【摘要】：目的:通過隨機(jī)對照試驗(yàn)的方法,觀察牡甲化纖方治療肝纖維化的臨床療效,并探討牡甲化纖方的作用機(jī)制。方法:將符合納入標(biāo)準(zhǔn)的患者隨機(jī)分成治療組與對照組各120例,治療組給予牡甲化纖方膠囊,由黃石市中醫(yī)醫(yī)院(傳染病醫(yī)院)制劑室代加工提供,主要藥物有:制鱉甲、海藻、生牡蠣、丹參、莪術(shù)、枳實(shí)、白術(shù)等,每次4粒,每日3次。對照組給予鱉甲軟肝片(由內(nèi)蒙古福瑞中蒙藥科技股份有限公司生產(chǎn)):0.25g/粒,每次4粒,每日3次,3個月一個療程,4個療程后判定療效。治療期間,研究對象應(yīng)作息規(guī)律,勿使用與本研究無關(guān),特別是對研究結(jié)果影響較大的藥物。所有患者均在治療前及各療程結(jié)束后常規(guī)采集清晨空腹時靜脈血查丙氨酸氨基轉(zhuǎn)移酶(ALT)、天門冬氨酸氨基轉(zhuǎn)移酶(AST)、總膽紅素(TBIL)及球蛋白(GLO)、γ-谷氨酰轉(zhuǎn)移酶(GGT);肝纖維化指標(biāo)透明質(zhì)酸(HA)、層黏蛋白(LN)、Ⅲ型前膠原(PcⅢ)、IV型膠原(IVC)、單胺氧化酶(MAO);氧化應(yīng)激指標(biāo)丙二醛(MDA)和細(xì)胞因子IL1、IL6;進(jìn)行肝臟穿刺活組織檢查術(shù),結(jié)果由副主任以上醫(yī)師負(fù)責(zé)評價。比較兩組患者治療前后的各項(xiàng)檢測指標(biāo),綜合判定療效。結(jié)果:1.臨床總體療效比較:治療24周后,治療組和對照組的總有效率分別為85.71%和76.32%;治療48周后,治療組和對照組的總有效率分別為93.10%和78.43%,兩組分別在24周、48周后相比均有顯著的統(tǒng)計(jì)學(xué)差異(P0.05),說明與對照組相比,治療組總體具有更好的療效。2.中醫(yī)證候總積分比較:從第24周開始兩組的中醫(yī)證候總積分相比有顯著的統(tǒng)計(jì)學(xué)差異(P0.05),且經(jīng)過48周治療后兩組的中醫(yī)證候總積分均較治療前明顯減少,說明治療后治療組的中醫(yī)癥候總積分比對照組明顯減少(P0.05)。3.中醫(yī)各主要癥候積分比較:兩組患者經(jīng)過48周治療后在倦怠乏力、食欲不振、面色晦暗、脅肋疼痛、脘悶腹脹、惡心嘔吐、口干口苦、身目發(fā)黃等證候積分上均有所改善。兩組之間相比從第24周開始在倦怠乏力、食欲不振、面色晦暗、脅肋疼痛、脘悶腹脹、惡心嘔吐的癥候積分有顯著的統(tǒng)計(jì)學(xué)差異(p0.05),說明與對照組相比,治療組改善上訴癥候的作用強(qiáng)于對照組。但經(jīng)過48周治療后兩組在口干口苦、身目發(fā)黃的癥候積分均無顯著性的差異(p0.05)。4.肝功能、肝纖維化指標(biāo)、MDA、IL-1、IL6及Ishak評分的比較:經(jīng)過48周治療后兩組患者的各項(xiàng)檢查指標(biāo)有明顯降低,從第24周開始兩組相比有顯著的統(tǒng)計(jì)學(xué)差異(p0.05或p0.01),說明治療組在改善各項(xiàng)檢查指標(biāo)上優(yōu)于對照組。5.兩組患者在整個治療過程中,未出現(xiàn)明顯不良反應(yīng),安全性好。結(jié)論:牡甲化纖方治療肝纖維化的臨床效果良好,在臨床總體療效、改善中醫(yī)癥候積分及肝功能等方面均優(yōu)于鱉甲軟肝片對照組,其抗纖維化的機(jī)制可能與改善肝纖維患者肝纖維化指標(biāo)、降低MDA、IL1、IL6及Ishak評分的水平有關(guān)。
[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), 緯 -glutamyltransferase (GGT);) were examined for hepatic fibrosis. Index of hyaluronic acid (HA), laminin (LN), 鈪，

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