CN116585410A - 一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药 - Google Patents
一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药 Download PDFInfo
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Abstract
本发明涉及基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,可有效解决治疗退行性膝关节病效果不佳、操作不便的问题,方法是,由以下重量计的原料药物制成:半夏18‑22g、当归47‑53g、秦艽27‑33g、生川乌18‑22g、制草乌18‑22g、透骨草47‑53g、穿山龙47‑53g、千年健47‑53g、威灵仙47‑53g、苏木27‑33g、伸筋草47‑53g、青风藤47‑53g、松节27‑33g、川牛膝47‑53g和甘草18‑22g,本发明借助三伏天特殊时间、人体阳气旺盛,气血充沛,皮肤腠理开泄之时,利用中药塌渍刺激局部穴位及腠理以培其阳,温经散寒,促邪外达,活血通络,协调阴阳,各种药物之间有机配合,协同增效,配制合理,共奏祛风散寒,化瘀通络,消肿散结,温阳止通的功效,原料丰富,方法简单,使用方便,疗效佳,成本低。
Description
技术领域
本发明涉及医药,特别是一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药。
背景技术
退行性膝关节病(osteoarthritis of the knee,KOA)又称退行性膝关节骨性关节炎,是临床常见病,好发于中老年人,是一种慢性、进行性膝关节病变,由于其起病复杂,病发时疼痛难忍,严重影响患者的日常活动和生活质量。近十年来,随着人们活动频率和强度的增加,世界范围内骨关节炎发病年龄逐渐年轻化,已引起人们的广泛关注。目前,临床上有许多治疗退行性膝关节骨性关节炎的药物,但却缺少既能正真发挥显著疗效又能减少机体损害且经济的治疗药物。研究显示,甾体或非甾体类抗感染镇痛药用于退行性膝关节骨性关节炎在短期改善患者局部疼痛、控制炎症方面具有一定的效果,但易引起消化道溃疡乃至出血等不良反应,尤其是在OA高发的中老年人群中更为显著,故不能长期使用。关节腔注射糖皮质激素若长期使用,可加剧关节软骨损害,加重症状。手术创伤性大,限制条件较多,术后复发率高,医疗负担重,因此以上这些并不是治疗退行性膝关节骨性关节炎最为安全、可靠的手段。
退行性膝关节骨性关节炎属于中医“痹症”的范畴,中医治病基于整体观念,采用辨证论治退行性膝关节病变上取得了一定的疗效。传统中医认为,由于人体肝肾亏虚,复受外感风寒湿邪,邪气滞留膝关节,导致气滞血瘀,经络痹阻不通,不通则痛,最终致使退行性膝关节骨性关节炎的发生。此外,中医亦有“血瘀致痹,久痹必瘀”和“久病必瘀”的说法。因此中医在治疗退行性膝关节骨性关节炎时多采用标本兼治,补虚泄实的综合治疗,如:滋补肝肾、行气活血,祛湿通络,祛风散寒,活血化瘀等。但针对骨性膝关节炎采用长期口服中药治疗,其便捷性、经济性、依从性并不能有很好的把握,另外中老年患者脾胃运化能力下降,长期用药不能保证药物的吸收效率,且长时间应用活血及滋补类中药对脾胃的损害亦应纳入治疗方案的考虑范畴。
中医外治用药同内服药一样,遵循辨证论治,唯一区别就是给药途径不同,《理瀹骈文》中说:“外治之理,即内治之理,外治之药,即内治之药,所异者法耳。”即指出外治与内治在病因、病机、辨证用药上是相同的,只是给药方法、吸收途径不同而已。因此,外治用药在遵循辨证施治的原则下,同样能取得良好的效果。《洄溪医案》曰:“大凡营卫脏腑之病,服药可至病所,经络筋节,俱属有形。煎丸之力,如太轻则不能攻邪,太重则恐伤其正,必用气厚力重之药,敷、拓、薰、蒸之法,深入病所,提邪外出。”对于经络筋节之病,外治法更能深入病灶、祛邪外出。近些年来,中医熏洗、热奄包、中药离子导入等进行外治,因其安全、有效、不良反应小,在骨关节炎的治疗方面体现了其强大的优势,深受病患青睐。
但中医的整体观念并非只局限于个体的经络气血、五脏六腑的一体观,还包括天人合一的整体变化,而这正是目前临床中医者所欠缺的,也是中医在做到明确病因病机诊断及精确辨证之后无法突破现有治疗瓶颈的问题所在。《素问·痹论》曰:“风寒湿三气杂至,合而为痹也”,痹病的发病一般在春、冬及秋冬交界之时症状较重,且多反复发作,病程延绵,夏季较轻,属于“冬病夏治”范畴。三伏天疗法是祖国医学天人合一整体观的一大创举,三伏天是全年最热的时段,也是人体阳气最旺盛的阶段,人体皮肤腠理开放,血液循环旺盛,此时中药塌渍有利于气血流通,通过对腠理及穴位的刺激引药气入经络脏腑达到活血通络止痛之功效。“冬病夏治”治未病理论起源于《素问·四气调神大论》:“夫四时阴阳者,万物之根本也,所以圣人春夏养阳,秋冬养阴,以从其根。”因此,如何提供一种基于“三伏”理论的治疗治疗寒凝血瘀型退行性膝关节病变的药物,是业界希望解决的技术问题。
发明内容
针对上述情况,为克服现有技术之缺陷,本发明之目的就是提供一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,可有效解决治疗退行性膝关节病效果不佳、操作不便的问题。
本发明解决的技术方案是,一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,由以下重量计的原料药物制成:半夏18-22g、当归47-53g、秦艽27-33g、生川乌18-22g、制草乌18-22g、透骨草47-53g、穿山龙47-53g、千年健47-53g、威灵仙47-53g、苏木27-33g、伸筋草47-53g、青风藤47-53g、松节27-33g、川牛膝47-53g和甘草18-22g,将原料药物分别粉碎,混合均匀,加水浸没,浸泡20-30min,武火煎开,转文火煎煮20-30min,即成。
本发明通过“夏至”即在夏天三伏天内,借助三伏天特殊时间、人体阳气旺盛,气血充沛,皮肤腠理开泄之时,利用中药塌渍刺激局部穴位及腠理以培其阳,温经散寒,促邪外达,活血通络,协调阴阳,采用纯天然的原料中草药物制成,各种药物之间有机配合,协同增效,配制合理,共奏祛风散寒,化瘀通络,消肿散结,温阳止通的功效,原料丰富,方法简单,使用方便,疗效佳,成本低,是治疗“膝痹”上的一大创新,有显著的经济和社会效益。
具体实施方式
以下结合实施例对本发明的具体实施方式作进一步详细说明。
实施例1
本发明一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,由以下重量计的原料药物制成:半夏20g、当归50g、秦艽30g、生川乌20g、制草乌20g、透骨草50g、穿山龙50g、千年健50g、威灵仙50g、苏木30g、伸筋草50g、青风藤50g、松节30g、川牛膝50g和甘草20g,将原料药物分别粉碎,混合均匀,加水浸没,浸泡20-30min,武火煎开,转文火煎煮20-30min,即成。
实施例2
本发明一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,由以下重量计的原料药物制成:半夏19g、当归52g、秦艽28g、生川乌21g、制草乌19g、透骨草52g、穿山龙48g、千年健52g、威灵仙48g、苏木32g、伸筋草48g、青风藤52g、松节28g、川牛膝52g和甘草19g,制备方法同实施例1。
实施例3
本发明一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,由以下重量计的原料药物制成:半夏21g、当归48g、秦艽32g、生川乌19g、制草乌21g、透骨草48g、穿山龙52g、千年健48g、威灵仙52g、苏木28g、伸筋草52g、青风藤48g、松节32g、川牛膝48g和甘草21g,制备方法同实施例1。
实施例4
本发明一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,由以下重量计的原料药物制成:半夏18g、当归53g、秦艽27g、生川乌22g、制草乌18g、透骨草53g、穿山龙47g、千年健53g、威灵仙47g、苏木33g、伸筋草47g、青风藤53g、松节27g、川牛膝53g和甘草18g,制备方法同实施例1。
实施例5
本发明一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,由以下重量计的原料药物制成:半夏22g、当归47g、秦艽33g、生川乌18g、制草乌22g、透骨草53g、穿山龙53g、千年健47g、威灵仙53g、苏木27g、伸筋草53g、青风藤47g、松节33g、川牛膝47g和甘草22g,制备方法同实施例1。
本发明要指出的是,本发明请求保护的技术核心是组方(中药复方)、使用方法,凡是根据本复方中药制成的汤剂、丸剂、粉剂、胶囊剂、片剂以及熏洗装置的使用,均属于本发明请求保护的范围。
在上述药物中,其中:
半夏,为天南星科植物半夏的干燥块茎。主产于四川、湖北、河南、安徽、贵州。性味辛、温,有毒。归脾、胃、肺经。具有燥湿化痰,降逆止呕,消痞散结的功效。用于痰多咳喘,痰饮眩悸,风痰眩晕,痰厥头痛,呕吐反胃,胸脘痞闷,梅核气;生用外治痈肿痰核。姜半夏多用于降逆止呕。《药性论》:“消痰涎,开胃健脾,止呕吐,去胸中痰满,下肺气,主咳结。新生者摩涂痈肿不消,能除瘤瘿。气虚而有痰气,加而用之。”《主治秘要》云“燥胃湿,化痰,益脾胃气,消肿散结,除胸中痰涎。”主要含挥发油;茴香脑,柠檬醛,1-辛烯,β-榄香烯等。具有镇痛,镇吐,抗炎的作用,其所含生物碱可使炎症气囊内***素2明显降低。
当归,本品为伞形科植物当归的干燥根,分布甘肃、四川、云南、陕西、贵州、湖北等地。各地均有栽培。主产于甘肃、云南。此外,陕西、四川、湖北、贵州等地亦产。性味甘、辛、温,归肝、心、脾经。具有补血活血,调经止痛,润肠通便功效。用于血虚萎黄,眩晕心悸,***,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌扑损伤,痈疽疮疡。酒当归活血通经。用于经闭痛经,风湿痹痛,跌扑损伤。《本草蒙筌》:“逐跌打血凝,并热痢括疼滞住肠胃内。”《纲目》:“治头痛,心腹诸痛,润肠胃筋骨皮肤。治痈疽,排脓止痛,和血补血。”《本草再新》:“治浑身肿胀,血脉不和,阴分不足,安生胎,堕死胎。”。现代药理学研究,当归中的藁本内酯化学成份具有良好的镇静、安详作用,可对***引起的兴奋产生有效拮抗作用;胆碱也是临床镇痛药物主要组成成份,它的镇痛强度为乙酰水杨酸的1.7倍;另外,有研究证实,当动物机体因缺氧发生神经元变性时,当归还能对损伤神经进行保护,并促进VEGF激活和神经再生,因此,当归对神经***具有良好的抗惊厥、镇痛和神经修复等作用。当归有机酸中的阿魏酸可对血小板凝集产生有效的抑制作用,不仅能促进MDA引起的红细胞凝血显著降低,还能促使TXA2的生物活性降低和PGI2生物活性增强,从而升高PGI2/TXA2比值,进而达到良好的抑制凝血作用。
川牛膝,为苋科植物川牛膝或头花蒽草的根,性味甘、微苦、平,归肝、肾经。具有逐瘀通经,通利关节,利尿通淋功效。用于经闭症瘕,胞衣不下,关节痹痛,足痿筋挛,尿血血淋,跌扑损伤。《四川中药志》:“祛风利湿,通经散血。治寒湿腰腿骨痛,足痿筋挛,妇女经闭及症瘕,淋病,尿血,阴痿、失溺。”《中药材手册》:“功多祛风利湿,其他和怀牛膝相同。”《药材资料汇编》:“治打扑刀伤,有缓和疼痛之效。”。现代药理研究表明川牛膝不仅能抑制软骨基质葡糖氨基聚糖的降解,延缓骨关节炎发病进程,保护软骨细胞,还能促进G1/S期过渡,诱导软骨细胞增殖。
秦艽,为龙胆科植物秦艽、麻花秦艽、粗茎秦艽或小秦艽的干燥根,性味辛、苦、平,归胃、肝、胆经。具有祛风湿,清湿热,止痹痛的功效。用于风湿痹痛,筋脉拘挛,骨节酸痛,日晡潮热,小儿疳积发热。《本经》:“主寒热邪气,寒湿风痹,肢节痛,下水,利小便。”《别录》:“疗风,无问久新;通身挛急。”《本草正》:“解温疫热毒,骨蒸发热,潮热烦渴及妇人胎热,小儿疳热瘦弱。”现代药理学研究显示其根含秦艽碱甲即是龙胆碱,秦艽碱乙即是龙胆次碱,秦艽碱丙,龙胆苦甙,当药苦甙。能够降低MMP-3而升高组织基质金属蛋白酶抑制剂-1的表达,并减轻关节软骨破坏、减少炎性细胞浸润和血管增生。其醇提取物能抑制佐剂性关节炎模型大鼠滑膜组织p-JAK2、p-STAT3蛋白相对表达,而p-JAK2、p-STAT3蛋白相对表达的抑制可减轻RA症状。
生川乌。性味辛、苦、热;有毒。归心、肝、肾、脾经。具有祛风除湿,温经止痛等功效。用于风寒湿痹,关节疼痛,心腹冷痛,寒疝作痛,麻醉止痛。现代药理学研究发现,川乌中含有苯甲酰乌头原碱、苯甲酰新乌头原碱、苯甲酰次乌头原碱,能明显降低AIA大鼠的足肿胀情况,改善AIA大鼠膝关节滑膜组织的病理病变情况,减少滑膜增生及骨侵蚀的发生,其作用机理与其能够下调炎症因子IL-1β、IL-17A和COX-1、COX-2、CXCR1、CXCR2、CXCR3的蛋白表达有关。
制草乌,本品为草乌的炮制加工品。性味辛、苦、热;有毒。归心、肝、肾、脾经。具有祛风除湿,温经止痛作用。用于风寒湿痹,关节疼痛,心腹冷痛,寒疝作痛,麻醉止痛。现代药理学研究表明草乌具有明显的镇痛,抗炎,抗组胺及麻醉的作用。作用机理与其含有的乌头碱型生物碱相关。
透骨草,为大戟科植物地构叶或凤仙花科植物凤仙的全草。性味辛、苦、温,有小毒。归肝、肾经。具有祛风除湿,解毒止痛等功效。主要用于风湿关节痛。《纲目》:“治筋骨一切风湿疼痛挛缩,寒湿脚气。”《山东中草药手册》:祛风湿,活血,止痛。中药透骨草化学成分包括嘧啶类化合物、有机酸、挥发油类化合物、甾醇等,另外还包括生物碱以及***。具有镇痛抗炎、抗过敏、抗菌的疗效。
穿山龙,薯蓣科薯蓣属植物穿龙薯蓣,以根状茎入药。性味苦,平。功效舒筋活络,祛风止痛。主要用于风湿痛,风湿关节痛,筋骨麻木,大骨节病,跌打损伤,支气管炎。《东北药植志》:“舒筋活血,治腰腿疼痛,筋骨麻木”。《陕西中草药》:“治咳嗽,风湿性关节炎,大骨节病关节痛,消化不良,疟疾,跌打损伤,痈肿恶疮。”主要含薯蓣皂苷,纤细薯蓣皂苷,及对羟基苄基酒石酸,氨基酸等。穿山龙有显著的平喘作用,总皂苷、水溶性或水不溶性皂苷有明显的镇咳、祛痰作用;水煎剂对细胞免疫和体液免疫功能均有抑制作用,而对巨噬细胞吞噬功能有增强作用;对金黄色葡萄球菌等多种球菌及流感病毒等有抑制作用;总皂苷能增强兔心肌收缩力,减慢心率,降低动脉压,改善冠脉血液循环,增加尿量,并能显著降低血清总胆固醇及β/α脂蛋白比例。
千年健,为天南星科平丝芋属植物千年健的干燥根茎。性味苦,辛,温。归肝、肾经。具有祛风湿,健筋骨,活血止痛等功效。用于风寒湿痹,腰膝冷痛,下肢拘挛麻木。《饮片新参》:“入血分,祛风湿痹痛,强筋骨,治肢节酸疼。”《中药材手册》:“治风气痛,筋骨痪软,半身不遂。”现代药理学研究证明千年健主要含挥发油,主要为α-蒎烯、β-蒎烯、柠檬烯、芳樟醇、α-松油醇、β-松油醇、橙花醇、香叶醇、香叶醛、丁香油酚、异龙脑、广藿香醇等。千年健甲醇提取物有明显的抗炎、镇痛作用,醇提液有抗组胺作用,其水提液具有较强的抗凝血作用,所含挥发油对布氏杆菌、Ⅰ型单纯疱疹病毒有抑制作用。
威灵仙,毛茛科植物威灵仙棉团铁线莲或东北铁线莲的根及根茎。性味辛、咸、温。归膀胱经。功能祛除风湿,治骨鲠。主要用于风湿痹痛。《本草经疏》:“主诸风,而为风药之宣导善走者也。”《药品化义》:“性猛急,盖走而不守,宣通十二经络。主治风、湿、痰、壅滞经络中,致成痛风走注,骨节疼痛,或肿,或麻木”。现代药理学研究发现威灵仙主要含原齐墩果酸、常春藤皂苷元、原白头翁素、棕榈酸等。威灵仙有镇痛抗炎、抗利尿、抗疟、降血糖、降血压、利胆等作用;原白头翁素对革兰阳性及阴性菌和真菌都有较强的抑制作用;煎剂可使食管蠕动节律增强,频率加快,幅度增大,能松弛肠平滑肌;醋浸液对鱼骨刺有一定软化作用,并使咽及食道平滑肌松弛,增强蠕动,促使骨刺松脱;其醇提取物有引产作用。
苏木,本品为豆科云实属植物苏木的干燥心材。性味甘、咸、平。归心、肝、脾经。功效行血祛瘀,消肿止痛。主要用于经闭痛经,产后瘀阻,胸腹刺痛,外伤肿痛。《日华子本草》:“治妇人血气心腹痛,月侯不调及蓐劳。排脓止痛,消痈肿扑损瘀血,女人失音,血噤,赤白痢并后分急痛。”主要含色原烷类化合物,黄酮类成分,二苯并环氧庚烷类成分。苏木煎剂能使离体蛙心收缩增强,有镇静、催眠作用,并能对抗***和***的中枢兴奋作用。苏木水煎醇提液可增加冠脉流量,促进微循环。巴西苏木素和苏木精可抑制血小板聚集。苏木煎液和浸煎剂对白喉杆菌、金黄色葡萄球菌、伤寒杆菌等有抑制作用。苏木水提取物有抗肿瘤作用、抗菌作用。
伸筋草,为石松科植物石松的干燥全草。性味微苦、辛、温。归肝、脾、肾经。功效祛风除湿,舒筋活络。用于关节酸痛,屈伸不利。《本草拾遗》:“主久患风痹,脚膝疼冷,皮肤不仁,气力衰弱。”《东北常用中草药手册》:“舒筋活血,祛风散寒,止痛。治腰腿酸痛,风湿性关节肿痛,***。”《浙江民间常用草药》:“舒筋,消炎。治关节酸痛,带状疱疹。”主要含石松碱,棒石松宁碱等生物碱,石松三醇,石松四醇酮等萜类化合物,β-谷甾醇等甾醇,以及香草酸、阿魏酸等。伸筋草醇提取物有明显镇痛作用;水浸液有解热作用;其混悬液能显著延长戊巴比妥钠睡眠时间和增强***的毒性反应;其透析液对实验性矽肺有良好的疗效;所含石松碱对小肠及子宫有兴奋作用。
青风藤,本品为防己科植物青藤及毛青藤的干燥根茎,性味苦、辛,平。归肝、脾经。功效祛风湿,通经络,利小便。主要用于风湿痹痛,关节肿胀,麻木不仁,皮肤瘙痒,水肿,脚气肿痛。主要含青风藤碱,青藤碱,异青藤碱,土藤碱等。青藤碱有抗炎、镇痛、镇静、镇咳作用,对非特异性免疫、细胞免疫和体液免疫均有抑制作用。青风藤总碱的降压作用较强,多次给药不易产生快速耐受性,但青藤碱反复应用易出现快速耐受性。青风藤能抑制肠平滑肌的收缩,甲醇提取液能使子宫平滑肌收缩力增强、肌张力增高;注射青藤碱,能使血浆中组织胺含量上升。
松节,本品为松科植物油松或马尾松的干燥瘤状节或分枝节。性味苦、辛、温。归肝、肾经。功效祛风除湿,通络止痛。主要用于风寒湿痹,历节风痛,转筋挛急,跌打伤痛。主要含挥发油:α-蒎烯,D-苎烯,樟脑,α-红没药醇等;还含倍半萜烯类及萜醇类、萜酮类等。有一定的镇痛、抗炎作用;提取的酸性多糖显示抗肿瘤作用;提取的多糖类物质、热水提取物、酸性提取物都具有免疫活性。
甘草,本品为豆科植物甘草、胀果甘草或光果甘草的干燥根和根茎。性味甘,平。归心、肺、脾、胃经。功效补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。主要用于脾胃虚弱,倦怠乏力,心气不足,心悸气短,脉结代,痈肿疮毒,咽喉肿痛,咳嗽痰多,脘腹、四肢挛急疼痛.缓解药物毒性、烈性。主要含甘草皂苷、甘草酸、甘草次酸等三萜类,甘草黄酮、异甘草黄酮、甘草素、异甘草素等黄酮类,还含有生物碱、多糖、香豆素、氨基酸及少量的挥发性成分等。甘草次酸和黄酮类成分具有抗心律失常作用。甘草酸类和黄酮类物质是甘草抗溃疡的两大主要活性成分。甘草水提物、甘草次酸、甘草的黄酮部位具有抗幽门螺杆菌作用。甘草水煎液、甘草浸膏、甘草素、异甘草素、甘草总黄酮等均可降低肠管紧张度,减少收缩幅度,具有解痉作用。甘草酸、甘草次酸及甘草的黄酮类化合物具有镇咳、祛痰、平喘作用。此外,甘草有抗利尿、降血脂、保肝和类似肾上腺皮质激素样作用。
该方“三伏松骨洗剂”遣药严格把握“膝痹”的发病机理,融合了中医“久病多瘀”“怪病多痰”的思想,兼顾了“祛风”“散寒”“温阳”“燥湿”“祛痰”“活血”“通经”等治法,并结合中医“天人合一”的理论,运用“三伏天”时期机体阴阳转换的特点,使中医治疗“膝痹”的疗效得到进一步的提升。
三伏时节天气炎热、阳气旺盛、气血运行偏于外表,肌肤腠理疏松,全方以半夏为君药,其生当夏半,乃阴阳交换之时,与伏天相应,时为由阳转阴之侯,其性苦入阴,辛温开郁,三伏之时用之更能够增其通阴阳和表里、开窍透骨、拔邪外出之效。其味辛,开腠理,使阳有所入,邪有所出。其性温,可燥寒湿,化痰瘀。
透骨草祛风除湿,活血止痛,走而不守,内达外透,《纲目》言其善治筋骨一切风湿疼痛挛缩。松节祛风燥湿、舒筋活络,《本草通玄》言其善搜风舒筋。松节、透骨草共为臣药与君药相配,更增其宣开腠理,搜风剔邪,化瘀通经之效力。
当归补血和血,为血中润剂,可活血去瘀,且能防诸多风药燥湿伤阴。苏木逐瘀力专,行血破血,除顽疾血瘀。二者同用逐瘀力强,共助臣药活血止痛之效;穿山龙、千年健、伸筋草、秦艽、威灵仙、青风藤皆有祛风湿,利关节之效,助臣药搜风剔邪,除湿去痰,消肿止痛之效;川乌、草乌为佐搜风胜湿,散寒止痛,开痰消肿,二者合用佐君药搜风祛寒之力。且与君药半夏配成十八反,利用反药的猛烈性质,发挥其温阳散寒、通络祛痹、消肿止痛的效果,共为佐药。
川牛膝祛风,利湿,通经,活血,携诸药入经,搜刮膝府经络之寒湿痰瘀;甘草调和诸药药性,共为使药。
本发明中药遵循君臣佐使配伍原则,遣药精专,配伍严谨,紧扣“风”“寒”“瘀”“痰”的基本病机,应三伏阳盛之际,涤荡膝府阴邪,共奏祛风散寒,化瘀通络,消肿散结,温阳止通的功效,有效用于冬病夏治寒凝血瘀型退行性膝关节病变,并经实验取得了非常好的有益技术效果,有关实验资料如下(以实施例1为例):
1、西医诊断标准
西医诊断标准参考中华医学会骨科学分会发布的《骨关节炎诊治指南(2018年版)》中膝骨关节炎的诊断标准进行诊断:
(1)近1个月内反复多次出现膝关节疼痛;
(2)X线片(站立或负重位)显示患者膝关节间隙变窄,关节缘骨赘形成、软骨下骨硬化和(或)囊性变;
(3)年龄≧50岁;
(4)晨僵<30min;
(5)活动时有骨摩擦音(感)。
注:综合各项检查,符合1+(2/3/4/5中的任意2条)可诊断为KOA。
2、中医辨证标准
中医诊断标准参照中药新药临床研究指导原则(试行):患者均属寒凝血瘀证。
主症:膝部冷痛、遇寒加重、待暖稍舒。
次症:四肢欠温、痛有定处、行动受限、关节僵硬。
舌脉:苔白舌质紫或舌边有瘀点、脉沉弦。
3、纳入标准
①符合上述中西医诊断标准;
②Kellgren-Lawrence分级为Ⅰ~Ⅲ级;
0级:无改变(正常);
Ⅰ级:X线疑似骨赘,关节间隙疑似变窄;
Ⅱ级:X线有骨赘,关节间隙疑似变窄;
Ⅲ级:X线有较多骨赘,软骨下骨硬化,关节间隙变窄;
Ⅳ级:X线有大量骨赘,关节间隙变窄,出现屈曲挛缩畸形;
③年龄50—70岁,无严重心、脑、肝、肾疾病;
④无治疗禁忌证;
⑤同意本治疗方案,签署知情同意书。
4、排除标准
①排除合并严重心、肝、脑、肾等重要器官疾病、血液***疾病、内分泌***疾病的患者;
②排除合并风湿关节炎、类风湿关节炎、骨髓炎以及骨肿瘤的患者;
③排除具有精神意识障碍而不能配合治疗的患者;
④合并严重心血管、脑血管疾病,肝、肾功能不全、造血***等严重原发性疾病,严重心理疾病,精神病患者;
⑤过敏体质者。
5、脱落标准与剔除标准
5.1退出试验病例标准
①出现过敏反应或严重不良事件者,根据医生判断应该停止者;
②病程中病情恶化,根据医生判断应该停止者;
③患者在临床试验过程中依从性较差,不愿意继续进行治疗者。
5.2病例的脱落及处理
纳入观察病例,进入随机分组者,无论何时何因退出,只要没有完成方案所规定的观察周期者,均称为脱落病例。
5.3病例的剔除
未按医嘱应用药物治疗者;在随机化之后没有任何数据者给予剔除。
6、分组
90例筛选合格进入随机化试验的受试者按随机数字表法随机均分为3组,治疗组采用本发明中药在三伏天塌渍治疗,中医对照组采用本发明中药非三伏天中药塌渍治疗,西医对照组采用口服西药治疗,采用随机、平行、对照的临床试验方法,研究方案报请医院伦理委员会审批后进行。
7、治疗方案
治疗组采用本发明的中药在三伏天的初伏、中伏、末伏的前5天分别进行塌渍治疗,每日1剂,将药袋水煎30分钟后,置入塌渍袋内,冷却至45℃,分别置于膝盖上方和膝盖后方腘窝处,绷带固定,对膝关节进行30min塌渍治疗,分早晚两次。
中药对照组采用本发明的中药在非三伏天内进行塌渍治疗,每日1剂,将药袋水煎30分钟后,置入塌渍袋内,冷却至45℃,分别置于膝盖上方和膝盖后方腘窝处,绷带固定,对膝关节进行30min塌渍治疗,分早晚两次,连续塌渍5天后休息5天,每10天为一组,共进行三组。
西医治疗组者给予口服塞来昔布胶囊(辉瑞制药有限公司,国药准字J20120063)治疗,每次0.2g,每日1次,同时口服氨基葡萄糖胶囊(澳美制药厂,国药准字HC20140007),每次0.75g,每日2次,服用15天。
所有参与者均应接受健康宣教,注意休息,减少非计划的运动,适量有氧锻炼,避免进行对膝关节产生巨大压力的功能活动。
8、观察指标
8.1主要效应指标:
①膝关节功能评分:膝关节功能变化采用Lysholm膝关节评分量表(详见表1)进行评价,总分共100分,患者得分越高,表示膝关节功能恢复越好。
表1Lysholm膝关节评分量表
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注:积分95分以上为优秀,94~85分为良好,84~65分为尚可,小于65分为差
②WOMAC评分(详见表2):评定内容包括包括疼痛、僵硬和功能3个方面,共24个问题,每个问题均为0-4分,分值越高表明病情越重。
表2WOMAC评分
VAS:该方法采用一条10cm的直线或尺,两端标明0和10的字样,让患者在只想或尺上标出自己疼痛或功能受限程度的相应位置,如下:
③中医症候积分(详见表3)
表3中医症候积分
④VAS视觉疼痛评分。
8.2安全性评价指标:
血压、脉搏、心电图、血、尿常规化验,肝、肾功能检查。
9、疗效评定标准
以《中药新药临床研究指导原则》为参照拟定如下,KOA的临床疗效评价标准:以WOMAC评分作为疗效的评价指标,计算公式(尼莫地平法):疗效指数=[(治疗前积分-治疗后积分)/治疗前积分]*100%。
痊愈:临床症状基本消失,患者日常功能活动基本正常,积分减少≧95%。
显效:临床症状大部分减退,功能活动大部分正常,积分减少≧70%且小于95%;
有效:临床症状基本消除,部分功能活动受限,积分减少≧30%且小于70%。
无效:临床症状均无明显改善,大部分功能活动受限,积分减少小于30%。
总有效率=(痊愈+显效+有效)/总例数×100%
10、统计学处理
①计量资料:先进行正态性检验,符合正态分布者进行t检验或方差分析,方差分析前进行方差齐性检验。两组间比较采用t检验,不符合正态性分布者则采用两组间秩和检验;组内治疗前后自身比较采用配对t检验(Paired-Samples T Test),不符合正态性分布者则采用配对秩和检验(2Related Samples,Wilcoxon法)。多组间两两比较符合正态性分布、方差齐者采用方差分析(one-way ANOVA),两两组间比较用LSD法;不符合正态分布或方差不齐者用Wilcoxon秩和检验。
②计数资料:采用秩和检验,两两比较用Wilcoxon秩和检验;两个以上组间比较用Kruskal-Wallis检验。两个总体率(或构成比)之间比较,用χ2检验或确切概率法,多个样本率或构成比之间比较,采用列联表χ2检验。
③等级资料:采用Kruskal-Wallis H检验。α取0.05标准,以P<α为有显著性差异。
11、结果
11.1一般资料比较
注:三组组间比较,在性别、年龄、病程、单双膝比较中P值均大于0.05,差异没有统计学意义。
注:三组组间比较,在Lysholm评分、WOMAC评分、中医症候积分、VAS比较中P值均大于0.05,差异没有统计学意义。
11.2效应指标比较
①Lysholm评分
注:*:本组与治疗前比较,中药治疗组t=6.61P=0.00(<0.05),中药对照组t=3.72P=0.00(<0.05),西药对照组t=3.64P=0.00(<0.05);#:治疗后各组组间比较,中药对照组与中药治疗组比较t=2.09P=0.04(<0.05),中药治疗组与西药对照组比较t=-2.59P=0.01(<0.05),中药对照组与西药对照组比较t=-0.45P=0.65(>0.05)。
②WOMAC评分
注:*:本组与治疗前比较,中药治疗组P=0.00(<0.05),中药对照组t=14.75P=0.00(<0.05),西药对照组P=0.00(<0.05);#:治疗后各组组间比较,中药对照组与中药治疗组比较t=-4.18P=0.00(<0.05),中药治疗组与西药对照组比较t=11.57P=0.00(<0.05),中药对照组与西药对照组比较t=5.575P=0.00(<0.05)。
③中医症候评分
注:*:本组与治疗前比较,中药治疗组t=6.10P=0.00(<0.05),中药对照组t=-3.37P=0.00(<0.05),西药对照组t=1.634P=0.11(>0.05);#:治疗后各组组间比较,中药对照组与中药治疗组比较t=3.74P=0.00(<0.05),中药治疗组与西药对照组比较t=-4.78P=0.00(<0.05),中药对照组与西药对照组比较t=-2.11P=0.03(<0.05)。
④VAS疼痛评分
注:*:本组与治疗前比较,中药治疗组t=8.51P=0.00(<0.05),中药对照组t=-7.38P=0.00(<0.05),西药对照组t=7.214P=0.00(<0.05);#:治疗后各组组间比较,中药对照组与中药治疗组比较t=2.69P=0.01(<0.05),中药治疗组与西药对照组比较t=-234P=0.02(<0.05),中药对照组与西药对照组比较t=0.77P=0.43(>0.05)。
11.3综合疗效比较
三种治疗有效率两两比较
/>
注:中药治疗组与中药对照组治疗总体疗效无差异,中药治疗组与西药对照组治疗总体疗效差异具有统计学意义,中药对照组与西药对照组治疗总体疗效差异具有统计学意义。
11.4安全性指标异常率情况
经统计学处理,治疗组和对照组各项安全性指标血压、脉搏、心电图、血、尿常规化验,肝、肾功能,治疗前后比较均无异常。
11.5不良反应
在服药的不同阶段,两组患者均无明显不良反应发生。血压、脉搏、心电图、血、尿常规化验,肝、肾功能未见明显异常。
在上述对实施例1实验的同时,对其它实施例也做了同样实验,均取得了相同或相近似的结果,不一一列举。
12、结论
由上述表明,本发明中药稳定可靠,治疗效果好,见效快,无毒副作用,在改善患者Lysholm评分,降低WOMAC评分、VAS疼痛评分及改善患者中医症候上具有显著疗效,疗效高达96%,是中医药学上的一大创造,有良好的社会和经济效益。
Claims (6)
1.一种基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,其特征在于,由以下重量计的原料药物制成:半夏18-22g、当归47-53g、秦艽27-33g、生川乌18-22g、制草乌18-22g、透骨草47-53g、穿山龙47-53g、千年健47-53g、威灵仙47-53g、苏木27-33g、伸筋草47-53g、青风藤47-53g、松节27-33g、川牛膝47-53g和甘草18-22g,将原料药物分别粉碎,混合均匀,加水浸没,浸泡20-30min,武火煎开,转文火煎煮20-30min,即成。
2.根据权利要求1所述的基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,其特征在于,由以下重量计的原料药物制成:半夏20g、当归50g、秦艽30g、生川乌20g、制草乌20g、透骨草50g、穿山龙50g、千年健50g、威灵仙50g、苏木30g、伸筋草50g、青风藤50g、松节30g、川牛膝50g和甘草20g。
3.根据权利要求1所述的基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,其特征在于,由以下重量计的原料药物制成:半夏19g、当归52g、秦艽28g、生川乌21g、制草乌19g、透骨草52g、穿山龙48g、千年健52g、威灵仙48g、苏木32g、伸筋草48g、青风藤52g、松节28g、川牛膝52g和甘草19g。
4.根据权利要求1所述的基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,其特征在于,由以下重量计的原料药物制成:半夏21g、当归48g、秦艽32g、生川乌19g、制草乌21g、透骨草48g、穿山龙52g、千年健48g、威灵仙52g、苏木28g、伸筋草52g、青风藤48g、松节32g、川牛膝48g和甘草21g。
5.根据权利要求1所述的基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,其特征在于,由以下重量计的原料药物制成:半夏18g、当归53g、秦艽27g、生川乌22g、制草乌18g、透骨草53g、穿山龙47g、千年健53g、威灵仙47g、苏木33g、伸筋草47g、青风藤53g、松节27g、川牛膝53g和甘草18g。
6.根据权利要求1所述的基于“三伏”理论塌渍治疗寒凝血瘀型退行性膝关节病变的中药,其特征在于,由以下重量计的原料药物制成:半夏22g、当归47g、秦艽33g、生川乌18g、制草乌22g、透骨草53g、穿山龙53g、千年健47g、威灵仙53g、苏木27g、伸筋草53g、青风藤47g、松节33g、川牛膝47g和甘草22g。
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