Clinical study of Bailing Capsule with Entecavir in treatment of HBeAg positive chronic hepatitis B with no response to interferon
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摘要: [目的]摘要:[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。Abstract: [Objective] To observe the curative effect of traditional Chinese medicine(TCM), Bailing Capsule combined with western medicine(WM), entecavir on HBeAg positive chronic hepatitis B (Chronic hepatitis, B, CHB) with non-response to interferon.Discussing the mechanism of TCM and WM combined treatment to the disease, and providing a theoretical basis for how to use drug in clinical rational way.[Methods] 76 patients who had CHB with no response to interferon were divided into control group and combined treatment group group.Control group was treated with oral administration of Entecavir.The combination of traditional Chinese medicine and Western medicine group was treated with Entecavir and Bailing Capsule for a period of 2 years.In the treatment of half a year, 1 year and 2 years, quantitative HBV-DNA, HBsAg titer and TGF- beta L in peripheral blood were obeserved, in the mean time liver function, immunological and oxidative stress related indicators, and calculated HBeAg serum conversion rate and the total efficiency were detected in the second group, in order to compare the clinical efficacy.[Results] After 2 years of treatment, HBV-DNA, HBsAg and TGF-beta l in the combined group, was significantly lower than that of the control group (P<0.05); after treatment for six months, 1 years and 2 years, alanine aminotransferase (ALT), aspartate aminotransferase(AST), malondialdehyde(MDA) and creatine kinase (CPK) in the combined treatment group were lower than that of control group, glutathione (GSH) and superoxide dismutase (SOD) were higher than that of the control group (P<0.05);after the treatment of 1 and 2years, numbers of T lymphocyte cells and Mononuclear cells in combined treatment group were lower than that in control group.Serum total protein, albumin and hemoglobin, serum HBeAg conversion rate and the total efficiency in combined treatment group were higher than that in the control group (P<0.05).[Conclusion] Bailing capsule combined with Entecavir in treatment of CHB has curative effects.
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