CN103127466B - 治疗帕金森病认知障碍的中药汤剂 - Google Patents
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Abstract
本发明涉及一种药物配方领域，具体地说是一种治疗帕金森病认知障碍的中药汤剂，其特征是原料药组成的重量份为：黄芪20～30、党参17～22、制首乌17～22、熟地12～18、枸杞12～18、丹参12～18、石菖蒲12～18、郁金12～18、黄芩12～18、大黄3～9，上述10味原料药混合后用水浸泡，煎熬后去渣得滤液。本发明成本低，疗效高，无毒副作用，具有补中益气、滋补肝肾、补精益髓、清热燥湿、活血通络、豁痰醒脑的功能，以达到治疗帕金森病认知障碍之良效。
Description
技术领域
本发明涉及一种中成药制剂，具体地说是一种治疗帕金森病认知障碍的中药汤剂。
背景技术
众所周知，帕金森病(Parkinson disease，PD)是一种常见的中枢神经系统变性疾病，多见于中老年人。其运动症状表现为静止性震颤，肌强直、运动迟缓以及姿势平衡障碍等。迄今为止，特发性帕金森病的病因仍不完全清楚，一般认为主要与年龄老化、遗传和环境等因素有关。脑内黑质纹状体内多巴胺神经元的减少与疾病的发生有密切关系。随着中国老龄人数的增加，目前我国帕金森病病人已经高达200万，占老年人口的1％左右，预计每年新增病患10万人。最初认为PD患者没有认知功能方面的改变。1817年James Parkinson首次描述PD时写道：这是一种感觉和智能没有损害的震颤麻痹。近年来，随着对该疾病的认识，许多PD的非运动症状(Non-motor symptoms，NMS)越来越引起重视。非运动症状包括认知功能障碍和痴呆、抑郁、精神症状、植物神经紊乱、睡眠障碍等常贯穿整个病程之中。认知功能障碍非常常见，尤其表现在视空间感知及视觉构建功能、命名能力减退，以及执行功能，注意力，记忆缺陷、思维敏捷性和有计划进行活动能力减退。研究表明80％以上的PD患者会出现认知功能的改变。随着疾病的进展，约有30％的患者将最终发展为帕金森病痴呆(Parkinson’sdisease with dementia，PDD)。影响认知功能障碍的因素众多，其中年龄增长、发病晚、病程、症状严重程度、抑郁、幻觉的存在都是PD患者出现认知功能障碍的危险因素，其病理主要依赖于额叶-纹状体通路，以及顶叶和皮层下结构的完整性。PD的神经生化基础目前较公认的学说为“多巴胺学说”和“氧化应激学说”。前者指出DA合成减少使纹状体DA含量降低，黑质-纹状体通路多巴胺能与胆碱能神经功能平衡失调，胆碱能神经元活性相对增高，使锥体外系功能亢进。后者解释了黑质多巴胺能神经元变性的原因，即在氧化应激时，PD患者DA氧化代谢过程中产生大量H2O2和超氧阴离子，在黑质部位Fe2+催化下，进一步生成毒性更大的自由基，而此时黑质线粒体呼吸链的复合物I活性下降，抗氧化(特别是谷胱甘肽)功能减弱，无法清除自由基，因此，自由基通过氧化神经膜类脂、破坏DA神经元膜功能或直接破坏细胞DNA，最终导致神经元变性死亡。
近代医家根据古代医家的论述，结合临床实践，从不同角度对痴呆病机进行了探讨。有学者认为，痰浊蒙窍是本病的病理关键，瘀血痰浊贯穿本病始终，而痰瘀互结，久滞不化，酿毒损髓，败坏脑络则是本病发生及演变的核心环节。有学者认为，痴呆的病位在脑，其始于肝气郁结，终因瘀血阻窍，而致脑失所养，灵机记性皆失，出现善忘、痴呆等症状。而《中医心脑病学》将痴呆分为5型：肾虚髓亏、脾虚气陷、风痰阻络、瘀阻脑络、心火亢盛。有学者根据临床表现将本病分为4型即痰浊蒙蔽、瘀血内停、肝肾阴虚、髓海失充。尽管中医对帕金森病和认知损害的研究较深，但对帕金森伴发认知损害的认识还不够，仍需进一步实施大样本研究。
发明内容
本发明的目的就是为了克服上述现有的技术不足，提供一种治疗帕金森病认知障碍的中药汤剂，成本低，疗效高，无毒副作用，具有补中益气、滋补肝肾、补精益髓、清热燥湿、活血通络、豁痰醒脑的功能，以达到治疗帕金森病认知障碍之良效。
本发明解决上述技术问题采用的技术方案是：一种治疗帕金森病认知障碍的中药汤剂，其特征是原料药组成的重量份为：黄芪20～30、党参17～22、制首乌17～22、熟地12～18、枸杞12～18、丹参12～18、石菖蒲12～18、郁金12～18、黄芩12～18、大黄3～9，上述10味原料药混合后用水浸泡，煎熬后去渣得滤液。
本发明的有益效果是，成本低，疗效高，无毒副作用，具有补中益气、滋补肝肾、补精益髓、清热燥湿、活血通络、豁痰醒脑的功能，以达到治疗帕金森病认知障碍之良效。
具体实施方式
下面结合实施例对本发明作进一步的描述：
实施例1：
本实施例取上述10味原料药黄芪25克、党参20克、制首乌20克、熟地15克、枸杞15克、丹参15克、石菖蒲15克、郁金15克、黄芩15克、大黄6克。在室温下将10味原料药加净化水800毫升，浸泡6小时，然后用武火煮沸文火煎熬120分钟，去渣得滤液约150毫升，药渣再加水200毫升，煎熬30分钟，去渣得滤液约30毫升，共得约180毫升药汁，装入无菌玻璃瓶内，密封瓶盖备用。每日分早中晚3次口服上述制备药剂，每次约60毫升，每疗程30天。
本发明组方中黄芪乃补气之圣药，味甘，气微温，气薄而味浓，可升可降，阳中之阳也，无毒，专补气。现代研究发现黄芪具有增强免疫功能、增强机体耐缺氧及应激能力、促进机体代谢、改善心功能、降压、保肝、调节血糖、抗菌及抗病毒、类激素样作用等。重用黄芪大补元气之虚，而奏益气行瘀之功。党参具有补中益气，健脾益肺的功效。用于脾肺虚弱，气短心悸，食少便溏，虚喘咳嗽，内热消渴等。《本草从新》记载：“补中益气、和脾胃、除烦渴。中气微弱，用以调补，甚为平妥。”该品为临床常用的补气药，补脾益肺，效近人参而为较弱，适用于各种气虚不足者，常与黄芪等配伍应用；如血虚萎黄引起的气血两亏，常与熟地等配伍。现代药理学研究发现党参具有增强机体免疫功能、增强造血功能、抗应激、强心、抗休克、调节血压、抗心肌缺血和抑制血小板聚集等作用。党参还具有益智、镇静、催眠、抗惊厥等作用，能增强和改善小鼠的学习记忆能力。制首乌功能补肝肾、益精血、乌须发、强筋骨，改善中老年人的衰老征象，能促进人体免疫力的提高，抑制脂褐素在身体器官内的沉积。首乌还能扩张心脏的冠状动脉血管，降血脂，促进红细胞的生成，对冠心病、高血脂症、老年贫血、大脑衰退、早老征象等都有预防效果。对大鼠、小鼠离体脑内MAO-B活性均有显著抑制作用。老年大鼠服用何首乌2个月，能改善老年大鼠纹状体多巴胺能神经系统的功能。何首乌延缓衰老作用与其抗氧化作用有关，老年小鼠灌服何首乌水煎浓缩液，能明显增强血中SOD活性，降低小鼠心、肝、脑组织中及血中LPO含量。何首乌功效作用的物质基础主要为磷脂、蒽醌类、葡萄糖苷等。熟地味甘、性平而入血分，功能滋阴补血、补精益髓。《珍珠囊》：“大补血虚不足，通血脉，益气力。”熟地味甘微温质润，既补血滋阴，又能补精益髓。可用于肾阴不足的潮热骨蒸、盗汗、遗精、消渴等，如六味地黄丸。补精益髓功效用于肝肾精血亏虚的腰膝酸软，眩晕耳鸣，须发早白等。枸杞具有补肾益精，养肝明目，补血安神，生津止渴，润肺止咳之功效。现代药理学研究发现枸杞子含有丰富的枸杞多糖、β-胡萝卜素、维生素E、硒及黄酮类等抗氧化物质，有较好的抗氧化作用。丹参味苦，性微寒。能活血化瘀，凉血，安神。现代药理学研究发现丹参富含丹参酮、原儿茶醛、原儿茶酸、丹参素、维生素E等，能扩张冠状动脉，增加冠脉流量，改善心肌缺血和心脏功能，改善微循环；能提高机体耐缺氧能力；有抗凝血，促进纤溶，抑制血小板凝聚，抑制血栓形成的作用；能降低血脂，抑制冠脉粥样硬化形成；能抑制或减轻肝细胞变性、坏死及炎症反应，促进肝细胞再生，并有抗纤维化作用；具有抗菌、消炎作用、抗肿瘤作用。丹参能使大脑皮层自发电活动振幅减小，重复刺激引起后发放阈值升高。丹参具有抑制体外试验中各组织的环腺苷酸磷酸二酯酶的活力，尤以大脑和肺和抑制最为敏感。黄芩味苦性寒，入肺、心、胆、大肠经，有清热燥湿、泻火解毒、安胎的功能，对暑温胸闷呕吐、肺热咳嗽、血热妄行、高热烦渴、湿热下痢等有良好功效。现代研究证明，黄芩主要含黄芩甙、黄芩素、汉黄芩素，汉黄芩甙、黄芩新素、β-谷甾醇等成分。它的抗菌谱较广，对多种细菌、皮肤真菌、钩端螺旋体等都有抑制作用。黄芩还有降血压、镇静、利尿、保肝、利胆、抗过敏、解除平滑肌痉挛、抗氧化等作用。石菖蒲具有辛开苦燥温通，芳香走窜，不但有开窍醒神之功，且兼具化湿，豁痰，辟秽之效。擅长治痰湿秽浊之邪蒙蔽清窍所致之神志昏乱。治中风痰迷心窍，神志昏乱、舌强不能语，常与半夏、天南星、橘红等燥湿化痰药合用，如涤痰汤(《济生方》)；若治痰热蒙蔽，高热、神昏谵语者，常与郁金、半夏、竹沥等配伍，如菖蒲郁金汤(《温病全书》)；治痰热癫痫抽搐，可与枳实、竹茹、黄连等配伍，如清心温胆汤(《古今医鉴》)。现代药理研究发现石菖蒲具有抗惊厥、安神镇静、改善学习记忆及认知功能、清热解痉等多种功效。郁金味辛、苦，性凉。具有凉血清心，祛瘀止痛，行气解郁，利胆退黄等功效。主治温病邪蒙清窍，神志不清，胸脘痞闷；惊痫，癫狂；胸闷，胸痛；胁痛，黄疸；月经不调，痛经；吐血、衄血、尿血等病症。在治疗温病发热痉厥的安宫牛黄丸中，用郁金以协助清心开窍；在治疗湿温病，痹郁而哕的宣痹汤中，用郁金以宽胸解郁。在白金丸中郁金与白矾同用以治疗癫痫。现代药理研究表明郁金具有免疫抑制和抗变态反应、提高吞噬功能、保肝利胆、抑制动脉粥样斑块形成和脂质的沉积、增纤溶和抗血小板聚集、抑制胃酸和抗溃疡、解痉、镇痛和催眠、抗菌等多种功效。大黄味苦，性寒。归脾、胃、大肠、肝、心包经。具有攻积滞、清湿热、泻火、凉血、祛瘀、解毒等功效。国内外越来越多学者证明，大黄所含鞣质有很好的抗氧化作用。大黄能增加肠蠕动，抑制肠内水分吸收，促进排便；大黄有抗感染、利胆和健胃作用；此外，还有止血、保肝、降压、降低血清胆固醇等多重作用。
全方配伍严谨，诸药配合，气血并顾，益气扶正以固本虚，标本兼治，相得益彰。
本发明各原料还可按下表所列重量比例混合的实施例来实现。其加工工艺与实施例1相同。(单位：克)
下面结合我院，即山东省威海市文登中心医院进行的临床试验对本发明作进一步、详细地描述：
一、病例选择：2007年5月1日～2012年10月1日，68例被诊断为帕金森病患者纳入本观察，年龄48～81岁，其中男41例，女27例，病程2至26年。
PD认知障碍入选标准：
(一)入选标准：1、符合英国PD脑库帕金森病的诊断标准。2、在已明确PD诊断的基础上，由患者本人/知情者提供或临床医师观察到的认知功能的逐渐下降。3、基于正式的神经心理测试或总体认知功能量表明确的认知功能损害(详见第三部分)。4、认知功能损害并不足以显著干扰功能独立性，尽管执行复杂的功能性任务时可能会出现轻微的困难。
(二)排除标准：1、符合运动障碍协会(MDS)特别小组提出的帕金森病痴呆的诊断。2、其他可引起认知功能障碍的原因(如：谵妄，卒中，严重抑郁，代谢异常，药物副作用，头部外伤)。3、PD相关的共患病(如：运动障碍或严重的焦虑，抑郁，白天过度嗜睡，或精神障碍)，从临床医师的角度，这些状态严重影响认知功能测试。
二、疗效评价标准：评定标准：用PD统一评分量表(UPDRS)第III部分和Heohn-Yahr(HY)分级量表评估患者的运动症状严重程度。用PD统一评分量表(UPDRS)第II部分和日常生活能力问卷(ADCS-ADL)评估患者的日常生活能力。用PD统一评分量表(UPDRS)第I部分评估患者精神、行为和情绪。应用简易智能量表(MMSE)作为筛选手段，蒙特利尔认知评估量表(MOCA)对轻度认知功能障碍进行评定。Fuld物体记忆测验(FOM)评定短时记忆，言语流畅性测验(RVR)评定长时记忆和语言功能；积木测验(BD)评定空间结构能力；数字广度测验(DS)评定注意与瞬间记忆。用汉密尔顿抑郁量表(HRSD)和汉密尔顿焦虑量表(HAMA)评估患者的抑郁和焦虑状况。
(三)治疗方法：上述制备的中药合剂，每日分早、中、晚3次口服，每次60毫升，每疗程30天。共3个疗程。具有发热、颅压高、严重感染、高血压、糖尿病等症状或体征者给予相应处理。将68例PD认知障碍患者随机分成治疗组34例和安慰剂对照组34例。其中治疗组服用上述中药合剂，对照组服用安慰剂，两组均以美多巴等西药为基础治疗。分别于治疗后1个月、3个月和6个月进行评定。
(四)治疗效果：
1、精神、行为和情绪(UPDRS-I)评分：治疗组经治疗后，精神、行为和情绪积分较对照组有明显改善，统计学具有显著性意义(P＜0.05)，见表1。
2、日常生活活动(UPDRS-II)评分：治疗组经治疗后，日常生活活动积分较对照组有明显改善，统计学具有显著性意义(P＜0.05)，见表2。
3、帕金森病生活质量评分量表(PDQ)评分：治疗组经治疗后，帕金森病生活质量评分量表积分较对照组有明显改善，统计学具有显著性意义(P＜0.05)，见表3。
表1精神、行为和情绪(UPDRS-I)评分比较(x±s，n＝60)
注：与对照组相比(表2～3同)
表2日常生活活动(UPDRS-II)评分比较(x±s，n＝60)
表3帕金森病生活质量评分量表(PDQ)评分比较(x±s，n＝60)
Claims (1)
1.一种治疗帕金森病认知障碍的中药汤剂，其特征是原料药组成的重量份为：黄芪20～30、党参17～22、制首乌17～22、熟地12～18、枸杞12～18、丹参12～18、石菖蒲12～18、郁金12～18、黄芩12～18、大黄3～9，上述10味原料药混合后用水浸泡，煎熬后去渣得滤液。
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