益气养肝方剂干预干扰素治疗慢性丙型肝炎不良反应的临床观察

发布时间：2018-05-24 16:01

本文选题：益气养肝方剂 + 茵栀黄颗粒　；参考：《吉林大学》2017年硕士论文

【摘要】：目的:在干扰素联合利巴韦林抗丙型肝炎病毒治疗的基础上,以茵栀黄颗粒冲剂作对照,观察益气养肝方剂干预干扰素联合利巴韦林抗病毒治疗不良反应的临床疗效。方法:收集2014年9月至2015年12月期间就诊于吉林大学第二医院肝胆胰内科经门诊收入院并应用干扰素联合利巴韦林系统治疗的丙型病毒性肝炎患者40例,随机分为益气养肝方剂联合治疗实验组及茵栀黄颗粒冲剂联合治疗对照组,每组各20例;在给予聚乙二醇干扰素α-2a(商品名:派罗欣,上海罗氏制药有限公司生产)180ug,皮下注射,每周1次,利巴韦林(四川美大康药业股份有限公司生产)1000mg/次,1次/日的同时,实验组20例丙型肝炎患者给予益气养肝方制剂150 ml/次,3次/日,对照组20例患者给予茵栀黄颗粒冲剂3g/次,3次/日。每个疗程持续12周。分别于治疗前及治疗1周、2周、4周观察记录发热、乏力、肌肉关节酸痛、头痛、失眠等不良反应及血常规的变化情况;于治疗4周、12周、24周检查并记录患者HCV-RNA变化情况;于治疗前及治疗2周、4周、8周检查并记录肝功能(ALT、AST、TBIL、ALB)变化情况;于治疗前及治疗4周、8周、12周检测肝脏瞬时弹性成像(肝硬度值,单位为KPA)变化情况。结果:1.治疗前后不良反应复常情况根据临床观察,在治疗1周时益气养肝方剂联合治疗实验组在发热、肌肉关节酸痛、头痛方面的缓解率分别为63.2%、60.0%、50.0%,明显优于茵栀黄颗粒冲剂联合治疗对照组30.0%、21.4%、13.3%的缓解率,且差异有统计学意义(P0.05);在治疗2周时实验组在发热、乏力、肌肉关节酸痛、头痛、失眠方面的缓解率分别为89.5%、82.4%、86.7%、77.8%、72.7%,较对照组50.0%、44.4%、50.0%、40.0%、30.8%的缓解率优势明显,有统计学差异(P0.05);在治疗4周时实验组与对照组在粒细胞减少方面缓解率分别为84.6%及41.7%,两组比较差异有统计学意义(P0.05);在血小板减少方面,两组在所有治疗时间点缓解情况相似(P0.05)。2.治疗前后病毒学应答情况根据临床观察,在治疗4周、12周及24周时,益气养肝方剂联合治疗实验组的快速病毒学应答(RVR)率、早期病毒学应答(EVR)率及持续病毒学应答(SVR)率分别为60.0%、85.0%、75.0%,茵栀黄颗粒冲剂联合治疗对照组RVR率、EVR率及SVR率分别为50.0%、75.0%、70.0%,两组比较无统计学差异(P0.05)。3.治疗前后肝脏功能复常情况根据临床观察,益气养肝方剂联合治疗实验组与茵栀黄颗粒联合治疗对照组组内比较,在第4周及第8周时,两组患者ALT、AST、TBIL水平下降明显,差异有统计学意义(P0.05);整个治疗过程中,两组治疗前后组间比较及治疗前后肝功能各指标下降幅度(均值)组间比较均无明显差异(P0.05)。4.治疗前后肝硬度值变化情况根据临床观察,益气养肝方剂联合治疗实验组在治疗第12周与治疗前比较KPA值明显下降,差异有统计学意义(P0.05),对照组在治疗第12周与治疗前比较KPA值无明显变化(P0.05);在治疗第12周时实验组KPA值水平降幅(均值)明显高于对照组,差异有统计学意义(P0.05)。结论:益气养肝方剂干预干扰素联合利巴韦林治疗慢性丙型病毒性肝炎患者,可显著改善患者发热、乏力、肌肉关节酸痛、粒细胞减少、头痛、失眠等不良反应;具有明显溶解纤维、改善肝纤维化程度的作用;可作为聚乙二醇干扰素联合利巴韦林(PR)方案治疗慢性丙型肝炎的辅助治疗手段,值得推广应用。
[Abstract]:Objective: on the basis of interferon combined with ribavirin (ribavirin) anti hepatitis C virus, Yinzhi Huang granule was used as control to observe the clinical efficacy of interferon interferon combined with ribavirin for antiviral treatment. Methods: from September 2014 to December 2015, the liver and gallbladder pancreas of the second hospital of Jilin University were collected. 40 patients with viral hepatitis C treated by interferon combined with Leigh Bhave Lin system were randomly divided into the combination therapy group of Yiqi nourishing liver prescription and Yinzhi Huang granule in the control group, with 20 cases in each group, and were given pegylate alpha -2a (commodity name: pomroin, Shanghai Roche Pharmaceuticals. Limited company production) 180ug, subcutaneous injection, 1 times a week, Leigh Bhave Lin (Sichuan Mei Da Kang pharmaceutical Limited by Share Ltd production) 1000mg/ times, 1 times per day, while 20 cases of hepatitis C patients in the experimental group were given 150 ml/ times, 3 times per day, 20 patients in the control group were given Yinzhi Huang granule granules 3g/ times, 3 times per day. Each course lasted 12 weeks. The changes of fever, fatigue, muscle and joint pain, headache, insomnia and other adverse reactions and changes of blood routine were observed before and 1 weeks, 2 weeks and 4 weeks respectively. The changes of HCV-RNA were checked and recorded for 4 weeks, 12 weeks and 24 weeks, and the changes of liver function (ALT, AST, TBIL, ALB) were recorded before and 2 weeks, 4 weeks and 8 weeks before and after treatment. Before and after treatment, 4 weeks, 8 weeks and 12 weeks, the transient elastography of the liver (the value of liver hardness, unit KPA) was detected. Results: 1. of the adverse reactions were observed before and after 1. treatment. In the 1 week treatment, the remission rate of the combined treatment group of Yiqi Yang and liver prescription in the experimental group was 63.2% and 60%, respectively. 50%, obviously better than the Yinzhi yellow granule combined with the combined treatment of 30%, 21.4%, 13.3% remission rate, and the difference was statistically significant (P0.05). During the 2 week treatment, the experimental group was 89.5%, 82.4%, 86.7%, 77.8%, 72.7%, respectively, in fever, fatigue, muscle and joint ache, headache, and insomnia, 50%, 44.4%, 50%, 40%, compared with the control group. The remission rate had a significant difference (P0.05), and the rate of granulocytopenia was 84.6% and 41.7% in the experimental group and the control group at 4 weeks, and the two groups were statistically significant (P0.05). In the thrombocytopenia, the two groups were similar (P0.05) to the virological response before and after the treatment of.2.. According to clinical observation, the rate of rapid virology response (RVR), the rate of early virological response (EVR) and sustained virological response (SVR) were 60%, 85%, and 75% respectively at 4 weeks, 12 and 24 weeks, and the rate of RVR, EVR rate and SVR rate were 50%, 75 respectively in the control group. There was no statistically significant difference (P0.05) between the two groups (P0.05) before and after.3. treatment. According to the clinical observation, the level of ALT, AST, and TBIL in the two groups were significantly decreased in the group of two groups, and the difference was statistically significant (P0.05). During the treatment, there was no significant difference between the two groups before and after treatment and the decrease of the liver function before and after treatment (P0.05). The changes of liver hardness value before and after.4. treatment were observed. The KPA value of the experimental group of Yiqi nourishing liver prescription combined treatment group was significantly lower than that before treatment, and there was a difference between the two groups. There was no significant change in the value of KPA (P0.05) in the control group at twelfth weeks and before treatment (P0.05). The decrease of KPA in the experimental group was significantly higher than that of the control group at the twelfth week of treatment (P0.05). Conclusion: Yiqi Yang liver prescription interferon combined with Leigh Bhave Lin in the treatment of chronic hepatitis C patients It can significantly improve the patient's fever, fatigue, muscle and joint pain, granulocytic reduction, headache, insomnia and other adverse reactions; it can dissolve fiber obviously and improve the degree of liver fibrosis; it can be used as a supplementary treatment for the treatment of chronic hepatitis C with peginterferon combined with Leigh Bhave Lin (PR) scheme.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R512.63

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