CN114377092B - 一种治疗风寒阻络神经根型颈椎病的中药组合物、制剂与应用 - Google Patents
一种治疗风寒阻络神经根型颈椎病的中药组合物、制剂与应用 Download PDFInfo
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Abstract
本发明公开了一种治疗风寒阻络神经根型颈椎病的中药组合物、制剂与应用,所述中药组合物由按重量计的羌活15‑20g、葛根30‑40g、桂枝30‑40g、细辛3‑9g、桑枝30‑40g、当归15‑30g、川芎15‑30g、丹参20‑30g、赤芍10‑10g、熟地15‑30g、威灵仙10‑20g、蜈蚣1条、天麻15‑30g、益智仁20‑30g、炙远志15‑30g组成。本发明针对风寒阻络型颈椎病的治疗以欲通过三阳同治,表里兼顾达到缓解肩颈部酸麻胀痛等不适症状。本发明配伍精当,用药平淡清灵,能够有效缓解肩颈部疼痛症状,缓解上肢及肩颈部麻木不仁症状,缓解肌肉紧张状态,补益肾精,以固先天之本。两组对风寒阻络型颈椎病症状改善均有一定优势。中医症候疗效总有效率治疗组83.87%,对照组65.51%,本发明方剂在治疗风寒阻络型颈椎病在中医症候疗效方面优于对照组。
Description
技术领域
本发明属于中药组合物及制剂技术领域,具体涉及一种治疗风寒阻络神经根型颈椎病的中药组合物、制剂与应用。
背景技术
颈椎病是指颈椎间盘退行性该病及其继发性改变所导致的脊髓、神经、血管损害,以及由此所表现出的相应症状和体征。目前西医上其病因与发病机制尚未完全清楚,总的来说认为是多种因素共同作用的结果。颈椎病在中医上属于痹症、萎症、眩晕等范围,随着现在电子产品的普及和工作生活方式的改变,如长期低头办公、玩手机、看书等都使得颈椎病的发病率逐年增高,并呈年轻化的趋势。这不仅影响到患者日常的工作生活,更严重加重患者心理负担。目前,非手术治疗为临床医生治疗颈椎病的首选,如非甾体抗炎药、肌松剂等西药治疗起效快,效果明显常常为止痛的首选,但由于其对胃黏膜刺激大等副作用并不适合广泛适用,当病情严重、症状反复时,只能选择手术治疗。而相比较与西医的手术治疗有创且痛苦,经济费用高且伴并发症的发生可能,中医中药在疗效上则具有更大的优势。
在中医上常常将外感风寒湿邪、肝肾气血不足、长期慢性劳损等考虑为颈椎病的病因,并在此基础上将颈椎病主要分为:风寒阻络型、痰瘀阻络及肝肾不足型。相比于临床上常用的葛根汤等活血解肌类汤剂,甚少有人从经络入手。但若从经络入手,选用相应的引经药,不仅能将药物的作用精准定位于病变部位,调畅了全身的气血运行,更是能引药上行至颈部,最大程度的发挥方剂配伍的功效以达到缓解患者的临床症状的作用。但是,临床上常用药对此类病症的治疗效果不佳,导致患者的治疗时间延长,功能恢复效果不够理想。因此,针对这类症型研发更有效的中药制剂是极具临床意义的,一是可以减轻患者承受的病痛折磨;二是加速患者机体功能的恢复,三是降低用药成本。可见通过中医辨证论证,以中药方剂解决骨痹症的治疗问题,对加速患者康复与功能恢复是一种良好的途径,临床应用潜力很大。
发明内容
本发明的首要目的在于提供一种所述的治疗风寒阻络神经根型颈椎病的中药组合物;进一步提供该中药组合物之制剂,以及用途。
本发明的第一目的是这样实现的,所述的治疗风寒阻络神经根型颈椎病的中药组合物,所述中药组合物由重量份的羌活15~20g、葛根30~40g、桂枝30~40g、桑枝30~40g、川芎15~30g、熟地15~30g、当归15~30g、赤芍10~10g、细辛3~9g、威灵仙10~20g、丹参20~30g、蜈蚣1~2条、天麻15~30g、益智仁20~30g、炙远志15~30g组成,适用于风寒阻络症神经根型颈椎病。
进一步的目的是这样实现的,所述治疗风寒阻络神经根型颈椎病的中药组合物的药物制剂,所述中药组合物组方中加入医学上可以接受的辅料,制备成汤剂、颗粒剂、丸剂、片剂、胶囊剂、膏剂、糖浆剂、粉剂和散剂中的任意一种。
颈椎病在中医上属于痹症、萎症、眩晕等范畴,而神经根型颈椎病又是临床上所常出现的类型,常表现为肩颈部酸麻胀痛、颈部肌肉紧张等不适。颈部有足太阳膀胱、足阳明胃经、足少阳胆经等多条阳经经脉经行,为阳气汇聚之地,最易受外邪侵袭。外感六淫皆可导致颈椎病的发生,但尤以风寒最多。风善行而数变,故风邪所致之痹痛多为游走性关节疼痛;而寒邪伤及阳气则致气血不通,导致筋脉痹阻,不通则痛,则出现疼痛剧烈,同时寒主收引,可引起肌肉紧张等症状。同时当风寒邪气侵袭机体时,影响全身经络的循行,导致机体局部的气血痹阻、运行不畅,进而使筋脉失去气血的濡养,进而导致手臂麻木不仁等症状。风为百病之长,易袭阳位,足太阳膀胱经与督脉均为阳经,循行颈肩背部,则更易受风邪侵袭。颈椎不仅承受身体之重,更作为足太阳膀胱经与督脉的循行部位,发挥着联系机体脏腑、肢体脉络之功能,更有少阳与阳明等经络的通过,则其气血调和,经脉顺遂显得更为重要。
本发明方中以羌活、葛根共为君药,羌活辛苦性温,气味雄烈,专入太阳经,上至巅顶,横行肢臂,疏散经络之风,导风毒外出,外邪得祛,经络得通,疼痛症状自然缓解。风袭经络阻碍气机,气血壅滞经络经络,不通则痛。手阳明大肠经的循行经肩颈部,则选阳明经之引经药助气血畅行。葛根入阳明胃经,手足同名经同气相通,手阳明大肠经气血亦得由此畅通,则肩颈部局部症状得缓,且其不仅起解肌、与羌活止痹痛的作用,更能调畅胃经气血运行,防止脾胃受损,损伤气血生化之源。君药祛除风邪,外邪得祛,则经络气血畅行,痹痛得止。风邪痹阻经络,卫闭营郁,恐仅以羌活散风难以解营郁之滞。
桂枝、桑枝、川芎、熟地、当归、赤芍、细辛共有臣药,故臣以辛温甘品之桂枝辅以解肌发表,通达营卫,既助羌活、葛根之祛散风邪、解肌之作用,又可温通营卫。桑枝性味偏凉,与辛温之品桂枝寒热相伍共奏疏通经络之效,故为臣药。因全方药多辛温之品,易伤阴血,且本病症病机本为风邪阻络经脉气血运行,则以川芎、熟地、当归、赤芍等物以养血活血,补血柔筋,络通则风散,即寓“治风先治血,血行风自灭”之意,并制全方辛温之品之燥。川芎上行头目,旁通脉络,既可疏散周身风邪,又能活血行气而止头身之痛,与君臣药合用,能增强止痹痛之作用,且川芎作为少阳经之引经药,助调和少阳经之气血,经脉气血畅行,则局部筋脉得以濡养,麻木不仁、疼痛等不适随之消散,寓三阳同治之意。熟地补肾阴而滋润;寒性凝滞主痛,细辛入少阴肾经,尤能止痛,且其归肺肾二经,性善走窜,温筋散寒,通彻表里,增君药温通之力。
威灵仙、丹参、蜈蚣、天麻、益智仁、炙远志共为佐药:威灵仙、丹参合起活血化淤、通经止痛的作用,能增强全方之止痹痛的作用。蜈蚣、天麻合用,息风止痉,祛风通络,助细辛除筋骨关节顽固风寒湿,为表里兼顾之寓意。赤芍苦,微寒,归肝经,有清热凉血,活血祛瘀的功效。久病必及肾,益智仁、炙远志入肾经,温补肾阳,搭档熟地滋补肾阴,则阴阳并补,以助先天之本得以固本。诸药合用共奏祛风散寒,化瘀通络之效。
本发明针对风寒阻络型颈椎病的治疗以欲通过三阳同治,表里兼顾达到肩颈部酸麻胀痛等不适症状。选用太阳、阳明、少阳之引经药,三阳同治,当阳气得振,机体防御能力得以恢复,外邪无处可藏,则经络气血自然畅通,疾病自然随之好转。本发明配伍精当,用药平淡清灵,能够有效缓解肩颈部疼痛症状,缓解上肢及肩颈部麻木不仁症状,缓解肌肉紧张状态,补益肾精,以固先天之本。
本发明治疗风寒阻络型颈椎病患者,治疗组及对照组均对中医症状明显改善(P<0.05)。说明两组对风寒阻络型颈椎病症状改善均有一定优势。两组治疗后症状积分对比,治疗组明显优于对照组,具有统计学意义(P<0.05)。中医症候疗效总有效率治疗组83.87%,对照组65.51%,进一步证实治疗组在治疗风寒阻络型颈椎病患者在中医症候疗效方面优于对照组。
具体实施方式
下面结合实施例对本发明作进一步的说明,但不以任何方式对本发明加以限制,基于本发明技术教导所作的任何变换或替换,均属于本发明的保护范围。
本发明所述的治疗风寒阻络神经根型颈椎病的中药组合物,所述中药组合物由重量份的羌活15~20g、葛根30~40g、桂枝30~40g、桑枝30~40g、川芎15~30g、熟地15~30g、当归15~30g、赤芍10~10g、细辛3~9g、威灵仙10~20g、丹参20~30g、蜈蚣1~2条、天麻15~30g、益智仁20~30g、炙远志15~30g组成,适用于风寒阻络症神经根型颈椎病。
所述的治疗风寒阻络神经根型颈椎病的中药组合物,所述中药组合物中加附子5~10g、干姜5~10g,适用于风寒阻络症,兼有寒邪凝滞症;达到补火助阳,散寒止痛,两者合用以加散寒止痛之力。
所述的治疗风寒阻络神经根型颈椎病的中药组合物,所述中药组合物中加白术10~15g、薏苡仁15~30g,适用于风寒阻络症,兼有脾虚湿盛症;达到健脾渗湿,通络止痛,两者合用以加除湿通络、祛风散寒之力。
所述的治疗风寒阻络神经根型颈椎病的中药组合物,所述中药组合物中加黄芪10~30g,防风15~30g,适用于风寒阻络症,兼有气虚症;达到卫气固表,两者合用以加卫气固表、祛风散寒之力。
所述的治疗风寒阻络神经根型颈椎病的中药组合物的药物制剂,所述中药组合物组方中加入医学上可以接受的辅料,制备成汤剂、颗粒剂、丸剂、片剂、胶囊剂、膏剂、糖浆剂、粉剂和散剂中的任意一种。
所述治疗风寒阻络神经根型颈椎病的中药组合物之汤剂按下列工艺制备:将所有药物置于锅中,加水没过药物2~3cm,浸泡30min,先用大火煮沸,再改为小火煎30min,取汁约150ml。再次加入适量水,大火煮沸,小火煎10min,取汁约150ml,合并汤汁得汤剂。
所述治疗风寒阻络神经根型颈椎病的中药组合物制剂之颗粒剂由下列工艺制备:
(1)煎煮:将组方各药味按药水重量比1:6~10加水煎煮1~3次,每次30~60min,合并煎煮液;
(2)浓缩:将所得煎煮液在50~75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏50~60℃时密度为1.20~1.35g/ml;
(3)干燥:将稠膏于50~75℃,-0.02~-0.06MPa真空度下干燥成干膏,备用;
(4)干膏粉碎并过100目筛得混合干膏粉,加入10~30g制粒辅料混匀,加入适量70~90%的乙醇,湿法制粒,干燥后即得颗粒剂。
所述制粒辅料为糊精、麦芽糊精或蔗糖中的一种或一种以上的组合。
所述治疗风寒阻络神经根型颈椎病的中药组合物制剂之丸剂由下列工艺制备:
(1)煎煮:将组方中各药味按组方量称量,并按药水重量比1:6~10加水煎煮1~3次,每次30~60min,合并煎煮液;
(2)浓缩:将所得煎煮液在50~75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏50~60℃时密度为1.20~1.35g/ml;
(3)干燥:将稠膏于50~75℃,-0.02~-0.06MPa真空度下干燥成干膏,备用;
(4)干膏粉碎并过100目筛得混合干膏粉,用水或30%及以下浓度乙醇泛丸,即得丸剂。
所述中药组合物在制备治疗风寒阻络神经根型患者药物中的应用。
所述中药组合物在制备治疗颈椎病药物中的应用。
实施例1
组方:羌活20g、葛根30g、桂枝30g、桑枝30g、川芎15g、熟地15g、当归15g、赤芍10g、细辛3g、威灵仙10g、丹参20g、蜈蚣1条、天麻15g、益智仁20g、炙远志15g。将所有药物置于锅中,加水没过药物2~3cm,浸泡30min,先用大火煮沸,再改为小火煎30min,取汁约150ml;再次加入适量水,大火煮沸,小火煎10min,取汁约150ml,合并汤汁得汤剂。
实施例2
组方:羌活20g、葛根40g、桂枝40g、桑枝40g、川芎30g、熟地30g、当归20g、赤芍10g、细辛9g、威灵仙20g、丹参25g、蜈蚣2条、天麻30g、益智仁30g、炙远志30g。将组方各药味按药水重量比1:6加水煎煮1~3次,每次50min,合并煎煮液;将所得煎煮液在70℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏60℃时密度为1.35g/ml;将稠膏于65℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,加入20g蔗糖混匀,加入适量75%的乙醇,湿法制粒,干燥后即得颗粒剂。
实施例3
组方:羌活20g、葛根35g、桂枝35g、桑枝35g、川芎20g、熟地20g、当归30g、赤芍15g、细辛6g、威灵仙15g、丹参30g、蜈蚣2条、天麻20g、益智仁25g、炙远志20g。将组方中各药味按组方量称量,并按药水重量比1:9加水煎煮1~3次,每次60min,合并煎煮液;将所得煎煮液在70℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏50℃时密度为1.20g/ml;将稠膏于705℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,用水泛丸,即得丸剂。
实施例4
组方:羌活20g、葛根30g、桂枝30g、桑枝30g、川芎15g、熟地15g、当归25g、赤芍10g、细辛3g、威灵仙10g、丹参20g、蜈蚣1条、天麻15g、益智仁20g、炙远志15g、附子5g、干姜10g。将组方各药味按药水重量比1:6加水煎煮1~3次,每次45min,合并煎煮液;将所得煎煮液在605℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏50℃时密度为1.20g/ml;将稠膏于60℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,加入25g麦芽糊精混匀,加入适量75%的乙醇,湿法制粒,干燥后即得颗粒剂。本方适用于风寒阻络症,兼有寒邪凝滞症;达到补火助阳,散寒止痛,两者合用以加散寒止痛之力。
实施例5
组方:羌活20g、葛根35g、桂枝30g、桑枝35g、川芎25g、熟地25g、当归20g、赤芍15g、细辛9g、威灵仙20g、丹参30g、蜈蚣1条、天麻30g、益智仁30g、炙远志30g、附子10g、干姜5g。将组方中各药味按组方量称量,并按药水重量比1:10加水煎煮1~3次,每次30min,合并煎煮液;将所得煎煮液在75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏60℃时密度为1.35g/ml;将稠膏于75℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,用30%乙醇泛丸,即得丸剂。本方适用于风寒阻络症,兼有寒邪凝滞症;达到补火助阳,散寒止痛,两者合用以加散寒止痛之力。
实施例6
组方:羌活20g、葛根35g、桂枝35g、桑枝35g、川芎20g、熟地20g、当归25g、赤芍20g、细辛6g、威灵仙15g、丹参30g、蜈蚣1条、天麻15g、益智仁30g、炙远志30g、白术15g、薏苡仁15g。将组方各药味按药水重量比1:6加水煎煮1~3次,每次30min,合并煎煮液;将所得煎煮液在65℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏60℃时密度为1.35g/ml;将稠膏于65℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,加入30g麦芽糊精混匀,加入适量90%的乙醇,湿法制粒,干燥后即得颗粒剂。本方适用于风寒阻络症,兼有脾虚湿盛症;达到健脾渗湿,通络止痛,两者合用以加除湿通络、祛风散寒之力。
实施例7
组方:羌活20g、葛根40g、桂枝30g、桑枝30g、川芎15g、熟地30g、当归25g、赤芍15g、细辛9g、威灵仙20g、丹参20g、蜈蚣2条、天麻30g、益智仁20g、炙远志30g、白术10g、薏苡仁30g。将组方中各药味按组方量称量,并按药水重量比1:7加水煎煮1~3次,每次40min,合并煎煮液;将所得煎煮液在75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏55℃时密度为1.20g/ml;将稠膏于75℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,用30%乙醇泛丸,即得丸剂。本方适用于风寒阻络症,兼有脾虚湿盛症;达到健脾渗湿,通络止痛,两者合用以加除湿通络、祛风散寒之力。
实施例8
组方:羌活20g、葛根35g、桂枝35g、桑枝35g、川芎20g、熟地20g、当归25g、赤芍20g、细辛6g、威灵仙15g、丹参30g、蜈蚣2条、天麻15g、益智仁30g、炙远志30g、黄芪10g、防风30g。将组方各药味按药水重量比1:8加水煎煮1~3次,每次30min,合并煎煮液;将所得煎煮液在65℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏60℃时密度为1.35g/ml;将稠膏于65℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,加入30g麦芽糊精混匀,加入适量85%的乙醇,湿法制粒,干燥后即得颗粒剂。本方适用于风寒阻络症,兼有气虚症;达到卫气固表,两者合用以加卫气固表、祛风散寒之力。
实施例9
组方:羌活20g、葛根40g、桂枝30g、桑枝30g、川芎15g、熟地30g、当归25g、赤芍15g、细辛9g、威灵仙20g、丹参20g、蜈蚣1条、天麻30g、益智仁20g、炙远志30g、黄芪30g,防风15g。将组方中各药味按组方量称量,并按药水重量比1:10加水煎煮1~3次,每次450min,合并煎煮液;将所得煎煮液在75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏55℃时密度为1.20g/ml;将稠膏于75℃,-0.02~-0.06MPa真空度下干燥成干膏,干膏粉碎并过100目筛得混合干膏粉,用30%乙醇泛丸,即得丸剂。本方适用于风寒阻络症,兼有气虚症;达到卫气固表,两者合用以加卫气固表、祛风散寒之力。
病例1
马某,男性,35岁,于2020年1月10日因肩颈部疼痛半月,加重3天至云南省中医医院骨科门诊就诊。
患者诉半月前无明显诱因出现肩颈部疼痛,无头晕、头痛、恶心、呕吐等不适,无双上肢麻木、放射痛、踩棉感、行走不稳等特殊不适。三天前因晨起受凉感肩颈部头痛症状加重,自服布洛芬后稍有好转,数小时后疼痛又反复。畏寒喜暖,大便调,小便清长,纳可,眠稍差。舌淡,苔白,脉弦紧。查体:颈部肌肉紧张,臂丛牵拉试验阳性,霍夫曼征阴性。
西医诊断:混合型颈椎病;
中医诊断:颈痹;
辨证:风寒阻络症
治法:祛风散寒、养血活血,化瘀通络
处方:本发明方(临床药名“舒颈汤”)
制剂:羌活15g、葛根30g、桂枝30g、桑枝30g、当归15g、川芎15g、丹参20g、赤芍10g、熟地15g、威灵仙10g、蜈蚣1条、天麻15g、益智仁20g、炙远志15g、细辛6g,制汤剂。
用法:每日3次,每次150mL,每剂2天,共4剂。
按语:风寒邪气客于经络,气血运行不畅,则肩颈部疼痛不适,寒为阴邪,易袭阳气,则畏寒喜暖,小便清长,舌淡、苔白,寒主收引,则脉弦紧。其症属邪实,治宜驱邪为主,则以颈舒康加减祛风散寒、化瘀通络。
病例2
陈某,女,73岁,2021年3月因“反复肩颈部疼痛10余年,再发加重1月余”云南省中医医院骨科门诊就诊。
患者诉于10余年前无明显诱因出现颈肩部酸痛不适,伴活动不利,当时无恶心、呕吐、与视物旋转、行走不稳,无双上肢麻木、放射痛,偶感头晕、心慌等,休息及口服止痛药后稍缓解,1月前夜间受凉后上述症状再发加重,且伴双上肢放射性疼痛,偶感双上肢麻木,行颈椎MRI提示:颈椎间盘突出,颈椎椎管狭窄。二便调,纳眠差,舌淡、苔白,脉弦细。查体:颈部肌肉紧张,臂从牵拉试验阳性,压顶试验阳性,霍夫曼征阴性。
西医诊断:混合型颈椎病;
中医诊断:颈痹;
辨证:风寒阻络症,兼气虚症;
治法:祛风散寒、化瘀通络;
处方:本发明方(临床药名“舒颈汤”)加减
药物:羌活15g、葛根30g、桂枝30g、桑枝30g、当归20g、川芎15g、丹参20g、赤芍10g、熟地20g、威灵仙10g、蜈蚣1条、天麻15g、益智仁20g、炙远志15g、细辛5g、黄芪30g、防风15g,制汤剂。
二诊患者诉疼痛症状已明显缓解,但仍偶感双上肢麻木不适,舌淡夹瘀,苔白,脉弦细。患者疼痛症状明显减轻,在前方基础上去桃仁、丹参、威灵仙,仍有麻木不适,加阿胶9g、当归、熟地剂量加至20g以补血柔筋.用法同上,共5剂。
按:患者为老年女性,肝肾渐亏,营卫不足,加之受凉,则卫气不固,风寒易袭机体,经络受损,阻络不通,气滞血瘀,不通则痛,故见上述症状。辩证为实邪夹气虚,故加以黄芪以补气固表,防风以祛风解表。复诊时患者疼痛已缓,却仍有麻木症状,血不荣养筋脉则麻木,故加用补血药以养血柔筋。
下面介绍本发明方(临床命名“舒颈汤””,下同)临床药效试验情况
一、临床疗效实验
1.1临床资料
选取2020年8月~2021年8月云南省中医医院骨科门诊、住院符合风寒阻络型神经根型颈椎病患者诊断标准的患者作为观察对象。
1.1.1西医诊断标准
参考2018年颈椎病专家共识的诊断标准制定
①具有较典型的根性症状(手臂麻木、疼痛),且范围与颈脊神经所支配的区域相一致,体检示压颈试验或臂丛牵拉试验阳性;
②影象学检查所见与临床表现相符合;
③除外,颈椎外病变(胸廓出口综合征,网球肘,腕管综合征,肘管综合征,肩周炎,肱二头肌腱鞘炎及肺尖部肿瘤等)所致以上肢疼痛为主的疾患。
1.1.2中医诊断标准
参照2017年版《中医内科学》中关于风寒阻络之诊断标准:
①主症:颈背强痛或肩膀胸疼痛,颈部活动受限,恶风寒,无汗,喜温喜按。
②次症:颈项强痛,活动不利,肢端麻木疼痛,四肢拘急,或者肌肉萎弱,手指麻木。舌质淡,苔薄白,脉浮紧。
③辨证诊断:具备主症及次症中的2项或2项以上,结合舌脉即可诊断。
1.1.3纳入标准
①符合上述中西医的诊断标准
②年龄18-80岁之间
③治疗前1个月未接受其它相关治疗且未服用抗炎镇痛类药物者
④患者的意识清醒,可以配合资料采集,能够完成临床观察。
⑤患者了解研究内容及目的,并签署知情同意书。
1.14病例排出标准
①不符合纳入标准者
②符合诊断但合并严重心、脑血管、肝、肾、造血系统等疾病者。
③不能配合研究,临床资料缺乏,无法判断疗效者。
④不宜使用本次研究药物治疗的特殊人群,例如孕妇等
1.1.5剔除病例标准
①对于纳入后发现不符合纳入标准的病例予以剔除。
②未按治疗方案要求治疗或治疗不到规定疗程,无法判定疗效者。
③资料不全,影响到有效性和安全性判断者。
④在试验过程中出现其它病变,需要服用可能对本试验产生影响的药物者。
1.1.6病例脱落标准
①观察中自然脱落、失访的患者。
②受试者发生并发症或特殊生理变化等不宜继续接受试验,自行退出者。
1.1.7终止实验标准
①不能坚持治疗者。
②试验中出现过敏反应、或其它严重不良反应者。
2.1治疗方法
2.1.1分组
参加观察的72例患者,采取随机数字表法分组,按随机对照试验原则分为治疗组和对照组。治疗组36例,对照组36例,在研究过程中治疗组有5例脱落,对照组脱落7例,最终完成60例,其中治疗组31例,实验组29例。
2.1.2治疗方案
①治疗组予舒颈汤,主要成分羌活15g、葛根30g、桂枝30g、桑枝30g、熟地15g、当归15g、川芎15g、丹参20g、赤芍10g、威灵仙10g、蜈蚣1条、天麻15g、益智仁20g、炙远志15g、细辛5g。煎煮方法及服用方法:患者自煎。将所有药物置于锅中,加入适量水(一般没过药物2~3cm)浸泡30min,先用大火煮沸,再改为小火煎30min,取汁约150ml。再次加入适量水,大火煮沸,小火煎30min,取汁约150ml。将两次汤汁混合,分早晚两次服用,连服1月。
②对照组予痹祺胶囊(国药准字Z10910026,天津达仁堂京万红药业有限公司)口服,一次4粒(0.3g/粒),一日2次,饭后半小时服用,连服1月。
2.1.3观察项目
表1颈椎病症状量表
通过颈椎病症状量表1评价患者治疗前后总体状况。
患者治疗前后疼痛程度、疼痛持续时间、疼痛频数。
2.1.4疗效评定标准
①治愈:疼痛、麻木、活动不利等症状、体征积分减少≥95%。
②显效:疼痛、麻木、活动不利等症状、体征积分减少≥70%,<95%。
③有效:疼痛、麻木、活动不利等症状、体征积分减少≥30%,<70%。
④无效:疼痛、麻木、活动不利等症状、体征减少不足30%。
注:计算公式(尼莫地平法)为:[(治疗前积分-治疗后积分)/治疗前积分]×100%
2.1.5统计分析结果
①两组受试者一般信息资料统计对比
两组受试者中,治疗组男性15例,女性16例;对照组男性15例,女性14例。治疗组年龄最小为23岁,最大为69岁,平均年龄48岁;对照组年龄最小为23岁,最大为70岁,平均年龄48岁。两组受试者性别、年龄经检验计算,差异不显著,无统计学意义,(P﹥0.05),具有可比性。
表2两组受试者性别、年龄分布情况及其统计结果
②两组受试者总体状况及统计结果
受试者总体状况根据颈椎病症状量表确定,总体状况最大评分为18分,小评分为2分。治疗前两组受试者总体状况经独立样本t检验计算,t=-0.706,(P﹥0.05),总体状况差异不明显,无统计学意义,具有可比性。
表3受试者总体状况及统计结果
综合上述①、②可知,治疗前两组受试者在性别、年龄、总体状况方面评分差异均不明显,无统计学意义(P﹥0.05),具有可比性。
③用药前后两组受试者总体状况评分分析
用药后两组受试者总有效率经卡方检验计算,χ2=8.61,P=0.014<0.05,总有效率差异明显,有统计学意义,且治疗组总有效率明显高于对照组。
表4用药前后两组受试者总体状况评分
④用药前后两组受试者疼痛和麻木评分分析
疼痛程度:治疗组组内比较,t=5.381,P<0.05,用药前后差异明显,有统计学意义,且用药后评分明显优于用药前;对照组组内比较,t=4.076,P<0.05,用药前后差异明显,有统计学意义,且用药后评分明显优于用药前;用药后两组组间比较,t=-2.127,P<0.05,评分差异明显,有统计学意义,且治疗组评分明显优于对照组。
疼痛持续时间:治疗组组内比较,t=5.346,P<0.05,用药前后差异明显,有统计学意义,且用药后评分明显优于用药前;对照组组内比较,t=1.394,P>0.05,用药前后差异不明显,没有统计学意义;用药后两组组间比较,t=-3.897,P<0.05,评分差异明显,有统计学意义,且治疗组评分明显优于对照组。
疼痛频数:治疗组组内比较,t=4.793,P<0.05,用药前后差异明显,有统计学意义,且用药后评分明显优于用药前;对照组组内比较,t=2.544,P<0.05,用药前后差异明显,有统计学意义,且用药后评分明显优于用药前;用药后两组组间比较,t=-2.504,P<0.05,评分差异明显,有统计学意义,且治疗组评分明显优于对照组。
麻木程度:治疗组组内比较,t=2.474,P<0.05,用药前后差异明显,有统计学意义,且用药后评分明显优于用药前;对照组组内比较,t=0.596,P>0.05,用药前后差异不明显,没有统计学意义;用药后两组组间比较,t=-2.701,P<0.05,评分差异明显,有统计学意义,且治疗组评分明显优于对照组。
表5用药前后两组受试者疼痛和麻木评分
综上所述,两组在疼痛程度、持续时间、疼痛频数和麻木程度方面用药前后组内比较均差异明显,有统计学意义,且用药后评分明显优于用药前;用药后两组在疼痛程度、持续时间、疼痛频数和麻木程度方面组间比较均差异明显,有统计学意义,且治疗组评分明显优于对照组。
Claims (9)
1.一种治疗风寒阻络神经根型颈椎病的中药组合物,其特征在于所述中药组合物由重量份计的羌活15~20g、葛根30~40g、桂枝30~40g、桑枝30~40g、川芎15~30g、熟地15~30g、当归15~30g、赤芍10~10g、细辛3~9g、威灵仙10~20g、丹参20~30g、蜈蚣1~2条、天麻15~30g、益智仁20~30g、炙远志15~30g组成,适用于风寒阻络症神经根型颈椎病。
2.根据权利要求1所述的治疗风寒阻络神经根型颈椎病的中药组合物,其特征在于所述中药组合物中加附子5~10g、干姜5~10g,适用于风寒阻络症,兼有寒邪凝滞症;达到补火助阳,散寒止痛,两者合用以加强散寒止痛之力。
3.根据权利要求1所述的治疗风寒阻络神经根型颈椎病的中药组合物,其特征在于所述中药组合物中加白术10~15g、薏苡仁15~30g,适用于风寒阻络症,兼有脾虚湿盛症;达到健脾渗湿,通络止痛,两者合用以加强除湿通络、祛风散寒之力。
4.根据权利要求1所述的治疗风寒阻络神经根型颈椎病的中药组合物,其特征在于所述中药组合物中加黄芪10~30g,防风15~30g,适用于风寒阻络症,兼有气虚症;达到卫气固表,两者合用以加强卫气固表、祛风散寒之力。
5.一种根据权利要求1~4任意一项所述的治疗风寒阻络神经根型颈椎病的中药组合物的药物制剂,其特征在于所述中药组合物组方中加入医学上可以接受的辅料,制备成汤剂、颗粒剂、丸剂、片剂、胶囊剂、膏剂、糖浆剂和粉剂中的任意一种。
6.根据权利要求5所述治疗风寒阻络神经根型颈椎病的中药组合物药物制剂,其特征在于所述汤剂按下述方法制备:将所有药物置于锅中,加水没过药物2~3cm,浸泡30min,先用大火煮沸,再改为小火煎30min,取汁约150ml;再次加入适量水,大火煮沸,小火煎10min,取汁约150ml,合并汤汁得汤剂。
7.根据权利要求5所述治疗风寒阻络神经根型颈椎病的中药组合物药物制剂,其特征在于所述颗粒剂由下列工序制备:
(1)煎煮:将组方各药味按药水重量比1:6~10加水煎煮1~3次,每次30~60min,合并煎煮液;
(2)浓缩:将所得煎煮液在50~75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏50~60℃时密度为1.20~1.35g/ml;
(3)干燥:将稠膏于50~75℃,-0.02~-0.06MPa真空度下干燥成干膏,备用;
(4)干膏粉碎并过100目筛得混合干膏粉,加入10~30g制粒辅料混匀,加入适量70~90%的乙醇,湿法制粒,干燥后即得颗粒剂。
8.根据权利要求5所述治疗风寒阻络神经根型颈椎病的中药组合物药物制剂,其特征在于所述丸剂由下列工艺制备:
(1)煎煮:将组方中各药味按组方量称量,并按药水重量比1:6~10加水煎煮1~3次,每次30~60min,合并煎煮液;
(2)浓缩:将所得煎煮液在50~75℃,-0.02~-0.06MPa真空度下浓缩成稠膏,稠膏50~60℃时密度为1.20~1.35g/ml;
(3)干燥:将稠膏于50~75℃,-0.02~-0.06MPa真空度下干燥成干膏,备用;
(4)干膏粉碎并过100目筛得混合干膏粉,用水或30%及以下浓度乙醇泛丸,即得丸剂。
9.权利要求1~4任意一项所述中药组合物在制备治疗风寒阻络神经根型颈椎病药物中的应用。
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