CN116672377A - 一种治疗心力衰竭、防治虚弱状态及心衰失代偿发作的中药组合物及其制备方法 - Google Patents
一种治疗心力衰竭、防治虚弱状态及心衰失代偿发作的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药领域,涉及一种治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的的中药组合物及其制备方法。该组合物包括以下原料:黄芪20~30g,人参10~15g,山茱萸20~40g,肉桂6~12g,白芍20~30g,黄芩10~20g,生牡蛎15~25g,远志6~12g,补骨脂6~12g,炙甘草6~12g。本发明提供的治疗心力衰竭、并且能够防治心衰虚弱状态及心衰急性失代偿发作的中药组合物,补益脾肺,滋养营卫,防治虚劳虚损,尤其适用于营卫失调型心衰患者;且能提高患者生活质量,防治心衰急性失代偿发作。
Description
技术领域
本发明属于中药领域,涉及一种治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的的中药组合物及其制备方法。
背景技术
慢性心衰(Chronic heart failure, CHF)是多种原因导致心脏结构和/或功能的异常改变,使心室收缩和/或舒张功能发生障碍,从而引起的一组复杂临床综合征,主要表现为呼吸困难、疲乏和液体潴留。患者常由于各种诱因急性加重,导致病情反复发作,不断恶化。是目前心脏病治疗的重点及难点,严重危害人们健康,5年的存活率与恶性肿瘤相仿。心功能Ⅳ级(NYHA分级)患者的病死率可达40%~50%,未能控制的心衰患者,5年的病死率可达62%。
作为各种心脏疾病演变的终末阶段,CHF是全球住院率和死亡率最高的疾病之一。如何阻断或延缓CHF进程,减少终点事件以及改善患者生活质量是心血管领域面临的重大挑战。
慢性心衰多由于多种心脏疾病迁延难愈反复发作而来,2019年欧洲心脏病学会(The European Society of Cardiology,ESC)强调CHF患者虚弱评估的重要性,同时认为针对CHF患者的虚弱应定义为“与年龄无关,呈动态变化,由多种因素共同作用,最终能使得CHF患者应激状态下易损性增加的一种状态”。虚弱是CHF患者常见的临床现象,指患者生理储备下降导致机体易损性增加,对于寒冷、高温等压力源的耐受能力降低的非特异状态,是一种促进慢性心衰病程进展的独立危险因素。从目前的治疗来看,防治慢性心衰衰弱状态,在心衰缓解期防止急性失代偿期反复发作,是降低病死率的重要方法。慢性心衰多由于多种心脏疾病迁延难愈反复发作而来,从中医理论分析,属于“心损”“虚劳”范畴。
多种原因导致的心力衰竭,在经过强心、利尿、扩血管及常规现代医学治疗,及经过中医益气活血、温阳利水治疗后,虽然心衰的紧急状况得以缓解,但机体正气虚损,脾肺气虚,在外感邪气侵袭下容易反复发作,表现为动则气喘汗出、虚弱乏力,心悸气短、不耐风寒,口干纳呆,失眠等。慢性心衰多由于多种心脏疾病迁延难愈反复发作而来,从中医理论分析,属于“心损”“虚劳”范畴。
经典医籍《难经》云“损其心者,调其营卫”,因此在缓解期需要补益脾肺,建中益心,滋养营卫,防治虚劳虚损,提高患者抵抗力,提高患者生活质量,防治虚弱状态,防止病情迁延复发。目前心衰治疗中成药等制剂中,多以益气活血、温阳利水为治法,与本方立意组方不同。
目前对慢性心衰患者多按照各种指南,长期服药治疗,包括ARNI药物、β-受体阻滞剂、利尿剂等等。但对心衰失代偿发作的预防,目前没有好的治疗方案及药物,遇到诱发因素,导致急性失代偿发作。患者长期受到疾病带来的折磨,而且长期服用西药对身体副作用较大。
发明内容
针对上述现有技术存在的缺点,本发明提供了一种治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的中药组合物,疗效确切,针对慢性心衰患者病情特点,防治失代偿发作。本发明中药组合物能治疗心力衰竭、防治心衰急性失代偿发作的,改善患者预后。
本发明还提供了一种治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的中药组合物的制备方法。
本发明为了实现上述目的所采用的技术方案为:
本发明提供了一种治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的中药组合物,包括下列组分的原料,按重量为:黄芪20~30g,人参10~15g,山茱萸20~40g,肉桂6~12g,白芍20~30g,黄芩10~20g,生牡蛎15~25g,远志6~12g,补骨脂6~12g,炙甘草6~12g。
最优选的,包括下列组分的原料,按重量为:黄芪24g,人参12g,山茱萸30g,肉桂9g,白芍 24g,黄芩15 g,生牡蛎20g,远志9g,补骨脂9g,炙甘草9g。
本发明还提供了一种上述中药组合物的制备方法,包括以下步骤:每剂药物按重量称取原料药,温水浸泡180-360分钟,加水没过原料药材约1-2厘米,原料药材煎煮2次,第一煎煮沸后60-90分钟,第二煎煮沸后60分钟,合并两次药液。
本发明提供的中药组合物:水煎服;按重量称取原料药,冷水浸泡180-360分钟,加水没过原料药材约1-2厘米,原料药材煎煮2次,第一煎煮沸后约60分钟,第二煎煮沸后约60分钟,合并两次药液共400ml,分早、晚餐后2小时温服,每次200ml,每日一剂。
相较于现有技术,本发明具有显著的优势:
多种原因导致的心力衰竭,在经过强心、利尿、扩血管及常规现代医学治疗,及经过中医益气活血、温阳利水治疗后,虽然心衰的紧急状况得以缓解,但机体正气虚损,脾肺气虚,在外感邪气侵袭下容易反复发作,表现为动则气喘汗出、虚弱乏力,心悸气短、不耐风寒,口干纳呆,失眠等。本发明将其归属于中医“心损”、“虚劳”范畴。
因此在缓解期需要补益脾肺,滋养营卫,防治虚劳虚损,提高患者抵抗力,提高患者生活质量,防止病情迁延复发。目前心衰治疗中成药等制剂中,多以益气活血、温阳利水为治法,与本方立意组方不同。
(一)组方分析:
君药:黄芪、人参、肉桂
慢性心衰患者大多正气虚衰,卫外不足,易受外感邪气侵袭,诱发心衰失代偿发作,进一步加重病情。故本发明的中药组合物加入黄芪、人参补益脾肺之气,加入肉桂温阳益卫。人参味甘、微苦,性微温,归脾、肺经。《本草从新》:“甘温微苦,大补肺中元气,泻火除烦,生津止渴,开心益智,聪耳明目,安精神,定魂魄,止惊悸,通血脉。”《名医别录》:“微温,无毒。主治肠胃中冷,心腹鼓痛,胸胁逆满,霍乱吐逆,调中,止消渴,通血脉,破坚积,令人不忘。”黄芪味甘,性微温,归脾、肺经。《本草汇言》:“补肺健脾,实卫敛汗,驱风运毒之药也。”《医学衷中参西录》:“能补气,兼能升气,善治胸中大气下陷。”肉桂辛甘,性温。《本草经集注》:“味辛,温,无毒。主治上气咳逆,结气,喉痹,吐吸。心痛,胁风,胁痛,温筋通脉,止烦出汗,利关节,补中益气。”本发明的中药组合物用人参、黄芪两味补气药,补益脾肺之气,脾肺之气充足,卫气充盛,机体抗邪有力,邪气不易侵袭;气充则血行,气血运行通畅,周流全身,滋养五脏六腑、四肢百骸。黄芪兼能升阳,益卫固表,可升胸中下陷之气及益卫止汗。肉桂助心阳,通血脉,助气血运行全身,还可助卫气,抵抗外邪入侵。
臣药:白芍、黄芩、山萸肉
白芍味酸,有养血敛阴之功,与肉桂同用,一阴一阳,共达调和营卫之功。营气充盛,则能泌其津液,化而为血,充养血脉;卫气充足,则能固护脉体,维持血液正常流通。营卫和调,则血液充盈,血行通畅,心有所养。黄芩味苦、性寒,归肺、胆、胃、大肠经。《本草新编》:“退热除烦,泻膀胱之火,止赤痢,消赤眼,善安胎气,解伤寒郁蒸,润燥,益肺气。”心衰患者常有心悸心烦的症状,故本发明的中药组合物加入黄芩清泻郁热以除虚烦,同时还可制约人参、黄芪、肉桂的温热之性。山萸肉味酸、性微温,归肝、肾经。山萸肉补益肝肾,既能补精,又可助阳。《雷公炮制药性解》:“山茱萸大补精血,故入少阴、厥阴。六味丸用之,取其补肾而不伤于热耳。”山萸肉培元固本,收敛元气,元气充足,邪不可干。
佐药:生牡蛎、远志、补骨脂
牡蛎味咸、性微寒,归肝、肾经。《本草备要》:“微寒以清热补水,治虚劳烦热,温疟赤痢,利湿止渴,为肝、肾血分之药。”《长沙药解》:“敛心神而止惊。”牡蛎滋阴潜阳,收敛浮越之元气,重镇安神。远志味苦辛、性微温,归肺、心经。《玉楸药解》:“开心利窍,益智安神”《本草新编》:“安心气,定神益智,乃心经之药,凡心经虚病俱可治之。”心衰患者多为中老年人,其气血虚衰,气机不畅,营卫失和,昼不精而夜不瞑。故本发明的中药组合物加入生牡蛎、远志以收敛元气,滋阴潜阳,益智安神。补骨脂味辛、性温,归脾、肾、大肠经。《玉楸药解》:“补骨脂温暖水土,消化饮食,升达肝脾,收敛滑泄,甚有功效。”补骨脂温补脾肾阳气,培元固本。
使药:甘草
甘草:味甘、平,归心、肺、脾、胃经,能补益心气,益气复脉,同时善入中焦,补脾益气,《本草正》:“助参芪成气虚之功”。甘草不仅能补心、脾之气,同时与肉桂合用辛甘化阳,与芍药合用酸甘化阴,共达调和阴阳之功。
全方以黄芪、人参、肉桂为君,补益脾肺、温阳益卫;以白芍、黄芩、山萸肉为臣,滋阴敛营、泻火安神;以远志、补骨脂、牡蛎为佐药,滋阴潜阳、镇静安神,甘草调和诸药为佐。全方注重补益脾肺之气,调和营卫,脾肺之气充足,营卫和调,心有所养,正气抗邪有力,防治心衰失代偿的发作。
由于慢性心衰属于中医学“心损”“虚劳”的范畴,是一种本虚标实的疾病,依据“损其心者,调其营卫”的治疗原则,组方中药组合物,防治慢性心衰患者失代偿发作,并取得较好疗效。但由于慢性心衰病机复杂,多以气虚、气阴两虚、阳虚为本,瘀血、水湿、痰饮为标,本发明中药组合物以补益脾肺,调和营卫为用,以补虚为本,调理气血阴阳。故临床应用时多以中药组合物为基础方,根据患者的临床症状,随证加减,以调和营卫为本,兼以活血、利水、化痰或并行,以求标本兼治,最终达到改善患者临床症状,提高患者抵抗力,预防心衰急性失代偿发作的目的。
(二)现代药理研究
(1)黄芪
现代药理研究表明黄芪能够增加心肌收缩力,增加冠脉血流量,减慢心率,从而抗心肌缺血,黄芪皂甙(AS)有抑制血小板聚集,延长动脉血栓形成时间,从而发挥抗血栓形成的作用,黄芪能抑制阿霉素引起的心肌线粒体丙二醛、门冬氨酸氨基转移酶、血清肌酸磷酸激酶活性增高及降低超氧化物歧化酶活性,从而保护心脏。黄芪还能能抗心律失常,扩张冠状动脉和外周血管,降低血压。促进机体代谢、抗疲劳、有明显的利尿作用,能调节血糖,兴奋呼吸和增强和调节机体免疫功能,降血脂,抗衰老等作用。
(2)人参
现代药理研究表明人参皂苷具有抗心肌缺血再灌注损伤的作用,能显著降低心肌梗死面积和心肌酶。人参皂苷Rg1可以通过抑制线粒体过度自噬、下调核转录因子-κB通路、Rho A信号通路等多种途径抑制细胞凋亡、炎症反应、调节能量代谢。人参皂苷Rb1可以通过多种信号通路恢复心脏或线粒体的功能,从而发挥抑制心肌纤维化的作用。人参皂苷Re可以促进血管内皮细胞一氧化氮的释放,降低心房收缩力,延长左心房有效不应期,进而发挥抗心律失常的作用。人参多糖可以降低胆固醇、甘油三酯,恢复心肌线粒体活性,还有抗心肌肥厚的作用。
(3)肉桂
现代药理研究证明,肉桂能增加冠脉血流量,改善冠脉循环,增加心脉的营养血流量。肉桂的主要成分桂皮醛有中枢性及外周性血管扩张作用,能增加血液循环。肉桂蒸馏液能扩张冠状动脉,改善心肌缺血,抑制心肌细胞乳酸脱氢酶、磷酸肌酸激酶的释放,降低过氧化物的生成,提高超氧化物歧化酶活性,从而改善心肌细胞的缺血再灌注损伤。肉桂挥发油能够抑制前列腺素E(PGE)和炎症介质组织胺(Histamine)的释放,清除的自由基(LPO、MDA),从而对心肌细胞膜和细胞起抗氧化作用,减轻损伤。
(4)白芍
现在药理研究表明,白芍水溶物可明显改善异丙肾上腺素所致的心肌缺氧从而起保护作用,对抗由垂体后叶素引起的心肌缺血大鼠心电图的变化,抑制血小板聚集。白芍总苷能使离体的兔耳血管扩张,能增加去甲肾上腺素(NA)对兔主动脉的收缩作用,升高舒张压,减慢心率,同时,白芍能够调节细胞免疫功能,抑制急性炎症水肿及镇痛、解痉作用。
(5)黄芩
现代药理研究表明黄芩苷能够调节血脂、抑制单核细胞趋化蛋白-1(MCP-1)的分泌、抑制炎症反应、促巨噬细胞凋亡、稳定血管斑块、抑制血管平滑肌细胞增值,从而发挥抗动脉粥样硬化的作用。黄芩苷能够降低交感神经的兴奋性、减轻内质网应激、抑制心肌细胞凋亡、减轻炎症损伤和氧化应激,从而发挥保护心肌细胞的作用。黄芩苷还可以抑制氧自由基的释放、减轻线粒体损伤,保护心肌缺血/再灌注损伤。
(6)山萸肉
现代药理研究表明山萸肉水煎剂对大鼠离体心室乳头肌有显著正肌力效应,且能明显改善家兔左心功能不全;山茱萸醇提物能明显预防和对抗动物实验性心律失常;结合植物化学方法分离确定了山茱萸强心作用的有效部位,该有效部位能显著增强家兔和豚鼠的在体心脏心肌收缩力,其安全性优于洋地黄类强心甙。山萸肉配伍组分可调节血脂,恢复血管收缩和舒张动态平衡,改变血液流变性,保护糖尿病大鼠心血管病变。
(7)远志
现代药理研究表明远志具有显著的镇静催眠功效,远志醋酸乙酯提取成分对小鼠有中枢性镇静催眠作用,明显提升小鼠的入睡率和入睡时间。远志具有保护心脑血管的作用,远志中的活性成分可通过阻滞钙通道发挥对兔心肌细胞心律失常的抑制作用,远志皂苷元协同外周血内皮祖细胞移植可改善急性心肌梗死模型大鼠左室舒缩功能、提升心肌梗细胞VEGF基因和蛋白的表达水平以及心肌修复的作用。
(8)生牡蛎
现代药理研究表明牡蛎具有抗氧化作用,牡蛎多糖可以清除自由基,提高体内抗氧化酶活性,抑制脂质过氧化。牡蛎活性肽具有促进胰岛组织修复和恢复其分泌的功能,对四氧嘧啶诱导糖尿病小鼠的形成、胰岛的损伤有一定的保护作用。
(9)补骨脂
现代药理研究表明补骨脂中补骨脂乙素具有很好的强心作用,可以扩张冠状动脉,降低冠脉阻力,增加每搏输出量和心脏做功。补骨脂还具有免疫调节的作用,可以提升机体的免疫力,实现骨质的强化。
本发明提供的一种治疗心力衰竭、并且能够防治心衰虚弱状态及心衰急性失代偿发作的中药组合物有益效果为:
1)补益脾肺,滋养营卫,防治虚劳虚损,尤其适用于营卫失调型心衰患者。
2)提高生活质量,防治心衰急性失代偿发作。
具体实施方式
下面通过临床试验数据和具体实施例,来进一步说明本发明中药组合物的有益效果。
选取70例慢性心力衰竭患者,分为试验组和对照组,在西医常规治疗的基础上,试验组使用本发明中药组合物治疗,对照组使用芪苈强心胶囊治疗,对治疗效果进行临床跟踪观察,并对结果进行比对。
一、诊断标准
(一)中医诊断标准
依据《中药新药临床技术研究指导原则》中“中药新药治疗心力衰竭的临床研究指导原则——中医症候诊断标准”。
以《中医临床诊疗术语国家标准-证候部分》为主要辨证纲领,综合其卫气亏虚证、营气亏虚证、营卫不和证、肺卫气虚(不固)证、脾虚营亏证、邪袭卫表证、太阳经证、太阳伤寒证、太阳中风证症状表现,并参考《中医诊断学》教材(朱文峰主编),综合考虑慢性心衰临床发病情况,制定了营卫亏虚失调证型的中医诊断标准。
主证:动则胸闷憋喘、疲倦,乏力气短,恶风恶寒或身发紧,动则汗出或盗汗,易感冒。
次证:心悸心烦、失眠多梦、肢体浮肿、气喘、小便短少、咳嗽、咳痰、颈部青筋暴露、腹胀。
舌脉:舌淡白或舌红瘦小,脉弱,或脉浮缓,或脉沉细。
凡具备4项主证和具备次证任意3项及3项以上,同时参照舌脉即可诊断为营卫失调型。
(二)西医诊断标准
表1参照Framingham的心力衰竭诊断标准,如下
具备两项主要标准,或一项主要标准及两项次要标准,即可确诊。
(三)心功能分级标准
心功能NYHA分级法 参照美国纽约心脏病协会(NYHA)心功能分级标准,1928年标准。
表2美国纽约心脏病协会心功能分级标准(NYHA分级)
二、症状量化标准
评分标准参照《中药新药临床研究指导原则》中“中药新药治疗心力衰竭的临床指导原则”制定。
(一)心力衰竭中医症状评分标准
中医症候分级标准
轻度:中医症候积分≤11分。
中度:中医症候积分12~32分。
重度:中医症候积分≥33分。
(二)心力衰竭西医症状评分标准
采用Lee氏(N.Engl.J.Med 1982;306,699)于1982年根据临床与X射线改变制定的评分系统。
心力衰竭症状分级标准
轻度:心力衰竭症状积分<6分
中度:心力衰竭症状积分6~12分
重度:心力衰竭症状积分≥12分
三、病例选择标准
(一)病例纳入标准
(1)符合慢性心力衰竭的诊断标准,心功能分级为Ⅱ、Ⅲ级(NYHA分级)的轻、中度心力衰竭患者。
(2)年龄45岁~75岁。
(3)合并症(如高血压、冠心病、心肌病、糖尿病等)控制在理想范围内并维持稳定。
(4)中医辨证分型符合营卫失调的诊断标准。
(5)患者志愿受试,并知情同意者。
(二)病例排除标准
(1)不符合上述纳入标准及资料不全者。
(2)年龄<45岁或>75岁患者。
(3)心力衰竭为重度,心功能Ⅳ级患者。
(4)由于肝、肾等重要脏器功能衰竭导致心力衰竭者。
(5)妊娠或哺乳期妇女、过敏体质及对多重药物过敏者。
(6)合并有肝、肾及内分泌系统,造血系统等严重原发性疾病。
(7)有精神异常及不愿合作者。
(8)凡能增加死亡率的因素:如心源性休克、严重室性心律失常、完全性房室传导阻滞、梗阻型心肌病、未修补的瓣膜病、缩窄性心包炎、心包填塞、肺栓塞、有明显感染者,以及没有控制的高血压等,均不宜入选。
(三)脱落、剔除与终止观察的病例标准
(1)试验过程中发生严重不良反应或出现严重的并发症的患者。
(2)试验过程中自行要求退出或未按规定要求服药的患者。
(3)不能遵照研究方案,依从性较差的患者。
四、研究内容及方法
(一)分组方法
将符合纳入标准的70例患者,随机分为对照组和试验组,每组35例。
(二)治疗方法
参照我国2018年《中国心力衰竭诊断和治疗指南》推荐的方法方案及原则。
(1)一般治疗:
1)消除诱因,如感染、严重心律失常、电解质紊乱、肺梗死和药物使用不当;2)积极控制基础心血管疾病;3)限钠(<3g/d),心衰急性发作伴有容量负荷过重的患者,要限制钠摄入<2g/d,限制液体摄入、低脂饮食、戒烟等;4)保持心情舒畅,减少各种精神刺激。
(2)药物治疗:
1)ARNI药物:沙库巴曲缬沙坦钠片(进口药品注册标准 JX20160017,NovartisSingapore Pharmaceutical Manufacturing Private Ltd),100mg,2次/日,如患者耐受逐渐加量至目标剂量。
2)β-受体阻滞剂:琥珀酸美托洛尔片(国药准字 H32025391,阿斯利康有限公司),6.25-12.5mg,1次/日,从小剂量开始,如患者耐受,可2-4周将剂量加倍,逐渐加量至目标剂量。
3)利尿剂:氢氯噻嗪片(国药准字 H37020788,山东仁和堂药业有限公司),25mg,1次/日。根据液体潴留情况调整剂量,一旦病情控制,可以用最小有效剂量长时间维持。如水肿症状不能改善或加重,可改用呋塞米20mg,1次/日,并根据病情随时调整剂量。
4)ARB药物:缬沙坦(国药准字 H20010217,北京诺华制药有限公司),80mg,1次/日。
在上述四种药物联合应用下,应注意血压、心率变化,如仍有持续收缩性心衰症状表现,可加用地高辛片(洋地黄制剂,国药准字: H3102067,上海信宜药厂有限公司生产),0.125-0.25mg,1次/日,并根据病情调整剂量。
对照组:在常规西药治疗的基础上,服用芪苈强心胶囊(国药准字 Z20040141,石家庄以岭药业股份有限公司),1.2g,3次/日。
试验组:在常规西药治疗的基础上,服用本发明中药组合物。
本发明中药组合物:黄芪24g,人参12g,山茱萸30g,肉桂9g,白芍 24g,黄芩15 g,生牡蛎20g,远志9g,补骨脂9g,炙甘草9g。
以上中药均来自山东中医药大学附属医院中药房。
煎煮方法:每剂药物按重量称取原料药,温水浸泡180-360分钟,加水没过药物约1-2厘米,药物煎煮2次,第一煎煮沸后约60分钟,第二煎煮沸后约60分钟,合并两次药液共400ml,分早、晚餐后2小时温服,每次200ml,每日一剂。
疗程:两组均连续用药4周。
(三)观察指标
(1)动态心电图:观察记录治疗前后心率变异性指标,包括:
1)时域指标:正常窦性心搏间期的标准差(SDNN)、每5分钟窦性心搏间期平均值的标准差(SDANN)、24小时相邻窦性心搏间期之差的均方根(RMMSD)、24小时相邻窦性心搏间期差值大于50ms的心搏占总心搏间期数的百分比(PNN50%)
2)频域指标:高频功率(HF)、低频功率(LF)。
(2)超声心动图:检测治疗前、后左室射血分数(LVEF)的变化。
(3)检测血清氨基末端脑钠肽前体(NT-proBNP)治疗前、后的变化,评估心衰病情。
(4)中医证候积分:中医证候评分参考《中药新药临床研究指导原则》,主症按重(6分)、中(4分)、轻(2分)、无(0分)计分,次症按重(3分)、中(2分)、轻(1分)、无(0分)计分,分值越高症状越严重。
(5)随访:治疗结束6个月后,通过电话随访两组患者6个月内因心衰急性失代偿发作而再次入院情况。
(四)临床疗效评定
中医症候疗效判定标准
参照《中药新药临床研究指导原则》中心力衰竭积分法判定中医症候疗效:疗效指数(N)=(疗前积分-疗后积分)/疗前积分*100%
显效:临床症状、体征消失或明显改善,N≥70%;
有效:临床症状、体征均有好转,30%≤N<70%;
无效:临床症状、体征无明显好转,甚或加重,N<30%;
加重:原有症状治疗后有所加重,总积分较治疗前增加10%以上。
(五)统计学方法
应用统计软件SPSS25.0进行分析处理,计量资料采用t检验,用均数±标准差(X_±SD)表示,方差不齐进行秩和检验,等级资料用秩和检验,计数资料用x2检验。P<0.05为有显著性差异性,P<0.01为非常显著差异性。
五、疗效分析
表3两组患者治疗前后HRV的比较(X_±S)
表3各组治疗前后比较:*P<0.05,**P<0.01;治疗后两组比较:△P<0.05 ,△△P<0.01。
由表3可见,试验组治疗前后比较,SDNN、SDANN、RMSSD、PNN50、HF、LF治疗后均明显升高(P<0.05或0.01);对照组治疗后均升高,其中RMSSD、HF、LF具有统计学差异(P<0.05或0.01),SDNN、SDANN、PNN50无统计学差异(P>0.05);两组治疗后比较,试验组明显优于对照组(P<0.05)。
表4 两组患者治疗前后左室射血分数(LVEF)的比较(X_±S)
表4 各组治疗前后比较:**P<0.01;治疗后两组比较:△△P<0.01。
由表4可见,试验组和对照组治疗前后比较,左室射血分数均明显升高(P<0.01);两组治疗后比较,试验组明显优于对照组(P<0.01)。
表5两组患者治疗前后NT-proBNP的比较(X_±S)
表5各组治疗前后比较:**P<0.01;治疗后两组比较:△△P<0.01。
由表5可见,试验组和对照组治疗前后比较,NT-proBNP均明显下降(P<0.01);两组治疗后比较,试验组NT-proBNP下降更明显(P<0.01)。
表6两组患者治疗前后中医症状积分的疗效比较(%)
由表6可见,对照组与试验组的总有效率分别为68.6%、88.6%,经X2检验,X2=4.158,P=0.041,两组中医症状积分疗效比较,试验组优于对照组(P<0.05)。
表7两组患者治疗前后中医症候积分的比较(X_±S)
表7各组治疗前后比较:*P<0.05,**P<0.01;治疗后两组比较:△P<0.05 ,△△P<0.01。
表7可见,两组治疗前后比较,治疗后中医症状积分明显低于治疗前(P<0.01);治疗后两组比较,试验组明显优于对照组(P<0.05)。
表8两组患者治疗前后主要中医症状评分比较(X_±S)
表8各组治疗前后比较:*P<0.05,**P<0.01;治疗后两组比较:△P<0.05 ,△△P<0.01,治疗前两组比较:▲P<0.05,▲▲P<0.01。
由表8可见,两组治疗前后比较,主要中医症状积分治疗后明显小于治疗前,差异均有统计学意义(P<0.01);治疗后两组比较,试验组主要中医症状积分下降,其中气短乏力、恶风恶寒、动则汗出或盗汗、易感冒试验组积分明显低于对照组(P<0.05)。
表9两组患者治疗前后次要中医症状评分比较(X_±S)
表9各组治疗前后比较:*P<0.05,**P<0.01;治疗后两组比较:△P<0.05 ,△△P<0.01,治疗前两组比较:▲P<0.05,▲▲P<0.01。
由表9可见,两组治疗前后比较,次要中医症状积分治疗后明显小于治疗前(P<0.01);治疗后两组比较,试验组次要中医症状积分下降,其中心悸心烦、失眠多梦、气喘、咳嗽、咳痰、小便短少、腹胀治疗组积分明显低于对照组(P<0.05或0.01)。
表10 两组患者治疗后6个月内再入院率比较(%)
由表10可见,对照组和试验组再入院率分别为25.7%、5.71%,经卡方检验,χ2=5.28,P=0.022,两组治疗后半年内再入院率相比,试验组小于对照组(P<0.05)。
表11 两组患者治疗后6个月内再入院次数比较(X_±S)
表11两组治疗结束6个月后再入院次数比较:*P<0.05。
由表11可见,治疗结束后6个月内,试验组患者再入院次数明显少于对照组(P<0.05)。
由上述统计数据可见,本发明的中药组合物能改善心功能,改善患者的临床症状和体征,防治心衰失代偿发作疗效可靠。
下面选取典型病例及优选配方对本发明中药组合物进行具体说明。
实施例1
吕某,女,62岁,2020年因“胸闷、憋喘”于当地医院就诊,诊断为“心力衰竭”,给予西医常规治疗后好转出院,后患者因心力衰竭失代偿发作于当地医院多次住院治疗。患者既往高血压病史10余年,糖尿病病史10余年,冠心病病史5年余。
2021年12月9日一诊:患者近期无明显诱因出现夜间憋喘,不能平卧,端坐呼吸,活动后胸闷憋喘加重,心慌,气短乏力,夜间干咳,恶风恶寒,动则汗出,后背胀闷不舒,口干口苦。纳呆,脘腹胀满,眠差,入睡困难,多梦易醒,大便质干,2日1行,小便调。舌暗红苔薄白,脉沉细。辅助检查:心脏彩超示:左房前后径44mm,左室前后径71mm,右室前后径26mm,右房44*37,室间隔9mm,左室后壁7mm,升主动脉33mm,主肺动脉24mm。左室功能:EF:38%。二维及M型特征:左心扩大,余心脏各房、室腔内径正常范围。房室间隔连续完好。升主动脉及肺动脉内径正常。各组瓣膜结构未见明显异常。心包腔未见明显异常。下腔静脉宽约21mm,吸气塌陷率大于50%。室壁运动分析:部分左室壁运动减低。CDFI:二尖瓣可探及中量返流信号;三尖瓣可探及少量返流信号,CW测三尖瓣最大返流速204cm/s,最大返流压差23mmHg,估测肺动脉收缩压28mmHg;PW示二尖瓣前向血流频谱E峰/A峰<1。超声提示:左心扩大,部分左室壁运动降低,二尖瓣返流(中度),三尖瓣返流(轻度),左室收缩及舒张功能减低。中医诊断:心衰病(脾肺气虚,营卫失和);西医诊断:1.心力衰竭(心功能Ⅲ级 NYHA分级)2.冠心病3.高血压病4.2型糖尿病。
治疗上以补益脾肺,调和营卫为原则,使用本发明中药复合物加减,其配比,按重量为:黄芪24g,人参12g,山茱萸30g,肉桂9g,白芍 24g,黄芩15 g,生牡蛎20g,炙甘草9g,远志9g,补骨脂9g,葛根18g。
水煎服,每日一剂,分早晚两次温服,服用7天。
2021年12月16日二诊:患者诉胸闷憋喘较前好转,但仍不能取平卧位,乏力气短较前减轻,心慌减轻,恶风恶寒减轻,动则汗出改善,后背胀满不舒较前改善。纳食欲增,睡眠稍有改善,仍入睡困难。舌暗苔薄白,脉沉细。
继续服用上述本发明中药组合物7剂。
2021年12月23日三诊:患者诉胸闷憋喘较前改善,现可平卧,无心慌,稍有气短乏力,恶风恶寒较前减轻,动则汗出较前改善,稍感后背胀满。纳可,眠较前改善,二便调。舌暗红苔薄白,脉稍沉。
继续服用上述本发明中药组合物14剂。
2022年1月7日四诊:患者病情明显好转,基本无胸闷憋喘,夜间可平卧入睡,体力可,无气短,无恶风恶寒,汗出正常。纳眠可,二便调。舌暗红苔薄白,脉稍沉。心脏彩超复检结果:左房前后径41mm,左室前后径68mm,右室前后径23mm,右房44*36mm,室间隔10mm,左室后壁8mm,升主动脉34mm,主肺动脉24mm。左室功能:EF:42%。二维及M型特征:左心扩大,余心脏各房、室腔内径正常范围。房室间隔连续完好。升主动脉及肺动脉内径正常。各组瓣膜结构未见明显异常。心包腔未见明显异常。下腔静脉宽约21mm,吸气塌陷率大于50%。室壁运动分析:部分左室壁运动减低。CDFI:二尖瓣可探及中量返流信号;三尖瓣可探及少量返流信号,CW测三尖瓣最大返流速204cm/s,最大返流压差23mmHg,估测肺动脉收缩压28mmHg;PW示二尖瓣前向血流频谱E峰/A峰<1。超声提示:左心扩大,部分左室壁运动降低,二尖瓣返流(中度),三尖瓣返流(轻度),左室收缩及舒张功能减低。
实施例2
张某,女,65岁,2019年因“胸闷、憋喘”于当地医院住院治疗,诊断为“心力衰竭(心功能Ⅲ级 NYHA分级),陈旧性心梗,心室壁瘤,高血压病(2级)。”患者既往高血压病史10余年,心梗病史5年余。平素服用倍他乐克缓释片降低心率、减轻心肌耗氧量,拜阿司匹林抗血小板凝集,阿托伐他汀调节血脂、稳定斑块,呋塞米、螺内酯利尿,沙库巴曲缬沙坦舒张血管、排钠利尿、改善心室重构,效可。
2021年12月11日一诊:患者近期因劳累导致病情加重,胸闷憋喘,动则尤甚,夜间无法平卧,气短乏力,心悸,恶风恶寒,动则汗出,平素易感冒,咳嗽,咳痰色白质黏,晨起口干口苦,双下肢轻微水肿。纳食欲一般,食多易脘腹胀满,眠差,入睡困难,多梦易醒,二便调。舌淡胖苔薄白,脉沉细。辅助检查:心脏彩超:左房前后径44mm,左室前后径65mm,右室前后径28mm,右房43*35mm,室间隔9mm,左室后壁7mm,升主动脉33mm,主肺动脉24mm。左室功能:EF28%。二维及M型特征:左心扩大,余心脏各房、室腔内径正常范围。房、室间隔连续完好。升主动脉及肺动脉内径正常。各组瓣膜结构未见明显异常。心包腔未见明显异常。下腔静脉内径15mm,吸气塌陷率大于50%。室壁运动分析:室间隔中间段及心尖段、前壁中间段及心尖段、侧壁心尖及下壁心尖段室壁变薄,回声增强,运动近消失。部分心尖部室壁运动呈矛盾运动,向外膨出范围约43*20mm,左室下壁中间段及基底段厚度可,运动减低,余室壁运动略低。CDFI:主动脉瓣可见少量返流信号,二尖瓣可见少量返流信号,三尖瓣可见少量返流信号。CW测三尖瓣最大返流速208cm/s,最大返流压差17mmHg,估测肺动脉收缩压22mmHg。PW示二尖瓣前向血流频谱E峰/A峰<1。超声提示:缺血性心肌病,陈旧性心肌梗死,左室心尖部室壁瘤形成。左心扩大,主动脉瓣返流(轻度),二尖瓣返流(轻度),三尖瓣返流(轻度),左室收缩及舒张功能减低。中医诊断:心衰病(脾肺气虚,营卫失和);西医诊断:心力衰竭(心功能Ⅲ级 NYHA分级),陈旧性心梗,心室壁瘤,高血压病(2级)。
治疗上以补益脾肺,调和营卫为原则,使用本发明中药复合物加减,其配比,按重量为:黄芪24g,人参12g,山茱萸30g,肉桂9g,白芍 24g,黄芩15 g,生牡蛎20g,炙甘草9g,远志9g,补骨脂9g。
水煎服,每日一剂,分早晚两次温服,服用7天。
2021年12月18日二诊:患者诉胸闷憋喘较前减轻,乏力气短较前改善,心慌减轻,恶风恶寒减轻,动则汗出改善。纳食欲增,睡眠稍有改善,仍入睡困难。舌淡苔薄白,脉沉细。
继续服用上述本发明中药组合物7剂。
2021年12月25日三诊:患者诉胸闷憋喘较前明显改善,乏力气短明显减轻,心慌明显改善,稍感恶风恶寒,汗出基本正常。纳可,眠改善,二便调。舌淡苔薄白,脉稍沉。
继续服用上述本发明中药组合物14剂。
2022年1月9日四诊:患者诉基本无胸闷憋喘,无心慌,体力可,无恶风恶寒,汗出正常。纳眠可,二便调。舌淡红苔薄白,脉稍沉。心脏彩超复检结果:左房前后径42mm,左室前后径63mm,右室前后径28mm,右房43*35mm,室间隔9mm,左室后壁7mm,升主动脉33mm,主肺动脉24mm。左室功能:EF35%。二维及M型特征:左心扩大,余心脏各房、室腔内径正常范围。房、室间隔连续完好。升主动脉及肺动脉内径正常。各组瓣膜结构未见明显异常。心包腔未见明显异常。下腔静脉内径15mm,吸气塌陷率大于50%。室壁运动分析:室间隔中间段及心尖段、前壁中间段及心尖段、侧壁心尖及下壁心尖段室壁变薄,回声增强,运动近消失。部分心尖部室壁运动呈矛盾运动,向外膨出范围约43*18mm,左室下壁中间段及基底段厚度可,运动减低,余室壁运动略低。CDFI:主动脉瓣可见少量返流信号,二尖瓣可见少量返流信号,三尖瓣可见少量返流信号。CW测三尖瓣最大返流速208cm/s,最大返流压差17mmHg,估测肺动脉收缩压22mmHg。PW示二尖瓣前向血流频谱E峰/A峰<1。超声提示:缺血性心肌病,陈旧性心肌梗死,左室心尖部室壁瘤形成。左心扩大,主动脉瓣返流(轻度),二尖瓣返流(轻度),三尖瓣返流(轻度),左室收缩及舒张功能减低。
以上2例典型病例,表明本发明中药组合物能明显改善患者心衰的临床症状,提高患者的生活质量,增强患者的体质,预防心衰失代偿的发作。
Claims (3)
1.一种治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的中药组合物,其特征在于,包括下列组分的原料,按重量为:黄芪20~30g,人参10~15g,山茱萸20~40g,肉桂6~12g,白芍20~30g,黄芩10~20g,生牡蛎15~25g,远志6~12g,补骨脂6~12g,炙甘草6~12g。
2.根据权利要求1所述的治疗心力衰竭、防治虚弱状态及心衰急性失代偿发作的中药组合物其特征在于,包括下列组分的原料,按重量为:黄芪24g,人参12g,山茱萸30g,肉桂9g,白芍 24g,黄芩15 g,生牡蛎20g,远志9g,补骨脂9g,炙甘草9g。
3.一种如权利要求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:每剂药物按重量称取原料药,温水浸泡180-360分钟,加水没过原料药材约1-2厘米,原料药材煎煮2次,第一煎煮沸后60-90分钟,第二煎煮沸后60分钟,合并两次药液。
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