龙柴方联合恩替卡韦治疗慢性乙型肝炎肝郁脾虚，湿热瘀阻证的临床研究

发布时间：2018-03-11 01:07

本文选题：慢性乙型病毒性肝炎　切入点：龙柴方　出处：《南京中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：研究目的:探讨龙柴方治疗慢性乙肝的临床疗效,为中西医联合治疗慢性乙型肝炎提供新的治疗方法。研究方法:选取符合本研究纳入标准的慢乙肝患者60人,遵循随机分配的原理分为治疗组和对照组,每组各30人。以24周为总疗程,治疗组予中药汤剂龙柴方和恩替卡韦分散片口服,对照组单用恩替卡韦分散片,观察两组患者治疗前及治疗后相关临床症状、体征、肝功能指标、乙肝病毒标志物及乙肝病毒载量的变化,参照相关疗效评定标准,应用SPSS 20.0统计软件,统计分析临床疗效。研究结果:1.临床症状:治疗12周时,治疗组中医症状积分为15.53±6.20,与治疗前相比较下降了 6.90±3.49;对照组为17.47±6.77较前下降了 4.90±2.72。两组均有临床症状改善,差异显著,有统计学意义(P0.05)。治疗24周时,治疗组中医症状积分为8.73±5.79,与治疗前相比较下降了 13.70±4.92;对照组中医症状积分为13.40±7.23,与治疗前相比较下降了 9.03±4.58,两组比较差异显著(P0.01)。说明治疗组与对照组的治疗方案均能有效的改善临床症状体征,且治疗组在改善临床症状方面的效果要优于对照组,尤其是在改善胁肋疼痛、倦怠乏力、大便稀溏、舌苔黄腻、口干口苦症状方面,其优越性随疗程的延长更加显著。2.肝功能:治疗组与对照组在丙氨酸转氨酶、谷草转氨酶、谷氨酰转肽酶、总胆红素、结合胆红素等方面较治疗前均有明显改善,说明治疗组和对照组均能很好的改善患者肝功能指标。治疗组在降低丙氨酸转氨酶和谷草转氨酶方面与对照组比较有意义,说明治疗组在降低丙氨酸转氨酶和谷草转氨酶两组酶方面要优于对照组。3.乙型肝炎病毒e抗原:治疗组25例HBeAg阳性患者,24周治疗后18人仍呈阳性,转阴7例,阴转率28%;对照组24例HBeAg阳性患者,24周治疗后19人仍呈阳性,转阴5例,阴转率20.8%。两组数据比较无统计学意义(P=0.74)。4.病毒载量应答:治疗24周时,治疗组HBVDNA总应答数19例,总应答率63.30%;对照组HBV DNA总应答数17例,总应答率56.70%,两组间比较P=0.80,差异无统计学意义。治疗组HBVDNA完全应答数8例,完全应答率26.67%,部分应答数11例,部分应答率36.67%,无应答数11例,无应答率36.67%;对照组HBVDNA完全应答数为6例,完全应答率为20%,部分应答数为11例,部分应答率为36.67%,无应答数为13例,无应答率43.30%。两组数据间比较P=0.80,差异无统计学意义。5.安全性方面:治疗组与对照组在24周的疗程中未发生与药物有关的明显的不良反应。血常规、尿常规、肾功能等各项安全性指标未出现异常。研究结论:1.用龙柴方联合恩替卡韦治疗慢性乙型病毒性肝炎肝郁脾虚,湿热瘀阻型证,有较好的临床效果。对患者的临床症状、肝功能等实验室指标有一定的改善作用,且疗效优于单用恩替卡韦治疗。2.龙柴方组方新颖合理,治疗效果显著,预计在临床应用方面有广阔的前景,值得推广。
[Abstract]:Objective: to explore the clinical efficacy of Longchaifang in the treatment of chronic hepatitis B, and to provide a new method for the treatment of chronic hepatitis B by combining traditional Chinese and western medicine. According to the principle of random distribution, the treatment group and the control group were divided into treatment group and control group with 30 persons in each group. The treatment group was treated with Longchai decoction and entecavir dispersible tablets for 24 weeks, while the control group was only treated with entecavir dispersible tablets. The changes of clinical symptoms, signs, liver function indexes, hepatitis B virus markers and hepatitis B virus load were observed before and after treatment in the two groups. SPSS 20.0 statistical software was used to evaluate the efficacy of the two groups. The clinical symptom score of the treatment group was 15.53 卤6.20, which decreased by 6.90 卤3.49 compared with that before treatment, and that of the control group was 17.47 卤6.77 and 4.90 卤2.72.The clinical symptoms were improved in both groups. There was statistical significance (P 0.05). After 24 weeks of treatment, The score of TCM symptom in the treatment group was 8.73 卤5.79, which decreased by 13.70 卤4.92 compared with that before treatment, and that in the control group was 13.40 卤7.23, which was 9.03 卤4.58 compared with that before treatment. The difference between the two groups was significant (P 0.01). Can effectively improve clinical symptoms and signs, The effect of treatment group in improving clinical symptoms was better than that in control group, especially in improving rib pain, fatigue, loose stool, yellow and greasy tongue coating, dry mouth and bitter symptoms. Liver function: alanine aminotransferase, glutamic oxaloacetic transaminase, glutamyl transpeptidase, total bilirubin and conjugated bilirubin were significantly improved in treatment group and control group. It shows that both the treatment group and the control group can improve the liver function index of the patients. The treatment group has significance in reducing alanine aminotransferase and alanine aminotransferase compared with the control group. The results showed that the treatment group was superior to the control group in reducing alanine aminotransferase and alanine aminotransferase. 3. Hepatitis B virus e antigen: in the treatment group, 18 patients were still positive after 24 weeks of treatment with HBeAg positive, 7 patients turned negative. In the control group, 19 patients were still positive after 24 weeks of treatment, 5 patients turned negative, and the negative conversion rate was 20.8. there was no significant difference between the two groups. The viral load response: after 24 weeks of treatment, the total response of HBVDNA was 19 cases in the treatment group. The total response rate was 63.30% in the control group, 17 cases in the control group and 56.70% in the control group. There was no significant difference between the two groups in the total number of HBVDNA responses (8 cases), the complete response rate (26.67%), the partial response rate (11 cases), the partial response rate (36.67) and the non-response rate (11 cases). In the control group, there were 6 cases of complete response of HBVDNA, 20 cases of complete response, 11 cases of partial response, 36.67% of partial response and 13 cases of non-response. The non-response rate was 43.30.The difference between the two groups was not statistically significant. 5. Safety: there were no significant adverse reactions related to drugs in the treatment group and the control group during the 24-week course of treatment. Conclusion: 1. Using Longchaifang combined with entecavir in the treatment of chronic viral hepatitis B with liver stagnation and spleen deficiency, damp-heat stagnation, has a good clinical effect. The laboratory indexes such as liver function can be improved, and the curative effect is better than that of enticavir alone. The prescription of Longchaifang is novel and reasonable, and the therapeutic effect is remarkable. It is expected to have a broad prospect in clinical application and is worth popularizing.
【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】：2017
【分类号】：R512.62

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