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机构地区:[1]中南大学湘雅医院中西医结合科 [2]张家界市中医医院消化内科
出 处:《中医杂志》2011年第8期674-678,共5页Journal of Traditional Chinese Medicine
基 金:湖南省自然科学基金资助项目(09JJ3065);湖南省中医药科研计划项目(2008056);湖南省重点学科经费资助(湘教通2001-179号)
摘 要:目的通过小样本随机对照试验观察清肝利湿汤治疗肝胆湿热型慢性乙型肝炎的疗效和安全性。方法将符合要求的75例患者随机分为治疗组和对照组。治疗组34例予中药清肝利湿汤加拉米夫定片,对照组41例予复方甘草酸苷片加拉米夫定片治疗,两组疗程均为4周,观察两组患者的各单独症状指标和整体症状感受视觉模拟评分、丙氨酸氨基转移酶(ALT)水平、病毒标志物及HBV DNA定量值的变化,并监测不良反应。结果治疗后两组各单独症状和整体症状感受视觉模拟评分和ALT水平均出现下降(P<0.05或P<0.01),治疗组在治疗第2、3、4周时的整体症状感受视觉模拟评分显著低于对照组(P<0.05或P<0.01),在治疗第3周时ALT水平显著低于对照组(P<0.05)。与治疗前比较,继续拉米夫定治疗12周时试验组HBV DNA定量改变值显著高于对照组(P<0.05)。两组患者均未出现严重不良反应。结论清肝利湿汤对肝胆湿热型慢性乙肝患者在症状、病毒载量和肝功能方面可能有改善作用。Objective To evaluate the effect and safety of Qinggan Lishi Decoction(decoction for clearing heat and dissolving damp) on chronic hepatitis B with liver and gallbladder damp-heat syndrome in TCM through a randomized controlled trial of small-sized samples.Methods Seventy-five subjects met the designed criteria were randomized into a treatment group and a control group.The treatment group,34 cases,was administered Chinese medicine Qinggan Lishi Decoction and Lamivudine tablets,while the control group,41 cases,was administered Compound Glycyrrhizin tablets and Lamivudine tablets.Both groups were treated for 4 weeks.Changes in visual analogue scores(VAS) of independent symptoms and general symptomatic experience,level of alanine aminotransferase(ALT),viral markers and quantitative value of HBV DNA of the two groups were observed,and the adverse events were monitored in the whole process of trial.Results After treatment,the VAS of independent symptoms and general symptomatic experience and level of ALT were decreased in both groups.The VAS of general symptomatic experience of the treatment group in the 2nd,3rd,and 4th week was significantly lower than that of the control group(P〈0.05 or P〈0.01),and the level of ALT in the 3rd week was significantly lower than that of the control group(P〈0.05).Compared with before treatment,in the 12th week of continuous administration of Lamivudine tablets,the differential value of HBV DNA quantity of the experimental group was significantly higher than that of the control group(P〈0.05).No severe adverse events occurred during the whole trial.Conclusion Qinggan Lishi Decoction is possibly beneficial to hepatic symptoms,virus load,and liver function of those patients with chronic hepatitis B in TCM syndrome of liver and gallbladder damp-heat.
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