牡甲化纤方抗肝纤维化的临床研究

发布时间：2018-08-07 21:09

【摘要】：目的:通过随机对照试验的方法,观察牡甲化纤方治疗肝纤维化的临床疗效,并探讨牡甲化纤方的作用机制。方法:将符合纳入标准的患者随机分成治疗组与对照组各120例,治疗组给予牡甲化纤方胶囊,由黄石市中医医院(传染病医院)制剂室代加工提供,主要药物有:制鳖甲、海藻、生牡蛎、丹参、莪术、枳实、白术等,每次4粒,每日3次。对照组给予鳖甲软肝片(由内蒙古福瑞中蒙药科技股份有限公司生产):0.25g/粒,每次4粒,每日3次,3个月一个疗程,4个疗程后判定疗效。治疗期间,研究对象应作息规律,勿使用与本研究无关,特别是对研究结果影响较大的药物。所有患者均在治疗前及各疗程结束后常规采集清晨空腹时静脉血查丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBIL)及球蛋白(GLO)、γ-谷氨酰转移酶(GGT);肝纤维化指标透明质酸(HA)、层黏蛋白(LN)、Ⅲ型前胶原(PcⅢ)、IV型胶原(IVC)、单胺氧化酶(MAO);氧化应激指标丙二醛(MDA)和细胞因子IL1、IL6;进行肝脏穿刺活组织检查术,结果由副主任以上医师负责评价。比较两组患者治疗前后的各项检测指标,综合判定疗效。结果:1.临床总体疗效比较:治疗24周后,治疗组和对照组的总有效率分别为85.71%和76.32%;治疗48周后,治疗组和对照组的总有效率分别为93.10%和78.43%,两组分别在24周、48周后相比均有显著的统计学差异(P0.05),说明与对照组相比,治疗组总体具有更好的疗效。2.中医证候总积分比较:从第24周开始两组的中医证候总积分相比有显著的统计学差异(P0.05),且经过48周治疗后两组的中医证候总积分均较治疗前明显减少,说明治疗后治疗组的中医症候总积分比对照组明显减少(P0.05)。3.中医各主要症候积分比较:两组患者经过48周治疗后在倦怠乏力、食欲不振、面色晦暗、胁肋疼痛、脘闷腹胀、恶心呕吐、口干口苦、身目发黄等证候积分上均有所改善。两组之间相比从第24周开始在倦怠乏力、食欲不振、面色晦暗、胁肋疼痛、脘闷腹胀、恶心呕吐的症候积分有显著的统计学差异(p0.05),说明与对照组相比,治疗组改善上诉症候的作用强于对照组。但经过48周治疗后两组在口干口苦、身目发黄的症候积分均无显著性的差异(p0.05)。4.肝功能、肝纤维化指标、MDA、IL-1、IL6及Ishak评分的比较:经过48周治疗后两组患者的各项检查指标有明显降低,从第24周开始两组相比有显著的统计学差异(p0.05或p0.01),说明治疗组在改善各项检查指标上优于对照组。5.两组患者在整个治疗过程中,未出现明显不良反应,安全性好。结论:牡甲化纤方治疗肝纤维化的临床效果良好,在临床总体疗效、改善中医症候积分及肝功能等方面均优于鳖甲软肝片对照组,其抗纤维化的机制可能与改善肝纤维患者肝纤维化指标、降低MDA、IL1、IL6及Ishak评分的水平有关。
[Abstract]:Objective: to observe the therapeutic effect of Mujia Huaxian recipe on liver fibrosis and to explore its mechanism. Methods: the patients who met the inclusion criteria were randomly divided into treatment group (n = 120) and control group (n = 120). The treatment group was treated with Mujia Huaxian capsule, which was processed by the preparation room of Huangshi traditional Chinese Medicine Hospital (Infectious Diseases Hospital). Seaweed, oysters, Salvia miltiorrhiza, Curcuma, Fructus Aurantii, Atractylodes macrocephala, 4 capsules, 3 times a day. The control group was given Biejia Ruanggan tablet (produced by Inner Mongolia Furuizhong Mongolian Medicine and Technology Co., Ltd.): 0.25g / granule, 4 tablets each time, 3 times a day, 3 months a course of treatment, 4 courses of treatment to determine the curative effect. During the course of treatment, the subjects should not use drugs which were not related to the study, especially those that had a great influence on the results. Before treatment and after each course of treatment, all patients were routinely collected before and after each course of treatment. Venous blood samples were collected before and after each course of treatment. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL) and globulin (GLO), 纬 -glutamyltransferase (GGT);) were examined for hepatic fibrosis. Index of hyaluronic acid (HA), laminin (LN), 鈪，

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