CN113144080B - 一种治疗冠状动脉硬化斑块的中药 - Google Patents
一种治疗冠状动脉硬化斑块的中药 Download PDFInfo
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Abstract
本发明涉及治疗冠状动脉硬化斑块的中药,可有效解决现有冠状动脉硬化斑块的治疗手术风险比较高,中药治疗需要配合西药,服用量大,长期服用导致耐药性,疗效差的问题,由重量计的:黄芪、人参、生白术、瓜蒌、酒薤白、法半夏、炒枳实、丹参、红花、葛根、全蝎粉、蜈蚣粉、三七粉、水蛭粉、虻虫粉、琥珀粉、黑蚂蚁粉、血竭粉、醋鳖甲、土鳖虫、桃仁、乳香、没药和地龙制成,按常规方法制备成浓缩水丸,本发明通过补气活血,化痰祛瘀之法,治疗冠脉斑块及狭窄,能明显改善或消除临床症状,逆转斑块、增加心肌供血供氧,提高心肌细胞代谢能力,从根本上达到纠正心肌缺血缺氧的目的,使用安全可靠。
Description
技术领域
本发明涉及医学领域,特别是一种治疗冠状动脉硬化斑块的中药(又称冠脉回春丸)。
背景技术
冠状动脉硬化斑块是指发生在冠状动脉内膜上由脂质和复合糖类积聚、纤维组织增生和钙质沉着形成的斑块。控制冠状动脉硬化斑块的形成与进展是治疗冠心病的关键环节。西医在治疗方面主要包括介入手术、冠状动脉搭桥和他汀类药物。介入、搭桥手术风险比较高,且术后支架内、桥内容易再狭窄。中医药则可以通过多途径、多环节、多把点、多层次发挥作用,目前虽有治疗冠状动脉硬化斑块的中药,但同时还需要服用大量的西药,且疗效仍不满意,因此,如何使用中药治疗冠状动脉硬化斑块还需要再进一步的创新。
发明内容
针对上述情况,为克服现有技术缺陷,本发明之目的就是提供一种治疗冠状动脉硬化斑块的中药,可有效解决现有冠状动脉硬化斑块的治疗手术风险比较高,中药治疗需要配合西药,服用量大,长期服用导致耐药性,疗效差的问题。
本发明解决的技术方案是,由重量计的:黄芪90-110g、人参9-11g、生白术45-55g、瓜蒌18-22g、酒薤白27-33g、法半夏27-33g、炒枳实13-17g、丹参27-33g、红花13-17g、葛根54-66g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉9-11g、血竭粉3g、醋鳖甲27-33g、土鳖虫27-33g、桃仁9-11g、乳香27-33g、没药27-33g和地龙27-33g制成,按常规方法制备成浓缩水丸。
本发明通过补气活血,化痰祛瘀之法,治疗冠脉斑块及狭窄,能明显改善或消除临床症状,逆转斑块、增加心肌供血供氧,提高心肌细胞代谢能力,从根本上达到纠正心肌缺血缺氧的目的,使用安全可靠。
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详细说明。
实施例1
本发明由重量计的:黄芪100g、人参10g、生白术50g、瓜蒌20g、酒薤白30g、法半夏30g、炒枳实15g、丹参30g、红花15g、葛根60g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉10g、血竭粉3g、醋鳖甲30g、土鳖虫30g、桃仁10g、乳香30g、没药30g和地龙30g制成,按常规方法制备成浓缩水丸。
实施例2
本发明由重量计的:黄芪90g、人参9g、生白术45g、瓜蒌18g、酒薤白27g、法半夏27g、炒枳实13g、丹参27g、红花13g、葛根54g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉9g、血竭粉3g、醋鳖甲27g、土鳖虫27g、桃仁9g、乳香27g、没药27g和地龙27g制成,按常规方法制备成浓缩水丸。
实施例3
本发明由重量计的:黄芪110g、人参11g、生白术55g、瓜蒌22g、酒薤白33g、法半夏33g、炒枳实17g、丹参33g、红花17g、葛根66g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉11g、血竭粉3g、醋鳖甲33g、土鳖虫33g、桃仁11g、乳香33g、没药33g和地龙33g制成,按常规方法制备成浓缩水丸。
以上所述药物,其中:
黄芪:补气升阳,利水消肿,益脾肺之气;
人参:大补元气、复脉固脱、补脾益肺、生津安神;
生白术:健脾益气,燥湿利水,去脾胃中湿;
瓜蒌:涤痰散结,宽胸下气;
酒薤白:每千克薤白用黄酒2两,拌匀,稍润片刻,放入锅内用文火炒至黄色为度,酒薤白更具有通阳散结得作用;
法半夏:燥湿化痰;
炒枳实:取枳实片,照麸炒法(将净制或切制后的药物用麦麸熏炒的方法)炒至色变深,破气消积,化痰散痞;
丹参:活血祛瘀,通经止痛,清心除烦,凉血消痈;
红花:活血通经,祛瘀止痛;
葛根:解痉通络,升阳止泻;
全蝎粉:全蝎洗净,干燥,碾细粉,息风镇痉,通络止痛,攻毒散结;
蜈蚣粉:蜈蚣洗净,晒干,碾细粉,息风镇痉、攻毒散结、通络止痛;
三七粉:取三七,洗净,干燥,碾细粉,散瘀止血,消肿定痛;
水蛭粉:水蛭洗净,晒干,碾细粉,破血通经,逐瘀消癥;
虻虫粉:蛹羽化为幼虫之后捕捉,洗净,晒干,碾细粉,善破瘀血,能化宿癥;
琥珀粉:取琥珀研磨成粉末,镇静,利尿,活血;
黑蚂蚁粉:黑蚂蚁洗净,晒干,研磨成粉,治蛇咬伤和疔毒肿痛;
血竭粉:除去杂质,研成细末,活血定痛,化瘀止血,敛疮生肌;
制鳖甲:为醋鳖甲,取砂置炒制容器内,武火加热至滑利状态,容易翻动,投入大小分档的净鳖甲,炒至外表面淡黄色,质酥脆时,取出,筛去砂,趁热投入醋液中稍浸,捞出,干燥,捣碎,每100kg鳖甲,20kg醋,具滋阴潜阳、退热除蒸、软坚散结作用;
土鳖虫:破血逐瘀,续筋接骨;
桃仁:活血祛瘀,润肠通便,止咳平喘;
乳香:活血行气止痛,消肿生肌;
没药:散瘀定痛,消肿生肌;
地龙:清热定惊、通络、平喘、利尿。
由上述药物可知,本发明益气化痰,活血通脉的治疗原则而立方,全方配伍合理,协同作用,扶正不留邪,祛邪不伤正,共凑益气化痰,活血通脉之功,并经动物试验及临床应用,取得了显著的疗效,有关试验资料如下:
1一般资料
筛选2010年1月份至2020年1月份连续就诊于河南中医药大学第三附属医院、北京东城中医医院门诊符合纳入标准的患者82例,采用回访与资料收集的方法进行回顾性研究与观察前后治疗疗效指标。其中男48例,女34例,平均年龄(64±9)岁,治疗时长12-18个月,平均治疗时长15±2.17月。总计173段目标血管,每例患者至少有1处目标血管,左前降支73段,左回旋支45段,右冠状动脉55段。其中吸烟史38例,饮酒史30例,高血压病史50例,糖尿病史25例,高脂血症病史75例,冠心病家族史10例。
2观察方法
2.1诊断标准
2.1.1中医诊断标准:
参照《中药新药临床研究指导原则》、《中医心病诊断疗效标准与用药规定》拟定;
2.1.2西医诊断标准:
参照《心脏病学》和2018年《冠心病稳定型心绞痛中医诊疗专家共识》关于冠心病诊断标准拟定。
2.1.3中医症候诊断标准:
主症:胸闷,心胸刺痛或隐痛,气短、乏力,胸膈痞满,心悸,口粘有痰。
次症:头重身困,口粘乏味,纳呆腹胀,神疲自汗,面色晦暗,恶心呕吐,发枯肤燥,恶寒怕冷等。
舌象:舌质淡暗或紫暗,舌边有瘀点、瘀斑,舌下脉络紫暗、迂曲,苔腻或或白滑。
脉象:脉涩,或结代、或弦涩,或脉细滑或沉细。
2.2疗效判定标准
2.2.1临床症状疗效判定标准
(1)显效:心绞痛等主要症状消失或达到显效标准,心电图恢复正常或达到大致正常。
(2)有效:心绞痛等主要症状减轻或达到有效标准,心电图改善达到有效标准。
(3)无效:心绞痛等主要症状无改善,心电图基本与治疗前相同。
在综合诊疗判断时,若心绞痛等主要症状疗效与心电图疗效两者不一致时,应以疗效低的结果为综合疗效。
2.2.2中医证候积分疗效判定标准
疗效指数(n)=(治疗前总积分—治疗后总积分)/治疗前总积分×100%
(1)显效:临床症状、体征明显改善,证候积分减少≧70%;
(2)有效:临床症状、体征有好转,证候积分减少≧30%
(3)无效:临床症状、体征无明显改善,甚或加重,征候积分减少<30%;
2.2.3血脂疗效判定标准
参照2002年国家卫生部“中药新药临床研究指导原则”的标准:显效:达以下任一项者,TC(总胆固醇)下降≥20%或TG(三酰甘油)下降≥40%;有效:TC下降10%~19%或TG下降20%~39%;无效:未达到有效标准者;恶化:达以下任一项者,TC上升≥10%或TG上升≥10%。
2.2.4冠脉CTA观察统计标准
按照1975年WHO推荐的美国心脏病协会分段准则,主要评价左冠状动脉主干(LM)、左前降支(LAD)、左回旋支(LCX)和右冠状动脉(RCA)这4支冠状动脉。冠状动脉狭窄程度采用国际上通用的目测直径法,即以狭窄部位近心端相对正常的管腔直径作为参照值,对其狭窄程度进行定量评价。冠脉狭窄的评价采用目测直径法,直径狭窄率=(1-狭窄部位现存管径/正常参照部位管径)×100%,正常参照管径即为狭窄部位近心端与远心端之正常冠脉管径的平均值。
2.3纳入标准
(1)符合冠心病心绞痛西医诊断标准,冠脉CTA或造影提示至少一支以上冠脉狭窄程度在中度狭窄以上者;
(2)符合中医气虚痰瘀互结辨证标准者;
(3)连续就诊12-18个月,期间停药不超过1个月者;
(4)治疗前后均有冠脉CTA或造影检查结果;
(5)临床资料完整者(治疗前后肝肾、凝血功能)。
2.4排除标准
(1)经皮冠状动脉介入治疗(PCI)或冠状动脉旁路移植术(CABG)术后血管完全重建者;
(2)过敏体质及对本方其中某味药过敏者;
(3)严重心功能障碍、肝肾功能不全者;
(4)急性心肌梗死、重度心肺功能不全、重度心律失常(阵发性室速、持续性房颤、II型以上房室传导阻滞、左束支传导阻滞)等患者;
2.5治疗方法
(1)口服本发明,剂型:浓缩水丸,每次9克,每日4次,温开水送服。对已应用他汀类、硝酸酯类、抗血小板聚集等冠心病常规药物,及其他合并症治疗药物维持不变。
2.6安全性评价指标
(1)凝血功能PT、INR
(2)肝功能ALT、AST
(3)肾功能BUN、CR
2.7疗效性观察指标
(1)冠脉CTA或造影:治疗前后结果对比。
(2)血脂治疗前后结果对比。
(3)中医证候积分疗效比较:治疗前、治疗后各记录1次,按中医证候积分标准记录。
(4)硝酸甘油减停率:收集患者治疗前后平均每天的硝酸甘油使用情况。硝酸甘油停减率=(治疗前用药片数-治疗后用药片数)/治疗前用药片数×100%。停药(显效):治疗后完全停服;减量(有效):治疗后硝酸甘油停减率≥50%;不变(无效):治疗后硝酸甘油停减率<50%;总停减率=(停药例数+减药例数)/总例数×100%。
2.8统计学方法
用SPSS 19.0统计软件处理数据,本研究符合正态分布的计量资料采用均数±标准差描述;治疗前后定量资料符合正态分布且方差齐时采用配对t检验,非正态分布及定性资料采用秩和检验。P<0.05认为差异具有统计学意义。
3结果
3.1安全性评价指标
根据患者治疗前后检测的安全性指标:凝血功能,肝肾功能,治疗前与治疗后比较变化不明显无统计学意义(P>0.05),未发现不良反应及毒副作用。说明本发明逆转冠脉斑块(气虚痰瘀互结证)具有良好的安全性。具体见表1
表1治疗前后安全性指标比较
3.2中医证候积分疗效比较
本发明治疗冠心病冠脉狭窄中医证候积分判定标准见表2。通过数据分析后得出治疗后总有效率为95.12%,后得出P<0.05,中医证候积分治疗前后对比差异有显著性,具有统计学意义。说明本发明在改善中医证候积分方面明显。详见表3-4
表2本发明治疗冠心病冠脉狭窄中医证候积分判定标准
表3本发明治疗前后中医证候积分对比
表4本发明中医证候积分疗效评定
3.3冠脉狭窄治疗前后比较
纳入的患者在本发明治疗前后行冠脉CTA或造影后得到的数据经统计分析后显示本发明治疗后的管腔狭窄程度基线值由85.49±8.85%降至40.43±6.04%,较基线值下降45.06±7.34%,治疗前后管腔狭窄程度对比P=0.02<0.05,差异显著有统计学意义。具体见表5。
表5冠脉管腔狭窄程度的变化
3.4血脂情况比较
本发明治疗后TC由6.16±1.3mmol/L降至4.13±0.56mmol/L,TG由3.15±0.62mmol/L降至1.47±0.19mmol/L;经秩和检验,P<0.05,差异具有统计学意义;数据显示本发明降低血脂总有效率为98.78%。具体比较数据见表6-7。
表6治疗前后血脂TC、TG值比较(mmol/L)
表7血脂疗效评定
3.5硝酸甘油减停率疗效评定
治疗前共58例存在心绞痛症状,本发明治疗后显效38例,有效18例,无效2例,总有效率96.55%,详见表8。
表8硝酸甘油减停疗效评定
4动物实验
通过建立动脉粥样硬化模型大鼠,观察本发明对抗动脉粥样硬化的病理改变,并通过检测其总胆固醇(TC)、甘油三酯(TG)与血清中白介素-6(IL-6)、肿瘤坏死因子-a(TNF-a)含量的变化,探讨本发明对抗动脉粥样硬化形成过程中脂质代谢与泡沫细胞的含量、炎症作用及可能的机制,为本发明的临床应用提供可靠的实验依据。方法:将50只成年大鼠随机分为5组:空白对照组、模型对照组、阳性对照组(阿托伐他汀钙片组)、本发明低剂量组、本发明高剂量组,每组10只,适应性喂养一周后,除空白对照组给予普通饲料喂养外,其余各组均给予高脂饲料喂养,8周后,阳性对照组按照阿托伐他汀2.08mg/kg剂量灌胃给药,本发明高剂量组、本发明低剂量组分别按本发明144.58g/kg、72.29g/kg剂量灌胃给药,空白组及模型组按照生理盐水1ml/100g灌胃给药,清晨空腹,日一次(本发明中药剂量大时分为日两次),连续4周,禁食过夜,麻醉后腹主动脉采血,放置30min后进行离心,取血清并进行TC、TG、IL-6、TNF-a含量的检测与比较。与空白组比较,模型组TC、TG、IL-6、TNF-α水平明显升高(P<0.05),与模型组比较,阳性对照组、本发明低、高剂量组IL-6、TNF-α水平明显降低(P<0.05),与阳性对照组比较,本发明高、低剂量组TC、TG、IL-6、TNF-α水平明显降低(P<0.05),与本发明低剂量组比较,本发明高剂量组TC、TG、IL-6、TNF-α水平明显降低(P<0.05),详见表9。结果:本发明高、低剂量组能降低动脉粥样硬化大鼠模型血清TC、TG、IL-6、TNF-a的浓度(P<0.05),并能对抗动脉粥样硬化的形成,降低泡沫细胞的含量。结论:本发明可有效对抗动脉粥样硬化的形成并阻止其发展。
表9各组大鼠血清中TC、TG、IL-6、TNF-α水平的比较(`x±s)pg·ml-1
注:★表示与空白对照组相比,P<0.05;▲表示与模型组相比,P<0.05;■表示与阳性对照组相比,P<0.05,●表示与本发明低剂量组相比,P<0.05。
5讨论
本发明以益气化痰,活血通脉的治疗原则而立方,方中人参与黄芪配伍以扶正益气为君药以治其根;使其活血不伤其气;其中法半夏、生白术、瓜蒌、酒薤白、炒枳实涤痰化浊,健脾燥湿为臣药;红花、水蛭、虻虫、土鳖虫、三七(三七粉)、琥珀、血竭、地龙、桃仁、丹参、乳香、没药以活血祛瘀以治其标共为臣药,全蝎、蜈蚣、黑蚂蚁、葛根增加通络之功为佐药,醋鳖甲滋补肝肾,软坚散结引药入于血分为使药,全方配伍合理,协同作用,扶正不留邪,祛邪不伤正,共凑益气化痰,活血通脉之功。总之,本发明可通过补气活血,化痰祛瘀之法,治疗冠脉斑块及狭窄,且能显著改善临床症状,稳定斑块、增加心肌供血供氧,提高心肌细胞代谢能力,从根本上达到抗心肌缺血的目的,且能减少甚至减停硝酸酯类的服用量,极大的降低了硝酸酯类服用时间过长导致的抗药性及其它不良反应发生的问题,本发明疗效显著,使用安全可靠,值得临床运用。
Claims (4)
1.一种治疗冠状动脉硬化斑块的中药,其特征在于,由重量计的:黄芪90-110g、人参9-11g、生白术45-55g、瓜蒌18-22g、酒薤白27-33g、法半夏27-33g、炒枳实13-17g、丹参27-33g、红花13-17g、葛根54-66g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉9-11g、血竭粉3g、醋鳖甲27-33g、土鳖虫27-33g、桃仁9-11g、乳香27-33g、没药27-33g和地龙27-33g制成。
2.根据权利要求1所述的治疗冠状动脉硬化斑块的中药,其特征在于,由重量计的:黄芪100g、人参10g、生白术50g、瓜蒌20g、酒薤白30g、法半夏30g、炒枳实15g、丹参30g、红花15g、葛根60g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉10g、血竭粉3g、醋鳖甲30g、土鳖虫30g、桃仁10g、乳香30g、没药30g和地龙30g制成。
3.根据权利要求1所述的治疗冠状动脉硬化斑块的中药,其特征在于,由重量计的:黄芪90g、人参9g、生白术45g、瓜蒌18g、酒薤白27g、法半夏27g、炒枳实13g、丹参27g、红花13g、葛根54g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉9g、血竭粉3g、醋鳖甲27g、土鳖虫27g、桃仁9g、乳香27g、没药27g和地龙27g制成。
4.根据权利要求1所述的治疗冠状动脉硬化斑块的中药,其特征在于,由重量计的:黄芪110g、人参11g、生白术55g、瓜蒌22g、酒薤白33g、法半夏33g、炒枳实17g、丹参33g、红花17g、葛根66g、全蝎粉3g、蜈蚣粉2g、三七粉3g、水蛭粉3g、虻虫粉1.5g、琥珀粉6g、黑蚂蚁粉11g、血竭粉3g、醋鳖甲33g、土鳖虫33g、桃仁11g、乳香33g、没药33g和地龙33g制成。
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