疏肝健脾方治疗非酒精性脂肪性肝炎肝郁脾虚证临床疗效研究

发布时间：2018-06-21 08:25

本文选题：非酒精性脂肪性肝炎 + 肝郁脾虚证　；参考：《南京中医药大学》2016年硕士论文

【摘要】：目的：本临床研究课题旨在观察疏肝健脾方治疗非酒精性脂肪性肝炎(NASH)的临床疗效,通过与对照组(多烯磷脂酰胆碱胶囊)进行比较,客观评价本方的疗效性及安全性,以期为治疗NASH提供新的治疗思路与方法。方法：选择符合纳入标准的非酒精性脂肪性肝炎患者49例,按随机原则分为治疗组(26例)和对照组(23例,其中因患者依从性、未复诊等原因脱失4例,故对照组共19例)。两组患者在年龄、性别、体重指数(BMI)、腰围、病程及病情程度等方面比较,差异无显著意义(P0.05),具有可比性。治疗组予疏肝健脾方随症加减,日1剂,早晚水煎服；对照组予口服多烯磷脂酰胆碱(易善复),每次456mg,每日3次；另外两组病人均配合饮食控制和适当的运动进行辅助治疗；疗程均为12周。疗程结束后观察记录患者症状、体征、肝功能、血脂、B超、体重指数及安全性指标等变化情况,并作出评价。结果：1、两组总疗效对比：治疗组总有效率为92.30%；对照组总有效率为78.94%;差异具有统计学意义(P0.05),说明治疗组优于对照组。2、两组血脂变化比较：两组治疗前后TC、TG组间对比具有统计学意义(p0.01),且治疗组中TC、TG水平低于对照组。3、两组肝功能治疗前后比较：两组治疗前后ALT、AST、GGT组间对比具有统计学差异(p0.01),且治疗组ALT、AST、GGT水平低于对照组。4、两组肝脏B超疗效比较：治疗组总有效率为88.46%,对照组总有效率73.68%,差异有统计学意义(P0.05)。5、两组中医症状积分对比：治疗后治疗组、对照组中医症状积分分别为2.32±1.80、6.42±4.65,差异具有统计学意义(P0.01)。6、安全性评估：本次临床研究试验未发现不良反应及明显的毒副作用,安全性指标分析未见异常,说明疏肝健脾方安全性良好。结论：疏肝健脾方具有改善NASH患者临床症状、肝功能、血脂、体重指数及B超等作用,是治疗NASH的有效方药。
[Abstract]:Objective: to observe the clinical efficacy of Shugan Jianpi recipe in the treatment of non-alcoholic fatty hepatitis (NASH), and to evaluate the efficacy and safety of the prescription objectively by comparing it with the control group (Polyene phosphatidylcholine capsule). In order to provide new ideas and methods for the treatment of Nash. Methods: 49 patients with non-alcoholic fatty hepatitis were randomly divided into treatment group (n = 26) and control group (n = 23). There was no significant difference in age, sex, body mass index (BMI), waist circumference, course of disease and degree of disease between the two groups. The treatment group was treated with Shugan Jianpi recipe, 1 dose per day, morning and evening water decoction; the control group was given oral polyenylphosphatidylcholine (Yi Shanfu, 456mg, 3 times a day); the other two groups of patients were treated with diet control and proper exercise. The course of treatment was 12 weeks. The changes of symptoms, signs, liver function, blood lipid, B-ultrasound, body mass index and safety index were observed and evaluated after the course of treatment. Results: the total effective rate of the treatment group was 92.30; The total effective rate of the control group was 78.94, and the difference was statistically significant (P 0.05), indicating that the treatment group was better than the control group. The changes of blood lipid in the two groups were compared: the comparison between the two groups before and after treatment had statistical significance (p 0.01), and the level of TCN TG in the treatment group was lower than that in the control group. Comparison of liver function between two groups before and after treatment: there was a significant difference between the two groups before and after treatment, and the level of alt ASTT GGT in the treatment group was lower than that in the control group .4.The comparison of the effect of B-ultrasound in the two groups: the total effective rate was 88.46 in the treatment group and the total in the control group was lower than that in the control group. The effective rate was 73.68 and the difference was statistically significant (P 0.05). The scores of TCM symptoms in the two groups were compared: treatment group after treatment, The scores of TCM symptoms in the control group were 2.32 卤1.80 卤6.42 卤4.65, respectively. The difference was statistically significant (P 0.01). The safety evaluation: no adverse reactions and obvious side effects were found in this clinical study, and the safety indexes were not abnormal. It shows that the safety of Shugan Jianpi recipe is good. Conclusion: Shugan Jianpi prescription can improve the clinical symptoms, liver function, blood lipid, body mass index and B ultrasound in patients with Nash. It is an effective prescription for Nash.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R259

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