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WANG Peng, WU Zonggui, ZHANG Zhengyan. Effect of Huoxin Pill (concentrated pill) combined with Baduanjin on prognosis after interventional operation of acute myocardial infarction complicated with heart failure[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202308034
Citation: WANG Peng, WU Zonggui, ZHANG Zhengyan. Effect of Huoxin Pill (concentrated pill) combined with Baduanjin on prognosis after interventional operation of acute myocardial infarction complicated with heart failure[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202308034

Effect of Huoxin Pill (concentrated pill) combined with Baduanjin on prognosis after interventional operation of acute myocardial infarction complicated with heart failure

doi: 10.12206/j.issn.2097-2024.202308034
  • Received Date: 2023-08-16
  • Rev Recd Date: 2023-12-20
  •   Objective  To observe the effect of Huoxin Pill (concentrated pill) combined with Baduanjin on the prognosis of patients with acute myocardial infarction complicated by Percutaneous Coronary Intervention (PCI).   Methods  120 Patients with acute myocardial infarction complicated with heart failure who received emergency interventional treatment in our hospital from January 2022 to January 2023 were randomly divided into Western medicine treatment group and Traditional Chinese Medicine (TCM)comprehensive treatment group. Western medicine treatment: standard Western medicine treatment + five prescriptions for cardiac rehabilitation; Based on Western medicine treatment, Huaxin pill (concentrated pill) combined with Baduanjin therapy was added to the TCM comprehensive treatment group, and the follow-up was 6 months. The observed indexes were exertion angina pectoris scale, Chinese Medicine Syndrome Scale, Chinese medicine syndrome treatment effect evaluation, 6-minute walking test (6MWT), left ventricular ejection fraction (LVEF), and brain natriuretic peptide precursor (pro-BNP).   Results  Sixty patients were enrolled in the two groups respectively. During the treatment, 2 cases fell off in the Western medicine treatment group and 8 cases fell off in the TCM comprehensive treatment group, and a total of 110 cases were enrolled in the group. Compared with the western treatment group, TCM combined therapy significantly improved angina pectoris scale score, TCM Syndrome Scale score, pro-BNP, LVEF and 6MWT (P < 0.001). There were no significant differences in blood routine, liver and kidney function, potassium, blood glucose, blood lipids and cardiac Troponin I (cTnI) between the two groups (P > 0.05). No adverse cardiovascular events occurred during the entire treatment period in both groups.   Conclusion  Huaxin Pill (concentrated pill) combined with Baduanjin was more effective than Western therapy in improving LVEF, 6MWT distance, exercise tolerance and cardiac function in patients with acute myocardial infarction complicated with heart failure.
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    [8] 邓红芳. 知己健康管理模式下门诊冠心病患者的护理效果的相关研究[J]. 心血管病防治知识(学术版), 2018(32):73-75.
    [9] 孙党红, 许婷婷, 孟洁, 等. 心脏康复风险评估结合中医经络操对冠状动脉支架植入术后患者日常生活能力和生活质量的影响[J]. 护理实践与研究, 2019, 16(16):45-46. doi:  10.3969/j.issn.1672-9676.2019.16.018
    [10] 中华医学会心血管病学分会, 中国康复医学会心血管病专业委员会, 中国老年学学会心脑血管病专业委员会. 冠心病康复与二级预防中国专家共识[J]. 中华心血管病杂志, 2013, 41(4):267-275.
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    [12] HE J, WO D, MA E, et al. Huoxin pill prevents excessive inflammation and cardiac dysfunction following myocardial infarction by inhibiting adverse Wnt/β-catenin signaling activation[J]. Phytomedicine, 2022, 104:154293. doi:  10.1016/j.phymed.2022.154293
    [13] CHU J F, ZHOU X L, PENG M Z, et al. Huoxin pill attenuates cardiac inflammation by suppression of TLR4/NF-κB in acute myocardial ischemia injury rats[J]. Evid Based Complementary Altern Med, 2020, 2020:1-9.
    [14] HE J A, WO D, MA E, et al. Network pharmacology-based analysis in determining the mechanisms of Huoxin pill in protecting against myocardial infarction[J]. Pharm Biol, 2021, 59(1):1189-1200. doi:  10.1080/13880209.2021.1964542
    [15] SHEN Z Q, SHEN A L, CHEN X P, et al. Huoxin pill attenuates myocardial infarction-induced apoptosis and fibrosis via suppression of p53 and TGF-β1/Smad2/3 pathways[J]. Biomed Pharmacother, 2020, 130:110618. doi:  10.1016/j.biopha.2020.110618
    [16] PENG M Z, YANG M L, SHEN A L, et al. Huoxin pill (活心丸) attenuates cardiac fibrosis by suppressing TGF-β1/Smad2/3 pathway in isoproterenol-induced heart failure rats[J]. Chin J Integr Med, 2021, 27(6):424-431.
    [17] PENG M Z, YANG M L, LU Y, et al. Huoxin Pill inhibits isoproterenol-induced transdifferentiation and collagen synthesis in cardiac fibroblasts through the TGF-β/Smads pathway[J]. J Ethnopharmacol, 2021, 275:114061. doi:  10.1016/j.jep.2021.114061
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    [20] 张漳禄. 八段锦对急诊PCI术后患者Ⅱ期心脏康复的疗效评价[D]. 福州: 福建中医药大学, 2019.
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Effect of Huoxin Pill (concentrated pill) combined with Baduanjin on prognosis after interventional operation of acute myocardial infarction complicated with heart failure

doi: 10.12206/j.issn.2097-2024.202308034

Abstract:   Objective  To observe the effect of Huoxin Pill (concentrated pill) combined with Baduanjin on the prognosis of patients with acute myocardial infarction complicated by Percutaneous Coronary Intervention (PCI).   Methods  120 Patients with acute myocardial infarction complicated with heart failure who received emergency interventional treatment in our hospital from January 2022 to January 2023 were randomly divided into Western medicine treatment group and Traditional Chinese Medicine (TCM)comprehensive treatment group. Western medicine treatment: standard Western medicine treatment + five prescriptions for cardiac rehabilitation; Based on Western medicine treatment, Huaxin pill (concentrated pill) combined with Baduanjin therapy was added to the TCM comprehensive treatment group, and the follow-up was 6 months. The observed indexes were exertion angina pectoris scale, Chinese Medicine Syndrome Scale, Chinese medicine syndrome treatment effect evaluation, 6-minute walking test (6MWT), left ventricular ejection fraction (LVEF), and brain natriuretic peptide precursor (pro-BNP).   Results  Sixty patients were enrolled in the two groups respectively. During the treatment, 2 cases fell off in the Western medicine treatment group and 8 cases fell off in the TCM comprehensive treatment group, and a total of 110 cases were enrolled in the group. Compared with the western treatment group, TCM combined therapy significantly improved angina pectoris scale score, TCM Syndrome Scale score, pro-BNP, LVEF and 6MWT (P < 0.001). There were no significant differences in blood routine, liver and kidney function, potassium, blood glucose, blood lipids and cardiac Troponin I (cTnI) between the two groups (P > 0.05). No adverse cardiovascular events occurred during the entire treatment period in both groups.   Conclusion  Huaxin Pill (concentrated pill) combined with Baduanjin was more effective than Western therapy in improving LVEF, 6MWT distance, exercise tolerance and cardiac function in patients with acute myocardial infarction complicated with heart failure.

WANG Peng, WU Zonggui, ZHANG Zhengyan. Effect of Huoxin Pill (concentrated pill) combined with Baduanjin on prognosis after interventional operation of acute myocardial infarction complicated with heart failure[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202308034
Citation: WANG Peng, WU Zonggui, ZHANG Zhengyan. Effect of Huoxin Pill (concentrated pill) combined with Baduanjin on prognosis after interventional operation of acute myocardial infarction complicated with heart failure[J]. Journal of Pharmaceutical Practice and Service. doi: 10.12206/j.issn.2097-2024.202308034
  • 近年来,暴饮暴食、过量饮酒、熬夜通宵等不良生活习惯屡见不鲜,高脂食物摄入过多,缺少运动等因素导致血粘度升高,造成急性心肌梗死(AMI)和心力衰竭(HF)发病率激增[1-2]。急性心肌梗死合并心衰是目前死亡率最高的心血管疾病。除了药物治疗外,经皮冠状动脉介入术(PCI)是目前治疗AMI的常用且最有效的治疗方法之一[3]。2014年《中国心血管病报告》[4]显示,我国接受PCI治疗者约有45万人,但3年时间已经增加20万人接受治疗[5]。虽然PCI治疗死亡率稳定在0.21%的较低水平,但是也有一些副反应产生如炎症反应、血栓形成,血小板抵抗,术后缺血性再灌注损伤[6]。另外,患者自身心理压力繁重,心情焦虑、烦躁,生活质量远不如前[7],故在PCI术后对患者进行心脏康复是十分必要的,不仅可以预防并发症的产生,提高依存性和满意度,更可以减缓患者的心理压力,通过科学的康复计划,重新回到社会[8]

    如何进一步促进AMI合并HF患者的心脏康复是临床的难点,也是研究的热点。尽管国外研究发现心脏康复获益明显,但目前其康复治疗率仍然较低。究其原因,其以健身房为基础的心脏康复运动方式,深受场地及康复设备的限制,并且当患者进行较高强度的运动训练时有恶化心脏功能、突发心律失常、心脏骤停或其他严重损伤的可能。在中国,虽然患者对急性心肌梗死合并心衰的心脏康复虽起步较晚,但是传统中医康复方法的加入,丰富和强化了西医康复模式。结合中医理论,对患者体质进行辨识,对其生活习惯、饮食偏嗜进行指导,并在急性心肌梗死后早期辨证使用中药、针灸及功法训练[9],充分发挥中医养生学及针灸、康复学的优势,建立中国特色的中西医结合心脏康复医学模式,制定急性心肌梗死后中西医结合康复治疗规范意义重大。

    • 选择2022年1月至2023年1月就诊于海军军医大学第二附属医院(上海长征医院),诊断急性心肌梗死,通过急诊绿色通道进行冠脉造影明确诊断,并行介入治疗,且在24 h内出现心衰的患者120例,按照治疗方法随机化分为西医治疗组和中医综合治疗组,每组各60例。入选标准:(1)诊断为急性心肌梗死的患者(包括ST段抬高型及非ST段抬高型心肌梗死),且24 h内出现心衰(pro-BNP>125 ng/ml);(2)中医辨证属心血瘀阻型者;(3)年龄在35~75岁之间;(4)已自愿签署知情同意书患者。排除标准:(1)重度神经官能症者;(2)合并重度心律失常及心肺功能不全患者;(3)冠心病经冠脉搭桥术后;(4)对研究用药过敏、或者有过量酗酒、吸毒病史的;(5)合并肝、肾、造血系统等严重原发性疾病。该项目获得本院伦理委员会批准。

    • 参照指南共识[10]给予基础治疗如抗血小板聚集类药物、他汀类调脂固斑药物、同时根据患者病情个体化予血管紧张素转换酶抑制剂(ACEI)或血管紧张素Ⅱ受体拮抗剂(ARB)、β受体阻断剂、降压降糖等药物,另外依据患者的心肺运动功能个性化设计有氧运动。每周2次,每次30 min,时间6个月。

    • 在西医治疗的基础上,入组第1天开具活心丸(浓缩丸)2粒,每天三次,持续服用6个月。同时由康复师教授呼吸功,疗程1周,1周后开始坐位八段锦练习至1个月,并教授立位八段锦,供患者出院后自行练习6个月。

    • 患者1周、6个月行左心室射血分数(LVEF)、脑钠肽前体(pro-BNP)、6 min步行试验(6MWT)检验检查,用来评定运动耐力、心功能情况及治疗效果。

    • 患者1周、6个月通过西雅图心绞痛评分量表评估劳力性心绞痛发生情况。

    • 患者1周、6个月中医症候(胸痛、胸闷、心悸、唇、舌、脉等)积分情况,总积分:轻度:≤6分,中度:7-14分,重度:>14分,症候积分越低,患者健康程度越好。

    • 统计分析将采用SPSS 22.0统计软件进行分析。两组计量资料以均数±标准差($ \stackrel{-}{x}\pm s $)表示,两组间比较采用t检验或wilcoxon符号秩检验,两组内比较采用配对样本t检验或wilcoxon符号秩和检验比较组内前后差异;分类计数资料采用χ2检验。统计结果,当P<0.05时,统计学上有差异;当P<0.01时,表示统计学上有显著性差异;当P>0.05时,无统计学意义。

    • 本课题共纳入120例患者,两组随机分组,每组60例,但部分外地患者未能按时随访及少数患者未能按要求贯彻心脏康复方案,对照组脱落2例,干预组脱落例8例,最终计算得出共计入组110例,西医治疗组58例,中医综合治疗组52例。两组患者的性别、年龄、BMI、危险因素、合并病及西药用药处方情况、生化指标等基线一致P>0.05,差异无统计学意义(表1)。

      组别西医治疗组中医综合治疗组P
      性别(男)58(38)52(46)0.880
      年龄(岁)62.00±12.858.54±10.40.219
      BMI25.17±1.2824.53±2.010.594
      危险因素
      高血压58(30)52(24)0.726
      高脂血症58(35)52(30)0.622
      糖尿病58(32)52(20)0.081
      用药情况
      ACEI/ARB58(41)52(31)0.070
      Beta受体阻滞剂58(39)52(26)0.082
      血常规
      WBC(×109/L)10.40(4.00)10.30(3.90)0.802
      RBC(×1012/L)4.48(0.93)4.47(0.69)0.475
      PLT(×109/L)203.00(69.5)204.00(73.25)0.368
      Hb(g/L)137.00(25.8)140.50(21.50)0.600
      hs-CRP(mg/L)7.84(15.10)7.40(17.94)0.991
      肝功能
      AST(U/L)48.00(47.50)37.5(42.80)0.883
      ALT(U/L)41.00(48.50)33.50(25.50)0.064
      肾功能
      肌酐(umol/L)64.40(18.85)64.95(17.33)0.937
      电解质
      K+(mmol/L)3.89(0.40)3.90(0.61)0.863
      血糖
      HbA1c(%)6.05(2.20)6.45(2.90)0.719
      FPG(mmol/L)5.93(2.65)6.39(5.08)0.341
      血脂
      TC(mmol/L)5.20(1.80)4.45(1.70)0.089
      TG(mmol/L)1.70(1.42)1.45(0.88)0.127
      HDL-C(mmol/L)1.05(0.24)1.04(0.28)0.230
      LDL-C(mmol/L)3.15(1.21)2.82(1.27)0.137
      cTnI(ng/ml)8.40(23.13)5.20(13.80)0.897
    • 纳入的两组患者,经统计计算得到治疗前两组全部符合正态分布用($ \bar{x}\pm s $)表示,干预组呈非正态分布,用M(IQR)表示离散程度,两组组间比较选用非参数检验得到P=0.897>0.05,说明中医综合治疗组和西医治疗组在治疗前具有可比性。在两组治疗后可以得到P<0.001,说明中西医治疗均可在患者中医症候方面有所效果。两组治疗前后的组内比较,选用成对样本t检验,得到P<0.001,且对照组和干预组治疗后干预组中医症候评分1.0(1.0)优于对照组中医症候评分2.0(2.0)。(表2

      组别 n 治疗前 治疗后 统计值 P
      中医综合治疗组 52 13.1±3.4 1.0(1.0) t=22.75 <0.001
      西医治疗组 58 13.1±4.0 2.0(2.0) t=18.84 <0.001
      统计值 Z=−0.13 Z=−6.80
      P 0.897 <0.001
    • 两组患者治疗前后均不符合正态分布,用M(IQR)表示,两组组间比较数据无统计学差异(P>0.05),说明两组患者可以比较。治疗后两组心绞痛评分有统计学差异(P<0.001),且治疗后中医综合治疗组2.0(2.0)优于西医治疗组3.0(2.0)。两组的组内比较均显示两组治疗前后心绞痛症状评分有显著统计学差异(P<0.001)。提示治疗能够明显改善两组患者的心绞痛情况(表3)。

      组别 n 治疗前 治疗后 Z P
      中医综合治疗组 52 8.0(2.0) 2.0(2.0) −5.632 <0.001
      西医治疗组 58 8.0(2.0) 3.0(2.0) −6.576 <0.001
      Z 0.383 4.642
      P 0.702 <0.001
    • 对照组在治疗前和治疗后不符合正态分布,干预组也不符合,均用M(IQR)表示。两组间的治疗前后对比均选用两独立样本非参数检验,得到pro-BNP的差异不具有统计学意义(P>0.05),具有可比性。治疗后有统计学意义P=0.002<0.05。两组组内比较显示pro-BNP有差异(P<0.001)。说明了通过治疗能够明显改善两组患者的心功能预后。(表4

      组别 n 治疗前 治疗后 统计值 P
      中医综合治疗组 52 400.5(1647.0) 94.0(120.8) Z=−5.277 <0.001
      西医治疗组 58 302.0(708.3) 52.0(64.0) Z=−5.367 <0.001
      统计值 Z=−1.902 Z=−2.294
      P 0.057 0.022
    • 两组6MWT数据经统计学得出,两组在治疗前和治疗后符合正态分布,方差齐性。治疗后两组在改善患者6分钟步行距离差异不具有统计学意义(P=0.057),但有趋势。提示中医综合疗法在合并有心衰的患者中较西医康复治疗患者有一定优势(表5)。

      组别 n 1月 6月 t P
      中医综合治疗组 52 358.1±79.3 456.0±40.1 −6.51 <0.001
      西医治疗组 58 346.9±69.6 425.6±45.3 −8.89 <0.001
      t −0.42 −1.98
      P 0.674 0.057
    • 经统计发现中医综合疗法在改善患者LVEF较单纯西医康复治疗具有统计学意义但其证据度不高P=0.038。提示中医综合疗法在急性心肌梗死后合并心衰的患者中在改善患者左室收缩功能方面较西医康复治疗有一定优势。(表6

      组别 N 治疗前 治疗后 统计值 P
      中医综合治疗组 52 45.6±6.5 55.8±7.6 t=−7.367 <0.001
      西医治疗组 58 46.0(6.0) 52.1±5.4 t=−6.415 <0.001
      统计值 Z=−0.765 t=−2.174
      P 0.464 0.038
    • 心脏康复策略是有效降低急性心肌梗死合并心衰患者死亡率的一种安全有效的干预措施,改善患者预后。国外一项为期五年的研究发现在12 291例AMI患者中,心脏康复处方占43.6%,采用Cox多变量分析,心脏康复处方与整体人群1年死亡率较低有关,且从绝对值来看,与心脏康复相关的死亡率下降与风险水平呈正相关[11]。但中医综合疗法在降低患者Pro-BNP方面较单纯西医康复治疗有一定优势。心力衰竭并未记载于中国医学古籍中,但记载过类似心衰的症状,心衰与“喘证”、“水肿”、“胸痹”“心悸”等病名在症状方面有相似之处。心衰是很多心血管疾病的终末阶段,心肌梗死、心肌病、血流动力学负荷过重、炎症都可造成心肌损伤,最终导致心室泵血或充盈功能低下。血瘀证候的出现是由于心气虚衰,推动血液运行无力,血液瘀滞而为之。如果心肾衰竭,阴尽阳脱则可出现危候。心力衰竭病位在心,累及肺脾肾,以气虚阳虚为其基本病理变化。治疗心力衰竭患者最常用的就是益气活血类药物,本实验选用的活心丸(浓缩丸)中的药物为益气活血类代表药物,可以有效的抑制心肌重构、增强心肌收缩能力。我们研究发现,中医综合疗法在改善患者LVEF较单纯西医康复治疗具有统计学意义但其证据度不高(P=0.038)。提示中医综合疗法在合并心衰患者中改善患者左室收缩功能方面较单纯急性心肌梗死的患者对比西医康复治疗方面更有优势。

      活心丸(浓缩丸)由十味中药组成,方中人参、附子组成参附汤,具有益气回阳、温经通脉的功能又兼益气活血之功,针对气虚血瘀、阳气不足而设,故为本方之君药。红花、人工麝香活血通经、散瘀止痛,又能开窍醒神,针对瘀血阻络,胸痹心痛而设;灵芝协助君药益气又能安神,故以上三药共为臣药。方中体外培育牛黄、蟾酥、熊胆、珍珠、冰片开窍醒神、解毒止痛,佐助君臣药物通脉止痛之功,故共为佐药。全方配伍共收益气活血,温经通脉之功,用于气虚血瘀,胸阳不振所致胸痹心痛,胸闷气短,心悸怔忡,畏寒肢冷。研究证实,活心丸(浓缩丸)能通过抑制TLR4/NF-κB通路显著提高急性心肌缺血大鼠的心功能;可以降低急性心肌缺血大鼠血清中丙二醛(MDA)水平、提高超氧化物歧化酶(SOD)水平;通过抑制P53通路,下调Bax蛋白表达水平,提高Bcl-2蛋白表达水平减缓急性心肌缺血大鼠心肌细胞的凋亡;通过抑制TGF-β1/β-Smad2/3信号通路降低心衰大鼠心肌细胞纤维化;调节Wnt/β-catenin以及TLR4/NFκB/NLRP3信号通路发挥改善心梗后缺血再灌注心肌损伤,同时减低炎症反应;能降低心率和心肌耗氧量,通过调节交感/迷走神经活性,降低心律失常发生率[12-17]

      中医所讲的“康复”主要包含两方面,一方面是指疾病的治愈与恢复,另一方面是指精神情志的恢复[18]。中医心脏康复起源于上世纪80年代[19],以中医药理论为基础,主张辨证论治。本研究显示中医综合疗法在中医症候评分、中医症候疗效积分、心绞痛评分等。

      中医心脏康复形式多种多样,主要包括以太极拳、八段锦及五禽戏等为主的形体康复。考虑患者年龄、身体状态等条件,最终决定八段锦加入患者心脏康复处方中。八段锦长期锻炼可舒筋活络、调节脏腑机能,保证人体气血畅通,达到强身健体、延年益寿的效果。并且在呼吸、心血管、内分泌及代谢等疾病中采用八段锦运动康复均取得了满意的效果了,急诊PCI术成功的患者经过运动康复前一般情况和运动风险等评估后,以八段锦作为Ⅱ期心脏康复的运动处方是安全的。以八段锦作为急诊 PCI 术后患者Ⅱ期心脏康复的运动处方能够改善心肺功能和提高生活质量[20]。本课题探讨了中医综合疗法在心脏康复中的作用,因时间限制未对中药、针灸、功法等单个因素进行重点研究,这同样需要严格的临床对照试验设计,希望在今后的研究中能够进一步的探索。

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