【作者】 谢蓉；

【导师】 陈锦芳；

【作者基本信息】 福建中医学院 ， 中医临床基础， 2003， 硕士

【摘要】 目的：运用具有清热祛湿化瘀功用的茵芍散与湿热中阻证代表方连朴饮进行对照研究，观察茵芍散治疗慢性乙型肝炎湿热蕴脾证患者的临床疗效，探索治疗慢性乙型肝炎湿热蕴脾证的有效治法和方药。 方法：临床诊断为慢性乙型肝炎湿热蕴脾证患者90例，随机分成观察组(茵芍散胶囊联合常规保肝降酶治疗)、中药对照组(连朴饮胶囊联合常规保肝降酶治疗)及常规治疗组(单纯常规保肝降酶治疗)，每组各30例，并以20例健康人为正常对照组。三组疗程均为1个月，治疗前后检测肝功能，病毒复制指标(HBV DNA)，病毒标志物(HBVM)，血清免疫球蛋白IgG、IgM，血清补体C3、C4及外周血单个核细胞(PBMC)培养上清液中两种辅助性T细胞(Th1和Th2)的细胞因子γ干扰素(IFN-γ)和白介素—4(IL-4)，并观察治疗前后中医证候积分变化，用统计学分析三组间各项指标的差异。茵芍散、连朴饮胶囊均做急性毒性试验后使用。 结果：(1)在降低中医证候积分方面，观察组优于中药对照组(P＜0.05)，中药对照组优于常规治疗组(P＜0.05)。三组中医证候疗效比较，以观察组疗效最好(P＜0.05)。(2)三组在改善ALT、AST、TBIL、Alb等肝功能方面，观察组优于中药对照组和常规治疗组(P＜0.05)。(3)在降低HBV DNA方面，观察组优于中药对照组和常规治疗组(P＜0.05)；但在HBsAg、HBeAg阴转及Anti—HBe阳转等方面的差异无统计学意义(P＞0.05)。(4)三组患者IgG、IgM较正常对照组均显著升高(P＜0.01)，三组IgG、IgM治疗前后比较差别均有显著性意义(P＜0.05)，在降低IgG疗效方面观察组优于中药对照组(P＜0.05)，中药对照组优于常规治疗组(P＜0.05)；在降低IgM疗效方面观察组优于其它两组(P＜0.05)。(5)三组患者C3、C4较正常对照组均显著降低(P<0.01)，三组C3治疗前后比较差别均有显著性意义(P<0.01)，在升高C3疗效方面观察组优于中药对照组(P<0 .05)，中药对照组优于常规治疗组(P<0 .05);观察组和中药对照组C4治疗前后比较差别均有显著性意义(P<O.01)，常规治疗组治疗前后比较差别无显著性意义(P>0 .05)，在升高C4疗效方面观察组优于中药对照组(P<0.05)。(6)与正常对照组比较，三组患者PBMC培养上清液的IFN一Y显著降低(P<0.01)，IL一4显著升高(P(0.01)。观察组IFN一Y治疗前后比较差别有显著性意义(P(0.01)，其它两组治疗前后比较差别均无显著性意义(P>0.05)，仅有观察组具有升高工FN一Y的疗效。观察组和中药对照组丁L一4治疗自1J’后比较差别均有显著性意义(P<0.01)，常规治疗组治疗前后差别无显著性意义(P>0 .05)，在降低IL一4疗效方而观察组优于中药对照组(P<0 .05)。 结论:(1)茵芍散可明显改善临床症状，改善肝功能，具有调节体液免疫功能及Thl/ThZ细胞因子失衡的作用。(2)具有清热祛湿化癖功用的茵芍散在总体疗效上优于单纯清热祛湿功用的连朴饮，提示治疗慢性乙型肝炎湿热蕴脾证应重视活血化赢更多还原

【Abstract】 Objective:To observe the curative effect of Yin-shao-san capsule with the function of antipyretic drying damp and blood act stasis remove for patients with dampness-heat retention spleen syndrome of chronic hepatitis B, in comparison with Lian-pu-yin capsule with the function of antipyretic drying damp, and seek after the efficiency therapy and prescription for damp-heat in spleen syndrome of chronic hepatitis B.Method: ninety patients with dampness-heat retention spleen syndrome of chronic hepatitis B were divided into three groups : observe (OB) group (treated combination of Yin-shao-san capsule and routine drugs) Chinese drugs control (CC) group (treated combination of Lian-pu -yin capsule and routine drugs) and routine treatment (RT) group (only treated routine drugs) , consisted of 30 cases each group , with one month coures of treatment. 20 healthy persons served as normal control (NO group. Before and after treatment the patients’ serum biochemical criterion virus replication indes (HBV DNA), viral markers (HBVM), serum immunoglobulin IgG, IgM, serum complement C3 , C4 and the two kinds of cytokines (IFN- r. IL-4) of T helper lymphocyte in peripheral blood mononuclear cell (PBMC) were measured, and the marks of syndrome also were recorded before and after treatment. Before treatment acute toxicity of Yin-shao-san capsule and Lian-pu-yin capsule were also tested.Results: (1) The curative effect of OB group in decreasing the marks of syndrome was super to CC group (P<0.05) , and CC group was super to RT group (P<0.05) .Thecurative effects of OB group in improving symptoms were super to the other two groups(P<0.05 ).(2)The curative effect of OB group in improving liver function was super to the other two groups (P<0.05). (3) The curative effect of OB group in decreasing HBV DNA was super to the other two groups (P<0.05) , but there were no significantly differences among the three groups in negative conversions of HBsAg, HBeAg and positive conversion of Anti-HBe (P>0.05) . (4) The levels of IgG, IgM were increased significantly (P<0.01) in serum of the patients in comparison with the normal group. The levels of IgG . IgM in serum of the three groups post-treatment were all obviously lower than those of pre-treatment(P<0.05).The curative effect of OB group in decreasing the levels of IgG was super to CC group (P<0.05) ,and CC group was super to RT group (P<0.05 ) .The curative effect of OB group in decreasing the levels of IgM was super to the other two groups(P<0.05) . (5) The levels of C3> C4 were decreased significantly in serum of the patients in comparison with the normal control (P<0.01) . The levels of C3 in serum of the three groups post-treatment were obviously higher than those of pre-treatment (P<0. 01) , the curative effect of OB group in increasing the levels of C3 was super to CC group (P<0.05), and CC group was super to RT group (P<0.05). The levels of C4 in serum of OB group and CC group post-treatment were obviously higher than those of pre-treatment (P<0. 01) , the curative effect of OB group in increasing the level of C4 was super to CC group (P<0.05) .(6) The levels of IFN-gamma were decreased significantly (P<0. 01) in the supernatant of PBMC cultures of the patients in comparison with the normal control, and the levels of IL-4 were increased significantly (P<0.01) in comparison with the normal control. The levels of IFN-gamma of OB group post-treatment were obviously higher than those of pre-treatment(P<0.01), it indicated that only OB group increased the levels of IFN-gamma. The levels of IL-4 of OB group and CC group post-treatment were obviously lower than those of pre-treatment (P<0.01), the curative effect of OB group in decreasing the level of IL-4 was super to CC group (P<0.05) .Conclusions: (1) Yin-Shao-San capsule was effective in improving the symptoms and liver function, and regulated humoral immunity and the out-of-balance of Th1/Th2 cytokines. (2) Yin-Shao-San capsule with the function of antipyretic drying damp and bloodact stasis remove was更多还原