女性原发性胆汁性肝硬化失代偿期的临床疗效

Clinical efficacy of traditional Chinese medicine combined with ursodeoxycholic acid in treating decompensated primary biliary cirrhosis in elderly women

目的 观察中药联合熊脱氧胆酸(UDCA)治疗老年女性原发性胆汁性肝硬化(PBC)失代偿期患者的临床疗效。方法将收集的老年女性PBC失代偿期患者72例随机分为治疗组和对照组,每组36例。治疗组予失笑散合二至丸颗粒联合UDCA治疗,对照组予失笑散合二至丸颗粒模拟剂联合UDCA治疗。疗程均为6个月,观察中医证候疗效及不良反应发生率,比较相关生化指标、肝硬度值(LSM)、蔡尔德-特科特-皮尤改良评分(CTP)的变化情况。结果 (1)最终完成试验者64例,治疗组32例、对照组32例。(2)治疗前与治疗6个月组内比较,两组总胆红素(TBil)、碱性磷酸酶(ALP)、丙氨酸转氨酶(ALT)、总胆汁酸(TBA)、白球比(A/G)水平差异有统计学意义(P<0.05);组间治疗6个月比较,上述各指标差异无统计学意义(P>0.05)。治疗前与治疗6个月组内比较,两组雌二醇(E2)水平差异有统计学意义(P<0.05);组间治疗6个月比较,E2水平差异有统计学意义(P<0.05)。(3)治疗前与治疗6个月组内比较,两组LSM水平差异有统计学意义(P<0.05);组间治疗6个月比较,LSM水平差异有统计学意义(P<0.05)。(4)治疗前与治疗6个月、随访1年组内比较,两组CTP的A级构成比均增加,差异有统计学意义(P<0.05);组间治疗6个月、随访1年比较,治疗组CTP的A级构成比均明显高于对照组(P<0.05)。(5)治疗组、对照组总有效率分别为93.75%、68.75%;组间中医证候疗效比较,治疗组明显优于对照组(P<0.05)。(6)两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论 中药(失笑散合二至丸)联合UDCA治疗老年女性PBC,能改善患者的肝功能储备及临床症状,保肝利胆且不良反应较少。

Objective To observe the clinical efficacy of traditional Chinese medicine(TCM)combined with ursodeoxycholic acid(UDCA)in treating elderly female patients with decompensated primary biliary cirrhosis(PBC).Methods Seventy-two elderly female patients with decompensated PBC were randomly divided into a treatment group(n=36)and a control group(n=36).The treatment group received a combination of specific TCM formulas(Shixiao San and Erzhi Wan granules)and UDCA,while the control group received placebo equivalents of the TCM formulas combined with UDCA.Both groups underwent a six-month treatment period.The efficacy of TCM symptoms and the occurrence of adverse reactions were noted,and changes in relevant biochemical indicators,liver stiffness measurements(LSM),and Child-Turcotte-Pugh(CTP)scores were compared.Results①A total of 64 patients completed the trial,with 32 in each group.②Sigificant differences were observed in the levels of TBil,ALP,ALT,TBA and A/G within each group when comparing pre-treatment values with those after six months of treatment(P<0.05).However,there were no significant differences in these indicators between the groups after six months of treatment(P>0.05).Significant differences in E2 levels were observed both within and between groups before and after 6-month treatment(P<0.05).③Significant differences in LSM levels were observed within both groups before and after 6-month treatment(P<0.05).Upon comparison after six months of treatment between the groups,the difference in LSM levels was statistically significant(P<0.05).④The proportion of patients in CTP class A increased significantly in both groups after six months of treatment and after one year of follow-up(P<0.05),with the treatment group always having a higher proportion than the control group(P<0.05).⑤The overall effectiveness rates were 93.75%in the treatment group and 68.75%in the control group,with the treatment group showing significantly better TCM symptom efficacy(P<0.05).⑥The incidence of adverse reactions did not differ significantly between the two groups(P>0.05).Conclusion The combination of traditional Chinese medicine(Shixiao San and Erzhi Wan)and UDCA in treating elderly female patients with PBC improves liver function reserve and clinical symptoms,offering hepatoprotective and choleretic benefits with fewer adverse reactions.