摘要
本论文分为以下两个部分：
一、急性心肌梗死患者中医证候要素与心功能、住院死亡率的相关性研究
目的：研究北京地区5家三级甲等中医院AMI病人中医证候要素分布状况及其与心功能状况、住院死亡率的关系。
方法：收集2002年1月-2005年12月北京地区5家三级甲等中医院的AMI住院病人一般资料、危险因素、既往病史、中医证候、心功能分级、疗效等资料,用ACCESS建立数据库,采用SPSS 13.0统计软件进行一般资料、中医证候要素及其与心功能、住院死亡率关系等的分析。
结果：572例AMI病人按照气虚、血虚、阴虚、阳虚、气滞、血瘀、寒凝、痰浊8个基本证候要素进行辨证,其中虚证以气虚最多(371例,64.9%),实证以血瘀最多(505例,88.3%)。Logistic回归分析表明,气虚、阳虚、阴虚均与心功能状况相关(P<0.01),而血瘀、痰浊与心功能状况无明显相关性(P>0.05)。气虚者以心功能Ⅰ、Ⅱ级为主(分别为38.5%和39.9%),阳虚者以心功能Ⅲ、Ⅳ级分布为主(分别为37.2%和27.9%),两组比较心功能状况有显著性差异(Z=-5.583,P<0.01)。有无气虚和有无阴虚者住院死亡率均未见明显差异(P>0.05),而阳虚者住院死亡率明显高于无阳虚者(P<0.001)。
结论：AMI心功能状况与中医证候要素气虚、阳虚、阴虚有关,且阳虚者心功能较气虚者差,阳虚者住院死亡率明显高于无阳虚者。
二、中医药治疗急性心肌梗死的前瞻性队列研究
目的：通过前瞻性队列研究,观察中医药综合治疗AMI的临床疗效。
方法：2007年1月-2009年3月在中国中医科学院西苑医院住院的AMI患者,在西医标准治疗基础上应用中药(汤剂或中成药)≥1个月为治疗组,共169例；以同期入住中日友好医院及安贞医院的AMI患者(未服用中药)为对照组,共165例。收集患者一般资料及住院期间相关临床资料,随访6个月、12个月主要终点指标(包括死亡、非致死性心肌梗死、再次血运重建术)、次要终点指标(包括脑卒中、心绞痛再住院、心功能不全、休克等)、中医症状计分及血瘀证计分。用ACCESS建立数据库,采用SPSS 13.0统计软件进行两组一般资料、中医症状计分、血瘀证计分、主、次要终点指标等的分析,采用生存分析Kaplan-Meier法描绘生存曲线,并用log-rank检验进行比较。多因素分析采用Logistic回归分析。
结果：随访12个月治疗组中医症状计分明显低于对照组(3.78±1.61 vs 4.29±1.78,P=0.008),中医症状的差异主要表现在胸痛、自汗和不寐三个症状上。12个月治疗组血瘀证计分明显低于对照组(11.07±3.83 vs 13.73±5.25,P<0.01)。6个月治疗组心绞痛再住院发生率明显低于对照组(2.96%vs 7.88%,P<0.05),Kaplan-Meier生存曲线显示治疗组6个月未发生心绞痛再住院的概率高于对照组(Log Rank统计值=4.700,P=0.030)。多因素分析显示心功能不全和糖尿病为6个月发生终点事件的危险因素：心功能分级每增加1个等级,发生终点事件的风险增加至原来的1.775倍(95%CI=1.045-3.016,P=0.034),合并糖尿病者发生终点事件的风险是未合并糖尿病者的1.927倍(95%CI=1.004-3.697,P=0.049)。中药治疗、PCI治疗和早期使用ACEI为6个月终点事件的保护因素。中药治疗者发生终点事件的风险是未使用中药者的33.8%(95%CI=0.176-0.649,P=0.001),PCI治疗者发生终点事件的风险是未行PCI者的27.1%(95%CI=0.143-0.513,P<0.001),早期使用ACEI制剂者发生终点事件的风险是未使用者的45.1%(95%CI=0.230-0.884,P=0.020)。
结论：中医药治疗可以降低AMI患者12个月中医症状计分、血瘀证计分,降低6个月心绞痛再住院发生率。心功能不全、糖尿病是AMI 6个月发生终点事件的危险因素,而中药治疗、PCI治疗、早期应用ACEI制剂是AMI 6个月发生终点事件的保护因素。
This thesis was divided into two parts.
1. Correlation of Traditional Chinese Medicine (TCM) Syndrome Elements of Acute Myocardial Infarction (AMI) with Heart Function and Hospital Mortality
Objective:To investigate the distribution of TCM syndrome elements and their correlation with heart function and hospital mortality in patients with AMI in the five Grade III Class A hospitals.
Methods:A total of 572 AMI patients admitted from 2002 to 2005 were studied. The general information, risk factors, past medical history, TCM syndrome types, heart function and therapeutic effectiveness were investigated. The data bank was established with ACCESS, the correlation between TCM syndrome elements and heart function, hospital mortality were analyzed with SPSS 13.0 analytic software.
Results:Among the 572 AMI patients, there were 8 syndrome elements including qi deficiency, blood deficiency, yin deficiency, yang deficiency, qi stagnation, blood stasis, cold coagulation and phlegm turbidity. The syndrome element of qi deficiency (64.9%) is the most common element among patients of deficiency syndrome, while the syndrome element of blood stasis (88.3%) is the most common one in patients of excess syndrome. The syndrome element of qi deficiency, yang deficiency and yin deficiency were correlated significantly with heart function classification by the Logistical analysis (P<0.05, respectively), while there was no significant correlation between syndrome element of blood stasis or phlegm turbidity with heart functional classification (P>0.05). The patients differentiated as qi deficiency were mainly diagnosed as Killip's heart function of gradeⅠ(38.5%) and gradeⅡ(39.9%), while the patients differentiated as yang deficiency were mainly diagnosed as Killip's heart function of gradeⅢ(37.2%) and grade IV (27.9%). There existed significant difference between the qi deficiency and yang deficiency groups in Killip's heart function (Z=-5.583, P<0.01). There were no significant difference of hospital mortality between qi deficiency group and non-qi deficiency group, nor yin deficiency group and non-yin deficiency group (P>0.05), whereas the hospital mortality in yang deficiency group was much higher than that in non-yang deficiency group (P<0.001).
Conclusion:The syndrome element of qi deficiency, yang deficiency and yin deficiency were correlated with heart function, and those patients with yang deficiency were much more severe than those with qi deficiency in poorer heart function. The hospital mortality in yang deficiency group was much higher than that in non-yang deficiency group.
2. Prospective Cohort Study of AMI Treated with Chinese Medicine
Objective:Adopting prospective cohort study to observe the clinical efficacy of TCM treatment for AMI.
Methods:169 AMI patients admitted in Xiyuan Hospital from Jan 2007 to Mar 2009 treated with Chinese medicine more than one month were included into treatment group,165 AMI patients in China-Japanese Friendship Hospital and Anzhen Hospital who hadn't taken any Chinese medicine in the same period were included into control group. The corresponding clinical information was collected. The prognostic outcomes of each patient were observed, including main end-point (death, non-lethal myocardial infarction, revascularization), secondary end-point (cerebrovascular events, rehospitalization due to angina, heart failure and shock), TCM symptom scores and blood-stasis syndrome scores. Data bank was established with ACCESS. The baseline characteristics, TCM symptom scores, blood-stasis syndrome scores were analyzed by SPSS 13.0 analytic software. The methods of Kaplan-Meier and log-rank test were used to evaluate the prognosis. The Logistic regression analysis was used to calculate relative multi-factors.
Results:The TCM symptom scores of 12-month follow-up in the treatment group were much lower than that in the control group (3.78±1.61 vs 4.29±1.78, P=0.008). The difference of symptom scores was mainly shown in the symptoms of chest pain, spontaneous perspiration and insomnia. The blood-stasis syndrome scores of 12-month follow-up in the treatment group were much lower than that in the control group (11.07±3.83 vs 13.73±5.25, P<0.01). Rehospitalization due to angina during the 6-month follow-up in the treatment group was lower than that in the control group (2.96% vs 7.88%, P<0.05), and Kaplan-Meier survival curve showed that event-free cum survival in 6-month follow-up rehospitalization due to angina in the treatment group was higher than that in the control group (Log Rank 4.700, P=0.030). Multi-factor analysis showed that Diabetes Mellitus and cardiac insufficiency were hazard factors of end-point, relative risk (RR) of end-point were increased to 1.927(95% CI= 1.004-3.697, P=0.049) and 1.775(95% CI=1.045-3.016, P=0.034) if the Killip's heart functional classification rose 1 grade. Whereas Chinese medicine, PCI and early use of ACEI were protective factors, RR were33.8%(95% CI=0.176-0.649, P=0.001), 27.1%(95% CI=0.143-0.513, P<0.001) and 45.1%(95% CI=0.230-0.884, P=0.020).
Conclusion:Chinese medicine could reduce TCM symptom scores and blood-stasis syndrome scores, reduce the 6-month follow-up rehospitalization due to angina. Diabetes Mellitus and cardiac insufficiency were hazard factors of end-point in 6-month, whereas Chinese medicine, PCI and early use of ACEI were protective factors.
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