CN113577232A - 一种治疗慢性心力衰竭的中药 - Google Patents
一种治疗慢性心力衰竭的中药 Download PDFInfo
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Abstract
本发明涉及一种治疗慢性心力衰竭的中药,有效解决现有慢性心力衰竭的西药治疗易产生耐药及副作用,且疗效差,不能从根本上改善患者的心功能问题,由重量计的:黄芪、人参、麦冬、五味子、制附子、黄连、干姜、桂枝、丹参、红花、龙骨、牡蛎、炒葶苈子、桑白皮、大腹皮、茯苓、车前子、地龙、蜚蠊、炒白术和鹿角霜做原料药物制成,按常规方法制备成浓缩水丸,本发明治疗慢性心力衰竭疗效明显,能够控制慢性心力衰竭疾病的进展,改善临床症状,未发现明显的毒副作用和不良反应。
Description
技术领域
本发明涉及医学领域,特别是一种治疗慢性心力衰竭的中药(又称心衰康宁丸)。
背景技术
心力衰竭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,根据心衰发生的时间、速度,可分为慢性心衰和急性心衰,而慢性心力衰竭是大多数心血管疾病的终末期表现。目前认为神经内分泌系统激活导致心肌重构是引起心衰发生和发展的关键因素。西医治疗多选用β受体阻滞剂、ACEI、螺内酯等药物以改善症状,但易产生耐药及副作用,如内分泌紊乱、洋地黄中毒等,且于临床上并不能明确延缓心肌重塑。中医治疗该病有明显的优势,不但可以控制症状、心肌重构及再住院率,还可减少西药带来的不良反应和延长生存周期。
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慢性心力衰竭的中药,可有效解决现有慢性心力衰竭的西药治疗易产生耐药及副作用,且疗效差,不能从根本上改善患者的心功能问题。
本发明解决的技术方案是,由重量计的:黄芪90-110g、人参9-11g、麦冬27-33g、五味子18-22g、制附子9-11g、黄连9-11g、干姜9-11g、桂枝9-11g、丹参27-33g、红花13.5-16.5g、龙骨27-33g、牡蛎27-33g、炒葶苈子27-33g、桑白皮13.5-16.5g、大腹皮27-33g、茯苓27-33g、车前子27-33g、地龙27-33g、蜚蠊0.5-2g、炒白术27-33g和鹿角霜27-33g做原料药物制成,按常规方法制备成浓缩水丸。
本发明治疗慢性心力衰竭疗效明显,能够控制慢性心力衰竭疾病的进展,改善临床症状,未发现明显的毒副作用和不良反应。
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、麦冬30g、五味子20g、制附子10g、黄连10g、干姜10g、桂枝10g、丹参30g、红花15g、龙骨30g、牡蛎30g、炒葶苈子30g、桑白皮15g、大腹皮30g、茯苓30g、车前子30g、地龙30g、蜚蠊1.5g、炒白术30g和鹿角霜30g做原料药物制成,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、麦冬27g、五味子18g、制附子9g、黄连9g、干姜9g、桂枝9g、丹参27g、红花13.5g、龙骨27g、牡蛎27g、炒葶苈子27g、桑白皮13.5g、大腹皮27g、茯苓27g、车前子27g、地龙27g、蜚蠊0.5g、炒白术27g和鹿角霜27g做原料药物制成,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、麦冬33g、五味子22g、制附子11g、黄连11g、干姜11g、桂枝11g、丹参33g、红花16.5g、龙骨33g、牡蛎33g、炒葶苈子33g、桑白皮16.5g、大腹皮33g、茯苓33g、车前子33g、地龙33g、蜚蠊2g、炒白术33g和鹿角霜33g做原料药物制成,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;
麦冬:养阴生津,用于心阴不足之心悸易惊及热病后期热伤津液等证;
五味子:益气生津,补肾宁心。
制附子:回阳救逆,补火助阳,逐风寒湿邪;
黄连:清热燥湿;
干姜:温中散寒,回阳通脉,温肺化饮;
桂枝:通阳化气;
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;
龙骨:镇心安神;
牡蛎:敛阴,潜阳,止汗,化痰,软坚;
炒葶苈子:泻肺平喘,行水消肿;
桑白皮:泻肺平喘,行水消肿;
大腹皮:行气宽中,行水消肿;
茯苓:利水渗湿,宁心;
车前子:利水通淋、清热化痰;
地龙:通络、平喘。
蜚蠊:散瘀,化积,解毒;
炒白术:健脾益气,燥湿利水;
鹿角霜:温肾助阳,收敛止血。
由上述药物可知,本发明以温阳益阴、化瘀利水平喘为治法,全方配伍精当,扶正祛邪并用,化瘀利水不伤正,补益不留邪,并经临床应用治疗心力衰竭,取得了显著的疗效,有关试验资料如下:
1一般资料
筛选2011年1月份至2021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80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40例,女40例,平均年龄(65±8)岁,治疗时长1-3个月,平均治疗时长1.5±1.3月。其中吸烟史30例,饮酒史35例,原发性高血压病史60例,2型糖尿病史24例,高脂血症病史25例,冠心病家族史12例。
2观察方法
2.1诊断标准
2.1.1中医诊断标准:
参照《慢性心力衰竭中西医结合诊疗专家共识》、《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《中国心力衰竭诊断和治疗指南2018》和《实用心脏病学(第五版)》制定关于心力衰竭的诊断标准拟定。
2.1.3中医症候诊断标准:
主症:气喘,胸闷,下肢浮肿,活动后加重。
次症:脘腹痞满;气短乏力;胸痛;口唇紫暗;大便粘滞不爽。
舌象:舌质淡暗或紫暗,舌边有瘀点、瘀斑,舌下脉络紫暗、迂曲,苔腻或白滑。
脉象:脉沉细,滑或涩。
2.2疗效判定标准
2.2.1临床症状疗效判定标准
(1)显效:胸闷气喘等主要症状消失或达到显效标准,心功能提高2个等级及以上。
(2)有效:胸闷气喘等主要症状减轻或达到有效标准,心功能提高1个等级。
(3)无效:胸闷气喘等主要症状无改善,心功能提高不足1个等级。
在综合诊疗判断时,若胸闷气喘等主要症状疗效与心功能疗效两者不一致时,应以疗效低的结果为综合疗效。
2.2.2心功能疗效判定标准(参照NYHA分级)
根据2002年版《中药新药临床研究指导原则》进行判定。
显效:心功能提高2个等级及以上(如Ⅲ级转为Ⅰ级,Ⅳ级转为Ⅱ级)。
有效:心功能提高1个等级(如Ⅲ级转为Ⅱ级,Ⅳ级转为Ⅲ级,Ⅱ级转为Ⅰ级)。
无效:心功能提高不足1个等级或无改变。
2.2.3中医证候积分疗效判定标准采用尼莫地平法
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%;
2.3纳入标准
(1)符合冠心病慢性心力衰竭诊断标准;
(2)心功能等级为II、III、Ⅵ级;
(3)符合阴阳两虚、血瘀水停的中医辨证标准;
(4)年龄在40~75岁;
(5)近半月,未使用其它中医方法治疗;
(6)临床资料完整者(治疗前后肝肾、凝血功能)。
2.4排除标准
(1)合并有严重心律失常、肺栓塞、心源性休克、感染等危重情况者;
(2)合并有继发性高血压、1型糖尿病患者;
(3)合并有严重肝、肾功能损害者;
(4)精神异常及依从性差者;
(5)妊娠或哺乳期妇女;
(6)恶性肿瘤患者;
(7)已知对研究中所用药物有不良反应者。
2.5治疗方法
(1)口服本发明,剂型:浓缩水丸,每次6克,每日3次,温开水送服。对已应用ACEI类、利尿类、强心类等心力衰竭常规药物,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)心功能分级(NYHA)。
(2)心脏彩超(LVEF、LVDd)。
(3)NT-proBNP水平。
(4)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。
2.9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
本发明治疗心力衰竭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95.00%,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。说明在改善中医证候积分方面明显。详见表3-4
表2心衰康宁丸治疗心力衰竭中医证候积分判定标准
a:评分标准为0、3、6、9;b:评分标准为0、1、2、3;c:评分标准为0、1。
表3治疗前后中医证候积分对比
表4中医证候积分疗效评定
3.3 NT-proBNP结果比较
纳入的患者在治疗前后查NT-proBNP得到的数据经统计分析后显示治疗后的基线值由1744.70±807.10降至816.68±491.84,较基线值下降964.63±413.33,治疗前后NT-proBNP数值对比P<0.05,差异显著有统计学意义。具体见表5。
表5 NT-proBNP治疗前后的变化(ng/L)
3.4 LVEF、LVDd前后变化的比较
治疗后左室射血分数(LVEF)由33.90±3.41%升至50.03±3.74%,左室舒张末期内径(LVDd)由52.12±6.66mm降至51.13±7.14mm;经秩和检验,P<0.05,差异具有统计学意义。具体比较数据见表6-7。
表6治疗前后LVEF、LVDd比较
3.5心功能疗效的评价
治疗前80例心功能均在Ⅱ~Ⅲ级之间,治疗后显效41例,有效37例,无效2例,总有效率97.25%,详见表7。
表7心功能疗效评定
4讨论
心力衰竭是各种心脏疾病的严重表现或终末期,有着较高的住院率和死亡率,在我国心力衰竭患者的病因中,冠心病约占49.4%,其死亡的主要原因依次为左心衰竭(59%)、心律失常(13%)和心脏性猝死(13%)。在祖国医学中,心衰最早可追溯到《脉经》,对心衰的脉象进行陈述如:“心衰则伏,肝微则沉,故令脉伏而沉。”另外,根据心衰的症状,可将归属于《内经》中的“心胀、心痹”,如《灵枢·胀论》中述:“心胀者,烦心短气,卧不安”,《素问·痹论》中述“心痹者,……暴上气而喘”。另有医圣张仲景将其病因归于心水如:“心水者,其身重而少气,不得卧,烦而躁,其人阴肿”,并提出了用温药和从小便去之的治法。随着现代医学对心衰的深入研究,本申请认为心力衰竭是慢性、自行进展性疾病,是多种疾病综合导致的结果,如冠心病、高血压、糖尿病、肥胖等,常涉及多个脏腑。认为心衰的基本病机应归属于本虚标实、虚实夹杂,以心阴、心阳不足为本,血瘀是中心环节,血不利则为水,血瘀水停为其标。
本申请是基于“阴阳两虚、血瘀水停证”理论自拟出本发明的组方,因此,以温阳益阴、化瘀利水平喘为治疗原则而立方,方中人参、黄芪大补元气、温补心阳,气行则血行以助其用;麦冬、五味子养心阴,四药合用补心体助心用为君药;其中丹参、红花活血化瘀,桑白皮、大腹皮、茯苓、车前子、炒葶苈子平喘利水,桂枝、干姜、制附子、鹿角霜补肾温阳、化气以利水共为臣药;炒白术益气健脾,培土以制水,黄连清热燥湿防止化热,地龙通经活络以平喘,龙骨、牡蛎以镇静安神为佐药;蜚蠊散瘀解毒为使药。全方配伍精当,扶正祛邪并用,化瘀利水不伤正,补益不留邪,共奏补阳益阴,化瘀利水之功。总之,本发明可通过补气温阳、益阴化瘀、利水平喘之法,治疗心力衰竭,能明显改善临床症状,从根本上改善患者的心功能,延缓生存周期,减少再住院率,控制或逆转心肌重构,使用安全可靠,值得临床运用。
Claims (4)
1.一种治疗慢性心力衰竭的中药,其特征在于,由重量计的:黄芪90-110g、人参9-11g、麦冬27-33g、五味子18-22g、制附子9-11g、黄连9-11g、干姜9-11g、桂枝9-11g、丹参27-33g、红花13.5-16.5g、龙骨27-33g、牡蛎27-33g、炒葶苈子27-33g、桑白皮13.5-16.5g、大腹皮27-33g、茯苓27-33g、车前子27-33g、地龙27-33g、蜚蠊0.5-2g、炒白术27-33g和鹿角霜27-33g做原料药物制成,按常规方法制备成浓缩水丸。
2.根据权利要求1所述的治疗慢性心力衰竭的中药,其特征在于,由重量计的:黄芪100g、人参10g、麦冬30g、五味子20g、制附子10g、黄连10g、干姜10g、桂枝10g、丹参30g、红花15g、龙骨30g、牡蛎30g、炒葶苈子30g、桑白皮15g、大腹皮30g、茯苓30g、车前子30g、地龙30g、蜚蠊1.5g、炒白术30g和鹿角霜30g做原料药物制成,按常规方法制备成浓缩水丸。
3.根据权利要求1所述的治疗慢性心力衰竭的中药,其特征在于,由重量计的:黄芪90g、人参9g、麦冬27g、五味子18g、制附子9g、黄连9g、干姜9g、桂枝9g、丹参27g、红花13.5g、龙骨27g、牡蛎27g、炒葶苈子27g、桑白皮13.5g、大腹皮27g、茯苓27g、车前子27g、地龙27g、蜚蠊0.5g、炒白术27g和鹿角霜27g做原料药物制成,按常规方法制备成浓缩水丸。
4.根据权利要求1所述的治疗慢性心力衰竭的中药,其特征在于,由重量计的:黄芪110g、人参11g、麦冬33g、五味子22g、制附子11g、黄连11g、干姜11g、桂枝11g、丹参33g、红花16.5g、龙骨33g、牡蛎33g、炒葶苈子33g、桑白皮16.5g、大腹皮33g、茯苓33g、车前子33g、地龙33g、蜚蠊2g、炒白术33g和鹿角霜33g做原料药物制成,按常规方法制备成浓缩水丸。
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