CN115531479A - 一种治疗老年性脑梗塞的中药组合物及其制备方法、用途 - Google Patents
一种治疗老年性脑梗塞的中药组合物及其制备方法、用途 Download PDFInfo
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Abstract
本发明涉及中药技术领域,具体涉及一种治疗老年性脑梗塞的中药组合物及其制备方法、用途。该中药组合物按重量份数计由以下原料组成:黄芪200~280份、川芎90~150份、熟地黄200~280份、桃仁90~150份、红花90~150份、山药90~150份、枸杞子90~150份、山茱萸90~150份、川牛膝60~120份、菟丝子90~150份、鹿角胶90~150份、龟甲胶90~150份、茯苓90~150份。本发明提供的中药组合物对老年性脑梗塞具有较佳疗效,且毒副作用小,使用安全、方便,配制简单、合理,药源广。
Description
技术领域
本发明涉及中药技术领域,具体涉及一种治疗老年性脑梗塞的中药组合物及其制备方法、用途。
背景技术
脑卒中是全球第二大致死原因和造成残疾负担最重的神经疾病,脑卒中的主要类型是缺血性卒中,约占所有脑卒中的70%,其中老年性脑梗塞占的比例最大,预后多不良。由于缺血性脑卒中损伤涉及神经血管单位的所有组成部分,包括内皮细胞、周细胞、神经元、胶质细胞、髓鞘和细胞外基质蛋白等,目前有效的治疗措施很少,静脉注射组织型纤溶酶原激活剂与机械取栓术虽然有效,但受严格的时间窗及再出血等风险的限制,只有极少数患者从再通治疗中获益,多数患者留下后遗症。而对于恢复期和后遗症期的脑卒中患者,目前以康复治疗和预防治疗为主,但对患者神经功能的恢复效果并不理想,多数患者留下终身残疾,严重影响患者生活质量。
因此,需要一种能够针对老年性缺血性脑卒中且疗效佳、副作用小的治疗药物。
发明内容
鉴于以上技术问题,本发明提供以下技术方案:
本发明第一方面,提供一种治疗老年性脑梗塞的中药组合物,其按重量份数计由以下原料组成:黄芪200~280份、川芎90~150份、熟地黄200~280份、桃仁90~150份、红花90~150份、山药90~150份、枸杞子90~150份、山茱萸90~150份、川牛膝60~120份、菟丝子90~150份、鹿角胶90~150份、龟甲胶90~150份、茯苓90~150份。
优选地,所述中药组合物按重量份数计由以下原料组成:黄芪240份、川芎120份、熟地黄240份、桃仁120份、红花120份、山药120份、枸杞子120份、山茱萸120份、川牛膝90份、菟丝子120份、鹿角胶120份、龟甲胶120份、茯苓120份。
本发明第二方面,提供一种治疗老年性脑梗塞的中药组合物的制备方法,包括以下步骤:
按重量份数称取黄芪、川芎、熟地黄、桃仁、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、鹿角胶、龟甲胶、茯苓,备用;
将称取的鹿角胶、龟甲胶粉碎成细粉,得到细粉混合物;
将称取的川芎、桃仁混合,提取挥发油后进行包合,得到挥发油包合物;
将提取挥发油后收集的川芎及桃仁的药渣与黄芪、熟地黄、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、茯苓混合,加水煎煮,收集煎煮液,浓缩,得到浓缩物;
将所述浓缩物与所述细粉混合物、所述挥发油包合物混合,即得所述中药组合物。
优选地,所述加水煎煮的具体操作过程是:加入相当于药材混合物10~12倍量的水,煎煮2~3次,每次1.0~1.5h。
本发明第三方面,提供一种治疗老年性脑梗塞的药物,其包括所述中药组合物。
优选地,所述药物包括治疗急性缺血性脑卒中的药物。
优选地,所述治疗急性缺血性脑卒中的药物至少包括阿司匹林、硫酸氢氯吡格雷及阿托伐他汀钙片。
本发明第四方面,提供一种治疗老年性脑梗塞的中药颗粒,其是按照以下方法制备得到:
按重量份数称取黄芪、川芎、熟地黄、桃仁、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、鹿角胶、龟甲胶、茯苓,备用;
将鹿角胶、龟甲胶粉碎成细粉,得到细粉混合物;
将称取的川芎、桃仁混合,提取挥发油,所得挥发油用环糊精进行包合,得到挥发油包合物;
收集提取挥发油后川芎及桃仁的药渣,与黄芪、熟地黄、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、茯苓混合,加水煎煮,收集煎煮液,精制、浓缩,得到浓缩物;
将所述浓缩物与所述细粉混合物、所述挥发油包合物混合,加入辅料,制粒,分装,得到中药颗粒。
优选地,所述环糊精与所述挥发油的质量比为9~11∶1;
所述辅料为糊精,所述糊精与所述药物混合粉的质量比为0.8~1.2∶1;
所述精制是采用醇沉法进行。
本发明第五方面,提供了所述中药组合物、或所述药物或所述中药颗粒在制备治疗老年性脑梗塞的药物中的用途。
本发明从中医角度分析,提出“补益气血、填精补肾为主,活血通络化浊为辅”的治病主张。老年脑卒中的发病与“积损正衰”有密切关系,若久病正衰,或年老体衰,则肾精亏虚,气血津液亏耗,瘀血痰浊内生,脑失所养或脑窍闭塞,轻则“脑转耳鸣”,重则“中风”“偏枯”。瘀血阻滞,水津停聚,聚而为浊,浊蕴成毒,最终浊毒上犯脑之玄府,玄府瘀滞闭密,神机失乱。年老则肾脏衰,真阴不足,肾精亏虚,不能主骨而腰酸腿软;不能生髓,则髓海空虚而头目眩晕;真阴不足,失于封藏,故自汗盗汗;中风之后,正气亏虚,不能行血,以致脉络瘀阻,筋脉肌肉失去濡养,故见半身不遂、口眼斜。气虚血瘀,舌本失养,故语言謇涩;气虚失于固摄,故口角流涎、小便频数、遗尿失禁;舌暗淡,苔白,脉缓无力为气虚血瘀之象。本方证以气血肾精亏虚为本,痰浊瘀血阻滞为标,即王清任所谓“因虚致瘀”。治当以补益气血、填精补肾为主,活血通络化浊为辅。
本发明提供的中药组合物是由左归丸与补阳还五汤两方化裁而成,具有补肾填精、益气活血的作用。左归丸是著名的填精补髓方,出自《景岳全书》卷五十一,为补益剂,主治精髓内亏,津液枯涸之证;补阳还五汤是著名的益气活血代表方,出自《医林改错》,为理血剂,具有补气、活血、通络之功效,主治中风之气虚血瘀证。与左归丸与补阳还五汤相比,本方既沿用了两方补益、益气活血的功效,又减弱了原方活血通络的作用,偏重补气、滋阴补肾之功,这与老年人肾精亏虚、正气不足所致的脑梗塞病机相符合。同时考虑到现代医学在急性期治疗时多使用活血化瘀的药物,而过多使用活血化瘀药物有损正气,故本方在左归丸及补阳还五汤的基础上,加茯苓,去当归尾、赤芍及地龙,使本方在健脾益肾、益气活血的基础之上,同时发挥部分活血通络化浊之功效。另外,本方对于改善气短乏力、自汗出、腰膝酸软的临床症状尤为适宜,有效弥补了单用补阳还五汤滋肾阴作用弱、左归丸补气方面不足的缺陷,更满足临床对急性期老年性脑梗塞的治疗需求。
本方重用黄芪、熟地黄、川芎为君药;黄芪,补益元气,意在气旺则血行,瘀去络通;熟地黄滋肾阴,益精髓,以补真阴不足;川芎为血中之气药,辛温香燥,走而不守,既能行散,上行可达巅顶;又入血分,下行可达血海,活血祛瘀;三药合用,则达气血足、肾精旺,正气得复的效果。枸杞子补肾益精、养肝明目;鹿龟二胶,为血肉有情之品,峻补精髓,其中龟板胶偏于补阴,滋阴补髓,鹿角胶偏于补阳,补益精血,温壮肾阳;山药补脾益阴、滋肾固精;桃仁、红花活血祛瘀,以上药物共为臣药,发挥补肾健脾益气活血的作用。菟丝子性平,益气强阴,补髓填精,坚筋骨;山茱萸养肝滋肾、涩精敛汗以固秘精气;茯苓健脾益肾、利湿泻浊;川牛膝益肝肾、强腰膝、健筋骨、活血,与上药合用共为佐使药。诸药合用共奏补肾填精,益气活血之效,可显著改善急性期老年脑卒中病人的临床症状,提高患者的生活质量,取得了良好的临床疗效,值得临床推广应用。
本发明提供的中药组合物,适用于老年性脑梗塞,尤其是对急性期老年脑卒中治疗效果显著,值得临床推广。
本方除了治疗脑梗死之外,同时可填精补肾,有效的发挥抗衰老作用,以改善衰老细胞积累所致的年龄相关的疾病的发生发展,如动脉粥样硬化等。
本发明提供的中药组合物,毒副作用小,使用安全,配制简单、合理,药源广,使用方便。
附图说明
图1为治疗组和对照组两组的患者NIHSS评分比较之柱状统计图;
图2为治疗组和对照组两组的患者中医证候积分比较之柱状统计图;
图3为治疗组和对照组两组的患者有效率比较之柱状图。
具体实施方式
为了更好的解释本发明,以便于理解,下面结合具体实施例,对本发明作详细描述。
本发明提供一种治疗老年性脑梗塞的中药组合物,其按重量份数计由以下原料组成:黄芪200~280份、川芎90~150份、熟地黄200~280份、桃仁90~150份、红花90~150份、山药90~150份、枸杞子90~150份、山茱萸90~150份、川牛膝60~120份、菟丝子90~150份、鹿角胶90~150份、龟甲胶90~150份、茯苓90~150份。
本发明提供的中药组合物,各原料药材的功效和特点如下:
黄芪:甘,微温。归脾、肺经。补气升阳,固表止汗,利水消肿,托疮生肌。用于气虚乏力,食少便溏,中气下陷,久泻脱肛,便血崩漏,表虚自汗,气虚水肿,痈疽难溃,久溃不敛,血虚痿黄,内热消渴;慢性肾炎蛋白尿,糖尿病。黄芪的有效成分主要为葡聚糖、杂多糖、黄酮类及皂苷类。黄芪的提取物可以通过抑制炎症反应、改善能量代谢、抗氧化、清除氧自由基、抑制细胞凋亡、保护血脑屏障及缓解细胞内钙超载等多种机制起到对缺血性脑卒中神经保护作用。
川芎:辛,温。归肝、胆、心包经。活血行气,祛风止痛。用于月经不调,经闭痛经,症瘕腹痛,胸胁刺痛,跌扑肿痛,头痛,风湿痹痛。其主要的药理活性物质为苯酞类(如藁本内酯、丁基苯酞)、有机酚酸类(如川芎嗪)及生物碱类(如阿魏酸)等。川芎嗪可以扩张血管,起到改善微循环的作用,有效改善患者的脑部供血量;阿魏酸钠可明显降低血清和脑组织中TNF-α、IL-1β及IL-6水平,抑制神经炎症;黄芪-川芎药对中槲皮素、山柰酚等化合物可能通过TNF信号通路、IL-17信号通路等多条通路发挥治疗脑卒中的作用。
熟地黄:甘,微温。归肝、肾经。补血滋阴,益精填髓。用于肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。主要药理活性成分为主要为环烯醚萜类、紫罗兰酮类和苯乙醇类化合物。地黄可以抑制H2O2诱导的大鼠肾脂质过氧化及红细胞溶血,通过清除自由基的产生,抑制脂质过氧化,延缓细胞衰老。
桃仁:苦,甘,平。趋向沉降。归心、肝、大肠经。活血祛瘀,润肠通便,止咳平喘。用于经闭,痛经,癓瘕痞块,跌扑损伤,肠燥便秘。桃仁的化学成分主要为脂肪酸类、苦杏仁苷、野樱苷等。桃仁油抑制TNF-α诱导的转铁蛋白升高,提高人脐静脉内皮细胞活性,保护内皮细胞,下调组织因子(TF)蛋白的表达,从而抑制动脉粥样硬化斑块的形成。
红花:辛,温。归心、肝经。活血通经,散瘀止痛。用于经闭,痛经,恶露不行,症瘕痞块,跌扑损伤,疮疡肿痛。红花黄色素和红花红色素、红花多糖等是红花中主要的有效成分。红花有效成分不仅通过抑制NF-κB通路、调节糖酵解代谢水平、抑制氧化应激作用及拮抗血小板的激活的作用改善神经功能的缺损,还可通过Ras/Raf/MEK/ERK1/2通路、VHL/HIF-1α/VEGF通路阻断生长信号的释放与转导来调控血管平滑肌细胞的增殖和迁移。
山药:甘、平。归脾、肺、肾经。补脾养胃,生津益肺,补肾涩精。用于脾虚食少,久泻不止,肺虚喘咳,肾虚遗精,带下,尿频,虚热消渴。麸炒山药补脾健胃。用于脾虚食少,泄泻便溏,白带过多。山药中主要有效成分包括纤细薯蓣皂苷、薯蓣皂苷、延龄草皂苷等。现代药理研究发现山药具有抗炎、免疫调节、降尿酸、抗肿瘤等药理作用。
枸杞子:甘,平,趋向沉降。归肝、肾经。滋补肝肾,益精明目。用于虚劳精亏,腰膝酸痛,眩晕耳鸣,内热消渴,血虚萎黄,目昏不明。枸杞子中富含糖类、生物碱类、黄酮类及酚酸类成分,具有调节免疫、抗氧化、抗衰老、降血脂血糖、抗肿瘤等作用。枸杞多糖可提高老年和D-半乳糖致衰老小鼠脑内NOS的活性和NO的含量,抑制骨髓中c-myc基因表达,抑制细胞凋亡。
山茱萸:酸、涩,微温。归肝、肾经。补益肝肾,收涩固脱。用于眩晕耳鸣,腰膝酸痛,阳痿遗精,遗尿尿频,崩漏带下,大汗虚脱。内热消渴。山茱萸的主要药理活性成分为环烯醚萜、单宁和黄酮类。熟地黄和山茱萸可调节HIF-VEGFA神经干细胞增殖信号通路、TNF通路和NF-κB炎症反应通路、apoptosis凋亡信号通路,在缺血性脑卒中后遗症阶段通过促神经干细胞增殖、血管生成、抗神经细胞凋亡和调节炎症因子促进神经功能的恢复。
川牛膝:苦,甘,酸,平。归肝、肾经。逐瘀通经,补肝肾,强筋骨,利水通淋,引血下行。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。皂苷类及甾酮类是牛膝的主要化学成分。牛膝活性肽ABPPk2可通过抑制促凋亡蛋白Bax、caspase3的表达,促进抗凋亡蛋白Bcl-2、Bcl-x1的表达,改善MCAO大鼠长期神经功能缺陷和学习记忆能力。
菟丝子:辛,甘,平。归肝、肾、脾经。补益肝肾,固精缩尿,安胎,明目,止泻;外用消风祛斑。用于阳痿遗精,尿有余沥,遗尿尿频,腰膝酸软,目昏耳鸣,肾虚胎漏,胎动不安,脾肾虚泻;外治白癜风。研究发现菟丝子主要包含黄酮、多糖、糖苷、甾醇类、生物碱类、鞣酸、脂肪酸、氨基酸及微量元素等化学成分。菟丝子黄酮对H2O2诱导的人脐静脉内皮细胞的损伤具有保护作用。
鹿角胶:甘、咸,温。归肾、肝经。温补肝肾,益精养血。用于阳痿滑精,腰膝酸冷,虚劳羸瘦,崩漏下血,便血尿血,阴疽肿痛。鹿角胶作为胶类中药,动物蛋白是其重要的组成成分,同时含有铜、锌、锰、钴、钼等多种微量元素。鹿角胶通过降低氧自由基的产生以及提高其清除率对脑缺血大鼠脑组织具有保护作用。
龟甲胶:甘,微咸,平。养阴补肾,潜阳止血。主治年老衰弱,肾虚腰痛及男女贫血等症。龟甲胶的主要有效成分为氨基酸和多种微量元素。现代药理研究发现龟甲胶具有促进细胞增殖和抑制细胞凋亡的作用。
茯苓:甘、淡、平。趋向沉降。归心、肺、脾、肾经。利水渗湿,健脾,宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。茯苓的主要活性成分为三萜类及多糖类化合物。现代研究发现茯苓具有免疫调节、抗炎、抗肿瘤、降血脂等药理作用。
下面结合具体实施例进行说明。
实施例1
一种治疗老年性脑梗塞的中药组合物,其由以下原料组成:黄芪200g、川芎90g、熟地黄200g、桃仁90g、红花90g、山药90g、枸杞子90g、山茱萸90g、川牛膝60g、菟丝子90g、鹿角胶90g、龟甲胶90g、茯苓90g。
实施例2
一种治疗老年性脑梗塞的中药组合物,其由以下原料组成:黄芪280g、川芎150g、熟地黄280g、桃仁150g、红花150g、山药150g、枸杞子150g、山茱萸150g、川牛膝120g、菟丝子150g、鹿角胶150g、龟甲胶150g、茯苓150g。
实施例3
一种治疗老年性脑梗塞的中药组合物,其由以下原料组成:黄芪240g、川芎120g、熟地黄240g、桃仁120g、红花120g、山药120g、枸杞子120g、山茱萸120g、川牛膝90g、菟丝子120g、鹿角胶120g、龟甲胶120g、茯苓120g。
实施例4
一种治疗老年性脑梗塞的中药组合物,其由以下原料组成:黄芪280g、川芎120g、熟地黄240g、桃仁120g、红花150g、山药120g、枸杞子120g、山茱萸120g、川牛膝90g、菟丝子120g、鹿角胶90g、龟甲胶90g、茯苓120g。
实施例5
一种治疗老年性脑梗塞的中药组合物,其由以下原料组成:黄芪200g、川芎150g、熟地黄200g、桃仁150g、红花150g、山药90g、枸杞子120g、山茱萸120g、川牛膝90g、菟丝子120g、鹿角胶90g、龟甲胶90g、茯苓120g。
上述实施例1~5提供的中药组合物均是按照以下方法制备得到:
称取黄芪、川芎、熟地黄、桃仁、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、鹿角胶、龟甲胶、茯苓,备用;
将称取的鹿角胶、龟甲胶粉碎成细粉,得到细粉混合物;
将称取的川芎、桃仁混合,50℃、15MPa下超临界萃取1h,得到挥发油,取挥发油加入10倍量β-环糊精,采用饱和水溶液法在40℃包合3h,得到挥发油包合物;
将提取挥发油后收集的川芎及桃仁的药渣与黄芪、熟地黄、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、茯苓混合,第一次加入相当于混合物12倍量的水,煎煮1.5h,过滤,收集第一次煎煮液;滤渣中再加入相当于其10倍量的水,煎煮1h,收集第二次煎煮液,与第一次煎煮液合并,浓缩,得到浓缩物;
将所述浓缩物与所述细粉混合物、所述挥发油包合物混合,即得。
上述实施例1~5提供的中药组合物能够进一步制备成药学上可接受的中药制剂,如颗粒剂、胶囊剂、片剂等。下面以颗粒剂为例进行说明,但并不是对本发明提供的中药组合物能够制备成的中药剂型的限定。
实施例6
一种治疗老年性脑梗塞的中药颗粒剂,其是按照以下方法制备得到:
称取黄芪240g、川芎120g、熟地黄240g、桃仁120g、红花120g、山药120g、枸杞子120g、山茱萸120g、川牛膝90g、菟丝子120g、鹿角胶120g、龟甲胶120g、茯苓120g,备用;
将鹿角胶及龟甲胶粉碎成细粉,得到细粉混合物;
将川芎、桃仁混合,50℃、15MPa下超临界萃取1h,得到挥发油;取挥发油加入10倍量β-环糊精,采用饱和水溶液法在40℃包合3h,制得挥发油包合物;
收集川芎、桃仁萃取挥发油后的药渣,与黄芪、熟地黄、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子及茯苓混合,第一次加入相当于混合物12倍量的水,煎煮1.5h,过滤,收集第一次煎煮液;滤渣中再加入相当于其10倍量的水,煎煮1h,收集第二次煎煮液,与第一次煎煮液合并,浓缩,再加入等量的质量分数95%乙醇溶液,醇沉24h,滤过,收集滤液,回收乙醇,继续浓缩成浸膏,所得浸膏经喷雾干燥制得浸膏粉;
将浸膏粉与细粉混合物、挥发油包合物混合均匀制得药物混合粉,取药物混合粉加入1倍量糊精,混合均匀,干法制粒,制得中药颗粒剂。规格:10g/袋。
下面通过临床试验进一步说明本发明提供的中药组合物的治疗效果,由于上述各实施例提供的中药组合物及中药颗粒的治疗效果基本接近,故以下试验采用本发明上述实施例6制备获得的中药颗粒剂为例进行试验。
临床试验
1、临床资料
1.1、病例来源
研究对象病例来源于2021年12月至2022年2月来河南中医药大学第一附属医院脑病门诊及住院部就诊的老年脑梗死患者60例,依据随机对照原则分配到治疗组和对照组,治疗组及对照组各30例。
随机对照法:将60张小纸条依次从1~64编号,采用SPSS25.0统计软件操作按1∶1随机平行对照原则将编号随机分成治疗组和对照组,将小纸条分别装入相同的信封,按患者就诊顺序由患者随机抽取,按原先分好组的编号将患者分成治疗组和对照组。
1.2、诊断标准
1.2.1、西医诊断标准
缺血性脑卒中诊断标准参照《中国急性缺血性脑卒中诊治指南2018》,具体标准如下:
(1)急性起病;
(2)局灶神经功能缺损(一侧面部或肢体无力或麻木,语言障碍等),少数为全面神经功能缺损;
(3)影像学出现责任病灶或症状/体征持续24h以上;
(4)排除非血管性病因;
(5)脑CT/MRI排除脑出血。
1.2.2、中医诊断标准
(1)中风病诊断标准参照《中风病诊断与疗效评定标准(试行)》中的病名诊断标准。
主症:半身不遂,神识昏蒙,言语謇涩或不语,偏身感觉异常,口舌歪斜;
次症:头痛,眩晕,瞳神变化,饮水发呛,目偏不瞬,共济失调;
起病方式:急性起病,发病前多有诱因,常有先兆症状;
发病年龄:多在40岁以上;
具备2个主症以上,或1个主症及2个次症,结合起病、诱因、先兆症状、年龄即可确诊;不具备上述条件,结合影像检查结果亦可确诊。
(2)证候诊断标准
参考《中风病诊断与疗效评定标准(试行)》、《中风病辨证诊断标准(试行)》、2002年版郑筱萸主编《中药新药临床研究指导原则》、《中药(新药)治疗老年病临床研究指导原则》与导师临床经验制定。
主症:半身不遂,口舌歪斜,言语蹇涩或不语,感觉减退或消失;
舌象:舌质暗淡,舌苔少或白;
脉象:脉沉细;脉细数
具备2个主症、1个次症及以上,或1个主症、2个次症及以上,结合舌脉即可确诊。
(3)老年病病例选择标准参照《新药(中药)治疗老年病临床研究指导原则》
年龄:老年期(≥60岁)
1.3、病例选择
1.3.1、病例纳入标准
(1)符合中医诊断标准及证型诊断标准;
(2)符合西医诊断标准;
(3)年龄≥60岁;
(4)神经功能缺损评分在1~30分;
(5)生命体征相对平稳;
(6)患者或家属知情同意并签字。
1.3.2、病例排除标准
(1)不符合上述中医及西医诊断者;
(2)有脑外伤、颅内感染、脑内原发肿瘤者;
(3)病情不稳定,合并多脏器代谢障碍或多脏器衰竭等严重疾病者;
(4)出现严重感染、压疮、电解质紊乱等并发症者;
(5)服药依从性差、不配合临床研究者;
(6)对所用药物过敏者。
1.3.3、病例剔除及脱落标准
(1)病人自动退出者;
(2)不符合或未按方案(试验)规定用药者;
(3)发生重大不良事件或出现严重并发症不宜继续接受试验者,破盲脱落病例,未完成整个疗程而影响疗效或安全性判断者;
(4)研究未结束而失访或死亡的病例;
2、研究方法
2.1、依据上述标准,选取有效实验对象。
2.2、治疗方案
(1)药物治疗方案:
对照组:参照《中国急性缺血性脑卒中诊治指南2018》及《中国脑梗死中西医结合诊治指南(2017)》依据患者实际病情,予西医常规药物及康复治疗,具体为:阿司匹林肠溶片0.1g、1日1次+硫酸氢氯吡格雷片75mg、1日1次+阿托伐他汀钙20mg、1日1次+血栓通注射液40mg静脉注射,对所有治疗药物的药品名称、治疗剂量、使用方法等进行详细记录,尽量保证用药的统一性。
治疗组:予实施例6提供的中药颗粒并联合西医常规治疗,一日两次,一次1袋,西医常规治疗同对照组。
2.3、观察和统计项目
一般项目包括姓名,性别,身高,体重,年龄,既往史,个人史。
(1)疗效观察指标:美国国立卫生研究院卒中量表(NHISS)评分;改良Rankin评分(mRS评分)、中医证候积分。以入组当日和治疗4周后作为观察时间点,对每位纳入病例进行NHISS评分、mRS评分和中医证候积分评分。
NHISS评分如表1所示,mRS评分量表如表2所示,中医证候积分量表如表2所示。
表1美国国立卫生研究院卒中量表(NIHSS评分)
表2mRS评分量表
患者状况 | 评分标准 |
完全无症状 | 0 |
尽管有症状,但无明显功能障碍,能完成所有日常工作和生活 | 1 |
轻度残疾,不能完成病前所有活动,但不需要帮助能照料自己的日常事务 | 2 |
中度残疾,需部分帮助,但能独立行走 | 3 |
中重度残疾,不能独立行走,日常生活需别人帮助 | 4 |
重度残疾,卧床,二便失禁,日常生活完全依赖他人 | 5 |
表3中医证候积分量表
(2)实验室指标:观察并评价治疗前、后的实验室指标:血清VEGF、Ang-1水平。实验室指标采用ELISA方法测得。观察并评价治疗前、后的实验室指标。
2.4、疗效评定标准
(1)神经功能缺损程度评分(NHISS评分)参照《脑卒中患者临床神经功能缺损程度评分标准(1995)》进行评价。基本痊愈:NIHSS评分减少91%~100%;显效:NIHSS评分减少46%~90%;有效:NIHSS评分减少18%~45%;无效:NIHSS评分减少在18%以内。
采用尼莫地平法,疗效指数=[(治疗前积分-治疗后积分)/治疗前积分]×100%。
(2)中医证候疗效评定
参照《中药新药临床研究指导原则(试行)》对中医证候改善情况进行评价。
临床痊愈:中医临床症状、体征消失或基本消失,证候积分减少≥95%;
显效:中医临床症状、体征改善,证候积分减少≥70%,<95%;
有效:中医临床症状、体征均有好转,证候积分减少≥30%,<70%;
无效:中医临床症状、体征均无明显改善,甚或加重,证候积分减少<30%;
采用尼莫地平法,疗效指数=[(治疗前积分-治疗后积分)/治疗前积分]×100%。
2.5、不良事件的观察与处理
研究者需每日查看患者病情并详细记录患者每日的症状、体征,密切关注患者血常规等安全性指标,如患者发生不良事件,需判断是否因试验药物所致,并填写不良事件表。同时,研究者需配合医师对患者进行及时正确的处理或抢救,对处理经过及结果进行详细的记录。研究者应当继续追踪该不良事件,直到患者病情趋于平稳。
2.6、统计方法
采用SPSS25.0软件对所有统计数据进行分析:若数据满足正态性、方差齐性,计量资料用均数加减标准差表示,组间比较用两独立样本t检验,组内比较用两配对样本t检验;若不符合,采用四分位数表示:中位数(第一分位数,第三分位数),组间比较用Mann-WhitneyU秩和检验,组内比较用Wilcoxon符号秩和检验;计数资料两组比较釆用卡方检验;以P<0.05为差异有统计学意义。
3、研究结果
3.1、基线资料的比较
共纳入60例急性脑梗死患者,每组30例,其中有2例中脏腑患者,余均为中经络患者;两组患者的年龄、身高、体重采用两独立样本t检验(P>0.05),性别、既往史(高血压、糖尿病、冠心病)和个人史(吸烟史、饮酒史)采用卡方检验(P>0.05),具有可比性。(见表4,表5)
表4基线资料的比较
例数 | 年龄(岁) | 性别 | 身高(cm) | 体重(kg) | |
治疗组 | 30 | 63.86±10.09 | 18/12 | 165.53±8.74 | 71.46±13.02 |
对照组 | 30 | 62.73±11.68 | 22/8 | 167.83±7.48 | 70.28±11.39 |
T/χ<sup>2</sup> | 1.466 | 1.200 | ~1.094 | 0.375 | |
P | 0.148 | 0.273 | 0.278 | 0.709 |
表5基线资料的比较
3.2、NIHSS评分的比较
治疗前两组间无差异(ΔP>0.05),治疗后治疗组NIHSS评分低于对照组(*P<0.05);治疗后两组NIHSS评分均较治疗前降低(▲#P<0.05),结果表明治疗组能更好的改善神经功能缺损评分。(见表6及图1)
表6两组治疗前后NIHSS评分比较(分)
组别 | 例数 | 治疗前 | 治疗后 |
治疗组 | 30 | 12.13±1.87<sup>Δ▲</sup> | 4.26±2.44<sup>*▲</sup> |
对照组 | 30 | 11.20±1.95<sup>Δ#</sup> | 7.70±2.23<sup>*#</sup> |
注:两组治疗前相比:ΔP>0.05;两组治疗后相比:*P<0.05;同组治疗前后相比:▲#P<0.05。
3.3、mRS评分的比较
治疗前两组间无差异(ΔP>0.05),治疗后治疗组mRS评分低于对照组(*P<0.05);治疗后两组mRS评分均较治疗前降低(▲#P<0.05),结果表明治疗组能更好的改善独立生活能力评分。(见表7)
表7两组治疗前后mRS评分比较(分)
组别 | 例数 | 治疗前 | 治疗后 |
治疗组 | 30 | 3(2~4)<sup>Δ▲</sup> | 1(1~1)<sup>*▲</sup> |
对照组 | 30 | 4(3~4)<sup>Δ#</sup> | 2(1~2)<sup>*#</sup> |
注:两组治疗前相比:ΔP>0.05;两组治疗后相比:*P<0.05;同组治疗前后相比:▲#P<0.05。
3.4、中医症候积分的比较
治疗前两组间无差异(ΔP>0.05),治疗后治疗组中医症候积分低于对照组(*P<0.05);治疗后两组中医症候积分均较治疗前降低(▲#P<0.05),结果表明治疗组能更好的改善患者临床症状。(见表8及图2)
表8两组治疗前后中医症候积分比较(分)
组别 | 例数 | 治疗前 | 治疗后 |
治疗组 | 30 | 23.50±5.71<sup>Δ▲</sup> | 7.50±4.10<sup>*▲</sup> |
对照组 | 30 | 22.16±3.89<sup>Δ#</sup> | 14.23±2.81<sup>*#</sup> |
注:两组治疗前相比:ΔP>0.05;两组治疗后相比:*P<0.05;同组治疗前后相比:▲#P<0.05。
3.5、临床有效率的比较
治疗组总有效率(93.33%)高于对照组(73.33%)(P<0.05),表明联合西医常规治疗具有更好的疗效。(见表9及图3)
表9两组治疗后有效率的比较(n%)
组别 | 例数 | 基本痊愈 | 显效 | 有效 | 无效 | 总有效 |
治疗组 | 30 | 5(16.67) | 21(70.00) | 2(6.67) | 2(6.67) | 28(93.33) |
对照组 | 30 | 0(0.00) | 6(20.00) | 16(53.33) | 8(26.67) | 22(73.33) |
注:与对照组比较,P<0.05。
3.6、中医症候疗效的比较
治疗组中医症候疗效(96.67%)高于对照组(66.67%)(P<0.05),表明芪芎左归颗粒联合西医常规治疗能更好的的改善中医临床症状。(见表10)。
表10两组治疗后中医症候疗效的比较(n%)
组别 | 例数 | 临床痊愈 | 显效 | 有效 | 无效 | 总有效 |
治疗组 | 30 | 1(3.33) | 14(46.67) | 14(46.67) | 1(3.33) | 29(96.67) |
对照组 | 30 | 0(0.00) | 0(0.00) | 20(66.67) | 10(33.33) | 20(66.67) |
注:与对照组比较,P<0.05。
3.7、VEGF的比较
治疗前两组间无差异(ΔP>0.05),治疗后治疗组VEGF高于对照组(*P<0.05);治疗后两组VEGF评分均较治疗前升高(▲#P<0.05)。(见表11)表11两组治疗前后VEGF比较(ng/ml)
组别 | 例数 | 治疗前 | 治疗后 |
治疗组 | 30 | 22.13±1.87<sup>Δ▲</sup> | 28.26±2.44<sup>*▲</sup> |
对照组 | 30 | 21.20±1.95<sup>Δ#</sup> | 24.70±2.23<sup>*#</sup> |
注:两组治疗前相比:ΔP>0.05;两组治疗后相比:*P<0.05;同组治疗前后相比:#P<0.05。
3.8、Ang-1的比较
治疗前两组间无差异(ΔP>0.05),治疗后治疗组血清中Ang-1含量较对照组有升高趋势,差异无统计学意义(*P>0.05);两组血清中Ang-1含量治疗后较治疗前均有升高趋势,差异无统计学意义(▲#P>0.05)。(见表12)
表12两组治疗前后Ang-1比较(ng/ml)
组别 | 例数 | 治疗前 | 治疗后 |
治疗组 | 30 | 27.11±4.76<sup>Δ▲</sup> | 28.20±3.98<sup>*▲</sup> |
对照组 | 30 | 27.48±2.89<sup>Δ#</sup> | 27.87±3.24<sup>*#</sup> |
注:两组治疗前相比:ΔP>0.05;两组治疗后相比:*P>0.05;同组治疗前后相比:▲#P>0.05。
3.9、不良事件
治疗组中1人出现胃肠道不适,对照组1人出现头晕,1人发生头痛,1人出现胃肠道不适,但上述症状均能自行缓解。两组患者安全性指标(生命体征、血常规、肝肾功能)均未见明显异常。经统计学比较,两组患者的不良反应发生率差异无统计学意义(P>0.05)(见表13)。
表13两组治疗后不良反应的比较(n%)
组别 | 例数 | 头晕 | 头痛 | 胃肠道不适 | 总发生情况 |
治疗组 | 30 | 0(0.00) | 0(0.00) | 1(3.33) | 1(3.33) |
对照组 | 30 | 1(3.33) | 1(3.33) | 1(3.33) | 3(10.00) |
注:与对照组比较,P>0.05。
综上,本发明提供的中药组合物联合西医常规治疗和西医常规治疗均可改善患者神经功能缺损评分、降低mRS评分、改善中医证后积分,但是本发明提供的中药组合物联合西医常规治疗能够更好的改善患者神经功能,提高患者独立生活能力,改善患者临床症状,且具有更好的疗效。
由此可见,本发明本发明提供的中药组合物配伍合理,诸药合用共奏补肾填精、益气活血之效,可显著改善老年脑梗死患者症状,提高患者生活质量,取得了良好的临床疗效,值得临床推广应用。
案例
患者杨某某,男,63岁,以左上肢活动不利半月余为主诉。
现病史:患者自诉2022年3月5日无明显诱因出现左侧上肢无力,遂当地医院就诊,诊断为急性脑梗死,予阿司匹林肠溶片联合硫酸氢氯吡格雷片抗血小板、阿托伐他汀钙片降脂稳斑、中成药活血化瘀,经治疗后病情稳定,但左侧肢体仍活动不利,好转不明显,遂至我院就诊。
查体:体温:36.8℃血压:142/90mmhg呼吸:20次/分心率:80次/分,左侧上肢肌张力稍高,肌力Ⅲ级,霍夫曼征阳性,舌暗淡,苔少,脉细缓无力,实验室检查:VEGF:22ng/ml,Ang~1:18ng/ml。西医诊断:脑卒中中医诊断:中风肾虚血瘀型。治则:补益气血,填精补肾为主,活血通络化浊为辅。
治疗方法:芪芎左归颗粒(×10剂)联合西医脑卒中二级预防治疗。
黄芪240g、川芎120g、熟地黄240g、桃仁120g、红花120g、山药120g、枸杞子120g、山茱萸120g、川牛膝90g、菟丝子120g、鹿角胶120g、龟甲胶120g、茯苓120g制为颗粒剂1000g。
用法:中药颗粒水冲服,50g/次,一日2次,分早晚两次冲服。服药期间禁忌进食辛辣、刺激饮。阿司匹林肠溶片100mg/d,1天1次;硫酸氢氯吡格雷片75mg/d,1天1,阿托伐他汀钙片20mg/d,1天1次。
2022年3月15日第一次复诊,患者诉左上肢活动不利轻微改善,查体:左侧上肢肌张力稍高,肌力Ⅲ级,霍夫曼征阳性,舌暗淡,苔白或少,脉细缓无力。中医方面:患者证型无明显变化,维持原方,10剂;西医方面:停止服用硫酸氢氯吡格雷片,余治疗不变。
2022年3月25日患者第二次复诊,患者诉左上肢活动不利有所改善改善,查体:左侧上肢肌张力稍高,肌力Ⅲ+级,霍夫曼征阳性,舌暗淡,苔少,脉细。中医方面:患者气虚有所改善,但依旧肾精不足,在原方基础上减少黄芪用量为200g,增加山茱萸用量为150g,10剂;西医方面:治疗不变。
2022年4月5日患者第三次复诊,患者诉左上肢活动不利有所改善改善,查体:左侧上肢肌张力有所降低,肌力Ⅲ+级,霍夫曼征阳性,舌暗淡,苔薄,脉稍弱。实验室检查:VEGF:28ng/ml,Ang~1:20ng/ml。中医方面:患者肾精不足有所改善,维持原方,10剂;西医方面:治疗不变。
需要说明的是,上述实施例不以任何形式限制本发明,凡采用等同替换或等效变换的方式所获得的技术方案,均落在本发明的保护范围内。
Claims (10)
1.一种治疗老年性脑梗塞的中药组合物,其特征在于,其按重量份数计由以下原料组成:黄芪200~280份、川芎90~150份、熟地黄200~280份、桃仁90~150份、红花90~150份、山药90~150份、枸杞子90~150份、山茱萸90~150份、川牛膝60~120份、菟丝子90~150份、鹿角胶90~150份、龟甲胶90~150份、茯苓90~150份。
2.根据权利要求1所述的中药组合物,其特征在于,所述中药组合物按重量份数计由以下原料组成:黄芪240份、川芎120份、熟地黄240份、桃仁120份、红花120份、山药120份、枸杞子120份、山茱萸120份、川牛膝90份、菟丝子120份、鹿角胶120份、龟甲胶120份、茯苓120份。
3.一种权利要求1或2所述的中药组合物的制备方法,其特征在于,包括以下步骤:
按重量份数称取黄芪、川芎、熟地黄、桃仁、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、鹿角胶、龟甲胶、茯苓,备用;
将称取的鹿角胶、龟甲胶粉碎成细粉,得到细粉混合物;
将称取的川芎、桃仁混合,提取挥发油后进行包合,得到挥发油包合物;
将提取挥发油后收集的川芎及桃仁的药渣与黄芪、熟地黄、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、茯苓混合,加水煎煮,收集煎煮液,浓缩,得到浓缩物;
将所述浓缩物与所述细粉混合物、所述挥发油包合物混合,即得所述中药组合物。
4.根据权利要求3所述的制备方法,其特征在于,所述加水煎煮的具体操作过程是:加入相当于药材混合物10~12倍量的水,煎煮2~3次,每次1.0~1.5h。
5.一种治疗老年性脑梗塞的药物,其特征在于,其包括权利要求1或2所述的中药组合物。
6.根据权利要求5所述的药物,其特征在于,包括治疗急性缺血性脑卒中的药物。
7.根据权利要求6所述的药物,其特征在于,所述治疗急性缺血性脑卒中的药物至少包括阿司匹林、硫酸氢氯吡格雷及阿托伐他汀钙片。
8.一种治疗老年性脑梗塞的中药颗粒,其特征在于,其是按照以下方法制备得到:
按重量份数称取黄芪、川芎、熟地黄、桃仁、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、鹿角胶、龟甲胶、茯苓,备用;
将鹿角胶、龟甲胶粉碎成细粉,得到细粉混合物;
将称取的川芎、桃仁混合,提取挥发油,所得挥发油用环糊精进行包合,得到挥发油包合物;
收集提取挥发油后川芎及桃仁的药渣,与黄芪、熟地黄、红花、山药、枸杞子、山茱萸、川牛膝、菟丝子、茯苓混合,加水煎煮,收集煎煮液,精制、浓缩,得到浓缩物;
将所述浓缩物与所述细粉混合物、所述挥发油包合物混合得到药物混合粉,加入辅料,制粒,分装,得到中药颗粒。
9.根据权利要求8所述的中药颗粒,其特征在于,
所述环糊精与所述挥发油的质量比为9~11∶1;
所述辅料为糊精,所述糊精与所述药物混合粉的质量比为0.8~1.2∶1;
所述精制是采用醇沉法进行。
10.权利要求1或2所述中药组合物、或权利要求5~7任一项所述药物或权利要求8~9任一项所述中药颗粒在制备治疗老年性脑梗塞的药物中的用途。
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