机构地区:[1]上海中医药大学附属岳阳中西医结合医院肝病科,上海200437 [2]上海中医药大学附属市中医医院肝病科,上海200071 [3]上海中医药大学附属龙华医院肝病科,上海200032
出 处:《上海中医药杂志》2024年第2期79-83,共5页Shanghai Journal of Traditional Chinese Medicine
基 金:国家自然科学基金项目(82305334,82074386);上海市卫健委肝硬化腹水(水臌病)上海市中医专病联盟项目(2021-2023);上海市科委“科技创新行动计划”生物医药科技支撑专项(23S21900100)。
摘 要: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 diffe
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