CN111743988A - 一种治疗股骨头坏死的中药组合物 - Google Patents
一种治疗股骨头坏死的中药组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗股骨头坏死的中药,是由下列重量份的原料药组成:知母、列当、淫羊藿、红景天、赤芍、莪术、补骨脂、续断、木豆叶、龙须菜、大叶骨碎补、接骨木、驳骨丹、大驳骨、四季青、乌贼骨、绞股蓝、槲寄生。
Description
技术领域
本发明属于中药技术领域,尤其是涉及一种治疗股骨头坏死的中药。
背景技术
目前,股骨头坏死已成为多发病、常见病,其病理表现是股骨头缺血,比较一致公认的理论是血液供应受阻。股骨头坏死的临床主要症状表现为疼痛,可为间歇性或持续性,行走活动后加重,疼痛多为针刺样、钝痛或酸痛不适等,其关节僵硬,活动受限;其次是下蹲困难,不能久站;由于髋痛及股骨头塌陷,或晚期出现髋关节半脱位还会引起跛行;早期往往出现间歇性跛行,外展、外旋或内旋活动受限,患肢可缩短,肌肉萎缩,甚至有半脱位体征。
西医多采用钻孔减压、血管移植术、游离植骨术、截骨术、人工关节置换术等方法,其不足之处在于手术风险大,治疗费用高,会给患者带来极大的痛苦,效果常不理想。
中医主要从疏通血络、活血理气、强健筋骨、补血散寒、补肝益胃、生新止痛入手,治疗股骨头坏死,尽管现有治疗股骨头坏死的中药有一定疗效,但疗效仍不理想,且容易复发。
目前,没有治疗股骨头坏死的特效药。
发明内容
本发明的目的在于改进已有技术的不足而提供一种治疗股骨头坏死的中药组合物,可以有效地改善甚至消除患者的临床症状,具有治疗效果显著、治疗周期短、无毒副作用等特点。
祖国医学将股骨头坏死归属于骨痹、骨蚀、顽痹、尪痹、历节风等范畴。“骨蚀”一病名最早见于《内经》。《灵枢·刺节真邪篇》曰:“虚邪之人于身也,寒与热搏,久留而内著,寒胜其热,则骨疼肉枯,热胜其寒,则烂肉腐肌为脓,内伤骨为骨蚀”《素问·经脉别论》“因而强立,肾气不长,高骨乃坏”。《难经·第二十四难》“足少阴气绝,即骨枯”。《济生方》“在骨则重而不举,在脉则血凝而不流,在筋则屈而不伸,……骨痹之为病应乎肾,其状骨重不可举,不遂而痛,喜胀”。 中医学认为本病的发病机制是由于肝肾亏虚,外邪侵袭,气血瘀滞,经脉痹阻所致股骨头骨质失去了抗压的能力和自行修复的能力而形成坏死。祖国医学认为“肝主筋、肝藏血”、“肾主骨生髓”,指出筋骨的生长,依赖于肝、肾正常的生理功能。另外,外部损伤、气血瘀滞、寒邪痹阻、痰湿留滞等,都会影响经络气血的灌注,使股骨头血供障碍,股骨头缺少营养,骨髓供血受阻,形成股骨头缺血性坏死。
西医认为造成股骨头坏死原因如下:
(1)风湿:患有风湿病的患者,体内大量的抗原和抗体存在,形成的免疫复合物容易沉积在小血管壁上,使血管壁受到损伤,继而影响到股骨头附近的血运,使髋关节髋臼处骨质疏松,从而造成股骨头坏死。
(2)类风湿:类风湿如不及时治疗,会使使软骨或软骨下营养摄取、血运等方面受影响,从而继发软骨和软骨下坏死,若骨坏死发生在股骨头部位,即为股骨头坏死。
(3)长期酗酒:长期大量饮酒刺激前列腺素升高,使局部发生血管炎,在股骨头微血管存在病变的情况下局部形成血栓。酒精代谢导致脂质过氧化,过氧化脂质引起细胞膜的重度损伤,局部缺血;酒精及其代谢产物具有直接细胞毒性作用,使缺血状态下的骨细胞进一步损害,导致不可逆的变性坏死。饮酒可造成维生素D代谢紊乱,骨细胞代谢降低,成骨能力减低,发生骨质疏松,导致局部受力面积减少而产生高应力的成骨反应,骨细胞破坏,软骨下出现微小骨折,引起局部骨内压升高和出血,导致骨坏死。酒精代谢的结果使脂肪在肝内出现堆积,形成脂肪肝,不断放出脂肪栓子进入血液,脂肪栓子滞留于软骨下血管床内,引起软骨缺血而坏死。
(4)长期服用激素药物:长期服用激素药物可引起机体脂代谢紊乱,可引起脂肪肝和高脂血症,脂肪肝可引起软骨下骨内小血管脂肪栓塞;诱发微小血管炎,并使血黏度增加,易形成血栓造成骨内微循环障碍,小静脉内血栓和脂肪填塞静脉窦,使得髓内压力增高;引起蛋白和胶原的合成障碍,使骨基质代谢受到明显损害,从而引起骨质疏松。在这些变化的共同作用下,易发生骨坏死,最常见于股骨头、其次为肱骨头。
(5)髋关节发育不良:由于髋臼发育不良,使髋关节应力分布发生异常,丧失髋臼和股骨头放射状分布压应力,股骨头失去了对内体重力的分散能力,使股骨头局部产生应力集中,引起关节压力增高,导致软骨软化,进而使软骨表面发生磨损、变薄,出现水平裂隙,并且失去细胞的营养供给,软骨破裂成小块,由于应力和摩擦,软骨出现全层破坏,应力最小的部位出现骨质疏松,应力最大的部位产生微细骨折和坏死。由于髋臼不能完全包容股骨头,仅能包容正常位置的2/3,股骨头不能与髋臼形成同心圆,出现受力不均,局部受力过大,即髋臼上缘与股骨头接触为着力点,由于常时间负重摩擦,导致股骨头着力点下方骨小梁反复发生骨折塌陷,软骨下骨骨质密度增加,变硬,骨小梁增粗,呈象牙状改变,引起股骨头局部血液循环障碍、缺血、坏死。股骨头包容不佳,还会导致关节软骨营养障碍,使支持带血液运输减少而加重股骨头软骨下骨小梁缺血性坏死。
(6)创伤:创伤性股骨头坏死常见于股骨颈骨折,髋关节外伤脱位。股骨头主要供血动脉为旋股外动脉,旋股内动脉,臀上动脉。进入股骨头小血管为终末血管支,无吻合支,易发生缺血。血管细小,在股骨颈基底部形成动脉环,由环向股骨头发出血管支。血管紧贴股骨颈表面,局部水肿,血肿或骨折移位时都会遭受损伤。
综上所述,治疗股骨头坏死消除股骨头血管炎症,再生、修复股骨头血管;纠正脂质代谢紊乱,清除脂肪肝和高脂血症;消除蛋白和胶原的合成障碍;促进骨髓细胞再生、重建骨小梁、增加骨密度。补肾壮骨,舒筋活络,活血化瘀。从整体上调节人体机能,以达到一个新的平衡态,从而达到彻底治愈目的。
基于上述理论,本发明提供了一种治疗股骨头坏死的中药,由下列重量份的原料药组成:知母、列当、淫羊藿、红景天、赤芍、莪术、补骨脂6~12重量份;续断、木豆叶、龙须菜、大叶骨碎补10~20重量份;接骨木、驳骨丹、大驳骨、四季青、乌贼骨、绞股蓝、槲寄生15~30重量份;
在一个优选的实施方案中,所述治疗股骨头坏死的中药组合物由下列重量份的原料药组成:知母、列当、淫羊藿、红景天、赤芍、莪术、补骨脂12重量份;续断、木豆叶、龙须菜、大叶骨碎补20重量份;接骨木、驳骨丹、大驳骨、四季青、乌贼骨、绞股蓝、槲寄生30重量份;
其中,续断:苦、辛,微温。归肝、肾经。补肝肾,强筋骨,续折伤,止崩漏。川断补肝肾,续筋骨,常用于跌打损伤,筋断骨折。川断又名接骨草,有明显的促进骨损伤愈合的作用,能促进骨髓质皮质新生,促进骨折断端毛细血管的开放量,改善局部血循环,促进血肿的吸收、机化,促进软骨细胞增生,加速各型胶原的合成、改善胶原的结构和排列、从量和质两个方面影响骨折愈合中胶原的合成,促进骨折愈合。与接骨木配伍能促进不易愈合的骨折、外伤性骨坏死的骨质愈合。对服用皮质激素引起的骨坏死,能改善症状,阻止坏死扩大。对服用皮质激素引起的骨坏死,川断与接骨木、大叶骨碎补同用,能改善症状,阻止坏死扩大。对于类风湿关节炎、骨关节炎,川断不但止痛,而且可以控制炎症肿痛,早期使用川断与接骨木,可以避免骨质的疏松和破坏。
接骨木:味甘、苦,平。归肝经。接骨续筋,活血止痛,祛风利湿。接骨木能明显促进骨痂形成和钙、磷骨折部位沉积。接骨木茎枝中香草醛、松柏醛、白桦醇、羟基桂皮酸促进成骨细胞增殖及分化;对羟基苯甲酸、原儿茶酸、白花醇促进细胞碱性磷酸酶活性,具有抗骨质疏松症作用。接骨木有镇痛强度次于吗啡,优于安乃近。接骨木明显降低总胆固醇(Tch),三酰甘油(TG),低密度脂蛋白胆固醇(LDL-Ch)、极低密度脂蛋白胆固醇及动脉硬化指数;具有明显的降血脂和抗动脉硬化作用。
大叶骨碎补:苦;温。活血化瘀;补肾壮骨;祛风止痛。
大叶骨碎补对骨原基生长和钙磷沉积有明显促进作用,有利于骨钙化和骨盐形成,增加骨密度,促进骨形成,抑制破骨细胞;能提高组织总碱性磷酸酶活性,促进蛋白多糖合成;能显著抑制皮质激素引起的骨丢失,防治肾上腺皮质激素引起的骨质疏松;降低胆固醇、三酰甘油,降低高脂血症,防止动脉粥样硬化斑块形成。大叶骨碎补水煎剂改善软骨细胞、推迟细胞退行性变、具有刺激骨关节软骨细胞代偿性增生作用,并能部分改善由于力学应力线改变造成关节软骨的退行性变,从而降低骨关节病变率。随剂量加大,作用增加,且在给药二个月后作用较佳。
知母:苦、甘,寒。归肺、胃、肾经。可拮抗外源性皮质激素引起的反馈性血浆皮质酮水平降低,防止肾上腺萎缩,改善皮质激素引起的股骨头坏死。
乌贼骨:咸、涩,温。归脾、肾经。收敛止血,涩精止带,制酸止痛;收湿敛疮。乌贼骨含碳酸钙85%以上,具有良好成骨支架作用,能明显的促进骨缺损修复。
木豆叶:淡;平;有小毒。归心经。解毒消肿。木豆叶能抑制骨丢失,明显增加骨小梁数量,改善骨小梁结构。
补骨脂:辛、苦,温。归肾、脾经。补肾助阳,温脾止泻,纳气,增强免疫力。补骨脂有壮骨作用,可有效抑制骨的吸收且不抑制骨的形成。可以增加皮质厚度和小梁骨的骨矿含量,因此增加骨密度和骨的负荷强度。
龙须菜:味甘;咸;寒。归大肠;胃经。清热解毒;和胃通便。龙须菜胶可促进结缔组织及骨胶原的生长,增加骨胳对钙的吸收。
淫羊藿:味辛、甘,温。归肝、肾经。补肾阳,强筋骨,祛风湿。淫羊藿能促进新生血管生成,总黄酮对核结合因子的表达有促进作用,从而促进成骨细胞的分化。淫羊藿具有强烈的刺激细胞增殖活性并显着提高骨钙素的分泌量、矿化结节数和钙盐沉积量,延长骨保护素信使RNA的表达,抑制骨保护素配体信使RNA的表达,淫羊藿可抑制破骨细胞作用,可降低破骨细胞内Ca2+浓度,可能引起肌动蛋白环回缩和细胞内超氧阴离子自由基减少,导致吸收陷窝面积减小,进而抑制破骨细胞的吸收功能。相关研究表明淫羊藿具有促进骨髓细胞DNA的合成作用,可通过黄酮类化合物抑制前破骨细胞株的增殖,进而抑制前破骨细胞株分化成破骨细胞而发挥抗骨质疏松的作用。
绞股蓝:味苦;微甘;性凉。归肺;脾;肾经。清热;补虚;解毒。绞股蓝总皂甙可拮抗糖皮质激素副作用,防止皮质激素引起的肾上腺和胸腺萎缩以及血浆皮质醇含量的减少,且能使升高的肾上腺维生素C含量降低。绞股蓝总皂甙能明显对抗血清总胆固醇升高,抗动脉粥样硬化。绞股蓝总皂甙能明显降低低密度脂蛋白水平及其大分子形式沉积于动脉壁,对预防管壁平滑肌细胞增生、血管内皮细胞损伤、粥样斑块具有良好作用。绞股蓝能抑制脂肪细胞产生游离脂肪酸及合成中性脂肪,具有调节脂质代谢作用。
槲寄生:辛;微苦;性平归肝;肾经。祛风湿;补肝肾;活血止痛。槲寄生总苷可明显抑制血小板的聚集,防止其活性物质释放,从而避免血管收缩和血栓形成,可明显改善微循环障碍,微循环流态流速由云絮状流者转变为直线流者占64%~86%。它可使微血管再通,微血流增加,白细胞解集,血小板聚集率降低,改变临床“血瘀状态”。槲寄生能抑制人血小板凝聚和TXA2释放的作用,修复静脉内皮细胞和功能。
红景天:寒;甘;涩。归肺经。补气清肺;益智养心;活血止血;散瘀消肿。红景天具有益气、活血、化淤的功效,可增强缺血心脏的泵血功能,加快血流,能清除血管垃圾,提高血红蛋白数量,提高血氧含量,促进新生血管生成,其作用优于丹参。
赤芍:味苦,微寒。归肝经。清热凉血,散瘀止痛,活血祛瘀。赤芍煎剂能促进新生血管生成,能使血栓形成时间明显延长,长度缩短,重量减轻;凝血酶原时间和白陶土部分凝血活酶时间延长,优球蛋白溶解时间缩短,明显抑制凝血酶凝集牛纤维蛋白原。此外能激活纤溶酶原,使凝固的纤维蛋白溶解,通过抑制凝血酶和激活纤溶酶原而发挥抗血栓作用。赤芍能使血浆总胆固醇,三酰甘油,低密度脂蛋白胆固醇、极低密度脂蛋白胆固醇显着降低;显着增加高密度脂蛋白胆固醇,减少钙和磷脂沉积于动脉壁,改善脂蛋白组分比值、抑制血小板聚集,调节TXA2/PGI2平衡和激活腺苷酸环化酶而增加动脉壁内cAMP浓度可降低血浆过氧化脂质、动脉壁脂质及主动脉斑块面积。
莪术:味辛、苦,温。归肝、脾经。行气破血,消积止痛。莪术能促进新生血管生成,莪术增加股动脉血流量的作用在活血化瘀药中最为明显,血流量峰值增加252%,用药10分钟后血流量增加36.0%,血管阻力减少66.4%,莪术油可有效治疗血栓闭塞性脉管炎,随着病人临床症状的好转,肢体血流图也见到明显改善。
四季青:苦;涩;凉。清热解毒;生肌敛疮;活血止血。用于下肢溃疡;血栓闭塞性脉管炎等。有扩张血管,促进血液循环的作用,四季青扩张冠脉作用较强。
驳骨丹:味辛;苦;性平。归肝;肾;肺经。祛风湿;散瘀血;续筋骨,消肿止痛。
大驳骨:味辛;微酸苦;性平。归肝;脾经。活血散瘀;接骨续伤;止痛止血;
列当:味甘;性温。归肾;肝;大肠经。补肾壮阳;强筋骨;润肠。
本发明是由中国传统的中草药制成,根据中医辨证论治及现代医学的若干原则,以某些成分确定、功效明晰的天然提取物的有序配伍,组合成了有效治疗股骨头坏死的中药。
本发明可以贯穿于股骨头坏死治疗的全过程,标本兼治,不易复发,安全可靠,无明显毒副反应,便于患者长期坚持服用,用药多年来,患者无任何不良反应,跟踪血液检查正常。
本发明的中药组合物原料易得,工艺简单,成本低,效率高,有利于制药企业进行药品生产、质量控制;产品价格低,易于被患者接受。
本发明还提供了一种由上述治疗股骨头坏死的中药组合物制成的口服制剂,所述口服制剂包括口服液、片剂、胶囊剂、丸剂等,优选剂型为片剂和胶囊剂,一日一剂,分早晚两次服用。
本发明的中药组合物可以制备成多种剂型。例如,将煎煮后的药液杀菌消毒后装袋,制成口服液;或者将煎煮后的药液进行浓缩,烘干后,加入医学上可接收的辅料,然后制成片剂、胶囊剂、丸剂等。
所述医学上可接收的辅料包括淀粉、糊精、羧甲基纤维素钠、聚乙二醇、磷酸氢钙、海藻酸钠、山梨酸钾等。
本发明的中药组合物也显示出对强直性脊柱炎、骨质增生、骨质疏松、风湿、类风湿等症的良好的治疗效果。
本发明的中药组合物在用于治疗强直性脊柱炎、骨质增生、骨质疏松、风湿、类风湿等疾病的用途。
本发明的中药组合物采用不同药性的中药材,进行科学配伍,能够迅速缓解患者疼痛,提高免疫力,增加股骨头血液循环,达到治疗股骨头坏死的效果。
为进一步说明本发明的中药组合物的效果,利用制备的口服液对股骨头坏死的患者进行治疗。
1、股骨头坏死的治疗效果
(1)股骨头坏死分期标准
参照1992年国际骨循环研究协会(ARCO)提出的国际分期标准。
0期:活检结果表示有缺血坏死,其他检查正常。
I期:ECT或MRI阳性。
I-A股骨头病变范围<15%
I-B 股骨头病变范围15%~30%
I-C 股骨头病变范围>30%
II期:股骨头斑点状表现,骨硬化,囊性变,骨质稀少;X线检察及CT扫描无股骨头塌陷,骨扫描及MRI呈阳性,髋臼无改变。
II-A股骨头病变范围<15%
II-B 股骨头病变范围15%~30%
II-C股骨头病变范围>30%
III期:X线片上出现新月征。
III-A 股骨头塌陷<2mm或新月征<15%
III-B 股骨头塌陷2mm~4mm或新月征15%~30%
III-C 股骨头塌陷>4mm 或新月征>30%
IV期:X线片上见股骨头关节面变扁,关节间隙变窄,髋臼骨硬化,囊性变,边沿骨赘形成。
(2)用药方式
以三个月为一个疗程,一日一剂,分早晚两次服用。
(3)疗效评定标准
治愈:疼痛消失,关节活动正常,无任何不适症状。
有效:疼痛明显减轻或基本消失。
无效:疼痛不减,临床症状基本没有改观。
(4)股骨头坏死治疗效果
病例选择符合股骨头缺血性坏死诊断标准,挑选股骨头坏死患者50例,年龄在31-68岁,其中,男性患者38例,女性患者12例。病例分布见表1。
表1
病例 | 0期 | I期 | II期 | III期 | IV期 |
50 | 0 | 0 | 16 | 27 | 7 |
服用本发明制备的口服液一个疗程后,症状均有所好转。治疗四个疗程后,治愈率达到80%,总有效率达到100%,表2为经过四个疗程以后的治疗效果。
表2 (两个疗程治疗)
病例分期 | 病例数 | 治愈 | 有效 | 无效 | 治愈率 | 总有效率 |
II期 | 16 | 14 | 2 | 0 | 87.5% | 100% |
III期 | 27 | 21 | 6 | 0 | 77.8% | 100% |
IV期 | 7 | 5 | 2 | 0 | 60% | 100% |
合计 | 50 | 40 | 10 | 0 | 80% | 100% |
Claims (4)
1.一种治疗股骨头坏死的中药,其特征是由下列重量份的原料药组成:知母、列当、淫羊藿、红景天、赤芍、莪术、补骨脂6~12重量份;续断、木豆叶、龙须菜、大叶骨碎补10~20重量份;接骨木、驳骨丹、大驳骨、四季青、乌贼骨、绞股蓝、槲寄生15~30重量份。
2.根据权利要求1所述的一种治疗股骨头坏死的中药,其特征是由下列重量份的原料药组成:知母、列当、淫羊藿、红景天、赤芍、莪术、补骨脂12重量份;续断、木豆叶、龙须菜、大叶骨碎补20重量份;接骨木、驳骨丹、大驳骨、四季青、乌贼骨、绞股蓝、槲寄生30重量份。
3.一种治疗股骨头坏死的口服制剂,其特征是由权利要求1或2中任一项所述的中药组合物制成。
4.根据权利要求3所述的一种治疗股骨头坏死的口服制剂,其特征是包括口服液、片剂、胶囊剂、丸剂,优选口服液和片剂。
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