冠心病血瘀证诊断标准的临床评价研究
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摘要
冠心病(coronary heart disease, CHD)是冠状动脉粥样硬化使血管腔狭窄或阻塞,或(和)因冠状动脉功能性改变(痉挛)导致心肌缺血缺氧或坏死而引起的一类心脏病。该病的发病率逐年增高,已经成为危害人类健康的重要杀手。虽然血瘀证是冠心病最常见的证候,但只有1986年修订的“血瘀证诊断标准”指导临床临床实践。近年来,相关研究人员遵循循证医学理念,采用文献研究、专家咨询、临床流行病学横断面调查等方法,数理统计与数据挖掘相结合,建立了病证结合的“冠心病血瘀证诊断标准(草案)”。
但是,“冠心病血瘀证诊断标准(草案)”尚未进行临床实践验证和评价,其指导临床实践的普适性尚不明确,尤其与冠脉造影病变特点的相关性,尚缺乏循证医学实践。本研究采用横断面研究和随机双盲对照研究设计,以方测证,对“冠心病血瘀证诊断标准(草案)”进行临床验证和评价。
研究一“冠心病血瘀证诊断标准”计分与未经血运重建术冠脉造影特点的横断面研究
目的：为减少血运重建干预对Gensini评分和血瘀证计分的影响,本研究仅对未经血运重建干预的CHD患者进行研究,分析Gensini评分与血瘀证计分、“冠心病血瘀证诊断标准”计分及中医证候分布之间的相关性,以期为临床辨证治疗提供依据。
方法：选取2011年3月至2012年6月于首都医科大学附属安贞医院经冠脉造影检查确诊且未经血运重建干预的CHD患者209例,进行临床观察,记录并采集一般资料、中医证候等临床信息,并计算血瘀证计分和“冠心病血瘀证诊断标准”计分,根据CAG结果进行Gensini评分。分析Gensini评分与血瘀证计分、“冠心病血瘀证诊断标准”计分及中医证候分布之间的相关性。
结果：209例CHD患者中,稳定性心绞痛15例,不稳定性心绞痛163例,急性心肌梗死31例,陈旧性心肌梗死11例。常见中医证型依次是血瘀144例(68.9%)、痰浊93例(44.5%)、气滞8例(3.8%)、气虚74例(35.4%)、阴虚17例(8.1%)、阳虚21例(10%)、寒凝0例,阳脱1例(0.5%)。本研究中CHD患者的证型以血瘀证、痰浊证和气虚证最为常见,并相互兼夹为患,与既往的研究相似。
将CHD患者分为血瘀与非血瘀、痰浊与非痰浊、气滞与非气滞、气虚与非气虚、阳虚与非阳虚、阴虚与非阴虚六组,将各组内患者的冠状动脉病变特点进行比较发现,血瘀证患者的冠状动脉最重狭窄与Gensini评分数值均高于非血瘀证患者(P<0.05),痰浊患者的Gensini评分较非痰浊患者严重(P<0.05),提示血瘀、痰浊是CHD的主要证候要素。
血瘀证计分与Gensini评分双变量相关分析显示,血瘀证计分与Gensini评分有明显相关性(Pearson相关系数为0.68,P=0.0128)。
“冠心病血瘀证诊断标准”计分与Gensini评分的相关性分析显示,“冠心病血瘀证诊断标准”计分与Gensini评分有明显相关性(Pearson相关系数为0.72,P=0.0054)。
结论：本研究中CHD患者的证型以血瘀证、痰浊证和气虚证最为常见,且相互兼夹。血瘀证患者的冠状动脉最重狭窄与Gensini评分均高于非血瘀证患者,痰浊患者的Gensini评分数值高于非痰浊患者。血瘀证计分、“冠心病血瘀证诊断标准”计分均与冠脉造影Gensini评分呈正相关,与血瘀证计分比较,“冠心病血瘀证诊断标准”计分与Gensini评分的相关性更强。
研究二冠心丹参滴丸治疗冠心病血瘀证的随机双盲安慰剂对照研究
目的：基于“冠心病血瘀证诊断标准(草案)”,以方测证,以“冠心病血瘀证诊断标准”计分和临床疗效为依据,评价“冠心病血瘀证诊断标准(草案)”的临床普适性。
方法：采用多中心、前瞻性、随机、双盲、安慰剂对照研究设计,按照GCP流程,经伦理委员会批准后,自2011年9月至2012年9月于首都医科大学附属安贞医院、中国医学科学院阜外心血管病医院、中日友好医院、中国中医科学院西苑医院入选符合标准的CHD稳定期患者240例。两组均给予西医标准化药物治疗,试验组给予冠心丹参滴丸(0.04g/粒),每次10粒,每日3次,连续口服1个月；对照组给予冠心丹参滴丸模拟剂(0.04g/粒),每次10粒,每日3次,连续口服1个月。分别于试验前、服药后14天、服药结束后(28天)对心绞痛计分、中医主症计分、血瘀证计分、“冠心病血瘀证诊断标准”计分、理化指标(包括Hs-CRP、TC、TG、LDL、HDL)及安全性指标进行观察并记录。采用SPSS13.0软件进行统计学分析。
结果：最终入选符合研究标准的病例共212例,剔除28例,其中治疗组108例,对照组104例。组内比较显示,两组治疗后的心绞痛计分、中医主症计分、血瘀证计分、“冠心病血瘀证诊断标准”计分均较治疗前降低(P<0.05)。组间比较显示,治疗组在降低心绞痛计分程度方面有优于对照组的趋势,但未达到统计学差异(P=0.055)。治疗组在降低中医主症计分程度方面有优于对照组的趋势,但未达到统计学差异(P=0.065)。治疗组经治疗后血瘀证计分较对照组降低(P=0.002),治疗组在降低血瘀证计分程度方面优于对照组(P=0.001)。治疗组经治疗后“冠心病血瘀证诊断标准”计分较对照组降低(P=0.034),治疗组在降低“冠心病血瘀证诊断标准”计分程度方面优于对照组(P=0.006)。两组患者治疗过程中及治疗后均未发生不良反应及终点指标。两组患者“冠心病血瘀证诊断标准”计分疗效和临床疗效的比较分析显示,治疗组在“冠心病血瘀证诊断标准”计分疗效和临床疗效方面优于对照组(95.4%vs82.7%,P=0.011；97.2%vs86.5%,p=0.014)。
结论：冠心丹参滴丸能够降低心绞痛计分、中医主症计分、血瘀证计分、“冠心病血瘀证诊断标准”计分,改善临床症状。“冠心病血瘀证诊断标准”计分较血瘀证计分能更好地反映临床病情,是客观评价冠心病临床疗效的量化指标,“冠心病血瘀证诊断标准(草案)”具有良好的临床普适性。
Coronary heart disease is the type of heart disease which is caused by myocardial ischemia, hypoxia or necrosis. The reason of that pathological change is due to stenosis or obstruction or spasm of coronary artery, which is based on Coronary atherosclerosis. The incidence of the disease increased significantly year by year, and it has become a major killer to people's health. Although blood stasis is the most common TCM syndromes of coronary heart disease, but we only have the1986revision of the "diagnostic criteria of blood stasis syndrome" to guide the clinical treatment. In recent years, the relevant researchers following the concept of evidence-based medicine, using method of literature research, expert advice, clinical epidemiology investigation, mathematical statistics, have set up a "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" based on the theory of combination of TCM syndrome and disease criteria preliminary.
However,"diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" hasn't got a clinical evaluation, and the universality of guiding clinical practice remains unclear, especially for the relevance with the CAG characteristics, are lack of clinical practice based on evidence-based medicine. This research adopts the design of the cross-sectional study and randomized double-blind control study. Using the curative effect to explane reason, evaluats the clinical applicability of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease".
Reaserch I
Correlation research between TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and the Gensini score of coronary angiography in coronary heart disease patients without intervention Objective:In order to reduce influence of PCI on the Gensini score and score of
blood stasis syndrome, we only study the patients without PCI history. In order to
provide the basis for syndrome differentiation and clinical treatment, we analysis the
correlation of Gensini score and blood stasis score and TCM blood stasis syndrome
score made by "diagnostic criteria of blood stasis syndrome for patients with coronary
heart disease" and TCM syndrome distribution. Method:Select209patients from Anzhen hospital which are diagnosed with
CHD using CAG, from March2011to June2012,and make the collection of clinical
information.Make the Gensini score according to the result of CAG, record TCM
syndromes, and calculate of the score of blood stasis syndrome and the " diagnostic
criteria of blood stasis syndrome for patients with coronary heart disease ".Analysis the
correlation between the Gensini score and score of blood stasis syndrome, the "
diagnostic criteria of blood stasis syndrome for patients with coronary heart disease "
score and TCM syndrome distribution. Results:209cases of CHD patients were involved, including15cases of chronic
stable angina,163cases of unstable angina,31cases of acute myocardial infarction,
and11cases of old myocardial infarction.The common TCM syndrome types in209
patients was144cases with blood stasis (68.9%),93cases with phlegm turbidity
(44.5%), and8cases with Qi stagnation (3.8%),74cases with Qi deficiency (35.4%),
17cases with Yin deficiency (8.1%),21cases with Yang deficiency (10%),0cases
with cold, case with Yang exhausted(0.5%).Qi deficiency, blood stasis and phlegm
turbidity is the most common TCM syndrome type in this study, and often combined
with each other, which is similar to the prior research. CHD patients are divided into6groups, including blood stasis and non blood
stasis, phlegm turbidity and non phlegm turbidity, qi stagnation and non qi stagnation,
qi deficiency and non qi deficiency, Yang deficiency and non Yang deficiency, Yin
deficiency and non Yin deficiency. Analysis the CAG characteristics in each group, and
found that patients with blood stasis syndrome have higher Gensini score and coronary
stenosis than patients without blood stasis (P<0.05), patients with phlegm turbidity
have higher Gensini score and coronary stenosis than patients without phlegm turbidity (P<0.05).We conclude that blood stasis, phlegm turbidity is the main pathogenesis of CHD.
Bivariate correlation analysis of blood stasis syndrome score and the Gensini score showed that they have obvious correlation with each other (Pearson correlation coefficient is0.68, P=0.0128).
Bivariate correlation analysis of TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and the Gensini score showed that they have obvious correlation with each other (Pearson correlation coefficient was0.72, P=0.0054).
Conclusion:Qi deficiency, blood stasis and phlegm turbidity is the most common TCM syndrome type in this study, and often combined with each other. Patients with blood stasis syndrome have higher Gensini score and coronary stenosis than patients without blood stasis, patients with phlegm turbidity have higher Gensini score than patients without phlegm turbidity.
Both blood stasis syndrome score and TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" have significant correlation with CAG Gensini score, but compared with the blood stasis syndrome score, the TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" can reflect the severity of coronary lesions better.
Research Ⅱ
Randomized double-blind placebo-controlled study of Guanxin salvia drop pill
Objective:On the basis of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)", using curative effect to explane reason, Using TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and clinical curative effect as a reason,evaluate the universality of guiding clinical practice of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)".
Methods:Using multicenter,prospective, randomized,double-blind, Placebo-controlled study design, according to the GCP process, after approved by the ethics committee,240patients with coronary heart disease in stable period was selected from Anzhen hospital, Fuwai hospital, China-Japan friendship hospital, and Xiyuan hospital, from September2011to September2011. The two groups were both given western medicine therapy, treatment group were given Guanxin salvia drop pill (0.04g/pill),10pills each time,3times daily,1month; Control group were given placbo,(0.04g/pill),10pills each time,3times daily,1month.Having follow-up14days later,28days later, record angina score, primary TCM symptom score, blood stasis syndrome score, TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and experimental index observation (including hsCRP, TC, TG, LDL, HDL) and security index were observed. SPSS13.0is used to make statistical analysis.
Results:According to the cases excluding standard, a total of28patients were excluded.212patients were involved in the study according to the study standard, including the treatment group of108cases, the placebo group of104cases. Comparison shows that in the group, the two groups' score of angina pectoris, primary TCM symptom, the blood stasis syndrome and "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score was lower than treatment (P<0.05). According to the comparison between two groups, treatment group has a tendency of lowing angina score to superior to control group, but did not reach statistical difference (P=0.055). Treatment group has a tendency of lowing primary TCM symptom score to superior to control group, but did not reach statistical difference (P=0.065).After treatment, blood stasis syndrome score was lower in treatment group than in control group (P=0.002), and in term of lowing the degree of blood stasis syndrome score, treatment group is better than control group(P=0.001). After treatment,"diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score was lower in treatment group than in control group (P=0.034), and in term of lowing the degree of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score, treatment group is better than control group(P=0.006). There are no adverse reaction and ending index occurred in two groups of patients during treatment and after treatment.
Comparative analysis of curative effect of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and Clinical curative effect in two group suggests that in term of curative effect of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and Clinical curative effect, treatment group is better than control group(95.4%vs82.7%, P=0.011;97.2%vs86.5%, p=0.014).
Conclusion:Guanxin salvia drop pill could reduce angina score, TCM syndrome score, blood stasis syndrome score,"Diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and improve clinical symptoms."Diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score can reflect the degree of illness, and it is the quantitative index which can have objective evaluations of clinical curative effect of coronary heart disease, and "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" has a good clinical universality.
但是,“冠心病血瘀证诊断标准(草案)”尚未进行临床实践验证和评价,其指导临床实践的普适性尚不明确,尤其与冠脉造影病变特点的相关性,尚缺乏循证医学实践。本研究采用横断面研究和随机双盲对照研究设计,以方测证,对“冠心病血瘀证诊断标准(草案)”进行临床验证和评价。
研究一“冠心病血瘀证诊断标准”计分与未经血运重建术冠脉造影特点的横断面研究
目的：为减少血运重建干预对Gensini评分和血瘀证计分的影响,本研究仅对未经血运重建干预的CHD患者进行研究,分析Gensini评分与血瘀证计分、“冠心病血瘀证诊断标准”计分及中医证候分布之间的相关性,以期为临床辨证治疗提供依据。
方法：选取2011年3月至2012年6月于首都医科大学附属安贞医院经冠脉造影检查确诊且未经血运重建干预的CHD患者209例,进行临床观察,记录并采集一般资料、中医证候等临床信息,并计算血瘀证计分和“冠心病血瘀证诊断标准”计分,根据CAG结果进行Gensini评分。分析Gensini评分与血瘀证计分、“冠心病血瘀证诊断标准”计分及中医证候分布之间的相关性。
结果：209例CHD患者中,稳定性心绞痛15例,不稳定性心绞痛163例,急性心肌梗死31例,陈旧性心肌梗死11例。常见中医证型依次是血瘀144例(68.9%)、痰浊93例(44.5%)、气滞8例(3.8%)、气虚74例(35.4%)、阴虚17例(8.1%)、阳虚21例(10%)、寒凝0例,阳脱1例(0.5%)。本研究中CHD患者的证型以血瘀证、痰浊证和气虚证最为常见,并相互兼夹为患,与既往的研究相似。
将CHD患者分为血瘀与非血瘀、痰浊与非痰浊、气滞与非气滞、气虚与非气虚、阳虚与非阳虚、阴虚与非阴虚六组,将各组内患者的冠状动脉病变特点进行比较发现,血瘀证患者的冠状动脉最重狭窄与Gensini评分数值均高于非血瘀证患者(P<0.05),痰浊患者的Gensini评分较非痰浊患者严重(P<0.05),提示血瘀、痰浊是CHD的主要证候要素。
血瘀证计分与Gensini评分双变量相关分析显示,血瘀证计分与Gensini评分有明显相关性(Pearson相关系数为0.68,P=0.0128)。
“冠心病血瘀证诊断标准”计分与Gensini评分的相关性分析显示,“冠心病血瘀证诊断标准”计分与Gensini评分有明显相关性(Pearson相关系数为0.72,P=0.0054)。
结论：本研究中CHD患者的证型以血瘀证、痰浊证和气虚证最为常见,且相互兼夹。血瘀证患者的冠状动脉最重狭窄与Gensini评分均高于非血瘀证患者,痰浊患者的Gensini评分数值高于非痰浊患者。血瘀证计分、“冠心病血瘀证诊断标准”计分均与冠脉造影Gensini评分呈正相关,与血瘀证计分比较,“冠心病血瘀证诊断标准”计分与Gensini评分的相关性更强。
研究二冠心丹参滴丸治疗冠心病血瘀证的随机双盲安慰剂对照研究
目的：基于“冠心病血瘀证诊断标准(草案)”,以方测证,以“冠心病血瘀证诊断标准”计分和临床疗效为依据,评价“冠心病血瘀证诊断标准(草案)”的临床普适性。
方法：采用多中心、前瞻性、随机、双盲、安慰剂对照研究设计,按照GCP流程,经伦理委员会批准后,自2011年9月至2012年9月于首都医科大学附属安贞医院、中国医学科学院阜外心血管病医院、中日友好医院、中国中医科学院西苑医院入选符合标准的CHD稳定期患者240例。两组均给予西医标准化药物治疗,试验组给予冠心丹参滴丸(0.04g/粒),每次10粒,每日3次,连续口服1个月；对照组给予冠心丹参滴丸模拟剂(0.04g/粒),每次10粒,每日3次,连续口服1个月。分别于试验前、服药后14天、服药结束后(28天)对心绞痛计分、中医主症计分、血瘀证计分、“冠心病血瘀证诊断标准”计分、理化指标(包括Hs-CRP、TC、TG、LDL、HDL)及安全性指标进行观察并记录。采用SPSS13.0软件进行统计学分析。
结果：最终入选符合研究标准的病例共212例,剔除28例,其中治疗组108例,对照组104例。组内比较显示,两组治疗后的心绞痛计分、中医主症计分、血瘀证计分、“冠心病血瘀证诊断标准”计分均较治疗前降低(P<0.05)。组间比较显示,治疗组在降低心绞痛计分程度方面有优于对照组的趋势,但未达到统计学差异(P=0.055)。治疗组在降低中医主症计分程度方面有优于对照组的趋势,但未达到统计学差异(P=0.065)。治疗组经治疗后血瘀证计分较对照组降低(P=0.002),治疗组在降低血瘀证计分程度方面优于对照组(P=0.001)。治疗组经治疗后“冠心病血瘀证诊断标准”计分较对照组降低(P=0.034),治疗组在降低“冠心病血瘀证诊断标准”计分程度方面优于对照组(P=0.006)。两组患者治疗过程中及治疗后均未发生不良反应及终点指标。两组患者“冠心病血瘀证诊断标准”计分疗效和临床疗效的比较分析显示,治疗组在“冠心病血瘀证诊断标准”计分疗效和临床疗效方面优于对照组(95.4%vs82.7%,P=0.011；97.2%vs86.5%,p=0.014)。
结论：冠心丹参滴丸能够降低心绞痛计分、中医主症计分、血瘀证计分、“冠心病血瘀证诊断标准”计分,改善临床症状。“冠心病血瘀证诊断标准”计分较血瘀证计分能更好地反映临床病情,是客观评价冠心病临床疗效的量化指标,“冠心病血瘀证诊断标准(草案)”具有良好的临床普适性。
Coronary heart disease is the type of heart disease which is caused by myocardial ischemia, hypoxia or necrosis. The reason of that pathological change is due to stenosis or obstruction or spasm of coronary artery, which is based on Coronary atherosclerosis. The incidence of the disease increased significantly year by year, and it has become a major killer to people's health. Although blood stasis is the most common TCM syndromes of coronary heart disease, but we only have the1986revision of the "diagnostic criteria of blood stasis syndrome" to guide the clinical treatment. In recent years, the relevant researchers following the concept of evidence-based medicine, using method of literature research, expert advice, clinical epidemiology investigation, mathematical statistics, have set up a "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" based on the theory of combination of TCM syndrome and disease criteria preliminary.
However,"diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" hasn't got a clinical evaluation, and the universality of guiding clinical practice remains unclear, especially for the relevance with the CAG characteristics, are lack of clinical practice based on evidence-based medicine. This research adopts the design of the cross-sectional study and randomized double-blind control study. Using the curative effect to explane reason, evaluats the clinical applicability of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease".
Reaserch I
Correlation research between TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and the Gensini score of coronary angiography in coronary heart disease patients without intervention Objective:In order to reduce influence of PCI on the Gensini score and score of
blood stasis syndrome, we only study the patients without PCI history. In order to
provide the basis for syndrome differentiation and clinical treatment, we analysis the
correlation of Gensini score and blood stasis score and TCM blood stasis syndrome
score made by "diagnostic criteria of blood stasis syndrome for patients with coronary
heart disease" and TCM syndrome distribution. Method:Select209patients from Anzhen hospital which are diagnosed with
CHD using CAG, from March2011to June2012,and make the collection of clinical
information.Make the Gensini score according to the result of CAG, record TCM
syndromes, and calculate of the score of blood stasis syndrome and the " diagnostic
criteria of blood stasis syndrome for patients with coronary heart disease ".Analysis the
correlation between the Gensini score and score of blood stasis syndrome, the "
diagnostic criteria of blood stasis syndrome for patients with coronary heart disease "
score and TCM syndrome distribution. Results:209cases of CHD patients were involved, including15cases of chronic
stable angina,163cases of unstable angina,31cases of acute myocardial infarction,
and11cases of old myocardial infarction.The common TCM syndrome types in209
patients was144cases with blood stasis (68.9%),93cases with phlegm turbidity
(44.5%), and8cases with Qi stagnation (3.8%),74cases with Qi deficiency (35.4%),
17cases with Yin deficiency (8.1%),21cases with Yang deficiency (10%),0cases
with cold, case with Yang exhausted(0.5%).Qi deficiency, blood stasis and phlegm
turbidity is the most common TCM syndrome type in this study, and often combined
with each other, which is similar to the prior research. CHD patients are divided into6groups, including blood stasis and non blood
stasis, phlegm turbidity and non phlegm turbidity, qi stagnation and non qi stagnation,
qi deficiency and non qi deficiency, Yang deficiency and non Yang deficiency, Yin
deficiency and non Yin deficiency. Analysis the CAG characteristics in each group, and
found that patients with blood stasis syndrome have higher Gensini score and coronary
stenosis than patients without blood stasis (P<0.05), patients with phlegm turbidity
have higher Gensini score and coronary stenosis than patients without phlegm turbidity (P<0.05).We conclude that blood stasis, phlegm turbidity is the main pathogenesis of CHD.
Bivariate correlation analysis of blood stasis syndrome score and the Gensini score showed that they have obvious correlation with each other (Pearson correlation coefficient is0.68, P=0.0128).
Bivariate correlation analysis of TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and the Gensini score showed that they have obvious correlation with each other (Pearson correlation coefficient was0.72, P=0.0054).
Conclusion:Qi deficiency, blood stasis and phlegm turbidity is the most common TCM syndrome type in this study, and often combined with each other. Patients with blood stasis syndrome have higher Gensini score and coronary stenosis than patients without blood stasis, patients with phlegm turbidity have higher Gensini score than patients without phlegm turbidity.
Both blood stasis syndrome score and TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" have significant correlation with CAG Gensini score, but compared with the blood stasis syndrome score, the TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" can reflect the severity of coronary lesions better.
Research Ⅱ
Randomized double-blind placebo-controlled study of Guanxin salvia drop pill
Objective:On the basis of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)", using curative effect to explane reason, Using TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and clinical curative effect as a reason,evaluate the universality of guiding clinical practice of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)".
Methods:Using multicenter,prospective, randomized,double-blind, Placebo-controlled study design, according to the GCP process, after approved by the ethics committee,240patients with coronary heart disease in stable period was selected from Anzhen hospital, Fuwai hospital, China-Japan friendship hospital, and Xiyuan hospital, from September2011to September2011. The two groups were both given western medicine therapy, treatment group were given Guanxin salvia drop pill (0.04g/pill),10pills each time,3times daily,1month; Control group were given placbo,(0.04g/pill),10pills each time,3times daily,1month.Having follow-up14days later,28days later, record angina score, primary TCM symptom score, blood stasis syndrome score, TCM blood stasis syndrome score made by "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" and experimental index observation (including hsCRP, TC, TG, LDL, HDL) and security index were observed. SPSS13.0is used to make statistical analysis.
Results:According to the cases excluding standard, a total of28patients were excluded.212patients were involved in the study according to the study standard, including the treatment group of108cases, the placebo group of104cases. Comparison shows that in the group, the two groups' score of angina pectoris, primary TCM symptom, the blood stasis syndrome and "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score was lower than treatment (P<0.05). According to the comparison between two groups, treatment group has a tendency of lowing angina score to superior to control group, but did not reach statistical difference (P=0.055). Treatment group has a tendency of lowing primary TCM symptom score to superior to control group, but did not reach statistical difference (P=0.065).After treatment, blood stasis syndrome score was lower in treatment group than in control group (P=0.002), and in term of lowing the degree of blood stasis syndrome score, treatment group is better than control group(P=0.001). After treatment,"diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score was lower in treatment group than in control group (P=0.034), and in term of lowing the degree of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score, treatment group is better than control group(P=0.006). There are no adverse reaction and ending index occurred in two groups of patients during treatment and after treatment.
Comparative analysis of curative effect of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and Clinical curative effect in two group suggests that in term of curative effect of "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and Clinical curative effect, treatment group is better than control group(95.4%vs82.7%, P=0.011;97.2%vs86.5%, p=0.014).
Conclusion:Guanxin salvia drop pill could reduce angina score, TCM syndrome score, blood stasis syndrome score,"Diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score and improve clinical symptoms."Diagnostic criteria of blood stasis syndrome for patients with coronary heart disease" score can reflect the degree of illness, and it is the quantitative index which can have objective evaluations of clinical curative effect of coronary heart disease, and "diagnostic criteria of blood stasis syndrome for patients with coronary heart disease(the draft)" has a good clinical universality.
引文
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[1]陈灏珠主编.实用内科学[M].13版.北京：人民卫生出版社,2009：1504-1505.
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[1]陈灏珠主编.实用内科学[M].13版.北京：人民卫生出版社,2009：1504-1505.
[2]中国中西医结合学会心血管病专业委员会.冠心病中医辨证标准.中西医结合杂志.1991；11(5)：257-258.
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[4]付长庚,史大卓,陈可冀等.冠心病血瘀证诊断标准研究[J].中国中西医结合杂志2012；32(9)：1285-1286.
[5]郑筱萸.中药新药临床研究指导原则(试行).中国医药科技出版社,2002,57-61
[6]赵海燕.冠心丹参滴丸中丹参酮ⅡA的含量测定[J].黑龙江医药,2011.24(4)：529-530.
[7]弥宏,董方言,谷伟玲等.冠心丹参滴丸的成型工艺设计研[J].中成药,2000.22(3)：190-192.
[8]张志信,张仕秀,胡彦.三七茎叶中叶苷及黄酮的同步分离工艺研究[J].时珍国医国药,2010.21(5)：1139-1141.
[9]刘荣东,翟小燕,黄香君.三七总皂苷注射剂对痹证疼痛老年人血瘀指标的影响[J].中国老年学杂志,2010.30(3)：1802-1804.
[10]侯双,杨艳芳,白志川等.丹参有效成分合成积累及调控的分子机制研究进展[J].现代中药研究与实践,2010.24(4)：82-85.
[11]占琼英,张炜.丹参酮治疗输液性静脉炎的效果观察[J].中国医药导报,2010.7(21)：60-61.
[12]訾慧,张振秋.HPLC法测定降香药材中木犀草素的含量[J].中国药品标准,2009.10(3)：212-215.
[13]孙丽丽,王蕾,沈志滨等.不同来源降香中柚皮素与异甘草素含量的高效液相色谱测定[J].时珍国医国药,2010.21(6)：1382-1383.
[14]蔡中方等.冠心丹参滴丸治疗无症状性心肌缺血临床观察[J].中西医结合心脑血管病杂志,2007.5(10)：1028-1029.
[15]尹琼等.冠心丹参滴丸配合消心痛治疗冠心病心绞痛70例疗效观察[J].中现代药物应用,2012.6(19)：59-60.
[16]杨靖,夏阳.冠心丹参滴丸治疗冠心病及其危险因素研究[J].实用心脑肺血管病杂志,2012.20(7)：1100-1102.
[17]肖智谦,陈平姬,陈永坚.冠心丹参滴丸对冠心病初发型心绞痛患者血内皮素和P选择素浓度的影响[J].国际医药卫生导报,2004.10(22)：78-79.
[18]王怡,高秀梅,张伯礼.冠心丹参滴丸抗垂体后叶素致大鼠急性心肌缺血的研究[J].中国中西医结合急救杂志.2003.10(1)：6-8