CN115252737A - 治疗非酒精性脂肪性肝的中药组合物、制备方法及应用 - Google Patents
治疗非酒精性脂肪性肝的中药组合物、制备方法及应用 Download PDFInfo
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Abstract
本发明公开了一种治疗非酒精性脂肪性肝的中药组合物,包括组分生黄芪、生葛根、郁金、茯苓皮、皂荚刺、三棱、焦山楂、昆布、神曲、鹿衔草、决明子、绞股蓝以及荷叶。还公开该中药组合物的制备方法,称取上述组分后加水浸泡、煎煮后过滤即得。还公开该中药组合物在制备治疗非酒精性脂肪性肝的药物中的应用。本发明根据中医从脾论治疗非酒精性脂肪性肝病,以“健脾升阳,降毒化浊”为基本治疗方法恢复脾胃的升清降浊的生理特点,通过健运脾胃维护肠粘膜屏障功能而达到“治肝”效果,具体来说,本发明的中药组合物可有效降低非酒精性脂肪肝患者的体重,有效减少肝脏脂肪沉积,有效改善肝功能,降低血脂水平,且无任何明显不良反应。
Description
技术领域
本发明涉及肝病治疗药物技术领域,具体涉及一种治疗非酒精性脂肪性 肝的中药组合物,还涉及该中药组合物的制备方法,以及涉及该中药组合物 在制备治疗非酒精性脂肪性肝的药物中的应用。
背景技术
随着肥胖及其相关代谢综合征全球化的流行趋势,非酒精性脂肪性肝病 现已成为欧美等发达国家和我国富裕地区慢性肝病的重要病因,普通成人 NAFLD患病率10%~30%,其中10%~20%为NASH,后者10年内肝硬化发生率 高达25%。非酒精性脂肪性肝病除可直接导致失代偿期肝硬化、肝细胞癌和移 植肝复发外,还可影响其他慢性肝病的进展,并参与2型糖尿病和动脉粥样 硬化的发病。代谢综合症相关恶性肿瘤、动脉硬化性心脑血管疾病以及肝硬 化为影响非酒精性脂肪性肝病患者生活质量和预期寿命的重要因素。
一般认为非酒精性单纯性脂肪肝是自然病程中是一种温和或相对静止性 病变阶段,治疗主要通过以饮食控制和运动锻炼为基础的生活方式调整,愈 后良好;而一旦发展至非酒精性脂肪性肝炎阶段,常伴有炎症活动和纤维化, 疾病的进展会显著加速。我国非酒精性脂肪性肝患病率约为25.24%,其中非 酒精性脂肪性肝炎发病率为2%-8%,在非酒精性脂肪性肝炎伴肝纤维化患者 中,3年内原发性肝癌的发病率是12.8%,因此非酒精性单纯性脂肪肝是药物 干预治疗的重点。
遗憾的是,截止目前尚无针对非酒精性脂肪性肝的特效且安全的药物, 仍以生活方式干预和保肝降脂治疗为主,临床实践证实中医药防治非酒精性 脂肪性肝具有独特的疗效和优势。近年来,越来越多的证据显示代谢性疾病 发病与肠道微生态环境失衡密切相关,肠源性内毒素诱发的代谢性炎症是其 发病主要机制之一,而“脾”的功能失调与代谢性内毒素血症存在密切的相 关性,这将为中医从脾论治非酒精性脂肪性肝等代谢相关性疾病提供一定的 依据和思路。
发明内容
本发明的主要目的在于提供一种治疗非酒精性脂肪性肝的中药组合物, 解决了现有技术没有针对非酒精性脂肪性肝的特效且安全的药物的问题。
本发明的主要目的还在于提供一种上述中药组合物的制备方法。
本发明的主要目的还在于提供一种上述中药组合物在制备治疗非酒精性 脂肪性肝的药物中的应用。
为实现上述目的,本发明采取的第一个技术方案为:一种治疗非酒精性 脂肪性肝的中药组合物,包括如下组分:生黄芪、生葛根、郁金、茯苓皮、 皂荚刺、三棱、焦山楂、昆布、神曲、鹿衔草、决明子、绞股蓝以及荷叶。
进一步的,包括如下质量份数的组分:生黄芪18-22份、生葛根10-14 份、郁金4-8份、茯苓皮16-20份、皂荚刺4-8份、三棱4-8份、焦山楂8-12 份、昆布8-12份、神曲8-12份、鹿衔草10-14份、决明子10-14份、绞股 蓝10-14份、荷叶4-8份。
更进一步的,包括如下质量份数的组分:生黄芪19-21份、生葛根11-13 份、郁金5-7份、茯苓皮17-19份、皂荚刺5-7份、三棱5-7份、焦山楂9-11 份、昆布9-11份、神曲9-11份、鹿衔草11-13份、决明子11-13份、绞股 蓝11-13份、荷叶5-7份。
优选的,包括如下质量份数的组分:生黄芪20份、生葛根12份、郁金6 份、茯苓皮18份、皂荚刺6份、三棱6份、焦山楂10份、昆布10份、神曲 10份、鹿衔草12份、决明子12份、绞股蓝12份、荷叶6份。
该中药组合物中各组分的功能:重用生黄芪为君以健脾益气,升清阳, 升清而化浊;生葛根、郁金、茯苓皮、皂荚刺、三棱诸药为臣,生葛根鼓舞 脾胃清阳之气上升;郁金旨在活血、行气、解郁;茯苓皮利水消肿;三棱破 血行气;皂荚刺活血消痈、排脓;焦山楂、神曲、荷叶、决明子、绞股蓝共 为佐药,山楂、神曲消食化积,以助健运,焦山楂又可入血分,行气散淤, 加强郁金、三棱之力;荷叶醒脾升阳,而决明子则一药三用:(1)清肝润肠, 通泄二便,降泄浊气;(2)与葛根配伍体现升清降浊;(3)使药引药入达 肝与大肠经,体现“肝与大肠相通,治肝宜疏通大肠”的思想。
本发明采取的第二个技术方案为:一种上述中药组合物的制备方法,包 括步骤:按照上述配方称取各中药组分,然后加水浸泡、煎煮后过滤即得。
本发明采取的第三个技术方案为:一种上述中药组合物在制备治疗非酒 精性脂肪性肝的药物中的应用。
与现有技术相比,本发明具有如下有益效果:本发明根据中医从脾论治 疗非酒精性脂肪性肝病,以“健脾升阳,降毒化浊”为基本治疗方法恢复脾 胃的升清降浊的生理特点,通过健运脾胃维护肠粘膜屏障功能而达到“治肝” 效果,具体来说,本发明的中药组合物可有效降低非酒精性脂肪肝患者的体 重,有效减少肝脏脂肪沉积,有效改善肝功能,降低血脂水平,且无任何明 显不良反应。
附图说明
图1为各组大鼠肝组织HE染色图(×200);其中,图1(a)为正常对 照组的大鼠肝组织HE染色图,图1(b)为模型对照组的大鼠肝组织HE染色 图,图1(c)为服用本发明中药组合物组的大鼠肝组织HE染色图;
图2为各组大鼠肝油红O染色图(×200);其中,图2(a)为正常对照 组的大鼠肝油红O染色图,图2(b)为模型对照组的大鼠肝油红O染色图, 图2(c)为服用本发明中药组合物组的大鼠肝油红O染色图。
具体实施方式
本发明公开了一种治疗非酒精性脂肪性肝的中药组合物,包括如下组分: 生黄芪、生葛根、郁金、茯苓皮、皂荚刺、三棱、焦山楂、昆布、神曲、鹿 衔草、决明子、绞股蓝以及荷叶。
其可以达到健脾化浊,脾肝肠共治,升清降浊以调理脏腑气机,补消和 下并用以兼顾标本,达到治疗非酒精性脂肪性肝的效果。
进一步的,本发明的中药组合物的各组分包括以下质量份数:生黄芪 18-22份、生葛根10-14份、郁金4-8份、茯苓皮16-20份、皂荚刺4-8份、 三棱4-8份、焦山楂8-12份、昆布8-12份、神曲8-12份、鹿衔草10-14份、 决明子10-14份、绞股蓝10-14份、荷叶4-8份。
更进一步的,本发明的中药组合物的各组分包括以下质量份数:生黄芪 19-21份、生葛根11-13份、郁金5-7份、茯苓皮17-19份、皂荚刺5-7份、 三棱5-7份、焦山楂9-11份、昆布9-11份、神曲9-11份、鹿衔草11-13份、 决明子11-13份、绞股蓝11-13份、荷叶5-7份。
优选的,本发明的中药组合物的各组分包括以下质量份数:生黄芪20份、 生葛根12份、郁金6份、茯苓皮18份、皂荚刺6份、三棱6份、焦山楂10 份、昆布10份、神曲10份、鹿衔草12份、决明子12份、绞股蓝12份、荷 叶6份。
本发明的各组分的性味、归经、功效,具体见下表1:
表1 本发明中各组分的来源、性味、归经及功效表
具体来说,本发明各组分的药解分析如下:
生黄芪:性味甘、微温,归肺、脾经,具有益气升阳、利水消肿之效。 始载于《神农本草经》,位列上品。《名医别录》及《药性赋》也分别记 载了黄芪“益气”、“益元气而补三焦”的功效。《本草正义》张山正谓黄 芪曰:“黄芪补益中土,温养脾胃,凡中气不振,脾土虚弱,清气下陷者最宜。 其皮味浓质厚,力量皆在皮中,故能直达人之肤表肌肉,固护卫阳,充实表分,是其专长,所以表虚诸病,最为神剂。”《本经疏证》记载“黄芪一源 三派,浚三焦之根,利营卫之气,故凡营卫间阻滞,无不尽通。所谓源清流 自洁者也。”以上论述均说明白术有健脾升阳,行滞降浊的功效。现代药理 学研究证明:黄芪多糖具有改善肠动力、调节肠功能紊乱、修复肠粘膜损伤、 抑制肠道炎症等作用,其有效成分黄芪多糖能显著提高肠道双歧杆菌的水平 和黏附性。
生葛根:性味甘、辛、凉,归脾、胃、肺经,具有,升阳止泻,通经活络 之功效。《本草正义》:“葛根,气味皆薄,最能升发脾胃清阳之气,《伤 寒论》以阳明主药,正惟表寒过郁于外,胃家阳气不能散布,故以此轻扬升 举之药,捷动清阳,捍御外寒,斯表邪解而胃阳舒展。”据《本草纲目》、《中 药大辞典》、《功能性食品》等权威资料著述,葛根及其制品有清火、排毒、 降血脂、降血压、降胆固醇、降血糖、减肥、通便等多种功效。
郁金:性味辛、苦、寒,归肝经、心经和肺经,具有行气、化瘀的作用。 《本草经疏》:郁金本入血分之气药,其治已上诸血证者,正谓血之上行,皆 属于内热火炎,此药能降气,气降即是火降,而共性又入血分,故能降下火 气,则血不妄行。药理研究表明,郁金在抗肿瘤、降血脂及保肝利胆方面有 着突出的作用。
茯苓皮:多孔菌科真菌茯苓的干燥菌核的外皮,性味平、淡。有利水, 消肿的作用。《本草纲目》:“主水肿肤胀,开水道,开腠理。”研究发现 茯苓提取物能增强机体疫功能,对肠道分泌型免疫球蛋白A也有调节作用; 用茯苓干预小鼠菌群失调模型可对肠道菌群具有扶植作用,可降低肠道的pH 值,提高双歧杆菌的黏附性。
皂荚刺:性味辛、温,归肝、胃经。具有消肿托毒,排脓之功效。
昆布:性寒、味苦、咸,归肝经、胃经、肾经。具有软坚散结、消痰、 利水之功效。药理研究表明,海藻有降低胆甾醇水平或脏器中胆甾醇含量的 作用。
三棱:性味辛、苦,平。归肝、脾经。具有破血行气,消积止痛。药理 研究表明,可抑制血栓形成,降低全血粘度。
焦山楂:性味酸、甘,微温。归脾、胃、肝经。具有消食化积、活血化 瘀的功效。药理学研究表明,山楂酮能显著降低血清和肝脏丙二醛(MDA)含 量,增强红细胞和肝脏超氧化物
神曲:味甘、辛,性温。归脾胃经,其中含有酶类维生素B复合体、酵 母菌、麦角固醇、挥发油和苷类等成分。对双歧杆菌等有益于机体的厌氧菌 水平的升高具有明显促进作用,可以降低肠杆菌、肠球菌的数量,并可以促 进肠损伤的恢复。
鹿衔草:性味甘、苦,温。归肝、肾经,具有祛风湿,强筋骨的功效。 药理学研究表明,单味鹿衔草茶剂有明显降低血清胆固醇的作用。
决明子:为豆科一年生草本植物,最早载于《神农本草经》,性味咸、 甘、苦、性微寒,归肝、大肠经,有“久服能益精光,轻身”之效,亦被列 为上品,也是原卫生部公布的69种药食同源的物质之一,不仅可作为功能性 食品,也是保健饮料的良好原料。其主要有效成分为蒽醌类化合物,包括: 决明素、大黄素、芦荟大黄素等,具有保肝降脂,降血压、抑菌、抗氧化等 生理效应,被广泛应用于治疗肥胖、高脂血症、脂肪性肝病等代谢性疾病的 治疗。决明子内壳(SCⅡ)的主要成分水溶性多糖可促进肠道有益菌的繁殖, 竞争性抑制肠道病原菌或有害菌增殖,改善机体的消化能力和抵抗力。其乙 醇提取物可明显降低高脂血症模型大鼠血清炎性细胞因子IL-6、TNF-α水平。
绞股蓝:味甘、苦,性微寒。归脾、肺经,具有益气健脾,化痰止咳, 清热解毒的作用。药理研究表明,绞股蓝有降血脂、降血压、降血糖、镇静、 催眠、抗紧张、抗溃疡、抗疲劳、延长细胞寿命以及增进食欲,增强抵抗力, 通畅大便,平喘止咳,消痔、减肥等功效。
本发明还公开一种上述中药组合物的制备方法,包括步骤:按照上述配 方称取各中药组分,然后加水浸泡、煎煮后过滤即得。
本发明还公开一种上述中药组合物在制备治疗非酒精性脂肪性肝的药物 中的应用。
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行 清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而 不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做 出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本实施例公开一种治疗非酒精性脂肪性肝的中药组合物的制备方法,包 括步骤:
分别称取生黄芪18克、生葛根10克、郁金4克、茯苓皮16克、皂荚刺 4克、三棱4克、焦山楂8克、昆布8克、神曲8克、鹿衔草10克、决明子 10克、绞股蓝10克、荷叶4克。然后加水没过上述药材浸泡10分钟,武火 煮沸、文火煎煮30分钟后过滤得药汁即得。
实施例2
本实施例公开一种治疗非酒精性脂肪性肝的中药组合物的制备方法,包 括步骤:
分别称取生黄芪19克、生葛根11克、郁金5克、茯苓皮17克、皂荚刺 5克、三棱5克、焦山楂9克、昆布9克、神曲9克、鹿衔草11克、决明子 11克、绞股蓝11克、荷叶5克。然后加水没过上述药材浸泡15分钟,武火 煮沸、文火煎煮25分钟后过滤得药汁即得。
实施例3
本实施例公开一种治疗非酒精性脂肪性肝的中药组合物的制备方法,包 括步骤:
分别称取生黄芪20克、生葛根12克、郁金6克、茯苓皮18克、皂荚刺 6克、三棱6克、焦山楂10克、昆布10克、神曲10克、鹿衔草12克、决明 子12克、绞股蓝12克、荷叶6克。然后加水没过上述药材浸泡15分钟,武 火煮沸、文火煎煮28分钟后过滤得药汁即得。
实施例4
本实施例公开一种治疗非酒精性脂肪性肝的中药组合物的制备方法,包 括步骤:
分别称取生黄芪21克、生葛根13克、郁金7克、茯苓皮19克、皂荚刺 7克、三棱7克、焦山楂11克、昆布11克、神曲11克、鹿衔草13克、决明 子13克、绞股蓝13克、荷叶7克。然后加水没过上述药材浸泡15分钟,武 火煮沸、文火煎煮28分钟后过滤得药汁即得。
实施例5
本实施例公开一种治疗非酒精性脂肪性肝的中药组合物的制备方法,包 括步骤:
分别称取生黄芪22克、生葛根14克、郁金8克、茯苓皮20克、皂荚刺 8克、三棱8克、焦山楂12克、昆布12克、神曲12克、鹿衔草14克、决明 子14克、绞股蓝14克、荷叶8克。然后加水没过上述药材浸泡15分钟,武 火煮沸、文火煎煮28分钟后过滤得药汁即得。
本实施例公开的只是该治疗非酒精性脂肪性肝的中药组合物的最简单的 一种制备方法,当然,还可以根据需要制成口服液,或者加入辅料制成丸剂、 冲服颗粒剂等。
经动物药效学试验表明:本发明的中药组合物可以降低非酒精性单纯性 脂肪肝模型大鼠体质量及肝脏指数,又能降低血清TC和FFA的水平。实验数 据采用SPSS 17.0统计学软件进行分析,数据均以表示,两样本均数比较 采用两个独立样本的t检验;多个样本均数比较采用方差分析。以P<0.05为 差异有统计学意义。实验具体过程如下:
分组、造模与给药:将SPF级SD大鼠32只(6周龄,体质量150~200g) 随机分成3组:正常对照组(8只)、健脾化浊消脂方组(8只)、模型对照 组(16只)。采用高脂饲料诱导大鼠肝组织脂肪变性的方法复制NASH模型。 经适应性喂养3d后,正常组对照组大鼠给予常规饲料喂养,其余两组大鼠饲投 以高脂饲料(组成:普通词料60%,蔗糖6%,猪油22%,酪蛋白5%,玉米蛋白 粉3%,胆固醇2%,磷酸钙1.6%,添加剂0.4%),实验周期共16周。每4周从模型对照组大鼠中随机抽取2只,取肝组织行苏木精和伊红(HE)染色以动态 评估模型,经证实第4周末造模大鼠出现NAFLD改变。于第5周开始,健脾化 浊消脂方大鼠给予健脾化浊消脂方灌胃,参照《中药药理研究方法学》按照体表面积 折算出大鼠的等效剂量为12.5g·kg-1·d-1,其余两组大鼠予以等体积的0.9%氯化钠 溶液灌胃,并根据体质量变化调整给药量,共连续给药12周。
肝脏指数实验:分析天平准确称量各组大鼠完整肝脏组织的湿重,结合 末次大鼠体质量,计算肝脏指数,肝脏指数(%)=肝湿重/体质量×100%。统 计结果显示:第1周,各组大鼠间体质量差异无统计学意义。至第16周实验 结束时,模型对照组大鼠体质量和肝脏指数较正常对照组显著增加(P<0.01); 服用本发明中药组合物组较模型对照组大鼠体质量和肝脏指数均显著降低 (P<0.01,P<0.05),详见表2:
注:与正常对照组比较,*P<0.01,**P<0.01;与模型对照组比较,△P<0.05,△△P<0.01。
肝脏病理形态学检测HE染色:取4%多聚甲醛固定的肝组织,梯度酒精脱 水,石蜡包埋,切片并染色,光镜下观察肝脏病理学改变,进行NAFLD活动 度积分(NAFLD activityscore,NAS)评分。参见图1(a),结果显示: 正常对照组大鼠肝小叶结构完整,肝索排列整齐,肝窦清晰,肝细胞体积均 匀,细胞核结构清晰;参见图1(b)可知:模型对照组大鼠肝细胞呈弥漫性 大泡性脂肪变性,可见肝细胞气球样变,汇管区可见显著的炎症细胞浸润, 向小叶内延伸,部分小叶内有坏死灶;参见图1(c)可知:服用本发明中药 组合物组的肝细胞脂肪变及炎症较模型对照组有明显改善。
服用本发明中药组合物组的大鼠肝脏脂肪变性程度较模型对照组显著改 善(P<0.01),详见表3:
表3 各组大鼠肝脏组织NAS评分的比较(n=8)
肝脏病理形态学检测油红O染色:用70%乙醇溶液清洗肝组织,加入苏丹 Ⅲ染料,苏木素浅染胞核5min,70%乙醇溶液分化,水洗,光镜下观察脂肪变 性情况。参见图2(a),结果显示:正常对照组大鼠肝细胞内少见脂滴;参 见图2(b),结果显示:模型对照组大鼠肝细胞内脂滴呈弥漫性、颗粒状堆 积,融合成片状;参见图2(c),结果显示:服用本发明中药组合物组的大 鼠肝细胞脂滴数量减少,脂滴体积相对较小,呈小颗粒状不均匀分布。
血清TG、FFA的检测:腹主动脉取血后,室温静置30min后,离心半径 87mm,3000r/min离心10min,分离血清,采用全自动生化分析仪进行TG、FFA 检测。统计结果显示:与正常对照组比较,模型对照组大鼠血清TG、FFA水 平均显著上升(P<0.01);与模型对照组比较,服用本发明中药组合物组大 鼠血清TG、FFA水平显著降低(P<0.05,P<0.01),详见表4:
血浆LPS含量检测:在无菌技术下,抽取门静脉血1mL,装入无热原抗凝 管,离心半径87mm,3000r/min离心3min,取上清液标本,按照鲎试剂盒说 明书操作步骤检测。统计结果显示:与正常对照组比较,模型对照组大鼠血 浆LPS含量均显著升高(P<0.01);与模型对照组比较,服用本发明中药组 合物组大鼠血浆LPS含量显著下降(P<0.05),详见表5;
血清TNF-α、IL-1β水平检测:取血清采用ELISA法,按试剂盒说明书 操作步骤测定。统计结果显示:与正常对照组比较,模型对照组大鼠血清IL-1 β、TNF-α水平显著升高(P<0.01);与模型对照组比较,服用本发明中药 组合物组大鼠血清IL-1β、TNF-α水平显著降低(P<0.01),详见表5:
临床试验表明:本发明的中药组合物可有效降低非酒精性单纯性脂肪肝 患者的体重,减少肝脏脂肪沉积,降低血清ALT、AST、TC水平,降低血脂 水平,且无明显副作用,具体临床实验及数据如下:
患者资料:三甲级医院非单纯性脂肪肝患者共计60例。
诊断标准:现代医学诊断标准采用2010年中华医学会肝病学分会脂肪 肝和酒精性肝病学组修订的《非酒精性脂肪性肝病诊疗指南》中的标准。中 医辨证标准参照2010年中华中医药学会脾胃病分会制定的《非酒精性脂肪 性肝病中医诊疗共识意见》中痰湿中阻证的诊断标准。
纳入标准:①经彩超或CT扫描确定为中~重度脂肪肝或肝脏 FibroScan扫描测量受控衰减参数(CAP)值>259dB·m-1;②ALT和/或AST 持续升高4周以上,1.5倍ULN(正常值上限)<ALT<4ULN,且排除其他原 因引起者;③符合上述诊断标准;④试验前4周未使用过与本治疗方案的同 类药物;⑤年龄18~60岁;⑥患者均签订知情同意书。
排除标准:①有饮酒史者(男性每天饮酒折合乙醇量≥30g,女性≥ 20g);②排除药物或其他原因引起的脂肪肝、局灶性脂肪肝者;③合并严重 的肝功能损害者;④过敏体质或对本研究药物已知成分过敏者;⑤哺乳、妊 娠期妇女,或准备妊娠者;⑥合并其他内、外科急性疾病者及精神病、肿瘤 患者;⑦合并药物性肝炎、病毒性肝炎者。
治疗方案:治疗方案分行为疗法和药物疗法。
行为治疗:2组患者均给予饮食和运动指导,并督促强化。根据个体情况 合理调整饮食,控制膳食热量摄入,在平日基础上每天减少热量500~ 1000Kcal,优化饮食结构,建议适量脂肪和碳水化合物的平衡膳食,限制高 碳酸饮料和深加工精致食品,增加全谷类食物、膳食纤维、蔬菜及低含糖量 水果的摄入;三餐定时适量,严格控制晚餐的量及加餐行为;避免久坐少动, 根据患者自身情况并以能够坚持为原则采取适合的锻炼方式,每天坚持中等 强度有氧运动30min,每周5次,或每天高强度有氧运动20min,每周至少3 次。
药物治疗:对照组患者口服水飞蓟宾胶囊(商品名:水林佳),105mg/ 次,3次/d;治疗组患者在对照组治疗基础上,加服本发明的中药组合物散装 颗粒剂(黄芪22g,茯苓皮20g,葛根、鹿衔草、决明子、绞股蓝各14g,焦 山楂、昆布、神曲12g,郁金、皂荚刺、三棱、荷叶各8g),1剂/d,水冲服, 每周至少服用5剂。疗程均为24周,治疗期间不加用其他保肝及调脂药物, 观察记录患者的不良反应。
观察指标:①两组患者治疗前后的主要临床症状评分,根据症状程度按 无、轻、中、重度主症分别计0、2、4、6分,次症分别计0、1、2、3分; ②体重指数(BMI),BMI=体质量kg/身高m2;③血清生化指标:包括丙氨酸 氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)、血清甘油三酯(TG)、 血清总胆固醇(TC),采用Olympus型全自动生化仪检测;④肝脏CAP值,采用瞬时弹性成像仪(法国Echosens公司)检测。
疗效评价标准:参照《中药新药临床研究指导原则》和《2017年版非酒 精性脂肪性肝病中医诊疗专家共识意见》中关于肝脏脂肪含量测定疗效评价 标准。①临床治愈:症状、体征消失,肝功能指标恢复正常,B超检查示脂 肪肝消失或CAP值<238dB·m-1;②显效:症状、体征消失,肝功能基本恢 复正常,B超检查脂肪肝表现下降2个级别或CAP值减少2个级别,(从重度 下降为轻度);③有效:临床症状基本消失,肝功能基本正常,B超显示脂肪 肝好转或CAP值下降1个级别(重度脂肪肝恢复为中度或中度恢复为轻度); ④无效:治疗前后症状无改善,肝功能、B超、CAP值较前治疗无改善或加重。
统计学方法:采用SPSS 22.0软件处理。计数资料以例数和百分率表 示,采用χ2检验;计量资料以x±s表示,采用t检验,P<0.05时差异有统计学 意义。
治疗效果:本研究结果均提示本发明的中药组合物有助于减轻非酒精性 单纯性脂肪肝患者体重,改善肝功能和血脂水平、减少肝脏脂肪的沉积。详 见表6、表7和表8。
表6 两组患者临床疗效比较表[例(%)]
从表6中可知,与对照组比较,△△P<0.01。
表7 两组患者BMI、CAP值检测结果比较表(x±s)
从表7中可知,与本组治疗前比较,*P<0.05,**P<0.01;与对照组 治疗后比较,△P<0.05。
表8 两组患者血清肝功能、血脂检测结果比较表(x±s)
从表8中可知,与本组治疗前比较,*P<0.05,**P<0.01;与对照组治 疗后比较,P<0.05。
不良反应:两组患者在治疗过程中均未出现明确的与药物相关的不良反 应。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而 言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行 多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限 定。
Claims (6)
1.治疗非酒精性脂肪性肝的中药组合物,其特征在于:包括如下组分:生黄芪、生葛根、郁金、茯苓皮、皂荚刺、三棱、焦山楂、昆布、神曲、鹿衔草、决明子、绞股蓝以及荷叶。
2.如权利要求1所述的中药组合物,其特征在于:包括如下质量份数的组分:生黄芪18-22份、生葛根10-14份、郁金4-8份、茯苓皮16-20份、皂荚刺4-8份、三棱4-8份、焦山楂8-12份、昆布8-12份、神曲8-12份、鹿衔草10-14份、决明子10-14份、绞股蓝10-14份、荷叶4-8份。
3.如权利要求1所述的中药组合物,其特征在于:包括如下质量份数的组分:生黄芪19-21份、生葛根11-13份、郁金5-7份、茯苓皮17-19份、皂荚刺5-7份、三棱5-7份、焦山楂9-11份、昆布9-11份、神曲9-11份、鹿衔草11-13份、决明子11-13份、绞股蓝11-13份、荷叶5-7份。
4.如权利要求1所述的中药组合物,其特征在于:包括如下质量份数的组分:生黄芪20份、生葛根12份、郁金6份、茯苓皮18份、皂荚刺6份、三棱6份、焦山楂10份、昆布10份、神曲10份、鹿衔草12份、决明子12份、绞股蓝12份、荷叶6份。
5.如权利要求1-4所述的中药组合物的制备方法,其特征在于,包括步骤:按照配方称取各中药组分,然后加水浸泡、煎煮后过滤即得。
6.如权利要求1-4任意一项所述的中药组合物在制备治疗非酒精性脂肪性肝的药物中的应用。
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