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[目的]观察中药制剂百令胶囊联用西药恩替卡韦对干扰素无应答HBeAg阳性慢性乙型肝炎(Chronic hepatitis B,CHB)的疗效,探讨中西医结合治疗该病的可能机制,为临床合理用药提供理论依据。[方法]将76例干扰素治疗无应答的CHB患者均分为对照组和中西医结合组;对照组口服恩替卡韦;中西医结合组加服百令胶囊,治疗2年。于治疗半年、1年及2年时对HBV-DNA进行定量分析并检测外周血HBsAg滴度和TGF-βl,同时检测肝功能、免疫学和氧化应激相关指标,并计算2组HBeAg血清转换率和总有效率,籍此比较临床疗效。[结果]治疗2年时,中西医结合组HBV-DNA、HBsAg和TGF-βl明显低于对照组(P<0.05);药后半年、1年和2年时的检测结果中谷丙转氨酶(ALT)、谷草转氨酶(AST)、丙二醛(MDA)及肌酸磷酸激酶(CPK)均低于对照组,还原型谷胱甘肽(GSH)和超氧化物歧化酶(SOD)高于对照组(P<0.05);在1年、2年两次检测结果中T淋巴细胞和单核细胞低于对照组,血清总蛋白、白蛋白和血红蛋白、HBeAg血清转换率及总有效率高于对照组(P<0.05)。[结论]百令胶囊联用恩替卡韦治疗CHB疗效显著。
[Objective] To observe the curative effect of traditional Chinese medicine Bailing capsule combined with western medicine entecavir on interferon non-response to HBeAg-positive chronic hepatitis B (CHB) and to explore the possible mechanism of combining traditional Chinese and western medicine in the treatment of this disease for clinical rational drug use Theoretical basis. [Methods] Sixty-six patients with CHB who did not respond to interferon treatment were divided into control group and Integrative Medicine Group. The control group was treated with entecavir. The combination of Chinese and Western medicine was given Bailing capsule for 2 years. The levels of HBsAg titers and TGF-β1 in peripheral blood were measured quantitatively at 6 months, 1 year and 2 years after treatment. The indexes related to liver function, immunology and oxidative stress were also detected. Two groups of HBeAg seroconversion Rate and total efficiency, to compare the clinical efficacy. [Results] After two years of treatment, the levels of HBV DNA, HBsAg and TGF-β1 in the combination group were significantly lower than those in the control group (P <0.05). After six months, one year and two years, the alanine aminotransferase ), AST, MDA and CPK were lower than those in the control group, and GSH and SOD were higher than those in the control group (P <0.05). T lymphocytes and monocytes were lower than those in the control group at 1 year and 2 years. The total serum, albumin and hemoglobin, HBeAg seroconversion rate and total effective rate were higher than those in the control group (P <0.05). [Conclusion] Bailing capsule combined with entecavir is effective in treating CHB.