冠心病心绞痛病证结合疗效评价体系研究
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摘要
本研究从病证结合入手,按照临床流行病学/循证医学方法和国际量表研制的原则,于2008年3月至2009年5月在中国中医科学院广安门医院、北京中医药大学东方医院、首都医科大学附属安贞医院、河南中医学院第一附属医院及湖北中医学院(同济医院)5个中心共收集经冠脉造影证实的冠心病心绞痛患者(或冠状动脉硬化症非冠心病心绞痛患者)1488例,回收有效量表1843份,咨询全国七大行政区域的24家三甲医院(或大学、研究机构)的专家529人次。较系统的对冠心病心绞痛血瘀证疗效评价量表、冠心病心绞痛中医证候疗效评价量表、以证候要素为内容的冠心病心绞痛疗效评价体系、冠心病心绞痛患者报告的结局评价量表和冠心病心绞痛中医疗效综合评价体系进行了研究。
1冠心病心绞痛中医疗效评价体系的文献研究
通过文献检索,利用Epidata2.0软件建立冠心病心绞痛疗效评价指标文献数据库,数据库包括中医药治疗冠心病心绞痛的139篇文献(10646例冠心病心绞痛患者),研究冠心病心绞痛中医药疗效评价标准的应用情况及存在问题,结果发现现有的冠心病心绞痛中医疗效评价标准种类多,但每一种中医疗效评价标准的使用率均未超过40%。冠心病心绞痛疗效评价标准的构成条目应主要包括疾病疗效、证候疗效、理化指标、重要临床事件、生存质量等方面。说明目前冠心病心绞痛中医疗效评价标准不能满足当前临床需要,急需建立中西医界普遍认可的冠心病心绞痛中医疗效评价标准。冠心病心绞痛中医疗效评价应采用多维综合的指标体系。
2冠心病心绞痛血瘀证疗效评价量表的研究
在文献研究的基础上,通过全国130位专家的咨询,确定了冠心病心绞痛血瘀证疗效评价量表的4个维度：①疾病的症状、体征②血瘀证的症状、体征③舌脉象④理化病理检查,形成了冠心病心绞痛血瘀证疗效评价量表的理论框架。
通过多中心、较大样本的临床流行病学调查,收集了481例经冠脉造影证实的冠心病心绞痛血瘀证患者。采用6种统计方法(离散趋势法、因子分析法、相关系数法、Longistic回归法、判别分析法及专家咨询)从不同角度筛选冠心病心绞痛血瘀证疗效评价量表的条目,多种方法综合运用,确定了冠心病心绞痛血瘀证疗效评价量表的条目(包括12个条目)。并采用条件概率/指数法、M指数非线性量化和专家重要性评分3种方法对量表条目进行了综合量化,最终形成了冠心病心绞痛血瘀证疗效评价量表。
多中心收集了经冠脉造影证实的冠心病心绞痛患者350例,对冠心病心绞痛血瘀证疗效评价量表进行了科学性考核,结果发现量表的Cronbach'sa系数为0.886,评定者信度在0.863～0.979之间,提示量表具有较好的信度。通过因子分析,发现累计贡献率达56.20%,提示量表具有良好的结构效度。研究还发现冠心病心绞痛血瘀证疗效评价量表具有较好的区分效度、内容效度和反应度。
3冠心病心绞痛中医证候疗效评价量表的研究
通过多中心、大样本的临床流行病学调查,收集了800例经冠脉造影证实的冠心病心绞痛患者,采用多种统计方法进行冠心病心绞痛中医证候疗效评价量表的条目筛选,多种方法综合评价运用,确定了冠心病心绞痛中医证候疗效评价量表的条目(包括20个条目)。并采用条件概率/指数法、M指数非线性量化等方法对量表条目进行了综合量化,最终形成了冠心病心绞痛中医证候疗效评价量表。
多中心收集了经冠脉造影证实的冠心病心绞痛患者219例,对冠心病心绞痛中医证候疗效评价量表进行了科学性考核,结果发现量表的Cronbach'sα系数为0.817,评定者信度在0.805～0.959之间,提示量表具有较好的信度。通过因子分析,发现累计贡献率达54.05%,提示量表具有良好的结构效度。研究还发现冠心病心绞痛中医证候疗效评价量表具有较好的区分效度、内容效度和反应度。
4以证候要素为内容的冠心病心绞痛疗效评价体系的研究
利用100mm刻度法、综合集成研讨厅法,通过咨询全国23家三甲医院的130位专家,并结合文献分析,形成了冠心病心绞痛常见症状体征量化方案,并且利用综合层次分析法,构建了以证候要素为内容的冠心病心绞痛中医疗效评价体系。从5个中心收集了409例经冠脉造影证实的冠心病心绞痛患者来验证以证候要素为内容的冠心病心绞痛疗效评价体系。结果发现构建的以证候要素为内容的冠心病心绞痛疗效评价体系与心绞痛周发作次数(Spearman系数0.325,P=0.00)、生存质量(Spearman系数为0.285,P=0.00)有较强相关性,说明构建的以证候要素为内容的冠心病心绞痛疗效评价体系能体现中医治疗目标与结果的相关性。由于以证候要素为内容的冠心病心绞痛疗效评价体系涉及诸多公式和变量,临床操作起来比较困难,开发了以证候要素为内容的冠心病心绞痛疗效评价体系软件,并成功申请了软件著作权(软著登字0144805号)。
5冠心病心绞痛患者报告的结局评价量表的研究
通过对患者报告的结局指标(PRO)研究内容的回顾和对冠心病心绞痛的中医理论认识的探讨,认为冠心病心绞痛中医PRO疗效评价量表的研制应结合中医理论,参照国际PRO量表的理论框架,具体包括生理、心理、独立、社会关系、社会环境领域4个维度。冠心病心绞痛中医PRO疗效评价量表在生理领域,以“心为主,五脏相关”理论为主线,分设各个项目(方面),体现引起患者自我不适感觉的各个环节,最终形成了胸痛、胸闷、心悸、积极感受、消极感受、所需社会支持程度等19个方面,构成了冠心病心绞痛PRO疗效评价量表的理论结构模型。
收集了319例经冠脉造影证实的患者(冠心病心绞痛患者203例,冠状动脉硬化症患者116例),回收量表847份。采用6种统计方法从不同角度筛选冠心病心绞痛PRO疗效评价量表的条目,多种方法综合评价,确定了冠心病心绞痛PRO疗效评价量表的最终条目(包括31个条目),并在研究量表反应尺度的基础上,形成了冠心病心绞痛PRO疗效评价量表。
多中心收集了经冠脉造影证实的冠心病心绞痛患者237例,对冠心病心绞痛PRO疗效评价量表进行了科学性考核,发现量表的Cronbach's a系数为0.813,分半信度为0.707,提示量表具有较好的信度。通过因子分析,发现累计贡献率达50.08%,提示量表具有良好的结构效度。研究还发现冠心病心绞痛PRO疗效评价量表具有较好的内容效度、区分效度和反应度。
6冠心病心绞痛中医疗效综合评价体系的研究
通过大量文献分析,咨询全国范围内的131位专家,借助数学综合评价方法(TOPSIS法)构建了冠心病心绞痛中医疗效综合评价体系,冠心病心绞痛中医疗效综合评价体系包括6个维度：①对病常规疗效评价指标②以证候要素为内容的疗效评价指标③重要临床事件发生率④患者报告的疗效评价指标⑤安全性疗效评价指标⑥卫生经济学疗效评价指标。冠心病心绞痛中医疗效综合评价体系是包括目标层、维度层和指标层的疗效综合评价三层递阶层次结构体系。
收集了60例经冠脉造影证实的冠心病心绞痛患者,采用随机、双盲双模拟、平行对照的试验方法,治疗组给予银丹通络胶囊,对照组给予血府逐瘀胶囊。采用构建好的冠心病心绞痛中医疗效综合评价体系模型对两组进行评价,结果发现银丹通络胶囊组与正理想解的接近程度Ci值为0.8361,血府逐瘀胶囊组与正理想解的接近程度C,值为0.1639,结果提示银丹通络胶囊组的中医综合疗效优于血府逐瘀胶囊组。通过本临床试验初步验证了冠心病心绞痛中医疗效综合评价体系模型的可行性。
7主要结论
(一)提出了从对“病”的常规疗效评价、以证候要素为内容的疗效评价、主要结局指标(重要临床事件发生率)的疗效评价、基于患者报告的结局疗效评价、安全性评价和卫生经济学评价6个方面(维度),构建中医药治疗冠心病心绞痛的病证结合疗效评价指标体系。
(二)研制了冠心病心绞痛血瘀证疗效评价量表,该量表具有较好的信度、效度和反应度,可以用于临床进行冠心病心绞痛血瘀证的疗效评价。
(三)研制了冠心病心绞痛中医证候疗效评价量表,该量表具有较好的信度、效度和反应度,可以应用于临床冠心病心绞痛的中医疗效评价。
(四)构建了以证候要素为内容的冠心病心绞痛中医疗效评价体系并进行了临床验证。还开发了以证候要素为内容的冠心病心绞痛疗效评价体系软件(软著登字0144805号)。
(五)研制了冠心病心绞痛PRO疗效评价量表,量表具有较好的信度、效度和反应度,可以应用于临床冠心病心绞痛患者的疗效评价。
(六)构建了冠心病心绞痛中医疗效综合评价体系,该体系是包括目标层、维度层和指标层的疗效综合评价三层递阶层次结构体系。并通过临床试验初步验证了冠心病心绞痛中医疗效综合评价体系模型的可行性。
This research was carried out according to clinical epidemiology/ evidence-based medicine methods and principles of international scale development. And this research was also based on combination diseases and syndromes.1488 patients (with angina pectoris angina pectoris or coronary artery sclerosis) confirmed by coronary angiography and 1843 valid scales were enrolled with multi-center from Guang'anmen Hospital, China Academy of Chinese Medical Sciences,Dongfang Hospital, Beijing University of Chinese Medicine,Anzhen Hospital, Capital Medical University,First Affiliated Hospital of Henan traditional Chinese medical college and Hubei traditional Chinese medical college (Tongji Hospital) in March 2008 to May 2009. And 529 times expert advices which come from nationwide 24 the top three hospitals (universities or research institutions). Clinical rating scale of angina pectoris with blood stasis syndrome, Clinical rating scale on angina pectoris with TCM syndrome, system of efficacy evaluation on angina pectoris based syndrome element, rating scale based on angina pectoris patients-reported outcomes and comprehensive efficacy assessment system of angina pectoris were researched systematically
1 The literature research on evaluation standard of TCM efficacy of angina pectoris
The efficacy evaluation database of angina pectoris was established by the literature search and the software Epidata2.0.139 documents(10,646 cases of angina pectoris in patients with coronary heart disease)which were treated with traditional Chinese medicine(TCM)of angina pectoris were researched, and the application and existing problems of TCM evaluation standards of the efficacy of angina pectoris were studied. The results suggested that there were many kinds of evaluation standards of TCM efficacy of angina pectoris, but the utilization rate of each standard was lower than 40%. The main constructive item in evaluation standards of angina pectoris should include:the effect of the disease, syndrome effects, physical and chemical indicatrix, important clinical event, quality of life and so on.The current evaluation standards of TCM efficacy of angina pectoris could not meet the clinical needs.A received evaluation standard should be established.The evaluation of TCM efficacy of angina pectoris should adopt integrated multi-dimensional index system.
2 Research on clinical rating scale of angina pectoris with blood stasis syndrome
On the basis of the literature research and the expert advisory (130 experts),the 4 dimensios(①symptoms and signs of disease②symptoms and signs of blood stasis③tongue and pulse signs④chemical pathology)of clinical rating scale of angina pectoris with blood stasis syndrome was developed, which established the theory foundatio for the further development of PRO scale.
481 patients with angina pectoris and blood stasis syndrome confirmed by coronary angiography were enrolled with multi-center by epidemiologic survey. Six methods (The discrete tendency method, correlation coefficient, factor analysis, Longistic regression,stepwise discriminant method and expert advice)were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 12 items) for clinical rating scale of angina pectoris with blood stasis syndrome. The rating scale was developed based on comprehensively quantify of the scale items with 3 methods (conditional probability/index, M nonlinear index and experts score of the importance on items).
350 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of Clinical rating scale of angina pectoris with blood stasis syndrome were analysised. The Cronbach's a coefficient of scale was 0.886, rater reliability was 0.863～0.979. It was suggested that the rating scale has good reliability. Total variance explained of scale was 56.20% by factor analysis. It was suggested that the rating scale has good construction validity. Clinical rating scale of angina pectoris with blood stasis syndrome also has good discrimination validity, content validity and responsiveness.
3 Research on Clinical rating scale on angina pectoris with TCM syndrome
800 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center by epidemiologic survey. Many methods were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 20 items) for Clinical rating scale on angina pectoris with TCM syndrome. The rating scale was developed based on comprehensively quantify of the scale items with conditional probability/index method, M nonlinear index method, etc.
219 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of Clinical rating scale on angina pectoris with TCM syndrome were analysised. The Cronbach's a coefficient of scale was 0.817, rater reliability was 0.805～0.959. It was suggested that the rating scale has good reliability. Total variance explained of scale was 54.05% by factor analysis. It was suggested that the rating scale has good construction validity. Clinical rating scale on angina pectoris with TCM syndrome also has good discrimination validity, content validity and responsiveness.
4 Research on system of efficacy evaluation on angina pectoris based syndrome element
The quantization scheme on common symptoms and signs of angina pectoris was formated by 100mm scale method, hall for workshop of metasynthetic engineering method, experts, which comes from 23 the top three hospitals, and literature analysis. And the system of efficacy evaluation on angina pectoris based syndrome element was constructed by AHP.409 patients with angina pectoris confirmed by coronary angiography were enrolled from 5 centers in order to authenticate the system of efficacy evaluation on angina pectoris based syndrome element. The results showed that the system of efficacy evaluation on angina pectoris based syndrome element and the number of angina attacks per week (Spearman coefficient 0.325, P=0.00), quality of life (Spearman coefficient 0.285, P=0.00) have very strong correlation. It was believed that the system of efficacy evaluation would reflect the relevance between TCM treatment goals and the results. Clinical operations is difficult due to the system of efficacy evaluation on angina pectoris based syndrome element involves many formulas and variables,, So software was developed for the system of efficacy evaluation, and was successfully applied for software copyright (soft registration No.0144805).
5 Research on rating scale based on angina pectoris patients-reported outcomes
By reviewing the research on patient reported outcomes(PRO)and the understanding of the theory of traditional Chinese medicine in coronary heart disease.The rating scale based on angina pectoris patients-reported outcomes should be guided by the theory of TCM and modern theoretical framework of PRO scale.It was believed that the physical, psychological, independence and social sphere constructed a special PRO efficacy scale of traditional Chinese medicine in coronary heart disease.The field of physiology on the scale was guided by'heart-based,five internal organs correlation'theory as the main line, and the scale was divided into various aspects in order to reflect all aspects of uncomfortable self-feeling of patients.Finally,19 sides such as chest pain,chest tightness,heart palpitations, positive feelings,negative feelings, and social support needed and so on,which established the theory foundatio for the further development of PRO scale.
319 patients (203 patients with angina pectoris and 116 patients with coronary artery sclerosis) confirmed by coronary angiography were enrolled with multi-center. And 1843 scales were enrolled. Six methods were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 31 items) for rating scale based on angina pectoris patients-reported outcomes. The rating scale was developed based on the research on item response.
237 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of rating scale based on angina pectoris patients-reported outcomes were analysised. The Cronbach's a coefficient of scale was 0.813, split-half reliability was 0.707. It was suggested that the rating scale based on angina pectoris patients-reported outcomes has good reliability. Total variance explained of scale was 50.08% by factor analysis. It was suggested that the rating scale based on angina pectoris patients-reported outcomes has good construction validity. The rating scale based on angina pectoris patients-reported outcomes also has good content validity, discrimination validity and responsiveness.
6 Research on comprehensive efficacy assessment system of angina pectoris
Comprehensive efficacy assessment system of angina pectoris based on literature analysis,131 experts advice and TOPSIS method. Comprehensive efficacy assessment system of angina pectoris have 6 dimension:①efficacy evaluation of "disease"②syndrome factors③main endpoints (the incidence of important clinical events)④patient reported outcomes⑤safety evaluation,⑥edical economics. Comprehensive efficacy assessment system of angina pectoris includes the target layer, the dimension layer and index layer, and it was a comprehensive evaluation system of the efficacy with three-tier hierarchical structure.
60 patients with angina pectoris confirmed by coronary angiography were enrolled,A randomized, double-blind, double dummy, parallel controlled trial was set up. The treatment group was treated with Ying-Dan-Tong-Luo Capsule, the control group was treated with Xue-Fu-Zhu-Yu capsules. And the comprehensive efficacy assessment system was used for assessing two groups. The result was that the proximity of the positive ideal solution in Ying-Dan-Tong-Luo Capsule group is 0.8361, The proximity of the positive ideal solution in Xue-Fu-Zhu-Yu capsules group is 0.1639. It was suggested that Ying-Dan-Tong-Luo Capsule group was better than the Xue-Fu-Zhu-Yu capsules group. The clinical trials had proved comprehensive evaluation system model was feasible.
7 Major conclusion
(1) We try to set up a new index system of efficacy evaluation, combining both disease and syndrome differentiation for CHD angina pectoris. The system was composed of six aspects, including efficacy evaluation of "disease", syndrome factors and main endpoints (the incidence of important clinical events), as well as patient reported outcomes, safety evaluation and medical economics.
(2) The clinical rating scale of angina pectoris with blood stasis syndrome was developed. It was believed that the clinical rating scale of angina pectoris with blood stasis syndrome has good reliability,validity and responsiveness. And the clinical rating scale can be used for clinical evaluation on angina pectoris with blood stasis syndrome.
(3) The clinical rating scale on angina pectoris with TCM syndrome was developed. It was believed that the clinical rating scale on angina pectoris with TCM syndrome has good reliability,validity and responsiveness. And the the clinical rating scale can be used for clinical evaluation on angina pectoris with TCM syndrome.
(4) The system of efficacy evaluation on angina pectoris based syndrome element was constructed, and patients with angina pectoris were enrolled in order to authenticate the system of efficacy evaluation on angina pectoris based syndrome element.Software was developed for the system of efficacy evaluation, and successfully applied for software copyright (soft registration No.0144805).
(5) The rating scale based on angina pectoris patients-reported outcomes was developed. It was believed that the rating scale based on angina pectoris patients-reported outcomes has good reliability,validity and responsiveness.And the the rating scale based on angina pectoris patients-reported outcomes can be used for clinical evaluation.
(6) Comprehensive efficacy assessment system of angina pectoris was constructed. The assessment system of angina pectoris includes the target layer, the dimension layer and index layer, and it was a comprehensive evaluation system of the efficacy with three-tier hierarchical structure. And a clinical trials had proved comprehensive evaluation system model was feasible.
1冠心病心绞痛中医疗效评价体系的文献研究
通过文献检索,利用Epidata2.0软件建立冠心病心绞痛疗效评价指标文献数据库,数据库包括中医药治疗冠心病心绞痛的139篇文献(10646例冠心病心绞痛患者),研究冠心病心绞痛中医药疗效评价标准的应用情况及存在问题,结果发现现有的冠心病心绞痛中医疗效评价标准种类多,但每一种中医疗效评价标准的使用率均未超过40%。冠心病心绞痛疗效评价标准的构成条目应主要包括疾病疗效、证候疗效、理化指标、重要临床事件、生存质量等方面。说明目前冠心病心绞痛中医疗效评价标准不能满足当前临床需要,急需建立中西医界普遍认可的冠心病心绞痛中医疗效评价标准。冠心病心绞痛中医疗效评价应采用多维综合的指标体系。
2冠心病心绞痛血瘀证疗效评价量表的研究
在文献研究的基础上,通过全国130位专家的咨询,确定了冠心病心绞痛血瘀证疗效评价量表的4个维度：①疾病的症状、体征②血瘀证的症状、体征③舌脉象④理化病理检查,形成了冠心病心绞痛血瘀证疗效评价量表的理论框架。
通过多中心、较大样本的临床流行病学调查,收集了481例经冠脉造影证实的冠心病心绞痛血瘀证患者。采用6种统计方法(离散趋势法、因子分析法、相关系数法、Longistic回归法、判别分析法及专家咨询)从不同角度筛选冠心病心绞痛血瘀证疗效评价量表的条目,多种方法综合运用,确定了冠心病心绞痛血瘀证疗效评价量表的条目(包括12个条目)。并采用条件概率/指数法、M指数非线性量化和专家重要性评分3种方法对量表条目进行了综合量化,最终形成了冠心病心绞痛血瘀证疗效评价量表。
多中心收集了经冠脉造影证实的冠心病心绞痛患者350例,对冠心病心绞痛血瘀证疗效评价量表进行了科学性考核,结果发现量表的Cronbach'sa系数为0.886,评定者信度在0.863～0.979之间,提示量表具有较好的信度。通过因子分析,发现累计贡献率达56.20%,提示量表具有良好的结构效度。研究还发现冠心病心绞痛血瘀证疗效评价量表具有较好的区分效度、内容效度和反应度。
3冠心病心绞痛中医证候疗效评价量表的研究
通过多中心、大样本的临床流行病学调查,收集了800例经冠脉造影证实的冠心病心绞痛患者,采用多种统计方法进行冠心病心绞痛中医证候疗效评价量表的条目筛选,多种方法综合评价运用,确定了冠心病心绞痛中医证候疗效评价量表的条目(包括20个条目)。并采用条件概率/指数法、M指数非线性量化等方法对量表条目进行了综合量化,最终形成了冠心病心绞痛中医证候疗效评价量表。
多中心收集了经冠脉造影证实的冠心病心绞痛患者219例,对冠心病心绞痛中医证候疗效评价量表进行了科学性考核,结果发现量表的Cronbach'sα系数为0.817,评定者信度在0.805～0.959之间,提示量表具有较好的信度。通过因子分析,发现累计贡献率达54.05%,提示量表具有良好的结构效度。研究还发现冠心病心绞痛中医证候疗效评价量表具有较好的区分效度、内容效度和反应度。
4以证候要素为内容的冠心病心绞痛疗效评价体系的研究
利用100mm刻度法、综合集成研讨厅法,通过咨询全国23家三甲医院的130位专家,并结合文献分析,形成了冠心病心绞痛常见症状体征量化方案,并且利用综合层次分析法,构建了以证候要素为内容的冠心病心绞痛中医疗效评价体系。从5个中心收集了409例经冠脉造影证实的冠心病心绞痛患者来验证以证候要素为内容的冠心病心绞痛疗效评价体系。结果发现构建的以证候要素为内容的冠心病心绞痛疗效评价体系与心绞痛周发作次数(Spearman系数0.325,P=0.00)、生存质量(Spearman系数为0.285,P=0.00)有较强相关性,说明构建的以证候要素为内容的冠心病心绞痛疗效评价体系能体现中医治疗目标与结果的相关性。由于以证候要素为内容的冠心病心绞痛疗效评价体系涉及诸多公式和变量,临床操作起来比较困难,开发了以证候要素为内容的冠心病心绞痛疗效评价体系软件,并成功申请了软件著作权(软著登字0144805号)。
5冠心病心绞痛患者报告的结局评价量表的研究
通过对患者报告的结局指标(PRO)研究内容的回顾和对冠心病心绞痛的中医理论认识的探讨,认为冠心病心绞痛中医PRO疗效评价量表的研制应结合中医理论,参照国际PRO量表的理论框架,具体包括生理、心理、独立、社会关系、社会环境领域4个维度。冠心病心绞痛中医PRO疗效评价量表在生理领域,以“心为主,五脏相关”理论为主线,分设各个项目(方面),体现引起患者自我不适感觉的各个环节,最终形成了胸痛、胸闷、心悸、积极感受、消极感受、所需社会支持程度等19个方面,构成了冠心病心绞痛PRO疗效评价量表的理论结构模型。
收集了319例经冠脉造影证实的患者(冠心病心绞痛患者203例,冠状动脉硬化症患者116例),回收量表847份。采用6种统计方法从不同角度筛选冠心病心绞痛PRO疗效评价量表的条目,多种方法综合评价,确定了冠心病心绞痛PRO疗效评价量表的最终条目(包括31个条目),并在研究量表反应尺度的基础上,形成了冠心病心绞痛PRO疗效评价量表。
多中心收集了经冠脉造影证实的冠心病心绞痛患者237例,对冠心病心绞痛PRO疗效评价量表进行了科学性考核,发现量表的Cronbach's a系数为0.813,分半信度为0.707,提示量表具有较好的信度。通过因子分析,发现累计贡献率达50.08%,提示量表具有良好的结构效度。研究还发现冠心病心绞痛PRO疗效评价量表具有较好的内容效度、区分效度和反应度。
6冠心病心绞痛中医疗效综合评价体系的研究
通过大量文献分析,咨询全国范围内的131位专家,借助数学综合评价方法(TOPSIS法)构建了冠心病心绞痛中医疗效综合评价体系,冠心病心绞痛中医疗效综合评价体系包括6个维度：①对病常规疗效评价指标②以证候要素为内容的疗效评价指标③重要临床事件发生率④患者报告的疗效评价指标⑤安全性疗效评价指标⑥卫生经济学疗效评价指标。冠心病心绞痛中医疗效综合评价体系是包括目标层、维度层和指标层的疗效综合评价三层递阶层次结构体系。
收集了60例经冠脉造影证实的冠心病心绞痛患者,采用随机、双盲双模拟、平行对照的试验方法,治疗组给予银丹通络胶囊,对照组给予血府逐瘀胶囊。采用构建好的冠心病心绞痛中医疗效综合评价体系模型对两组进行评价,结果发现银丹通络胶囊组与正理想解的接近程度Ci值为0.8361,血府逐瘀胶囊组与正理想解的接近程度C,值为0.1639,结果提示银丹通络胶囊组的中医综合疗效优于血府逐瘀胶囊组。通过本临床试验初步验证了冠心病心绞痛中医疗效综合评价体系模型的可行性。
7主要结论
(一)提出了从对“病”的常规疗效评价、以证候要素为内容的疗效评价、主要结局指标(重要临床事件发生率)的疗效评价、基于患者报告的结局疗效评价、安全性评价和卫生经济学评价6个方面(维度),构建中医药治疗冠心病心绞痛的病证结合疗效评价指标体系。
(二)研制了冠心病心绞痛血瘀证疗效评价量表,该量表具有较好的信度、效度和反应度,可以用于临床进行冠心病心绞痛血瘀证的疗效评价。
(三)研制了冠心病心绞痛中医证候疗效评价量表,该量表具有较好的信度、效度和反应度,可以应用于临床冠心病心绞痛的中医疗效评价。
(四)构建了以证候要素为内容的冠心病心绞痛中医疗效评价体系并进行了临床验证。还开发了以证候要素为内容的冠心病心绞痛疗效评价体系软件(软著登字0144805号)。
(五)研制了冠心病心绞痛PRO疗效评价量表,量表具有较好的信度、效度和反应度,可以应用于临床冠心病心绞痛患者的疗效评价。
(六)构建了冠心病心绞痛中医疗效综合评价体系,该体系是包括目标层、维度层和指标层的疗效综合评价三层递阶层次结构体系。并通过临床试验初步验证了冠心病心绞痛中医疗效综合评价体系模型的可行性。
This research was carried out according to clinical epidemiology/ evidence-based medicine methods and principles of international scale development. And this research was also based on combination diseases and syndromes.1488 patients (with angina pectoris angina pectoris or coronary artery sclerosis) confirmed by coronary angiography and 1843 valid scales were enrolled with multi-center from Guang'anmen Hospital, China Academy of Chinese Medical Sciences,Dongfang Hospital, Beijing University of Chinese Medicine,Anzhen Hospital, Capital Medical University,First Affiliated Hospital of Henan traditional Chinese medical college and Hubei traditional Chinese medical college (Tongji Hospital) in March 2008 to May 2009. And 529 times expert advices which come from nationwide 24 the top three hospitals (universities or research institutions). Clinical rating scale of angina pectoris with blood stasis syndrome, Clinical rating scale on angina pectoris with TCM syndrome, system of efficacy evaluation on angina pectoris based syndrome element, rating scale based on angina pectoris patients-reported outcomes and comprehensive efficacy assessment system of angina pectoris were researched systematically
1 The literature research on evaluation standard of TCM efficacy of angina pectoris
The efficacy evaluation database of angina pectoris was established by the literature search and the software Epidata2.0.139 documents(10,646 cases of angina pectoris in patients with coronary heart disease)which were treated with traditional Chinese medicine(TCM)of angina pectoris were researched, and the application and existing problems of TCM evaluation standards of the efficacy of angina pectoris were studied. The results suggested that there were many kinds of evaluation standards of TCM efficacy of angina pectoris, but the utilization rate of each standard was lower than 40%. The main constructive item in evaluation standards of angina pectoris should include:the effect of the disease, syndrome effects, physical and chemical indicatrix, important clinical event, quality of life and so on.The current evaluation standards of TCM efficacy of angina pectoris could not meet the clinical needs.A received evaluation standard should be established.The evaluation of TCM efficacy of angina pectoris should adopt integrated multi-dimensional index system.
2 Research on clinical rating scale of angina pectoris with blood stasis syndrome
On the basis of the literature research and the expert advisory (130 experts),the 4 dimensios(①symptoms and signs of disease②symptoms and signs of blood stasis③tongue and pulse signs④chemical pathology)of clinical rating scale of angina pectoris with blood stasis syndrome was developed, which established the theory foundatio for the further development of PRO scale.
481 patients with angina pectoris and blood stasis syndrome confirmed by coronary angiography were enrolled with multi-center by epidemiologic survey. Six methods (The discrete tendency method, correlation coefficient, factor analysis, Longistic regression,stepwise discriminant method and expert advice)were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 12 items) for clinical rating scale of angina pectoris with blood stasis syndrome. The rating scale was developed based on comprehensively quantify of the scale items with 3 methods (conditional probability/index, M nonlinear index and experts score of the importance on items).
350 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of Clinical rating scale of angina pectoris with blood stasis syndrome were analysised. The Cronbach's a coefficient of scale was 0.886, rater reliability was 0.863～0.979. It was suggested that the rating scale has good reliability. Total variance explained of scale was 56.20% by factor analysis. It was suggested that the rating scale has good construction validity. Clinical rating scale of angina pectoris with blood stasis syndrome also has good discrimination validity, content validity and responsiveness.
3 Research on Clinical rating scale on angina pectoris with TCM syndrome
800 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center by epidemiologic survey. Many methods were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 20 items) for Clinical rating scale on angina pectoris with TCM syndrome. The rating scale was developed based on comprehensively quantify of the scale items with conditional probability/index method, M nonlinear index method, etc.
219 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of Clinical rating scale on angina pectoris with TCM syndrome were analysised. The Cronbach's a coefficient of scale was 0.817, rater reliability was 0.805～0.959. It was suggested that the rating scale has good reliability. Total variance explained of scale was 54.05% by factor analysis. It was suggested that the rating scale has good construction validity. Clinical rating scale on angina pectoris with TCM syndrome also has good discrimination validity, content validity and responsiveness.
4 Research on system of efficacy evaluation on angina pectoris based syndrome element
The quantization scheme on common symptoms and signs of angina pectoris was formated by 100mm scale method, hall for workshop of metasynthetic engineering method, experts, which comes from 23 the top three hospitals, and literature analysis. And the system of efficacy evaluation on angina pectoris based syndrome element was constructed by AHP.409 patients with angina pectoris confirmed by coronary angiography were enrolled from 5 centers in order to authenticate the system of efficacy evaluation on angina pectoris based syndrome element. The results showed that the system of efficacy evaluation on angina pectoris based syndrome element and the number of angina attacks per week (Spearman coefficient 0.325, P=0.00), quality of life (Spearman coefficient 0.285, P=0.00) have very strong correlation. It was believed that the system of efficacy evaluation would reflect the relevance between TCM treatment goals and the results. Clinical operations is difficult due to the system of efficacy evaluation on angina pectoris based syndrome element involves many formulas and variables,, So software was developed for the system of efficacy evaluation, and was successfully applied for software copyright (soft registration No.0144805).
5 Research on rating scale based on angina pectoris patients-reported outcomes
By reviewing the research on patient reported outcomes(PRO)and the understanding of the theory of traditional Chinese medicine in coronary heart disease.The rating scale based on angina pectoris patients-reported outcomes should be guided by the theory of TCM and modern theoretical framework of PRO scale.It was believed that the physical, psychological, independence and social sphere constructed a special PRO efficacy scale of traditional Chinese medicine in coronary heart disease.The field of physiology on the scale was guided by'heart-based,five internal organs correlation'theory as the main line, and the scale was divided into various aspects in order to reflect all aspects of uncomfortable self-feeling of patients.Finally,19 sides such as chest pain,chest tightness,heart palpitations, positive feelings,negative feelings, and social support needed and so on,which established the theory foundatio for the further development of PRO scale.
319 patients (203 patients with angina pectoris and 116 patients with coronary artery sclerosis) confirmed by coronary angiography were enrolled with multi-center. And 1843 scales were enrolled. Six methods were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 31 items) for rating scale based on angina pectoris patients-reported outcomes. The rating scale was developed based on the research on item response.
237 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of rating scale based on angina pectoris patients-reported outcomes were analysised. The Cronbach's a coefficient of scale was 0.813, split-half reliability was 0.707. It was suggested that the rating scale based on angina pectoris patients-reported outcomes has good reliability. Total variance explained of scale was 50.08% by factor analysis. It was suggested that the rating scale based on angina pectoris patients-reported outcomes has good construction validity. The rating scale based on angina pectoris patients-reported outcomes also has good content validity, discrimination validity and responsiveness.
6 Research on comprehensive efficacy assessment system of angina pectoris
Comprehensive efficacy assessment system of angina pectoris based on literature analysis,131 experts advice and TOPSIS method. Comprehensive efficacy assessment system of angina pectoris have 6 dimension:①efficacy evaluation of "disease"②syndrome factors③main endpoints (the incidence of important clinical events)④patient reported outcomes⑤safety evaluation,⑥edical economics. Comprehensive efficacy assessment system of angina pectoris includes the target layer, the dimension layer and index layer, and it was a comprehensive evaluation system of the efficacy with three-tier hierarchical structure.
60 patients with angina pectoris confirmed by coronary angiography were enrolled,A randomized, double-blind, double dummy, parallel controlled trial was set up. The treatment group was treated with Ying-Dan-Tong-Luo Capsule, the control group was treated with Xue-Fu-Zhu-Yu capsules. And the comprehensive efficacy assessment system was used for assessing two groups. The result was that the proximity of the positive ideal solution in Ying-Dan-Tong-Luo Capsule group is 0.8361, The proximity of the positive ideal solution in Xue-Fu-Zhu-Yu capsules group is 0.1639. It was suggested that Ying-Dan-Tong-Luo Capsule group was better than the Xue-Fu-Zhu-Yu capsules group. The clinical trials had proved comprehensive evaluation system model was feasible.
7 Major conclusion
(1) We try to set up a new index system of efficacy evaluation, combining both disease and syndrome differentiation for CHD angina pectoris. The system was composed of six aspects, including efficacy evaluation of "disease", syndrome factors and main endpoints (the incidence of important clinical events), as well as patient reported outcomes, safety evaluation and medical economics.
(2) The clinical rating scale of angina pectoris with blood stasis syndrome was developed. It was believed that the clinical rating scale of angina pectoris with blood stasis syndrome has good reliability,validity and responsiveness. And the clinical rating scale can be used for clinical evaluation on angina pectoris with blood stasis syndrome.
(3) The clinical rating scale on angina pectoris with TCM syndrome was developed. It was believed that the clinical rating scale on angina pectoris with TCM syndrome has good reliability,validity and responsiveness. And the the clinical rating scale can be used for clinical evaluation on angina pectoris with TCM syndrome.
(4) The system of efficacy evaluation on angina pectoris based syndrome element was constructed, and patients with angina pectoris were enrolled in order to authenticate the system of efficacy evaluation on angina pectoris based syndrome element.Software was developed for the system of efficacy evaluation, and successfully applied for software copyright (soft registration No.0144805).
(5) The rating scale based on angina pectoris patients-reported outcomes was developed. It was believed that the rating scale based on angina pectoris patients-reported outcomes has good reliability,validity and responsiveness.And the the rating scale based on angina pectoris patients-reported outcomes can be used for clinical evaluation.
(6) Comprehensive efficacy assessment system of angina pectoris was constructed. The assessment system of angina pectoris includes the target layer, the dimension layer and index layer, and it was a comprehensive evaluation system of the efficacy with three-tier hierarchical structure. And a clinical trials had proved comprehensive evaluation system model was feasible.
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[1]孙振球.医学综合评价方法.化学工业出版社,2006：53.
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