CN109224013B - 治疗类风湿关节炎活动期的中药方剂 - Google Patents
治疗类风湿关节炎活动期的中药方剂 Download PDFInfo
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Abstract
本发明公开了一种治疗类风湿关节炎活动期的中药方剂,其由下列重量配比的中药原料制备而成:麻黄6‑15克,桂枝10‑20克,青风藤10‑30克,蜂房10‑15克,防风6‑15克,川芎6‑15克,土茯苓10‑30克,苍术10‑20克,金雀根10‑30克。本发明为纯中药方剂,毒副作用小,能有效缓解临床症状,改善预后,提高患者生活质量。且其药源广、成本较低,易于被患者接受,适合临床推广应用。
Description
技术领域
本发明涉及一种中药方剂,尤其涉及的是一种治疗类风湿关节活动期的中药方剂。
背景技术
类风湿关节炎是一种高度异质性的、慢性、系统性自身免疫性疾病。流行病学调查显示,该病男女患病比率为1﹕3,30~50岁为发病高峰,中国大陆地区RA患病率为0.2%~0.4%,全球患病率为0.5%~1%,年发病率为20/100万~50/100万人。其主要病理特征为关节受累、增生性滑膜炎、骨与软骨的破坏,最终导致关节畸形和功能障碍,致残率非常高。RA的发生与遗传、感染、激素、环境刺激以及免疫调节紊乱等多种因素有关,机制十分复杂,至今仍未完全清楚,主要涉及多种细胞、细胞因子、遗传物质和信号通路之间的相互作用。
本病以关节肿胀疼痛,晚期出现关节僵硬、畸形为主要表现,隶属于祖国医学“痹证”、“历节风”、“鹤膝风”范畴。现代医家亦称之为“尪痹”、“顽痹”等。“痹症”被记载于《素问·痹论篇》之中,其原文记载曰:“所谓痹者,各以其时重感于风寒湿之气也”,“风寒湿三气杂至,合而为痹”,一般认为本病多因营卫俱虚、气血不足、脾肝肾亏,复感风寒湿热等外邪,病久痰浊瘀血胶着、进一步加重内虚,导致虚实夹杂,缠绵难愈。病机在早期以邪实为主,多以外邪侵袭肌肤经络为病;中期多为虚实夹杂,以气血闭阻经络而兼正虚,中晚期则多为痹邪、痰湿、瘀血交阻流注关节,总属本虚标实。目前中医治疗上一般主张将其进行辨证分型治疗,主要可分为风寒湿痹阻、风湿热痹、痰瘀痹阻,肝肾亏虚,气血亏虚,寒热错杂六类。主要方剂“桂枝芍药知母汤”、“麻黄加术汤”、“独活寄生汤”,“乌头汤”,“白虎加桂枝汤”等。
在临床上类风湿关节炎活动期常表现为肢体关节疼痛、肿胀、酸楚、重着,形寒怕冷,遇寒痛增,得热痛减,苔多白腻,脉多弦紧。根据审证求因的原则,说明寒湿阻络是类风湿关节炎活动期的主要病机之一。本病为达到治疗目标,减少致残率的目的,必须对活动期类风湿关节炎病情及时加以控制。治疗类风湿性关节炎的方法众多,可对患者的日常生活进行教育和指导,此外目前治疗RA的药物依据发展的时间及原理,共分为五代:第一代是非甾体类抗炎药物,如美洛昔康、塞来希布、扶他林等,此类药物的副作用为胃肠道症状;第二代是糖皮质激素,如甲泼尼龙、氢化可的松等,此类药物不能阻断RA的病程进展和关节破坏,长期应用可诱发感染、皮质功能亢进、骨质疏松及高血压等副作用;第三代是改变病情药(慢作用抗风湿药),如雷公藤、柳氮磺吡啶、环磷酰胺、甲氨蝶呤等,DMARDs主要通过减轻滑膜炎症来控制关节病发展,甚至起到修复作用,但大多有呕吐、皮疹、白细胞降低及肝肾功能损害等较大的副作用;第四代是以TNF-α抑制剂为主的早期生物制剂;第五代为直接针对T细胞发生作用的新型生物制剂。生物制剂具有药理作用选择性高和毒副作用较小的优点,但费用较高,不利于普及。西药治疗类风湿性关节炎虽然近期疗效可,但一般会有较大的不良反应,往往患者不能长期服用。采用中医疗法治疗此病副作用小,临床疗效肯定,但临床对于类风湿关节炎活动期的中医辨证分型尚不明确统一,且缺乏一种针对性的,具有切实临床疗效的方剂。
发明内容
本发明的目的正是在于克服现有技术的不足,提供了一种疗效好,治愈率高,疗程短,毒副作用小,成本低的治疗类风湿关节炎活动期的中药方剂。
本发明是通过以下技术方案实现的:
一种治疗类风湿关节炎活动期的中药方剂,所述中药方剂由下列重量配比的中药原料制备而成:
麻黄6-15克,桂枝10-20克,青风藤10-30克,蜂房10-15克,防风6-15克,川芎6-15克,土茯苓10-30克,苍术10-20克,金雀根10-30克。
作为所述治疗类风湿关节活动期炎活动期的中药方剂的优选,其由下列重量配比的中药原料制备而成:
麻黄6克,桂枝12克,青风藤15g,蜂房10克,防风6克,川芎12克,土茯苓15克,苍术10克,金雀根10克。
本发明的中药方剂为原生中药材,可根据需要在现代生物工艺下制成汤剂、片剂、丸剂、散剂、颗粒、胶囊颗粒等。
本发明中各味中药原料的主要功效及药理作用为:
麻黄:辛、微苦,性温。归肺经、膀胱经。具有发汗解表,宣肺平喘,利水消肿的功效。临床常用于风寒痹证,风寒表实证,咳喘实证,风水水肿,阴疽,痰核等。
现代药理研究:麻黄挥发油有发汗作用,麻黄碱能使处于高温环境下的人汗腺分泌增多、增快。麻黄挥发油乳剂有解热作用。麻黄碱和伪麻黄碱均有缓解支气管平滑肌痉挛的作用。伪麻黄碱有明显的利尿作用。麻黄碱能兴奋心脏,收缩血管,升高血压;对中枢神经有明显的兴奋作用,可引起兴奋、失眠、不安。挥发油对流感病毒有抑制作用。其甲醇提取物有抗炎作用。其煎剂有抗病原微生物作用。麻黄碱能兴奋心脏,收缩血管,升高血压;对中枢神经有明显的兴奋作用,可引起兴奋、失眠、不安。挥发油对流感病毒有抑制作用。其甲醇提取物有抗炎作用。其煎剂有抗病原微生物作用。
桂枝:辛、甘,性温,归肺、心、膀胱经。具有发汗解肌,温通经脉,助阳化气的功效。临床常用于治疗风寒表证,寒凝血滞诸痛证,痰饮,蓄水证等。
现代药理研究:桂枝中含桂枝皮醛、桂皮酸等挥发油,还含有酚类、有机酸、苷类、香豆精等成分。桂枝煎剂有降温、解热作用;煎剂及醇浸也对金黄色葡萄球菌、伤寒杆菌、流感病毒等均有抑制作用;所含挥发油能刺激汗腺、扩张血管,还能利尿、强心、止咳、祛痰等;所含桂皮醛有镇痛、镇静、抗惊厥作用。
青风藤:苦、辛,性平。归肝、脾经。具有祛风湿,通经络,利小便的功效。临床常用于治疗风湿痹痛,关节肿胀,麻痹瘙痒等。
现代药理研究:青藤的茎和根含青藤碱、双青藤碱、木兰花碱、尖防己碱、四氢表小檗碱、异青藤碱、土杜拉宁、清风藤碱、dl-丁香树脂酚、十六烷酸甲酯、N-去甲基尖防已碱、白兰花碱、光千金藤碱。又含β-谷甾醇、豆甾醇。青藤的茎含清风藤碱甲等多种生物碱。具有镇痛作用、抗炎作用,对胃肠道有抑制作用、降压作用,对滴虫、疟原虫也有抑制作用。
蜂房:味甘,性平,归胃经。具有祛风止痛、攻毒杀虫的功效。临床常用于风湿痹痛,疮疡肿毒,乳痈,瘰疬,皮肤顽癣,鹅掌风,牙痛等。
现代药理研究:蜂房的主要化学成分除了直接从蜂房中分离得到的化学成分,如对苯二酚、原儿茶酸、对羟基苯甲酸等,还包括了自蜂胶、蜂蜡、蜂房油等提取分离得到的化合物,如黄酮类、维生素类、氨基酸、多糖等。具有抗炎、镇痛、抗肿瘤、调节免疫等多种药理活性。
防风:味辛、甘,性微温。归膀胱、肺、脾、肝经。具有祛风湿解表止痛,止痉之功效。临床常用于风湿痹痛及外感表证等。
现代药理研究:防风主要含有挥发油、甘露醇、谷甾醇等多种有机酸,具抗炎、镇静、解热、抗过敏、抗惊厥等作用。
川芎:辛,性温,归心包、肝胆经。具有活血行气,祛风止痛之功效。临床常用于治疗各种气滞血瘀所形成的各种疾患。
现代药理研究:川芎主要含有川芎嗪,挥发油,酚类物质,内脂素等,具有扩展血管,减低血管阻力,尤其脑血管,改善心肌的供氧,还可以通过加速骨折断端的血肿的吸收,来促使骨折断的骨痂形成等作用。
土茯苓:甘、淡,性平。归肝、胃经。具有解毒,除湿,通利关节之功效。临床常用于治疗梅毒及汞中毒所致的肢体拘挛,筋骨疼痛;湿热淋浊,带下,痈肿,瘰疬,疥癣等。
现代药理研究:土茯苓中挥发油、鞣质、树脂、甾醇、糖、淀粉、落新妇苷、异黄杞甙、胡萝卜甙、琥珀酸、棕榈酸、β-谷甾醇等。具有心血管药理作用、抗肿瘤、抗炎、免疫调节、抗氧化、抑菌、降尿酸、保护肾功能等方面的功效。
苍术:味辛、苦,性温。归脾、胃、肝经。具有燥湿健脾,祛风散寒,明目。临床常用于治疗湿阻中焦,脘腹胀满,泄泻,水肿,脚气痿蹙,风湿痹痛,风寒感冒,夜盲,眼目昏涩等。
现代药理研究:苍术中的化学成分主要有倍半萜及其苷类、烯炔类、三萜和甾体类、芳香苷类、苍术醇类等,具有抑制胃酸分泌、促进肠胃运动及胃排空、降血糖、抗菌抗炎、心血管保护和神经系统作用等。
金雀根:甘、微辛,性平。归入肺、脾经。具有清肺益脾,活血通脉之功效。临床常用于治疗关节痛风,跌打损伤,虚损劳热,咳嗽,高血压,妇女白带、血崩。
现代药理研究:金雀根中主要化学成分为黄酮、二苯乙烯低聚体类、苯丙素、香豆素、菇类和凿体等类型化合物。具有抗炎、镇痛、抗菌、抗癌和抗病毒的活性,还有类似雌激素样作用,可促进钙吸收,有治疗骨质疏松的潜在价值。
本发明主要是通过祛风除湿,散寒通络止痛来达到治疗类风湿关节炎活动期的目的。
根据《内经》“凡痹之类,逢寒则虫(急),逢热则纵”和“痛者寒气多也,有寒故痛也”之理论,提出寒湿阻络是类风湿关节炎活动期主要病机之一。寒主收引凝滞,痹痛多以寒邪为主因,寒与风湿相合而成风寒湿痹,或寒湿郁久化热,而致寒热夹杂,纯属热证者较为鲜见。《景岳全书》更明确指出:“然痹本阴邪,故惟寒者多而热者少也。”并且热证大多只是整个病程中的某一阶段,一般为时也比较短暂,热象消退之后,又可转成寒证。在临床上类风湿关节炎活动期主要表现是肢体关节疼痛、肿胀、酸楚、重着,形寒怕冷,遇寒痛增,得热痛减,苔多白腻,脉多弦紧。根据审证求因(机)的原则,也说明寒湿阻络是类风湿关节炎活动期的主要病机。寒为阴邪,易伤阳气,若寒邪束表,卫阳郁遏,则出现形寒怕冷;寒邪内侵,经脉气血失于阳气温煦,则致气血凝结,不通则痛。湿为阴邪,易阻气机,湿性重浊,湿滞经络关节,则关节疼痛重着、身体困重,苔腻等。“逢寒则虫(急),逢热则纵”,故肢体关节疼痛,遇寒痛增,得热痛减。因此,我们提出寒湿阻络是类风湿关节炎活动期主要病机之一。
因为寒湿阻络是类风湿关节炎的主要病机之一,病理性质以实为主,因此治疗原则是祛邪通络,治疗大法是祛风散寒、除湿通络。因风寒湿邪并存,风邪为百病之长,风邪易夹杂寒、湿之邪,故以祛风为先,同时需与散寒、除湿并举。又风邪深入骨骱,需用搜风剔络虫蚁之品。类风湿关节炎属于中医学痹证范畴,痹证多寒,临床用药需注重温散定窜。同时根据辨证和辨病相结合的原则,结合现代药理研究的成果,在辨证用药的基础上加用具有较强的抗炎镇痛、调节免疫功能的药物可以提高疗效。
本发明中汪悦教授结合其师汪履秋教授与自身临床经验,依照前贤在《金匮要略》及《药性论》的论述,倡用麻黄,临床上只要症状中无心慌、多汗者常首选麻黄,用量为6~15g,均生用。类风湿关节炎急性发作阶段,外邪袭表,病势尚浅,当用疏表开膝、解肌发汗的方法,因势利导,祛邪外出。常用发汗解表药,类风湿关节炎活动期此属于重者,必投以麻黄、桂枝等辛温之品。用量一般6-15g。用量不可过大,以免汗出过多耗气伤阴。痹症多宜温之,用药多以温热辛散走窜为主,即便是风湿热痹,也必须在寒凉药中加入温散之品,切忌一味寒凉,以免湿遏不化。据观察,不少类风湿性关节炎患者即使长期服用麻、桂、乌、附等温散之药,只要配伍得当,亦未发现伤阴耗血之副作用。枝藤、虫蚁等祛风通络药亦多为性温之品,对病久邪气沉伏筋骨之间者用之多有良效。本发明中青风藤具有祛风通络,达于四肢末节,疗效确切,现代药理学研究其提取物疗效显著是目前所知植物中最强的组织胺释放剂之一,可引起皮疹、瘙痒等反应,为减轻其副反应,控制用量在15-30g之间,此外配伍防风可以有效减少不良反应的发生。蜂房祛风毒、痰毒,由于虫类药富含异体蛋白,过敏体质者和孕妇禁用,临床用量根据药典控制在10-15g之间,与青风藤相同,临床均需密切关注不良反应,及时调整使用。此外,汪悦教授认为祛邪同时重视扶正,治风时宜养血活血,即所谓“治风先治血,血行风自灭”,本发明中川芎起到此效果。金雀根现代研究发现期中有抑制蛋白激酶C的活性成分,可消除炎症反应,并有延缓骨质破坏的作用。土茯苓选择性地抑制致敏T淋巴细胞释放淋巴因子以后的炎症过程,即选择性地抑制细胞免疫反应,而不抑制体液免疫反应。此两者从药理学上调节免疫,且与大部分治疗类风湿关节炎中药,如雷公藤、马钱子等不用,此二者常规剂量水煎服无副作用。
宗上从整体方义分析,方中寓有上中下痛风方之意,方中麻黄发散风寒,苍术苦温燥湿,防风祛风散寒,桂枝祛在上之风,土茯苓除在下之湿,川芎活血而使筋舒,又可祛风通络,有“治风先治血,血行风自灭”之功。蜂房搜风剔络,青风藤既能祛风邪于上,又能胜湿邪余下,又可散寒通络止痛。金雀根清肺益脾,活血通脉,祛风止痛。
类风湿关节炎活动期常见关节冷痛而肿,遇寒痛增,得热痛减,关节屈伸不利,晨僵,关节畸形等表现。但临床有些患者症状不典型,根据临床实践,一般无明显热象的患者,便可作寒证处理,即可应用本方施治。
本发明的中药方剂使用剂量及方法为:本发明的中药方剂为一日之剂量,每天一剂煎汤内服,煎2汁分两次服下。28天为一疗程,一般用药1-2个疗程。患者在使用本中药方剂期间,应注意:忌食生冷、刺激、辛热发的食物;高血压及肾炎患者慎用。
本发明相比现有技术具有以下优点:本发明为纯中药方剂,为汪悦教授结合其师汪履秋教授与自身临床经验所得,临床疗效好,加以现代药理毒理运用中药调节免疫及改善类风湿关节炎骨质病变,毒副作用小,此外其药源广、成本低、适于临床推广应用。
具体实施方式
下面对本发明的实施例作详细说明,以下实施例在以本发明技术方案为前提下进行实施,给出了详细的实施方式和具体的操作过程,但本发明的保护范围不限于下述的实施
实施例1
本实施例是治疗类风湿关节炎活动期的中药方剂的优选实施例,其中药方剂重量配比如下:
麻黄6克,桂枝12克,青风藤15g,蜂房10克,防风6克,川芎12克,土茯苓15克,苍术10克,金雀根10克。
实施例2
本实施例是治疗类风湿关节炎活动期的中药方剂的另一个实施例,其中药方剂重量配比如下:
麻黄10克,桂枝12克,青风藤15g,蜂房10克,防风6克,川芎12克,土茯苓15克,苍术10克,金雀根10克。
实施例3
本实施例是治疗类风湿关节炎活动期的中药方剂的另一个实施例,其中药方剂重量配比如下:
麻黄10克,桂枝12克,青风藤15g,蜂房10克,防风6克,川芎10克,土茯苓30克,苍术10克,金雀根10克。
以上三个实施例均可制成散剂、片剂、丸剂、胶囊颗粒剂等。
临床疗效观察:对时间2017.09-2018.03江苏省中医院风湿免疫科类风湿关节炎患者56例进行临床观察。
诊断标准
西医诊断标准:参照2010年ACR和EULAR联合颁布的类风湿关节炎诊断标准:
注:在每一部分中,选取最高分。如一个患者有5个小关节和4个大关节受累,则得3分。四个部分所得分数之和≥6分,则确诊为RA。受累关节数不包括远端指间关节、第一腕掌关节及第一跖趾关节;中、大关节:双肩关节、双肘关节、双髋关节、双膝关节及双踝关节。小关节:除中、大关节外,且不包括远端指间关节、第一腕掌关节及第一跖趾关节的其余关节。低滴度定义为超过正常上限,但不高于3倍正常上限。高滴度定义为超过3倍正常上限。
RA活动期判断标准(采用28个关节炎的疾病活动度(diseaseactivity score,DAS28):DAS28>2.6为疾病活动。低活动性2.6<DAS28≤3.2;中等活动性3.2<DAS28≤5.1;高活动性DAS28>5.1。
中医证候诊断标准:参照年国家药品监督管理局发布的《中药新药临床研究指导原则》证候诊断标准。寒湿痹阻证:主症:关节冷痛而肿,遇寒痛增,得热痛减,关节屈伸不利,晨僵,关节畸形。次症:口淡不渴,恶风寒,阴雨天加重,肢体沉重。舌脉:舌质淡,苔白,脉弦紧或弦缓或脉浮。注:凡符合舌脉具有三项主证加一项次证或二项主证加二项次证以上者即可诊断。
排除标准:
不符合纳入标准者;重叠其他风湿病,如系统性红斑狼疮、干燥综合征、严重骨关节炎等;本次发病后已使用其他治疗类风湿关节炎的中西药物;妊娠期或哺乳期妇女;过敏体质,如对两种或以上药物或食物过敏史者;或已知对本药成分过敏者;合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病者;精神病患者。伴有严重畸形疾病或者丧失劳动力者;怀疑或确有酒精、药物滥用病史;根据研究者的判断、具有降低入组可能性或使入组复杂化的其他病变,如工作环境经常变动等易造成失访的情况。
疾病疗效评定标准:
参照美国风湿病学会推荐的RA病情改善的ACR反应标准):①关节压痛数②关节肿胀数③患者对疼痛的评价④患者对疾病活动性的综合评价⑤医生对疾病活动性的综合评价⑥患者对生活能力的自我评价(HAQ)⑦急性炎症反应物(ESR)
ACR20标准:①改善≥20%、②改善≥20%、外加④⑤⑥⑦项指标中至少3项改善≥20%。
ACR50标准:①≥50%、②≥50%、外加④⑤⑥⑦项指标中至少3项改善≥50%。
ACR70标准:①≥70%、②≥70%、外加④⑤⑥⑦项指标中至少3项改善≥70%。
各项指标改善百分率:[(治疗前值-治疗后值)/(治疗前值)]×100%,达到ACR20标准为有效。
各组药效统计表:
结果分析:对两组患者进行观察分析,治疗组进行实施例1加减治疗后总有效率为93.75%,明显高于对照组的87.50%,二者之间的差异有统计学意义(P<0.05)。对比治疗组与对照组数据,可知本方对于类风湿关节炎活动期治疗具有显著优势。
典型病例:
病例1:孙某某,女,50岁。因“四肢多关节肿痛3年”就诊。患者3年前无明显诱因下出现双膝关节久坐后疼痛,双手小关节僵痛,于外院就诊查相关指标确诊为“类风湿性关节炎”(具体不详)。刻下:双膝关节久坐后起时感疼痛,现右手第二掌指,中指,双腕关节感酸痛沉重,左足外侧行走时感酸痛沉重,晨起明显,怕风,纳尚可,寐可,二便2-3次每天,不成形,小便正常,舌暗红,苔白腻边有齿痕,脉沉细。辅助检查:ESR 90mm/l,RF162U/ml,CRP8.72mg/l。予以本方治疗,每日一剂,早晚分服。服用2月后四肢关节疼痛沉重感较前明显减轻,无明显肿胀,复查血沉、C反应蛋白及类风湿因子逐渐下降,血沉及C反应蛋白稳定在正常范围,血常规及肝功能未见明显异常。
病例2:王某,女,34岁。因“多关节疼痛10余年”就诊。10余年前无诱因出现多关节疼痛,晨僵,不能行走,至外院就诊,查ESR:24mm/l,抗CCP、AKA、总ANA、RF均为阴性,予雷公藤治疗,因胃部不适停药,后至周仲瑛门诊治疗,诊为RA,予中药口服1年,症情明显好转后停药。2017-11-08咳嗽咳痰,痰白量多,后至外院查ESR 41mm/h,CCP+,RF 58.4U/ml,CRP10mg/l,血常规阴性,胸部CT:两肺间质性肺炎,纵隔多发淋巴结增大,后纵隔囊性灶,予莫西沙星、溴己新治疗,好转,至我院呼吸科予中药治疗。刻下:阴雨天双手小关节、双腕疼痛明显,右侧明显,双肘、肩、膝、踝时有疼痛,颞颌关节偶痛,疼痛时影响活动,现偶有咳嗽,痰多色白,怕风怕冷显,纳寐可,二便上课,月经正常,舌淡红苔白腻脉细弦。予以本方治疗,每日一剂,早晚分服。服用2月后双手小关节、双腕、双肘疼痛关节较前明显减轻,余关节稍减轻,复查血沉、C反应蛋白及类风湿因子逐渐下降,血沉及C反应蛋白稳定在正常范围,血常规及肝功能未见明显异常。
以上所述仅为本发明创造的部分实施例而已,并不用以限制本发明创造,凡在本发明创造的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明创造的保护范围之内。
Claims (4)
1.一种治疗类风湿关节炎活动期的中药组合物,其特征在于:所述中药方剂由下列重量配比的中药原料制备而成:麻黄6-15克,桂枝10-20克,青风藤10-30克,蜂房10-15克,防风6-15克,川芎6-15克,土茯苓10-30克,苍术10-20克,金雀根10-30克。
2.如权利要求1所述的治疗类风湿关节活动期的中药组合物,其特征在于:所述中药方剂由下列重量配比的中药原料制备而成:麻黄6克,桂枝12克,青风藤15g,蜂房10克,防风6克,川芎12克,土茯苓15克,苍术10克,金雀根10克。
3.如权利要求1所述的治疗类风湿关节活动期的中药组合物,其特征在于:所述中药方剂由下列重量配比的中药原料制备而成:麻黄10克,桂枝12克,青风藤15g,蜂房10克,防风6克,川芎12克,土茯苓30克,苍术10克,金雀根10克。
4.如权利要求1、2或3所述的治疗类风湿关节炎活动期的中药组合物在用于制备类风湿关节炎活动期的主要制剂中的应用。
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