冠脉搭桥围手术期中医疗效的临床研究
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摘要
背景：
国家十一五课题《冠心病血运重建后中医综合干预的临床研究》是通过大样本、多中心、随机、对照临床试验分别评价冠心病(心绞痛、心肌梗死)血运重建后中医综合干预的疗效与安全性,为制定冠心病中医临床与优势指南提供临床依据。实验设计采用多中心、随机、对照、双盲临床试验方案设计。
其中冠脉搭桥围手术期病例选择广东省中医院与各协作医院的冠心病冠脉搭桥病人,共10个单位：广东省中医院、广东省人民医院、新疆维吾尔族自治区中医院、江苏省中医院、福建省立医院、新疆维吾尔族自治区人民医院、陕西省人民医院、甘肃省人民医院、海南省人民医院、深圳孙逸仙心血管病医院。
参照2006年欧洲心脏病学会(European society of cardiology, ESC)《稳定型心绞痛诊治指南》、2005年美国心脏协会(American Heart Association, AHA)/美国心脏病学会(American College of Cardiology, ACC)《不稳定型心绞痛／非ST段抬高型心肌梗死诊疗指南》选择冠心病(心绞痛、心肌梗死)择期行冠脉搭桥手术病人,中医辨证为“心气不足,痰瘀痹阻”证。对符合入选标准的冠心病冠脉搭桥病人分别进行随机分组,分为治疗组和对照组。纳入270例。
两组病人均采用常规的冠脉搭桥治疗方案(具体参照2004年ACC/AHA发布的冠脉搭桥指南制定的治疗方案),治疗组在拔除胸腔引流管后采用协定1号方：人参、法夏、橘红、田七、红花等(采用免煎颗粒)治疗,时间6个月,对照组采用协定2号方即安慰剂,时间6个月。在12个月的研究期限,共剔除21例,脱落25例,完成224例。通过对以下指标：治疗、随访期间任何原因所致的死亡、非致命性心肌梗死；心血管事件入院次数；再次出现心脏缺血性事件需要血运重建；加拿大心血管学会心绞痛分级；纽约心脏病协会心功能分级；心绞痛积分量表；西雅图心绞痛量表；中西医生存质量量表进行总结随访,完成了冠脉搭桥围手术期中医疗效的总结。
随访的结果表明在术后12个月内,各个时间点,全因死亡率、非致命性心肌梗死发生率、再次血运重建率、加拿大心血管学会心绞痛分级、纽约心脏病协会心功能分级、心绞痛积分量表、西雅图心绞痛量表及中西医生存质量量表各维度均无显著性差异(P<0.05)。
目的：
在国家十一五课题《冠心病血运重建后中医综合干预的临床研究》的冠脉搭桥部分研究的基础上,采用病例随访研究方法,进行受试者的随访调查,收集相关信息,进行分析评价。对冠心病冠脉搭桥围手术期中医药干预的3年远期临床疗效进行总结。
研究的方法：
病例来源于国家“十一五”课题《冠心病血运重建后中医综合干预的临床研究》冠脉搭桥部分已完成12个月观察的受试病例。随访从2011年4月开始至2012年12月结束。共224例病人,其中治疗组共115例,其中男性96例,女性19例,对照组共109例,其中男性92例,女性17例,年龄治疗组62.86±8.098岁,对照组63.92±7.011岁。
随访的方式：通过电话及电子邮件发放调查问卷、信件发送调查问卷三者相结合的方式进行问卷调查。
随访的内容：1.主要终点指标：任何原因所致的死亡、非致命性的心肌梗死；2.次要终点指标：因心血管事件入院次数,再次出现心脏缺血性事件需要血运重建；3.加拿大心血管学会心绞痛分级；4.纽约心脏病协会心功能分级；5.心绞痛积分量表；6.西雅图心绞痛量表；7.中西医生存质量量表。
随访的时间：均为手术后3年。
结果：
在术后3年的随访中,脱落16例(其中13例病人因电话及地址更改失访,1例病人拒绝回答随访,2例病人部分问题不愿配合作答,不能完成随访),完成随访208例,其中治疗组106例,对照组102例。两组死亡各3例,各量表(心绞痛量表、西雅图量表、中西医生存质量量表)最终随访完成：治疗组103例病人,对照组99例。两组病人全因死亡例数：治疗组3例,对照组3例(P=1.00),非致命性心肌梗死发生例数：治疗组1例,对照组3例(P=0.362),血运重建例数：治疗组1例,对照组4例(P=0.205)；因心血管事件再次入院次数：治疗组因心血管事件再次住院1次患者1例,因心血管事件再次住院2次患者1例,对照组因心血管事件再次住院1次患者5例,因心血管事件再次住院2次患者3例(P=0.043)。加拿大心血管学会心绞痛分级：治疗组心绞痛1级92例,2级11例,3级0例,4级0例。对照组心绞痛1级80例,2级18例,3级1例,4级0例(P=0.086)。纽约心脏病协会心功能分级：治疗组心功能1级88例,2级14例,3级1例,4级0例。对照组心功能1级71例,2级24例,3级4例,4级0例(P=0.015)。心绞痛积分量表总积分及各项目两组评分无显著差异(心绞痛发作次数积分：治疗组0.19±0.595分,对照组0.32±0.740分,P=0.173；心绞痛持续时间积分：治疗组0.25±0.825分,对照组0.34±0.859分,P=0.443；心绞痛程度积分：治疗组0.26±0.681分,对照组0.36±0.920分,P=0.188；硝酸甘油用量积分：治疗组0.14±0.506分,对照组0.20±0.728分,P=0.453；心绞痛量表总积分：治疗组0.66±2.046分,对照组1.03±2.447分,P=0.244；)。西雅图心绞痛量表各维度两组均无显著性差异(躯体活动受限维度：治疗组73.12±7.99分,对照组72.53±9.73分,P=0.624；心绞痛稳定状态维度：治疗组89.81±19.31分,对照组86.62±24.04分,P=0.529；心绞痛发作频率维度：治疗组95.73±10.44分,对照组92.93±14.30分,P=0.292；疾病认知维度：治疗组84.39±15.69分,对照组82.66±18.12分,P=0.470；治疗满意维度：治疗组88.24±13.05分,对照组84.91±15.90分,P=0.105)。中西医生存质量量表各维度及总分无显著性差异(症状维度：治疗组82.77±5.62分,对照组81.52±7.77分,P=0.774；生活维度：治疗组86.33±9.55分,对照组85.25±10.75分,P=0.452；心理维度：治疗组85.48±8.73分,对照组84.00±8.91分,P=0.236；社交维度：治疗组96.31±8.44分,对照组96.57±6.83分,P=0.814；标准总分：治疗组90.90±5.27分,对照组89.83±7.77分,P=0.227)。
结论：
冠心病围手术期中医药干预可减少术后3年的因心血管事件再次入院次数和改善术后3年的纽约心脏病协会心功能分级。
Background:
The national subject of the11th Five-Year Plan, the Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease, respectively evaluated the curative effects and safety of comprehensive intervention of traditional Chinese medicine (hereafter referred to as TCM) after revascularization of CHD (angina and myocardial infarction (hereafter referred to as MI)) with large sample, multi-center, random and controlled clinical trial, so as to provide clinical basis for the preparation of clinical and advantages guide for coronary heart disease. The experimental design adopted multi-center, random, controlled and double-blind clinical trial protocol design.
During perioperative period of CABG, patients with coronary artery disease treated with CABG surgery from Guangdong Provincial Hospital of Traditional Chinese Medicine and its cooperative hospitals were selected as cases of illness. There were totally10units, including Guangdong Provincial Hospital of Traditional Chinese Medicine, Guandong General Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Fujian Provincial Hospital, Xinjiang Uygur Autonomous Region People's Hospital, Shanxi Provincial People's Hospital, Gansu Provincial Hospital, Hainan General Hospital, and Shenzhen Sun Yat-sen Cardiovascular Hospital. By referring to the Diagnosis and Treatment Guideline of Stable Angina Pectoris of European Society of Cardiology (ESC) in2006, the Diagnosis and Treatment Guideline of Unstable Angina Pectoris/Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) of American Heart Association (AHA)/American College of Cardiology (ACC) in2005, the patients with CHD (angina and MI) and determined to recive CABG in the seclected time and whose TCM symptom differentiation was heart-qi deficiency and phlegm&blood stasis were selected. The randomazation of patients coronary artery disease treated with CABG satisfying the inclusion criteria was performed,so as to divide them into the treatment group and the control group covering270cases.
These two groups of patients all adopted conventional therapeutic protocol of CABG (see therapeutic protocol established by guideline of CABG issued by ACC/AHA in2004for the detail information), and the treatment group adopted agreed No.1prescription of ginseng, halfsummer, red tangerine reel, pseudo-ginseng, and carthamus tinctorius (using boil-free granules) for6months treatment after removing the intrathoracic drain; besides, the control group applied the agreed No.2prescription, the placebo, for6months. Within12months of the study period, there were21excluded cases,25drop-out cases and224finished cases. Finish the conclusion of therapeutic effect of TEM during perioperative period of CABG by concluding and follow-up studying of the below criteria:the death resulted from any reasons during treatment and the follow-up survey, and new case of lethal or non-lethal MI;times of hospitalization because of cardiovascular events and the revascularization which is needed for the recurrence of cardiac ischemic events;angina classification of Canadian Cardiovascular Society (CCCS); cardiac functional grading of New York Heart Assocation (NYHA);Angina Grading Scale;Seattle angina questionnaire (SAQ);quality of life scale of traditional Chinese and western medicine.
The results show that in the postoperative follow-up of12months, each time point, there wsa no significant difference between treatment group and control group in all-cause mortality, rate of non-lethal MI, rate of revascularization, The angina classification of Canadian Cardiovascular Society, Cardiac functional grading of New York Heart Disease Association, and in terms of all dimensions of Angina Grading Scale, Seattle angina questionnaire and Chinese traditional and western medicine (P<0.05).
Object ive:
Case follow-up study was used for follow-up investigation of subjects based on the some studies on coronary artery bypass surgery (CABG) in the subject of the11th Five-Year Plan, the Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease, while related data was collected for analysis and evaluation.3-year long-term clinical effects of Chinese traditional treatment during perioperative period of CABG surgery were finally concluded.
Methods:
The case was taken from some of CABG subject cases of11th Five-Year Plan Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease that had already been completed for12-month observation. The follow up started from April2011and finished in December2012, involving224patients, where115patients for treatment group (96male-patients and19female patients, aged62.86±8.098), and109patients for control group (92male patients and17female patients, age63.92±7.011).
Method of follow up:The survey was performed by issuing the questionnaire via phone and E-mail and sending the questionnaire with postal mail synchronously.
Contents of the follow up:1)Primary outcome:the death resulted from any reasons, and non-lethal MI;2)Secondary outcome:times of hospitalization because of cardiovascular events and the revascularization which was needed by the recurring cardiac ischemic events;3)The angina classification of Canadian Cardiovascular Society (CCCS);4)The cardiac functional grading of New York Heart Disease Association (NYHA);5)Angina Grading Scale;6)The Seattle angina questionnaire (SAQ);7) Quality of life scale of TCM and western medicine.
Time of follow up:Three years after surgery for both groups.
Results:
After3years of follow-up,16cases lost to follow-up (13were due to the changes of telephone numbers and addresses, one refused to answer the questionnaire, and2refused to be investigated). Hence,208patients were finally followed up, where treatment group was106patients, and control group was102patients. The Angina Grading Scale, SAQ and quality of life scale of TCM and western medicine were completed for follow up,103patients for treatment group and99patients for control group (3deaths for both groups). the cases for non-lethal MI:there was1cases from treatment group and3cases from control group(P=0.362);the cases for revascularization:there was1 cases from treatment group and4cases from control group (P=0.205); times of readmission to the hospital resulted from cardiovascular event:from treatment group, there was1case for both one-time and two-time readmission to the hospital resulted from cardiovascular event. In contrast, there were5cases from control group for one-time readmission to the hospital resulted from cardiovascular event and3cases for two-time readmission to the hospital resulted from cardiovascular event (P=0.043). Canadian angina classification:there were92cases of1-level,11cases of2-level, no case of3-level and4-level from treatment group;besides, there were80cases of1-level,18cases of2-level,1case of3-level and no case of4-level from control group (P=0.086). Cardiac functional grading of New York Heart Disease Association (NYHA):there were88cases of1-level,14cases of2-level,1case of3-level and no case of4-level from treatment group;besides, there were71cases of1-level,24cases of3-level,4case of3-level and no case of4-level from control group(P=0.015).
There was no significant difference between treatment group and control group in terms of all dimensions and total scores of Angina Grading Scale (the score of anginal frequence, treatment group was0.19+0.595, control group was0.32±0.740, P=0.173. the score of anginal time, treatment group was0.25±0.825, control group was0.34±0.859, P=0.443. the score of angina pectoris degree, treatment group was0.26±0.681, control group was0.36±0.920, P=0.188. the score of nitroglycerin doses, treatment group was0.14±0.506, control group was0.20±0.728, P=0.453. the total score of Angina Grading Scale, treatment group was0.66±2.046, control group was1.03±2.447, P=0.244).
There was no significant difference between treatment group and control group in terms of dimensions of Seattle angina questionnaire (SAQ)(the score of physical limitation, reatment group was73.12±7.99, control group was72.53±9.73, P=0.624. the score of anginal stability, treatment group was89.81±19.31, control group was86.62±24.04, P=0.529. the score of anginal frequency, treatment group was95.73±10.44, control group was92.93±14.30, P=0.292.the score of disease recognition, treatment group was84.39±15.69, control group was82.66±18.12, P=0.470. the score of treatment satisfaction, treatment group was88.24±13.05, control group was84.91±15.90, P=0.105).
There was no significant difference between treatment group and control group in terms of all dimensions and total scores of Quality of life scale of traditionl chinese and western medicine (the score of symptoms, treatment group was82.77±5.62, control group was81.52±7.77, P=0.774. the score of life, treatment group was86.33±9.55, control group was85.25±10.75, P=0.452. the score of psychology, treatment group was85.48±8.73, control group was84.00±8.91, P=0.236. the score of social intercourse, treatment group was96.31±8.44, control group was96.57±6.83, P=0.814. the total score of Quality of life scale of traditionl chinese and western medicine, treatment group was90.90±5.27, control group was89.83±7.77, P=0.227).
Conclusion:
During perioperative period of CABG, treatment with TCM can reduced rehospitalization rate3years after opertation and improved the NYHA Cardiac functional grading3yeas after operation.
国家十一五课题《冠心病血运重建后中医综合干预的临床研究》是通过大样本、多中心、随机、对照临床试验分别评价冠心病(心绞痛、心肌梗死)血运重建后中医综合干预的疗效与安全性,为制定冠心病中医临床与优势指南提供临床依据。实验设计采用多中心、随机、对照、双盲临床试验方案设计。
其中冠脉搭桥围手术期病例选择广东省中医院与各协作医院的冠心病冠脉搭桥病人,共10个单位：广东省中医院、广东省人民医院、新疆维吾尔族自治区中医院、江苏省中医院、福建省立医院、新疆维吾尔族自治区人民医院、陕西省人民医院、甘肃省人民医院、海南省人民医院、深圳孙逸仙心血管病医院。
参照2006年欧洲心脏病学会(European society of cardiology, ESC)《稳定型心绞痛诊治指南》、2005年美国心脏协会(American Heart Association, AHA)/美国心脏病学会(American College of Cardiology, ACC)《不稳定型心绞痛／非ST段抬高型心肌梗死诊疗指南》选择冠心病(心绞痛、心肌梗死)择期行冠脉搭桥手术病人,中医辨证为“心气不足,痰瘀痹阻”证。对符合入选标准的冠心病冠脉搭桥病人分别进行随机分组,分为治疗组和对照组。纳入270例。
两组病人均采用常规的冠脉搭桥治疗方案(具体参照2004年ACC/AHA发布的冠脉搭桥指南制定的治疗方案),治疗组在拔除胸腔引流管后采用协定1号方：人参、法夏、橘红、田七、红花等(采用免煎颗粒)治疗,时间6个月,对照组采用协定2号方即安慰剂,时间6个月。在12个月的研究期限,共剔除21例,脱落25例,完成224例。通过对以下指标：治疗、随访期间任何原因所致的死亡、非致命性心肌梗死；心血管事件入院次数；再次出现心脏缺血性事件需要血运重建；加拿大心血管学会心绞痛分级；纽约心脏病协会心功能分级；心绞痛积分量表；西雅图心绞痛量表；中西医生存质量量表进行总结随访,完成了冠脉搭桥围手术期中医疗效的总结。
随访的结果表明在术后12个月内,各个时间点,全因死亡率、非致命性心肌梗死发生率、再次血运重建率、加拿大心血管学会心绞痛分级、纽约心脏病协会心功能分级、心绞痛积分量表、西雅图心绞痛量表及中西医生存质量量表各维度均无显著性差异(P<0.05)。
目的：
在国家十一五课题《冠心病血运重建后中医综合干预的临床研究》的冠脉搭桥部分研究的基础上,采用病例随访研究方法,进行受试者的随访调查,收集相关信息,进行分析评价。对冠心病冠脉搭桥围手术期中医药干预的3年远期临床疗效进行总结。
研究的方法：
病例来源于国家“十一五”课题《冠心病血运重建后中医综合干预的临床研究》冠脉搭桥部分已完成12个月观察的受试病例。随访从2011年4月开始至2012年12月结束。共224例病人,其中治疗组共115例,其中男性96例,女性19例,对照组共109例,其中男性92例,女性17例,年龄治疗组62.86±8.098岁,对照组63.92±7.011岁。
随访的方式：通过电话及电子邮件发放调查问卷、信件发送调查问卷三者相结合的方式进行问卷调查。
随访的内容：1.主要终点指标：任何原因所致的死亡、非致命性的心肌梗死；2.次要终点指标：因心血管事件入院次数,再次出现心脏缺血性事件需要血运重建；3.加拿大心血管学会心绞痛分级；4.纽约心脏病协会心功能分级；5.心绞痛积分量表；6.西雅图心绞痛量表；7.中西医生存质量量表。
随访的时间：均为手术后3年。
结果：
在术后3年的随访中,脱落16例(其中13例病人因电话及地址更改失访,1例病人拒绝回答随访,2例病人部分问题不愿配合作答,不能完成随访),完成随访208例,其中治疗组106例,对照组102例。两组死亡各3例,各量表(心绞痛量表、西雅图量表、中西医生存质量量表)最终随访完成：治疗组103例病人,对照组99例。两组病人全因死亡例数：治疗组3例,对照组3例(P=1.00),非致命性心肌梗死发生例数：治疗组1例,对照组3例(P=0.362),血运重建例数：治疗组1例,对照组4例(P=0.205)；因心血管事件再次入院次数：治疗组因心血管事件再次住院1次患者1例,因心血管事件再次住院2次患者1例,对照组因心血管事件再次住院1次患者5例,因心血管事件再次住院2次患者3例(P=0.043)。加拿大心血管学会心绞痛分级：治疗组心绞痛1级92例,2级11例,3级0例,4级0例。对照组心绞痛1级80例,2级18例,3级1例,4级0例(P=0.086)。纽约心脏病协会心功能分级：治疗组心功能1级88例,2级14例,3级1例,4级0例。对照组心功能1级71例,2级24例,3级4例,4级0例(P=0.015)。心绞痛积分量表总积分及各项目两组评分无显著差异(心绞痛发作次数积分：治疗组0.19±0.595分,对照组0.32±0.740分,P=0.173；心绞痛持续时间积分：治疗组0.25±0.825分,对照组0.34±0.859分,P=0.443；心绞痛程度积分：治疗组0.26±0.681分,对照组0.36±0.920分,P=0.188；硝酸甘油用量积分：治疗组0.14±0.506分,对照组0.20±0.728分,P=0.453；心绞痛量表总积分：治疗组0.66±2.046分,对照组1.03±2.447分,P=0.244；)。西雅图心绞痛量表各维度两组均无显著性差异(躯体活动受限维度：治疗组73.12±7.99分,对照组72.53±9.73分,P=0.624；心绞痛稳定状态维度：治疗组89.81±19.31分,对照组86.62±24.04分,P=0.529；心绞痛发作频率维度：治疗组95.73±10.44分,对照组92.93±14.30分,P=0.292；疾病认知维度：治疗组84.39±15.69分,对照组82.66±18.12分,P=0.470；治疗满意维度：治疗组88.24±13.05分,对照组84.91±15.90分,P=0.105)。中西医生存质量量表各维度及总分无显著性差异(症状维度：治疗组82.77±5.62分,对照组81.52±7.77分,P=0.774；生活维度：治疗组86.33±9.55分,对照组85.25±10.75分,P=0.452；心理维度：治疗组85.48±8.73分,对照组84.00±8.91分,P=0.236；社交维度：治疗组96.31±8.44分,对照组96.57±6.83分,P=0.814；标准总分：治疗组90.90±5.27分,对照组89.83±7.77分,P=0.227)。
结论：
冠心病围手术期中医药干预可减少术后3年的因心血管事件再次入院次数和改善术后3年的纽约心脏病协会心功能分级。
Background:
The national subject of the11th Five-Year Plan, the Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease, respectively evaluated the curative effects and safety of comprehensive intervention of traditional Chinese medicine (hereafter referred to as TCM) after revascularization of CHD (angina and myocardial infarction (hereafter referred to as MI)) with large sample, multi-center, random and controlled clinical trial, so as to provide clinical basis for the preparation of clinical and advantages guide for coronary heart disease. The experimental design adopted multi-center, random, controlled and double-blind clinical trial protocol design.
During perioperative period of CABG, patients with coronary artery disease treated with CABG surgery from Guangdong Provincial Hospital of Traditional Chinese Medicine and its cooperative hospitals were selected as cases of illness. There were totally10units, including Guangdong Provincial Hospital of Traditional Chinese Medicine, Guandong General Hospital, Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Fujian Provincial Hospital, Xinjiang Uygur Autonomous Region People's Hospital, Shanxi Provincial People's Hospital, Gansu Provincial Hospital, Hainan General Hospital, and Shenzhen Sun Yat-sen Cardiovascular Hospital. By referring to the Diagnosis and Treatment Guideline of Stable Angina Pectoris of European Society of Cardiology (ESC) in2006, the Diagnosis and Treatment Guideline of Unstable Angina Pectoris/Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) of American Heart Association (AHA)/American College of Cardiology (ACC) in2005, the patients with CHD (angina and MI) and determined to recive CABG in the seclected time and whose TCM symptom differentiation was heart-qi deficiency and phlegm&blood stasis were selected. The randomazation of patients coronary artery disease treated with CABG satisfying the inclusion criteria was performed,so as to divide them into the treatment group and the control group covering270cases.
These two groups of patients all adopted conventional therapeutic protocol of CABG (see therapeutic protocol established by guideline of CABG issued by ACC/AHA in2004for the detail information), and the treatment group adopted agreed No.1prescription of ginseng, halfsummer, red tangerine reel, pseudo-ginseng, and carthamus tinctorius (using boil-free granules) for6months treatment after removing the intrathoracic drain; besides, the control group applied the agreed No.2prescription, the placebo, for6months. Within12months of the study period, there were21excluded cases,25drop-out cases and224finished cases. Finish the conclusion of therapeutic effect of TEM during perioperative period of CABG by concluding and follow-up studying of the below criteria:the death resulted from any reasons during treatment and the follow-up survey, and new case of lethal or non-lethal MI;times of hospitalization because of cardiovascular events and the revascularization which is needed for the recurrence of cardiac ischemic events;angina classification of Canadian Cardiovascular Society (CCCS); cardiac functional grading of New York Heart Assocation (NYHA);Angina Grading Scale;Seattle angina questionnaire (SAQ);quality of life scale of traditional Chinese and western medicine.
The results show that in the postoperative follow-up of12months, each time point, there wsa no significant difference between treatment group and control group in all-cause mortality, rate of non-lethal MI, rate of revascularization, The angina classification of Canadian Cardiovascular Society, Cardiac functional grading of New York Heart Disease Association, and in terms of all dimensions of Angina Grading Scale, Seattle angina questionnaire and Chinese traditional and western medicine (P<0.05).
Object ive:
Case follow-up study was used for follow-up investigation of subjects based on the some studies on coronary artery bypass surgery (CABG) in the subject of the11th Five-Year Plan, the Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease, while related data was collected for analysis and evaluation.3-year long-term clinical effects of Chinese traditional treatment during perioperative period of CABG surgery were finally concluded.
Methods:
The case was taken from some of CABG subject cases of11th Five-Year Plan Clinical Research of Comprehensive Intervention of Traditional Chinese Medicine After Revascularization of Coronary Artery Heat Disease that had already been completed for12-month observation. The follow up started from April2011and finished in December2012, involving224patients, where115patients for treatment group (96male-patients and19female patients, aged62.86±8.098), and109patients for control group (92male patients and17female patients, age63.92±7.011).
Method of follow up:The survey was performed by issuing the questionnaire via phone and E-mail and sending the questionnaire with postal mail synchronously.
Contents of the follow up:1)Primary outcome:the death resulted from any reasons, and non-lethal MI;2)Secondary outcome:times of hospitalization because of cardiovascular events and the revascularization which was needed by the recurring cardiac ischemic events;3)The angina classification of Canadian Cardiovascular Society (CCCS);4)The cardiac functional grading of New York Heart Disease Association (NYHA);5)Angina Grading Scale;6)The Seattle angina questionnaire (SAQ);7) Quality of life scale of TCM and western medicine.
Time of follow up:Three years after surgery for both groups.
Results:
After3years of follow-up,16cases lost to follow-up (13were due to the changes of telephone numbers and addresses, one refused to answer the questionnaire, and2refused to be investigated). Hence,208patients were finally followed up, where treatment group was106patients, and control group was102patients. The Angina Grading Scale, SAQ and quality of life scale of TCM and western medicine were completed for follow up,103patients for treatment group and99patients for control group (3deaths for both groups). the cases for non-lethal MI:there was1cases from treatment group and3cases from control group(P=0.362);the cases for revascularization:there was1 cases from treatment group and4cases from control group (P=0.205); times of readmission to the hospital resulted from cardiovascular event:from treatment group, there was1case for both one-time and two-time readmission to the hospital resulted from cardiovascular event. In contrast, there were5cases from control group for one-time readmission to the hospital resulted from cardiovascular event and3cases for two-time readmission to the hospital resulted from cardiovascular event (P=0.043). Canadian angina classification:there were92cases of1-level,11cases of2-level, no case of3-level and4-level from treatment group;besides, there were80cases of1-level,18cases of2-level,1case of3-level and no case of4-level from control group (P=0.086). Cardiac functional grading of New York Heart Disease Association (NYHA):there were88cases of1-level,14cases of2-level,1case of3-level and no case of4-level from treatment group;besides, there were71cases of1-level,24cases of3-level,4case of3-level and no case of4-level from control group(P=0.015).
There was no significant difference between treatment group and control group in terms of all dimensions and total scores of Angina Grading Scale (the score of anginal frequence, treatment group was0.19+0.595, control group was0.32±0.740, P=0.173. the score of anginal time, treatment group was0.25±0.825, control group was0.34±0.859, P=0.443. the score of angina pectoris degree, treatment group was0.26±0.681, control group was0.36±0.920, P=0.188. the score of nitroglycerin doses, treatment group was0.14±0.506, control group was0.20±0.728, P=0.453. the total score of Angina Grading Scale, treatment group was0.66±2.046, control group was1.03±2.447, P=0.244).
There was no significant difference between treatment group and control group in terms of dimensions of Seattle angina questionnaire (SAQ)(the score of physical limitation, reatment group was73.12±7.99, control group was72.53±9.73, P=0.624. the score of anginal stability, treatment group was89.81±19.31, control group was86.62±24.04, P=0.529. the score of anginal frequency, treatment group was95.73±10.44, control group was92.93±14.30, P=0.292.the score of disease recognition, treatment group was84.39±15.69, control group was82.66±18.12, P=0.470. the score of treatment satisfaction, treatment group was88.24±13.05, control group was84.91±15.90, P=0.105).
There was no significant difference between treatment group and control group in terms of all dimensions and total scores of Quality of life scale of traditionl chinese and western medicine (the score of symptoms, treatment group was82.77±5.62, control group was81.52±7.77, P=0.774. the score of life, treatment group was86.33±9.55, control group was85.25±10.75, P=0.452. the score of psychology, treatment group was85.48±8.73, control group was84.00±8.91, P=0.236. the score of social intercourse, treatment group was96.31±8.44, control group was96.57±6.83, P=0.814. the total score of Quality of life scale of traditionl chinese and western medicine, treatment group was90.90±5.27, control group was89.83±7.77, P=0.227).
Conclusion:
During perioperative period of CABG, treatment with TCM can reduced rehospitalization rate3years after opertation and improved the NYHA Cardiac functional grading3yeas after operation.
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