自拟益气活血方治疗乙肝肝硬化腹水气虚血瘀证临床疗效与安全性研究

目的:本研究探讨自拟益气活血方结合指南推荐的西医治疗方案治疗乙肝肝硬化腹水气虚血瘀证患者的疗效优势点及安全性。方法:选取2013年2月至2014年2月期间经病历CRF表确认的乙肝肝硬化腹水气虚血瘀证患者62例,以随机、盲法原则分为观察组和对照组,以循证医学方法为指导,进行多中心、双盲试验研究,疗程为1个月。所有患者均接受指南推荐的西医基础治疗,观察组口服益气活血方颗粒,对照组口服益气活血方安慰剂颗粒。研究围绕患者利尿效果(24 h出入量、体重、腹围、超声下腹水量)、肝脏功能、凝血、智能水平以及中医症状改善等方面进行测定。结果:2组均在腹水量减少及利尿改善方面取得疗效,但从腹水减少趋势及净体重、腹围下降趋势看,观察组优于对照组,且通过治疗前后腹部超声示腹水量比较,差异有统计学意义(P 0. 01);通过血清学检测对肝脏功能改善进行评价,限于治疗周期,2组并无统计学意义,但根据治疗时点肝功能变化趋势图看,观察组在某些肝功能指标的改善趋势上具有一定优势;对患者智能水平改善情况进行评价,观察组与对照组患者数字连接试验(NCT-A)、数字符号试验(DST)均有所改善,但统计学意义不明显。在中医症状改善方面,观察组在气虚血瘀证症候群的改善较对照组明显(P 0. 01);通过安全性评价,益气活血方具有较好的安全性。结论:益气活血方能够协同指南推荐的西药治疗对乙肝肝硬化气虚血瘀证患者发挥更好的利尿作用,从而降低腹水量;限于治疗周期,益气活血方在肝功能某些方面的改善趋势上具有一定优势;益气活血方能够改善气虚血瘀证患者临床症状,提高患者生命质量;益气活血方未见明显不良反应。

Study on the Clinical Effects and Safety of Yiqi Huoxue Decoction on Qi Deficiency and Blood Stasis Syndrome Hepatocirrhosis with Ascites in Hepatitis B

To analyze and discover the curative effects and safety of Yiqi Huoxue Decoction combined with Western drugs.Methods:Clinical observations were based on multi-center,random,double-blind,and parallel controlled trial.A total of 62 patients were randomly divided into the observation group and control group with inclusion criteria from January 2012 to February 2014,which were under one course of treatment (30 days).The observation group was treated with Yiqi Huoxue Decotion combined with western drugs,while the control observation was treated with western drugs and herbal placebo.The abdominal perimeter,body weight,urinary volume in 24 hours,ascites volume,liver function,coagulation function,intellectuality level,the variation of symptom scores in traditional Chinese medicine were recorded in the course.Results:The observation group had better effects in diuresis facet according to the average body weight,abdominal perimeter,and urinary volume.There was statistical difference in ascites in the two groups tested in right lateral position (P<0.01).The control group of liver function between the two groups showed no statistical difference,but the index of the observation group improved than those in control group.There was no statistical difference in the intellectuality level between the two groups with shortened time in NCT-A,DST experiments.The variation of symptom score,such as pain in abdomen,abdominal distention,poor appetite,tiredness,lassitude and disinclination to talk,had a statistical difference (P<0.01).The safety of Yiqi Huoxue Decoction was without statistic difference.Conclusion:1)The combined therapy of Yiqi Huoxue Decoction and Western drugs has advantages in diuresis and relieve ascites.2)As there is no significant difference between two groups,but the tendency of liver function indicates synergistic effects in liver function among the specific period.3)There is potential advantage of Yiqi Huoxue Decoction in improving the liver function.4)The decoction is safe to some extent.