体外冲击波治疗难治性心绞痛的初步疗效及安全性
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摘要
背景:目前,冠心病的发病率和死亡率已经超过恶性肿瘤,位居第一位。在过去的20余年中,冠心病的治疗由单纯药物治疗,逐渐发展到经皮冠状动脉介入治疗(PCI)或冠状动脉旁路移植术(CABG)等多种治疗手段,但对于那些不适宜接受PCI或CABG术的年龄偏大的难治性心绞痛患者,单纯药物治疗效果不佳时,寻找一种安全有效的非侵入性治疗方法是目前该领域的研究热点之一。体外冲击波治疗(extracorporeal shock wave therapy,ESWT)应用于临床已有近30年的历史,并已广泛用于泌尿系统结石碎石术和某些矫形外科的治疗,如骨折或机化性腱炎等,近几年国外的基础和临床研究报道,体外心脏冲击波(震波)治疗(extracorporeal cardiac shock wave therapy,CSWT)是一种新型的安全、无损伤性的治疗性血管新生手段,该方法能够上调体内血管内皮生长因子(VEGF)及其受体的表达,增加细胞一氧化氮合酶的活性,有促进缺血心肌的毛细血管新生和加速侧枝循环建立的作用,可改善心肌缺血,为终末期冠心病的治疗提供了新的思路和方法。
目的:本研究基于国外报道的技术,目的在于初步评价CSWT应用于难治性心绞痛治疗中的临床疗效和安全性。
方法:在伦理委员会的批准下,入选复旦大学附属中山医院心内科门诊或住院部,经临床诊断明确的冠心病难治性心绞痛患者18例(男14例,女4例),年龄38～85岁,平均年龄(65.6±12.3)岁,采用以色列Medispec公司生产的体外心脏冲击波治疗仪(Cardiospec)实施体外冲击波治疗(100击/点,能量为0.09mJ/mm~2,每次3～6点,3次/周)),三次治疗为一组,间隔三周进行一组治疗,共治疗9周。观察治疗前和治疗后6个月心绞痛症状、活动耐力、生活质量改善情况(采用加拿大心绞痛分级,CCS分级;西雅图心绞痛量表,SAQ积分;6分钟步行距离;NYHA心功能分级等指标),核素心肌血流灌注情况及左心室收缩末期容积(LVESV)、左心室舒张末期容积(LVEDV)、左心室射血分数(LVEF)的变化,随访治疗前后心电图,心肌损伤标志物、NT-proBNP及其它实验室检查指标。
结果:入组18例患者中有1例提前退出,17例次完成治疗后6个月随访。治疗后6个月,患者心绞痛症状较治疗前明显改善(CCS分级治疗前2.5±0.5级vs治疗后2.0±0.0级,P＜0.001),SAQ积分较治疗前提高(活动能力受限情况、心绞痛稳定情况、心绞痛发作频度和治疗方法满意程度均较治疗前明显改善,P＜0.05;疾病主观感受情况有好转趋势,P＞0.05)。心功能较前改善(NYHA心功能分级治疗前2.0±0.7级vs治疗后1.8±0.6,P=0.03),6分钟步行距离较治疗前有增加趋势(术前389±142 vs术后434±134,P＞0.05),NT-proBNP较前也有下降趋势(术前1659±678 vs术后1641±601,P＞0.05)。99mTc-MIBI核素心肌显像显示,治疗后6个月的心肌区域血液灌流明显增加,缺血节段减少,以远离治疗节段作为对照提示治疗节段血流灌注改善(治疗节段vs远离治疗节段:治疗前后舒张末期灌注改变0.31%±5.31%vs-0.72%±6.06%,P=0.047;治疗前后收缩末期灌注改变0.75%±5.10%vs-0.77%±4.61%,P=0.005)。术后左室容积较术前有缩小趋势(LVEDV术前172.11±102.01 ml vs术后157.67±91.38 ml,LVESV术前114.56±99.37 ml vs术后99.44±86.44 ml,均P＞0.05),LVEF也有升高趋势(术前42.17%±18.77%vs术后45.94%±20.52%,P＞0.05)。患者在治疗中及治疗后均无新发心律失常、心绞痛发作等不适症状,也无心肌损伤标志物异常升高(P＞0.05)。治疗及随访期间行经胸超声心动图检查均未发现对功能性瓣膜反流、肺动脉高压、心包积液等产生不良影响,无新发心脏结构及功能损伤。
结论:对于晚期冠心病、弥漫性血管病变以及不适用于传统心肌再血管化治疗的难治性心绞痛患者,本研究提示CSWT是一种安全、可行的治疗方法。
Background:The current management of coronary artery disease(CAD) has three major therapeutic options including medical treatment,precutaneous coronary intervention(PCI),and coronary artery bypass grafting (CABG).Prognosis of severe coronary artery disease with no indication of PCI or CABG,however,still remains poor because medication is the only therapy to treat the disorder.Shock wave therapy has been widely used in the lithotripsy or the treatment of certain orthopedic conditions including bone fracture or calcifying tendonitis.Recently,it has been demonstrated that a low level of shock wave enhances the expression of vascular endothelial growth factor(VEGF) and its receptor,Flt-1,in cultured human endothelial cells in vitro.The results in clinical studies has demonstrated that extracorporeal cardiac shock wave therapy(CSWT) effectively induces neovascularization and improves myocardial ischemia in patients with severe CAD.
Objective:To evaluate the efficacy and safety of CSWT in patients with severe coronary artery disease with no indication of PCI or CABG.
Methods:With permission from the Ethical Committee of our Institute, eighteen patients with severe coronary artery disease with no indication of PCI or CABG(38～85 years old,mean age65.6±12.3years old,fourteen men and four women ) were treated with cardiac shock wave therapy (100shots/spot at 0.09mJ/mm~2 for 3-6 spots,3 times a week/series).Each patient received three applications per week on alternate days for 1 week a month for a total of nine applications in the 3 months.We followed-up the patients at 6 months after the therapy to examine the amelioration of myocardial ischemia.
Results:Cardiac shock wave therapy improved symptoms(Canadian Cardiovascular Society functional class score decreased from 2.5±0.5 to 2.0±0.0(P＜0.01),NYHA class decreased from 2.0±0.7 to 1.8±0.6(P=0.03) and Seattle Angina Questionnaire score increased significantly(P＜0.05). SPECT revealed an increase in perfusion in treated myocardial segments whereas in no treated there was no perfusion increase(P＜0.05).In addition,after 6 months the results also revealed LVEDV decreased from (172.11±102.01) ml to(157.67±91.38) ml(P＞0.05) and in LVESV from (114.56±99.37) ml to(99.44±86.44) ml,(P＞O.05),LVEF from 0.422±0.188 to 0.459±0.205(P＞0.05).There were no side effects during, immediately after or post treatment.There were no pain associated and no signs of local hemorrhage.Vital parameters,cardiac enzymes and ECG were unchanged.In addition,there was no indication of arrhythmias and new wall motion abnormalities.
Conclusion:The extracorporeal cardiac shock wave therapy may be an effective and non-invasive treatment for end-stage coronary artery disease,although further careful evaluation is needed.
目的:本研究基于国外报道的技术,目的在于初步评价CSWT应用于难治性心绞痛治疗中的临床疗效和安全性。
方法:在伦理委员会的批准下,入选复旦大学附属中山医院心内科门诊或住院部,经临床诊断明确的冠心病难治性心绞痛患者18例(男14例,女4例),年龄38～85岁,平均年龄(65.6±12.3)岁,采用以色列Medispec公司生产的体外心脏冲击波治疗仪(Cardiospec)实施体外冲击波治疗(100击/点,能量为0.09mJ/mm~2,每次3～6点,3次/周)),三次治疗为一组,间隔三周进行一组治疗,共治疗9周。观察治疗前和治疗后6个月心绞痛症状、活动耐力、生活质量改善情况(采用加拿大心绞痛分级,CCS分级;西雅图心绞痛量表,SAQ积分;6分钟步行距离;NYHA心功能分级等指标),核素心肌血流灌注情况及左心室收缩末期容积(LVESV)、左心室舒张末期容积(LVEDV)、左心室射血分数(LVEF)的变化,随访治疗前后心电图,心肌损伤标志物、NT-proBNP及其它实验室检查指标。
结果:入组18例患者中有1例提前退出,17例次完成治疗后6个月随访。治疗后6个月,患者心绞痛症状较治疗前明显改善(CCS分级治疗前2.5±0.5级vs治疗后2.0±0.0级,P＜0.001),SAQ积分较治疗前提高(活动能力受限情况、心绞痛稳定情况、心绞痛发作频度和治疗方法满意程度均较治疗前明显改善,P＜0.05;疾病主观感受情况有好转趋势,P＞0.05)。心功能较前改善(NYHA心功能分级治疗前2.0±0.7级vs治疗后1.8±0.6,P=0.03),6分钟步行距离较治疗前有增加趋势(术前389±142 vs术后434±134,P＞0.05),NT-proBNP较前也有下降趋势(术前1659±678 vs术后1641±601,P＞0.05)。99mTc-MIBI核素心肌显像显示,治疗后6个月的心肌区域血液灌流明显增加,缺血节段减少,以远离治疗节段作为对照提示治疗节段血流灌注改善(治疗节段vs远离治疗节段:治疗前后舒张末期灌注改变0.31%±5.31%vs-0.72%±6.06%,P=0.047;治疗前后收缩末期灌注改变0.75%±5.10%vs-0.77%±4.61%,P=0.005)。术后左室容积较术前有缩小趋势(LVEDV术前172.11±102.01 ml vs术后157.67±91.38 ml,LVESV术前114.56±99.37 ml vs术后99.44±86.44 ml,均P＞0.05),LVEF也有升高趋势(术前42.17%±18.77%vs术后45.94%±20.52%,P＞0.05)。患者在治疗中及治疗后均无新发心律失常、心绞痛发作等不适症状,也无心肌损伤标志物异常升高(P＞0.05)。治疗及随访期间行经胸超声心动图检查均未发现对功能性瓣膜反流、肺动脉高压、心包积液等产生不良影响,无新发心脏结构及功能损伤。
结论:对于晚期冠心病、弥漫性血管病变以及不适用于传统心肌再血管化治疗的难治性心绞痛患者,本研究提示CSWT是一种安全、可行的治疗方法。
Background:The current management of coronary artery disease(CAD) has three major therapeutic options including medical treatment,precutaneous coronary intervention(PCI),and coronary artery bypass grafting (CABG).Prognosis of severe coronary artery disease with no indication of PCI or CABG,however,still remains poor because medication is the only therapy to treat the disorder.Shock wave therapy has been widely used in the lithotripsy or the treatment of certain orthopedic conditions including bone fracture or calcifying tendonitis.Recently,it has been demonstrated that a low level of shock wave enhances the expression of vascular endothelial growth factor(VEGF) and its receptor,Flt-1,in cultured human endothelial cells in vitro.The results in clinical studies has demonstrated that extracorporeal cardiac shock wave therapy(CSWT) effectively induces neovascularization and improves myocardial ischemia in patients with severe CAD.
Objective:To evaluate the efficacy and safety of CSWT in patients with severe coronary artery disease with no indication of PCI or CABG.
Methods:With permission from the Ethical Committee of our Institute, eighteen patients with severe coronary artery disease with no indication of PCI or CABG(38～85 years old,mean age65.6±12.3years old,fourteen men and four women ) were treated with cardiac shock wave therapy (100shots/spot at 0.09mJ/mm~2 for 3-6 spots,3 times a week/series).Each patient received three applications per week on alternate days for 1 week a month for a total of nine applications in the 3 months.We followed-up the patients at 6 months after the therapy to examine the amelioration of myocardial ischemia.
Results:Cardiac shock wave therapy improved symptoms(Canadian Cardiovascular Society functional class score decreased from 2.5±0.5 to 2.0±0.0(P＜0.01),NYHA class decreased from 2.0±0.7 to 1.8±0.6(P=0.03) and Seattle Angina Questionnaire score increased significantly(P＜0.05). SPECT revealed an increase in perfusion in treated myocardial segments whereas in no treated there was no perfusion increase(P＜0.05).In addition,after 6 months the results also revealed LVEDV decreased from (172.11±102.01) ml to(157.67±91.38) ml(P＞0.05) and in LVESV from (114.56±99.37) ml to(99.44±86.44) ml,(P＞O.05),LVEF from 0.422±0.188 to 0.459±0.205(P＞0.05).There were no side effects during, immediately after or post treatment.There were no pain associated and no signs of local hemorrhage.Vital parameters,cardiac enzymes and ECG were unchanged.In addition,there was no indication of arrhythmias and new wall motion abnormalities.
Conclusion:The extracorporeal cardiac shock wave therapy may be an effective and non-invasive treatment for end-stage coronary artery disease,although further careful evaluation is needed.
引文
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[2]Okraine K,Banerjee DK,Eismberq MJ.Coronary artery disease in the developing world[J].Am Heart J.2004;148(1):7-15.
[3]金惠铭。治疗性血管新生研究的若干进展.国外医学生理病理科学与临床分册[J]。2003,23(4):331-333
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[1]Thadani U.Current medical management of chronic stable angina[J].J Cardiovasc Phamacol Ther.2004;9:s11-29.
[2]Loew M,Daecke W,Kusnierczak D,etal.Shock wave therapy is effective for chronic calcifying tendonitis of the shoulder[J].J Bone Joint Surg.1999;81-B:863-7.
[3]Okraine K,Banerjee DK,Eismberq MJ.Coronary artery disease in the developing world[J].Am Heart J.2004;148(1):7-15.
[4]Wang CJ,Wang FS,Yang KD.Shock wave therapy induces neovascularization at the tendon-bone junction.A study in rabbits[J].J orthop res. 2003;21:984-989.
[5] Cavalieri E, Mariotto S , Amelio E ,et al. Extracorporeal shock wave : from lithotripsy to anti-inflammatory action by NO production [J] . Biology and chemistry/official journal of the nitric oxide society. 2005; 12: 89-96.
[6] Gottea G, Ameliob E, Russoc S,et al. Short-time non-enzymatic nitric oxide synthesis from L-arginine and hydrogen peroxide induced by shock waves treatment [J] .Febs letters.2002;520:153-155.
[7] Seemann O,Rassweiler J,Chvapil M,et al.The effect of shock waves on the vascular system of artificially perfused rabbit kidneys [J] . J Stone Dis. 1993;5(3):172-8.
[8] Wang CJ, Huang HY, Pai CH. Shock wave enhanced neovascularization at the tendon-bone junction:An experiment in dogs [J . J Foot Ankle Surg.2002;41:16-22.
[9] Nishida T, Shimokawa H , Oi K,et al. Extracorporeal cardiac shock wave therapy markedly ameliorates ischemia-induced myocardial dysfunction in pigs in vivo [J] .Circulation.2004;110(19):3055-3061
[10] Caspari G ,Erbel R, Gutersohn A. Revascularization with cardiac shock wave therapy [J] . Circulation. 1999; 100(18):84-84.
[11] Gutersohn A, Caspari G, Erbel R. Short and long term clinical improvement in patients with refractory angina using cardiac shock wave therapy [J] .Circulation journal: official journal of the Japanese Circulation Society.2005 ;69:378.
[12] chmid JP. Extracorporeal Shock-Wave Therapy in Chronic Stable Angina Pectoris [J] .The eighth of International Congress of ISMST .2005.
[13] Fukumoto Y, Ito A, Uwatoku T, et al. Extracorporeal cardiac shock wave therapy ameliorates myocardial ischemia in patients with severe coronary artery disease.[J] Coronary Artery Diease. 2006;17:63-70.
[14] Ito K, Fukumoto Y, Shimokawa H. Extracorporeal shock wave therapy as a new and non-invasive angiogenic strategy [J] . Tohoku J Exp Med. 2009 ;219(1):1-9.
[15]Caspari GH,Brandt-Mainz K,Gutersohn A,et al.Improvement of myocardial perfusion by extracorporeal cardiac shock wave therapy[J].J Am Coil Cardiol.2001;37(2):143A-143A.
[16]Tse HF,Yiu KH,Lau CP.Bone marrow stem cell therapy for myocardial angiogenesis[J].Curr Vas Pharmacol.2007;5(2):103-12.
[17]Wang CJ,Wang FS,Yang KD.The effect of shock wave treatment at the tendon-bone interface-an histomorphological and biomechanical study in rabbits[J].J Orthop Res.2005;23(2):274-80.
[18]Uwatoku T,Ito K,Abe K,Oi K,et al.Extracorporeal cardiac shock wave therapy improves left ventricular remodeling after acute myocardial infarction in pigs[J].Coronary Artery Disease.2007;18(5):397-404.
[2]Okraine K,Banerjee DK,Eismberq MJ.Coronary artery disease in the developing world[J].Am Heart J.2004;148(1):7-15.
[3]金惠铭。治疗性血管新生研究的若干进展.国外医学生理病理科学与临床分册[J]。2003,23(4):331-333
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[2]Loew M,Daecke W,Kusnierczak D,etal.Shock wave therapy is effective for chronic calcifying tendonitis of the shoulder[J].J Bone Joint Surg.1999;81-B:863-7.
[3]Okraine K,Banerjee DK,Eismberq MJ.Coronary artery disease in the developing world[J].Am Heart J.2004;148(1):7-15.
[4]Wang CJ,Wang FS,Yang KD.Shock wave therapy induces neovascularization at the tendon-bone junction.A study in rabbits[J].J orthop res. 2003;21:984-989.
[5] Cavalieri E, Mariotto S , Amelio E ,et al. Extracorporeal shock wave : from lithotripsy to anti-inflammatory action by NO production [J] . Biology and chemistry/official journal of the nitric oxide society. 2005; 12: 89-96.
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[7] Seemann O,Rassweiler J,Chvapil M,et al.The effect of shock waves on the vascular system of artificially perfused rabbit kidneys [J] . J Stone Dis. 1993;5(3):172-8.
[8] Wang CJ, Huang HY, Pai CH. Shock wave enhanced neovascularization at the tendon-bone junction:An experiment in dogs [J . J Foot Ankle Surg.2002;41:16-22.
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[10] Caspari G ,Erbel R, Gutersohn A. Revascularization with cardiac shock wave therapy [J] . Circulation. 1999; 100(18):84-84.
[11] Gutersohn A, Caspari G, Erbel R. Short and long term clinical improvement in patients with refractory angina using cardiac shock wave therapy [J] .Circulation journal: official journal of the Japanese Circulation Society.2005 ;69:378.
[12] chmid JP. Extracorporeal Shock-Wave Therapy in Chronic Stable Angina Pectoris [J] .The eighth of International Congress of ISMST .2005.
[13] Fukumoto Y, Ito A, Uwatoku T, et al. Extracorporeal cardiac shock wave therapy ameliorates myocardial ischemia in patients with severe coronary artery disease.[J] Coronary Artery Diease. 2006;17:63-70.
[14] Ito K, Fukumoto Y, Shimokawa H. Extracorporeal shock wave therapy as a new and non-invasive angiogenic strategy [J] . Tohoku J Exp Med. 2009 ;219(1):1-9.
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[16]Tse HF,Yiu KH,Lau CP.Bone marrow stem cell therapy for myocardial angiogenesis[J].Curr Vas Pharmacol.2007;5(2):103-12.
[17]Wang CJ,Wang FS,Yang KD.The effect of shock wave treatment at the tendon-bone interface-an histomorphological and biomechanical study in rabbits[J].J Orthop Res.2005;23(2):274-80.
[18]Uwatoku T,Ito K,Abe K,Oi K,et al.Extracorporeal cardiac shock wave therapy improves left ventricular remodeling after acute myocardial infarction in pigs[J].Coronary Artery Disease.2007;18(5):397-404.