机构地区:[1]首都医科大学附属北京地坛医院,北京市朝阳区100015
出 处:《中医杂志》2023年第5期490-497,共8页Journal of Traditional Chinese Medicine
基 金:国家科技重大专项“十三五”课题(2018ZX10725505-001);首都卫生科研发展专项基金(2020-2-2172);北京市属医院科研培育计划项目(PZ2020030);全国名老中医药专家王融冰传承工作室建设项目(201612)。
摘 要:目的 评价益气养阴解毒化瘀方加减联合西药治疗轻微型肝性脑病的临床疗效及安全性。方法 纳入经Stroop测试诊断为轻微型肝性脑病患者100例,采用随机对照试验方法,以1∶1比例分为益气养阴解毒化瘀方加减联合西医治疗组(中西医结合治疗组)和西医治疗组进行治疗,记录两种疗法对轻微型肝性脑病患者治疗前及治疗4周后的Stroop测试时间(包括总关闭阶段时间、正确完成关闭阶段的次数、总开放阶段时间、正确完成开放阶段的次数、总开放阶段时间+总关闭阶段时间)和中医证候积分,并评价疗效;分别于治疗前及治疗1、2、4周后记录患者终末期肝病模型(MELD)评分,并检测肝功能[包括血氨(BA)、丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)、白蛋白(ALB)、血清总胆红素(TBiL)]、凝血功能[包括凝血酶原活动度(PTA)、国际标准化比值(INR)]及粒淋比(NLR),并观察患者生命体征,检测血常规及电解质肾功能,记录不良事件。结果 治疗后,中西医结合治疗组Stroop测试结果的总关闭阶段时间[97.01(85.61,110.98)s]、总开放阶段时间[106.47(93.82,125.89)s]、总开放阶段时间+总关闭阶段时间[201.63(180.72,231.34)s]较本组治疗前缩短,且分别较西医治疗组的109.53(97.56,140.37)s、127.46(106.66,148.02)s、234.40(212.19,283.68)s缩短更明显(P<0.05或P<0.01)。中西医结合治疗组有效率94%,优于西医治疗组的72%(P<0.01)。中西医结合治疗组治疗1、2、4周后ALT、AST、TBiL、BA、INR、NLR、MELD评分及中医证候积分逐渐下降,ALB、PTA上升,且除ALT外,其余指标改善均优于西医治疗组(P<0.05或P<0.01)。中西医结合治疗组1例患者在治疗2周后出现腹泻,调整方药后好转。结论 益气养阴解毒化瘀方加减联合西药治疗轻微型肝性脑病能改善患者认知能力,提高治疗有效率,且安全性好。ObjectiveTo evaluate the efficacy and safety of Yiqi Yangyin Jiedu Huayu Formula(益气养阴解毒化方)modifications combined with western medicine in the treatment of minimal hepatic encephalopathy(MHE).Methods In a randomized controlled study,100 patients diagnosed as MHE by the Stroop test were divided into the integrated treatment group(Yiqi Yangyin Jiedu Huayu Formula modifications combined with western medicine)and western medicine group at a ratio of 1:1.Before and after 4-week treatment,the Stroop test indicators including total OFF stage time,the number of correct completion of the OFF stage,total ON stage time,the number of correct completion of the ON stage,and total ON and OFF stage time,and TCM syndrome scores were assessed to evaluate the effects.Before and after 1-,2-,and 4-week treatment,score of the model for end-stage liver disease(MELD),liver function indicators including blood ammonia(BA),alanine aminotransferase(ALT),aspartic acid aminotransferase(AST),albumin(ALB),and serum total bilirubin(TBiL),coagulation function indicators including prothrombin activity(PTA)and international normalized ratio(INR),and granulocyte-to-lymph ratio(NLR)were assessed,and the patient's vital signs,blood routine and electrolyte renal function were assessed,the adverse events were also recorded.Results After treatment,the total OFF stage time[97.01(85.61,110.98)s],total ON stage time[106.47(93.82,125.89)s],total ON and OFF stage time[201.63(180.72,231.34)s]of Stroop test in the integrated treatment group significantly decreased,and were shorter than those in the western medicine group[respectively 109.53,(97.56,140.37)s,127.46(106.66,148.02)s,and 234.40(212.19,283.68)s)(P<0.05 or P<0.01).The effective rate of the integrated treatment group was 94%,higher than 72%of the western medicine group(P<O.01).The levels of ALT,AST,TBiL,BA,INR,NLR,the MELD score,and the TCM syndrome score in the integrated treatment group gradually decreased after 1-,2-and 4-week treatment,while the levels of ALB and PTA increased,and mo
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