“透邪解毒”法联合阿德福韦酯治疗慢性乙型肝炎临床研究

Clinical Study on the Method of "Outthrusting Evil and Detoxicating" Jointed with Adefovir Dipivoxil in the Treatment for Chronic Hepatitis B

目的:观察透邪解毒法联合阿德福韦酯治疗肝胆湿热型慢性乙型肝炎的临床疗效。方法:将慢性乙型肝炎患者200例随机分为治疗组80例,对照组、中西药联合组各60例,治疗组予加味升麻葛根方治疗。对照组予阿德福韦酯10 mg,1次/d口服;中西药联合组采用加味升麻葛根方联合阿德福韦酯治疗,疗程48周,比较3组患者中医证候、肝功能、乙肝两对半、HBV-DNA等变化情况。结果:应答总有效率对照组与治疗组比较差异无显著性(P>0.05),中西药联合组显著高于治疗组(P<0.05),中西药联合组与对照组比较无显著差异(P>0.05)。中医证候改善方面,治疗组和中西药联合组优于对照组(P<0.05),中西药联合组与治疗组比较,差异无显著性(P>0.05)。改善肝功能方面,3组总胆红素(TBIL)、谷草转氨酶(AST)、谷丙转氨酶(ALT)治疗后显著低于治疗前(P<0.05),治疗组和中西药联合组显著低于对照组(P<0.05),中西药联合组与治疗组比较,差异无显著性(P>0.05)。HBV-DNA阴转率方面,对照组高于治疗组(P<0.05)、中西药联合组与对照组比较,差异无显著性(P>0.05),中西药联合组高于治疗组(P<0.05)。HBeAg阴转率方面,对照组优于治疗组(P<0.05),中西药联合组高于对照组,但无显著差异(P>0.05),中西药联合组优于治疗组(P<0.01)。结论:加味升麻葛根方能够改善肝胆湿热型慢性乙型肝炎患者的临床症状及体征,能改善肝功能,具有一定抗病毒作用,能够提高HBV-DNA和HBeAg阴转率,增强抗病毒效果。

Objective： To observe clinical effects of the method of＂outthrusting evil and detoxicating＂ jointed with adefovir dipivoxil in treating chronic hepatitis B of liver-gallbladder dampness-heat pattern. Methods： All 200 patients were randomized into 80 cases in the treatment group, 60 cases in the control group and 60 cases in the group of integrative medicine respectively, the treatment group took modified ShengMa GeGen prescription, and the control group adefovir dipivoxil orally, 10mg, once each day; the group of integrative medicine adopted modified ShengMa GeGen prescription and adefovir dipivoxil, the course of the treatment was 48 weeks, the changes of TCM syndromes, liver function, serum markers of hepatitis B, HBV-DNA and others of the patients in three groups were compared. Results： The difference was insignificant when the control group was compared with the treatment group in total effective rates of the response （P〉0.05）, the group of integrative medicine was higher than the treatment group obviously（P〈0.05）, there was no significant difference when the group of integrative medicine was compared with the control group （P〉0.05）. The treatment group and the group of integrative medicine were better than the control group in the improvements of TCM syndromes （P〈0.05）, the difference was insignificant when the group of integrative medicine was compared with the treatment group （P〉 0.05）. TBIL, AST and ALT of three groups after treating were lower than these before treating in improving liver fimction （P〈0.05）, the treatment group and the group of integrative medicine were lower than the control group notably （P〈0.05）, the difference was insignficant when the group of integrative medicine was compared with the treatment group （P〉0.05）. The control group was higher than the control group in HBV-DNA negative-conversion rate （P 〈0.05）, the difference was insignificant when the group of integrative medicine was compared with the control group （P〉0.05）, the group of integrative medicine was higher than the treatment group （P〈0.05）. The control group was better than the treatment group in HBeAg negative-conversion rate （P〈0.05）, the group of integrative medicine was higher than the control group, while there was no significant difference （P〉0.05）, the group of integrative medicine was superior to the treatment group （P〈0.01）. Conclusion： Modified ShengMa GeGen prescription could improve clinical symptoms and body signs of the patients with chronic hepatitis B of liver-gallbladder dampness-heat pattern, it could improve liver timetion, fight against the virus to a certain extent, improve HBV-DNA and HBeAg negative-conversion rate and enhance the antiviral effects.