调脾护心法治疗冠心病诊疗方案的临床与推广评价研究
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摘要
目的：
通过邓铁涛教授调脾护心法治疗冠心病稳定型心绞痛气虚痰瘀阻络证的前瞻性队列研究及推广评价研究,第一,旨在观察邓铁涛教授调脾护心法治疗方案较其它中医方法的临床疗效及安全性,第二,旨在形成完整的推广方法并评估此方案在岭南地区中医院内的推广情况。
方法：
按照队列研究的方法,观察符合冠心病稳定型心绞痛气虚痰瘀阻络证纳入标准197例,分为暴露组与非暴露组。暴露组采用邓铁涛教授调脾护心法联合西医基础治疗,非暴露组其它经验方联合西医基础治疗。治疗周期为12周,观察治疗开始后,30±3天、90±3天、360±3天,三个时点进行随访。内容包括中医症候、心绞痛积分、心电图、西雅图心绞痛量表(SAQ)等,并对安全性做出评价。
推广方法采用多媒体教学与临床带教相结合,培训6周。评价方法采用两部分：第一部分为学员考核,采用试卷考核、独立诊疗考核和量表调查三种方法；第二部分为讲授者考核部分,主要采用量表调查。
结果：
一、临床研究
入组197例患者,治疗前基本情况无显著性差异(P>0.05),具有可比性。但两组男性比例明显高于女性。在治疗28周后,研究结果显示：
(一)临床疗效
1.中医症候：
(1)症候疗效(中医症征)
经卡方检验,治疗第90天中医症征,两组间无统计学意义(P>0.05),无差异。治疗360天症候疗效,有统计学意义(P<0.01)。说明两组在360天症候疗效方面,存在显著性差异,暴露组明显优于非暴露组。
(2)症候疗效(中医症状)
经卡方检验,有统计学意义(P<0.01),两组90天中医症状,存在显著性差异,暴露组明显优于非暴露组。在360天中医症状评价方面,有统计学意义(P<0.01),存在显著性差异。暴露组明显优于非暴露组。
2.心绞痛积分
经秩和检验,治疗30天,P>0.05,两组抗心绞痛疗效无差异；360天,P<0.01,两组心绞痛积分有差异,显示暴露组明显优于非暴露组。
3.心电图疗效方面
经卡方检验,治疗90天,无统计学意义(P>0.05),两组在心电图疗效上无显著差异。
4.SAQ评分
经秩和检验,第360天,在躯体活动受限程度、稳定状态维持度、发作情况维持度、满意程度维持度和认识程度维持度5个方面有显著性差异(P<0.01)。暴露组对心绞痛患者生活质量的改善程度明显优于非暴露组。
(二)安全性
暴露组与非暴露组均未出现严重不良反应,具有较好的安全性。
二、推广评价研究
(一)推广情况
三家研究单位分别有6位医生参加推广培训考核
1.试卷考核
所有被培训者试卷考核均在90分以上。
2.独立诊疗考核
18位被培训者共诊疗36位患者,其中3例患者治疗方面与培训方案存在差异,
符合度为91.6%。
3.评价量表分析
(1)三家医院普遍对总体教学目标、心脾气虚,痰瘀阻络的主症和次症概括及舌脉象、多媒体教学、舌像图、教学态度、教学效果的认知度和接受度最好,认为能够运用所学知识解决接诊中的实际问题,并且认为在原有的基础上得到提高；同时,对脉象示意图认知度和接受度较低,认为讲者在授课中的难点和重点不够突出,组织教学能力与课堂管理能力相对较弱。
(2)三家医院中,江门五邑中医院对本治疗方案的推广认知度与接受度为最好,而惠州市中医院的认知度和接受度相对较低。
(二)评价研究
对本研究方案的认知度和接受度高的江门五邑中医院,最终对研究方案的掌握度也较好,反之,另外两家医院则相对较差。
结论：
邓铁涛教授调脾护心法联合西医基础治疗对冠心病稳定型心绞痛气虚痰瘀证,较其它经验方治疗该病证,能够更好改善患者中医症候及心绞痛症状、提高生活质量等,有良好的远期疗效。且安全性高。是中医药治疗冠心病应用的一个良好的联合方法,其推广评价方案在岭南地区中医院培训推广运用中,得到认可,疗效肯定。
Objective
The study selected stable angina pectoris qi deficiency and phlegm network card, has two purposes. First, it was designed to observe the cli-nical efficacy and safetyindicators of Professor Deng Tietao Tiaopi care Heart treatment programs. Second, to form a complete promotional methods and to assess the promotion of this program in Chinese medicine hospital.
Methods
Clinical research in accordance with the methods of the cohort study, observation of the coronary heart disease with stable angina pectoris qi deficiency and phlegm network card the inclusion criteria (n=197), divid ed into exposed and non-exposed group. Western basic treatment, Professor Deng Tietao Tiaopi Heart care treatment exposure group I patients with no n-exposed group (including the basis of the treatment group purely Western, and Western basic treatment group joint other Chinese medicine decoction) Observation and treatment before and after one year of clinical efficacy (symptoms of angina, electrocardiogram, TCM symptoms, the SAQ score,etc.), and security to make the evaluation.
Ways to promote the combination of multimedia teaching and clinical teaching, training six weeks. The evaluation method uses two parts:the first part of preparing students for assessment paper assessment,independ ent clinic assessment and scale investigation of three methods;assessment part of the second part is taught by the main scale investigation.
Results
First, the clinical research enrolled211patients before treatment was no significant difference (P>0.05) were comparable. However, two groups of males was significantly higher than that offemales. Six months after t reatment, the findings show:
(A) The clinical efficacy
(1)Improvement of angina symptoms:the exposed group and the non-exposed group were significantly improved in the treatment of symptoms, angina symptomspoints lower(P<0.01);symptoms of angina and the treatment group were significantly better than the control group (P<0.01).
(2)Chinese medicine symptom improvement:the exposed group and non-exposed group were significantly improved in the treatment of symptoms, TCM syndr-ome score lower (P<0.01);TCM symptoms of the treatment group were signif-icantly better than the control group(P<0.01).
(3)ECG efficacy:After treatment, the exposed group ECG always more effic-ient than non-exposed group,but P>0.05, the two groups in the ECG efficac-y, no significantdifferences.
(4)Score of the SAQ score:the exposed group and non-exposed group after treatment, decreased quality of life improved significantly(P<0.01);betwe-en the two groups, the exposed group improved quality of life of patients with angina pectoris was significantly better than non-exposed group (P<0.01).
(B)The security index
The safety of the treatment group and control group there were signif icant differences (P>0.05) two sets of security, and no serious adverse reactions havegood security.
Second, the promotion of evaluation studies
(A)Promotion:three research units were six doctors to participate in the promotionof training and examination
(1)A paper assessment:papers assessment of all the trainers in more tha-n90points.
(2)An independent clinic assessment:18trainers clinic a total of36patients, including three cases of patients with the training programs are different,conformityof91.6%.
(3)Rating scale:the promotion of three hospitals,
(a)Three hospitals generally on the overall teaching objectives, heart s-pleen deficiency, phlegm and blood stasis blocking collaterals primary d- isease and thedisease is summed up the tongue and pulse, multimedia teach-ing, awareness of thetongue like a map, teaching attitudes, teaching effec-tiveness and acceptance that tobe able to use the knowledge to solve pra-ctical problems in the admissions, andimproved on the basis of the origi-nal; the same time, the pulse schematicawareness and acceptance of a lowe-r difficulty and focus of the speakers in theteaching not prominent, and the teaching ability and classroom managementcapacity is relatively weak.
(b) three hospitals, Jiangmen Wuyi Hospital of Traditional Chinese Medici ne topromote awareness and acceptance of the treatment options for the be st, and theawareness and acceptance of the Huizhou City Hospital is relat ively low.
(B) Evaluation
Of this research program awareness and acceptance of high Jiangmen Wuyi Hospital of Traditional Chinese Medicine, the final grasp of the re-search program is also good, on the contrary, the other two hospitals are relatively poor.
Conclusion
The retaining Heart of Western basic treatment,Professor Deng Tietao Tiaopiefficacy of stable angina pectoris Qi Deficiency and Phlegm and Bl-ood Stasis. Can improve symptoms of angina, TCM symptoms, improve quality of life, reducing theamount of nitroglycerin, and the safe, reliable, and can be used as the clinical application of a good joint to be recognize-d by the Chinese Medicine Hospital of theLingnan region, should be widely applied.
通过邓铁涛教授调脾护心法治疗冠心病稳定型心绞痛气虚痰瘀阻络证的前瞻性队列研究及推广评价研究,第一,旨在观察邓铁涛教授调脾护心法治疗方案较其它中医方法的临床疗效及安全性,第二,旨在形成完整的推广方法并评估此方案在岭南地区中医院内的推广情况。
方法：
按照队列研究的方法,观察符合冠心病稳定型心绞痛气虚痰瘀阻络证纳入标准197例,分为暴露组与非暴露组。暴露组采用邓铁涛教授调脾护心法联合西医基础治疗,非暴露组其它经验方联合西医基础治疗。治疗周期为12周,观察治疗开始后,30±3天、90±3天、360±3天,三个时点进行随访。内容包括中医症候、心绞痛积分、心电图、西雅图心绞痛量表(SAQ)等,并对安全性做出评价。
推广方法采用多媒体教学与临床带教相结合,培训6周。评价方法采用两部分：第一部分为学员考核,采用试卷考核、独立诊疗考核和量表调查三种方法；第二部分为讲授者考核部分,主要采用量表调查。
结果：
一、临床研究
入组197例患者,治疗前基本情况无显著性差异(P>0.05),具有可比性。但两组男性比例明显高于女性。在治疗28周后,研究结果显示：
(一)临床疗效
1.中医症候：
(1)症候疗效(中医症征)
经卡方检验,治疗第90天中医症征,两组间无统计学意义(P>0.05),无差异。治疗360天症候疗效,有统计学意义(P<0.01)。说明两组在360天症候疗效方面,存在显著性差异,暴露组明显优于非暴露组。
(2)症候疗效(中医症状)
经卡方检验,有统计学意义(P<0.01),两组90天中医症状,存在显著性差异,暴露组明显优于非暴露组。在360天中医症状评价方面,有统计学意义(P<0.01),存在显著性差异。暴露组明显优于非暴露组。
2.心绞痛积分
经秩和检验,治疗30天,P>0.05,两组抗心绞痛疗效无差异；360天,P<0.01,两组心绞痛积分有差异,显示暴露组明显优于非暴露组。
3.心电图疗效方面
经卡方检验,治疗90天,无统计学意义(P>0.05),两组在心电图疗效上无显著差异。
4.SAQ评分
经秩和检验,第360天,在躯体活动受限程度、稳定状态维持度、发作情况维持度、满意程度维持度和认识程度维持度5个方面有显著性差异(P<0.01)。暴露组对心绞痛患者生活质量的改善程度明显优于非暴露组。
(二)安全性
暴露组与非暴露组均未出现严重不良反应,具有较好的安全性。
二、推广评价研究
(一)推广情况
三家研究单位分别有6位医生参加推广培训考核
1.试卷考核
所有被培训者试卷考核均在90分以上。
2.独立诊疗考核
18位被培训者共诊疗36位患者,其中3例患者治疗方面与培训方案存在差异,
符合度为91.6%。
3.评价量表分析
(1)三家医院普遍对总体教学目标、心脾气虚,痰瘀阻络的主症和次症概括及舌脉象、多媒体教学、舌像图、教学态度、教学效果的认知度和接受度最好,认为能够运用所学知识解决接诊中的实际问题,并且认为在原有的基础上得到提高；同时,对脉象示意图认知度和接受度较低,认为讲者在授课中的难点和重点不够突出,组织教学能力与课堂管理能力相对较弱。
(2)三家医院中,江门五邑中医院对本治疗方案的推广认知度与接受度为最好,而惠州市中医院的认知度和接受度相对较低。
(二)评价研究
对本研究方案的认知度和接受度高的江门五邑中医院,最终对研究方案的掌握度也较好,反之,另外两家医院则相对较差。
结论：
邓铁涛教授调脾护心法联合西医基础治疗对冠心病稳定型心绞痛气虚痰瘀证,较其它经验方治疗该病证,能够更好改善患者中医症候及心绞痛症状、提高生活质量等,有良好的远期疗效。且安全性高。是中医药治疗冠心病应用的一个良好的联合方法,其推广评价方案在岭南地区中医院培训推广运用中,得到认可,疗效肯定。
Objective
The study selected stable angina pectoris qi deficiency and phlegm network card, has two purposes. First, it was designed to observe the cli-nical efficacy and safetyindicators of Professor Deng Tietao Tiaopi care Heart treatment programs. Second, to form a complete promotional methods and to assess the promotion of this program in Chinese medicine hospital.
Methods
Clinical research in accordance with the methods of the cohort study, observation of the coronary heart disease with stable angina pectoris qi deficiency and phlegm network card the inclusion criteria (n=197), divid ed into exposed and non-exposed group. Western basic treatment, Professor Deng Tietao Tiaopi Heart care treatment exposure group I patients with no n-exposed group (including the basis of the treatment group purely Western, and Western basic treatment group joint other Chinese medicine decoction) Observation and treatment before and after one year of clinical efficacy (symptoms of angina, electrocardiogram, TCM symptoms, the SAQ score,etc.), and security to make the evaluation.
Ways to promote the combination of multimedia teaching and clinical teaching, training six weeks. The evaluation method uses two parts:the first part of preparing students for assessment paper assessment,independ ent clinic assessment and scale investigation of three methods;assessment part of the second part is taught by the main scale investigation.
Results
First, the clinical research enrolled211patients before treatment was no significant difference (P>0.05) were comparable. However, two groups of males was significantly higher than that offemales. Six months after t reatment, the findings show:
(A) The clinical efficacy
(1)Improvement of angina symptoms:the exposed group and the non-exposed group were significantly improved in the treatment of symptoms, angina symptomspoints lower(P<0.01);symptoms of angina and the treatment group were significantly better than the control group (P<0.01).
(2)Chinese medicine symptom improvement:the exposed group and non-exposed group were significantly improved in the treatment of symptoms, TCM syndr-ome score lower (P<0.01);TCM symptoms of the treatment group were signif-icantly better than the control group(P<0.01).
(3)ECG efficacy:After treatment, the exposed group ECG always more effic-ient than non-exposed group,but P>0.05, the two groups in the ECG efficac-y, no significantdifferences.
(4)Score of the SAQ score:the exposed group and non-exposed group after treatment, decreased quality of life improved significantly(P<0.01);betwe-en the two groups, the exposed group improved quality of life of patients with angina pectoris was significantly better than non-exposed group (P<0.01).
(B)The security index
The safety of the treatment group and control group there were signif icant differences (P>0.05) two sets of security, and no serious adverse reactions havegood security.
Second, the promotion of evaluation studies
(A)Promotion:three research units were six doctors to participate in the promotionof training and examination
(1)A paper assessment:papers assessment of all the trainers in more tha-n90points.
(2)An independent clinic assessment:18trainers clinic a total of36patients, including three cases of patients with the training programs are different,conformityof91.6%.
(3)Rating scale:the promotion of three hospitals,
(a)Three hospitals generally on the overall teaching objectives, heart s-pleen deficiency, phlegm and blood stasis blocking collaterals primary d- isease and thedisease is summed up the tongue and pulse, multimedia teach-ing, awareness of thetongue like a map, teaching attitudes, teaching effec-tiveness and acceptance that tobe able to use the knowledge to solve pra-ctical problems in the admissions, andimproved on the basis of the origi-nal; the same time, the pulse schematicawareness and acceptance of a lowe-r difficulty and focus of the speakers in theteaching not prominent, and the teaching ability and classroom managementcapacity is relatively weak.
(b) three hospitals, Jiangmen Wuyi Hospital of Traditional Chinese Medici ne topromote awareness and acceptance of the treatment options for the be st, and theawareness and acceptance of the Huizhou City Hospital is relat ively low.
(B) Evaluation
Of this research program awareness and acceptance of high Jiangmen Wuyi Hospital of Traditional Chinese Medicine, the final grasp of the re-search program is also good, on the contrary, the other two hospitals are relatively poor.
Conclusion
The retaining Heart of Western basic treatment,Professor Deng Tietao Tiaopiefficacy of stable angina pectoris Qi Deficiency and Phlegm and Bl-ood Stasis. Can improve symptoms of angina, TCM symptoms, improve quality of life, reducing theamount of nitroglycerin, and the safe, reliable, and can be used as the clinical application of a good joint to be recognize-d by the Chinese Medicine Hospital of theLingnan region, should be widely applied.
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