软肝方治疗乙肝肝硬化代偿期（肝脾血瘀证）的临床研究

发布时间：2019-03-04 09:05

【摘要】：目的:观察软肝方联合恩替卡韦分散片治疗肝脾血瘀证乙肝肝硬化代偿期患者的临床疗效和用药的安全性。方法:临床选择符合纳入标准的慢性乙型肝炎肝硬化代偿期患者60例,随机分为两组,治疗组30例,对照组30例。最后完成试验56例:治疗组27例,对照组29例。脱落4例:治疗组3例,对照组1例。治疗组予软肝方联合恩替卡韦分散片口服;对照组予恩替卡韦分散片口服。连服3个月为1个疗程。观察两组患者治疗前后的临床症状、体征、肝功能、肝纤维化指标[透明质酸(hyaluronic acid,HA)、层粘连蛋白(laminin,LN)、Ⅳ型胶原(Ⅳcollagen,Ⅳ-C)]、肝脏Fibroscan检测值(FS值)、HBV DNA及腹部彩超(门静脉内径、脾脏厚度、脾静脉宽度)变化情况。所得数据采用SPSS19.0进行统计处理。结果:临床研究显示,治疗组总有效率为70.37%,与对照组比较,差异有统计学意义(P0.05)。治疗组中医证候总有效率81.48%,明显优于对照组,差异具有统计学意义(P0.05);治疗组患者的倦怠乏力、纳差症状较对照组改善明显,差异有显著统计学意义(P0.01),而胁下积块、右胁刺痛、脘腹胀满症状较对照组也有明显改善,差异有统计学意义(P0.05)。治疗后,治疗组与对照组的HA、LN、Ⅳ-C指标均显著下降,治疗组降低程度明显优于对照组,差异具有显著统计学意义(P0.01)。治疗组肝脏FS值疗后较疗前明显降低,差异具有显著统计学意义(P0.01),其与疗后的对照组对比,差异有统计学意义(P0.05)。治疗组肝功能AST、ALT治疗后显著降低,A/G显著升高,两组的AST、ALT、TBIL、A/G疗后组间比较,差异有显著统计学意义(P0.01)。治疗后,两组B超脾静脉内径、脾厚、门静脉内径宽度均较疗前有所改善,但疗后两组间比较差异无统计学意义(P0.05)。两组病例的HBV DNA载量疗后较疗前均有明显下降,差异均有统计学意义(P0.05),但疗后两组间比较差异无统计学意义(P0.05)。安全性检测:两组病例的心电图和血尿便常规等安全性指标治疗前后均未发现异常;两组患者均无不良事件和不良反应。结论:1、软肝方能明显降低肝脾血瘀证乙肝肝硬化代偿期患者的肝纤维化(HA、LN、Ⅳ-C)水平及肝脏FS检测值,有较好的抗肝纤维化作用,疗效优于单纯恩替卡韦抗病毒治疗。表明软肝方有缓解肝硬化进展的作用。2、软肝方可有效降低患者肝功能ALT、AST、TBIL水平,提高A/G比值。3、软肝方对临床症状、体征的改善作用明显优于单纯恩替卡韦抗病毒治疗。
[Abstract]:Aim: to observe the clinical efficacy and safety of Ruangfang combined with entecavir dispersible tablet in the treatment of hepatitis B cirrhosis patients with liver and spleen blood stasis syndrome. Methods: 60 patients with chronic hepatitis B cirrhosis compensated period were selected and randomly divided into two groups: treatment group (n = 30) and control group (n = 30). Finally, 56 cases were completed: treatment group (27 cases) and control group (29 cases). 4 cases of shedding: 3 cases in the treatment group and 1 case in the control group. The treatment group was treated with Ruanganfang combined with entecavir dispersible tablets, while the control group was given enecavir dispersible tablets. Three months of continuous administration was a course of treatment. The clinical symptoms, signs, liver function, hepatic fibrosis indexes [hyaluronic acid (hyaluronic acid,HA), laminin (laminin,LN), type 鈪，

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