大黄煎剂保留灌肠治疗肝性脑病的多中心临床研究  

Retention Enema with Rhubarb Decoction in Treating Hepatic Encephalopathy:Results from a Multi-center Clinical Trial

作　　者：黄古叶[1] 毛德文[1] 龙富立[1] 黄彬[2] 黄智芬[3] 李达芬 邱华[1] 陈闯[3] 张荣臻[1] 吕建林[1] 曾芳[1] 

机构地区：[1]广西中医学院第一附属医院,广西南宁530023 [2]广西中医学院附属瑞康医院,广西南宁530011 [3]广西医科大学附属肿瘤医院,广西南宁530021 [4]广西扶绥县中医院,广西扶绥532100

出　　处：《辽宁中医杂志》2011年第7期1364-1366,共3页Liaoning Journal of Traditional Chinese Medicine

基　　金：广西科学研究与技术开发计划项目(桂科攻0993003A-25);广西中医学院普通课题(P2009092)

摘　　要：目的:通过观察大黄煎剂保留灌肠治疗肝性脑病的多中心临床疗效,为制定中药保留灌肠技术的规范化方案提供参考。方法:采用多中心、随机、平行对照的研究方法,将360例肝性脑病患者按照随机对照的原则分为3组,优化组合技术方案组(A组)、常规技术方案组(B组)、内科常规基础治疗组(C组)。3组均给予常规基础治疗和护理,7天为1个疗程,治疗2个疗程后,观察治疗前后各组患者的苏醒时间及数字连接试验(NCT)、肝性脑病的分级改善、血氨(NH3)及肝功能变化等指标。结果:A组显著缩短患者清醒时间、有效降低NH3水平、促进肝功能恢复,将肝性脑病的整体有效率提高至86%,优于B组与C组(P<0.05、P<0.01);且A组的平均医疗费用仅为C组的73.1%,人均减少医疗费用达1.1万元,相比较具有显著性差异(P<0.01);3组均未见有明显不良反应。结论:优化组合技术方案能更好地发挥中医药治疗肝性脑病的作用,具有提高临床疗效、减少医疗费用等优势,应用前景广阔。Objective：To observe the effects of retention enema with rhubarb decoction on hepatic encephalopathy（HE） in a multi-center clinical trial.Methods：In a randomized,parallel group,controlled,multi-center trial,360 patients with HE were randomized to receive usual care alone（group C） or plus rhubarb decoction retention enema（group A） or routine enema（group B） for two 7-day courses.Changes in time to resuscitation,HE grade,number connection test（NCT）,blood ammonia（NH3） and liver function test from baseline to endpoint were observed.Results：Patients in group A had significantly shorter time to resuscitation,lower NH3,improved liver function and a higher response rate of up to 86%,compared with group B and C（P0.05 and P0.01,respectively）.In addition,the average medical cost for patients in group A was only 73.1% of that for group C,which represented a reduction in medical cost of 11,000 yuan per patient,a statistically significant difference（P0.01）.No significant adverse events were observed across the 3 groups.Conclusion：With the potential to boost clinical efficacy while reducing medical cost,retention enema with rhubarb decoction appears to be promising for the treatment of HE.

关 键 词：肝性脑病 大黄煎剂 保留灌肠 临床疗效 

分 类 号：R575[医药卫生—消化系统]