通窍救心油舌下给药对不稳定性心绞痛气滞血瘀证患者生活质量的影响
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摘要
背景不稳定性心绞痛辨病当属中医的"胸痹心痛",其病机为心脉痹阻,病性是本虚标实。通窍救心油具有芳香开窍、理气止痛之效,在治疗胸痹心痛方面独具特色。目的观察通窍救心油舌下给药途径对不稳定性心绞痛气滞血瘀证患者疗效及生活质量的影响。方法 2017年5月—2018年4月,纳入合格受试者240例,根据随机数字表将纳入的患者随机分为对照组59例、口服组60例、外搽组61例及舌下组60例。对照组在西医基础治疗上加口服硝酸异山梨酯片,3次/d,疗程7 d;口服组、外搽组、舌下组分别在西医基础治疗上,加用通窍救心油,给药方式依次为口服给药、外搽人中穴、舌下给药,3次/d,疗程7 d。于治疗前后采集中医证候疗效积分、心电图、西雅图心绞痛量表(SAQ)评分、12条简明健康状况调查表(SF-12)联合欧洲五维健康量表(EQ-5D)评分、安全性指标和不良反应事件资料,进行统计学处理。结果 4组患者心电图疗效评价总有效率比较,差异有统计学意义(P<0.05),舌下组高于口服组、外搽组(P<0.008 3),不劣于对照组(P>0.008 3)。治疗后,4组患者中医证候、SF-12、EQ-5D评分及治疗前后评分差值比较,差异有统计学意义(P<0.05),舌下组优于对照组、口服组、外搽组(P<0.05)。治疗后,4组患者SAQ在躯体活动受限程度、心绞痛稳定状态、心绞痛发作情况3个维度的评分及其差值比较,差异有统计学意义(P<0.05),舌下组优于口服组、外搽组(P<0.05)。治疗后通窍救心油各组安全性指标均无恶化,未见不良反应。结论通窍救心油舌下给药途径在确保疗效和安全性的同时,能明显改善不稳定性心绞痛气滞血瘀证患者的整体生活质量。
Background Unstable angina pectoris(UAP)should be classified as "chest pain and heart pain" in traditional Chinese medicine.The pathogenesis of UAP is cardiopulmonary obstruction,and the nature of the disease is deficiency in origin but excess in superficiality.Tongqiao Jiuxin Oil,owning aromatic and warm ingredients,has a unique therapeutic effect on this disease via resuscitating and restoring consciousness,and regulating qi to alleviate pain.Objective To explore the changes in clinical outcome and quality of life in response to sublingually administered Tongqiao Jiuxin Oil in UAP patients with qi stagnation and blood stasis syndrome.Methods Totals of 240 UAP patients with qi stagnation and blood stasis syndrome were included in this study from May 2017 to April 2018.By use of a random number table,they were divided into control group(59 cases),oral group(60 cases),external use group(61 cases)and sublingual group(60 cases).Oral Isosorbide Dinitrate Tablets were given to the control group,three times a day,for 7 consecutive days.Besides western treatment,Tongqiao Jiuxin Oil was given to the latter 3 groups via oral way,smearing on philtrum acupoint,and sublingual way,respectively,three times a day,for 7 consecutive days.Data concerning TCM symptoms score,heart fucnions evaluated by ECG,scores of SAQ,SF-12 and EQ-5 D,and safety parameters before and after treatment,and adverse events during treatment were collected and analyzed statistically.Results Post-treatment improvement in heart functions evaluated by ECG differed significantly across four groups(P<0.05).Specifically,the improvement in sublingual group was significantly better than that of oral group and external use group(P<0.008 3),and was similar to that of the control group(P>0.008 3).Pre-and post-treatment differences in TCM symptom score,SF-12 and EQ-5 D were significantly different in four groups(P<0.05).To be specific,post-treatment improvements in these three parameters in sublingual group were much better than those of other groups(P<0.05).After treatment,there were significant differences in SAQ scores and their differences among the four groups in terms of physical activity limitation,stable state of angina pectoris and attack of angina pectoris(P<0.05).Sublingual group was better than oral group and external use group(P<0.05).Safety measurements of the all groups treated with Tongqiao Jiuxin Oil were found with no deterioration,and no adverse events occurred.Conclusion Sublingual administration of Tongqiao Jiuxin Oil could achieve a positive efficacy with good safety,and significantly improve the overall quality of life in UAP patients with qi stagnation and blood stasis syndrome.
Background Unstable angina pectoris(UAP)should be classified as "chest pain and heart pain" in traditional Chinese medicine.The pathogenesis of UAP is cardiopulmonary obstruction,and the nature of the disease is deficiency in origin but excess in superficiality.Tongqiao Jiuxin Oil,owning aromatic and warm ingredients,has a unique therapeutic effect on this disease via resuscitating and restoring consciousness,and regulating qi to alleviate pain.Objective To explore the changes in clinical outcome and quality of life in response to sublingually administered Tongqiao Jiuxin Oil in UAP patients with qi stagnation and blood stasis syndrome.Methods Totals of 240 UAP patients with qi stagnation and blood stasis syndrome were included in this study from May 2017 to April 2018.By use of a random number table,they were divided into control group(59 cases),oral group(60 cases),external use group(61 cases)and sublingual group(60 cases).Oral Isosorbide Dinitrate Tablets were given to the control group,three times a day,for 7 consecutive days.Besides western treatment,Tongqiao Jiuxin Oil was given to the latter 3 groups via oral way,smearing on philtrum acupoint,and sublingual way,respectively,three times a day,for 7 consecutive days.Data concerning TCM symptoms score,heart fucnions evaluated by ECG,scores of SAQ,SF-12 and EQ-5 D,and safety parameters before and after treatment,and adverse events during treatment were collected and analyzed statistically.Results Post-treatment improvement in heart functions evaluated by ECG differed significantly across four groups(P<0.05).Specifically,the improvement in sublingual group was significantly better than that of oral group and external use group(P<0.008 3),and was similar to that of the control group(P>0.008 3).Pre-and post-treatment differences in TCM symptom score,SF-12 and EQ-5 D were significantly different in four groups(P<0.05).To be specific,post-treatment improvements in these three parameters in sublingual group were much better than those of other groups(P<0.05).After treatment,there were significant differences in SAQ scores and their differences among the four groups in terms of physical activity limitation,stable state of angina pectoris and attack of angina pectoris(P<0.05).Sublingual group was better than oral group and external use group(P<0.05).Safety measurements of the all groups treated with Tongqiao Jiuxin Oil were found with no deterioration,and no adverse events occurred.Conclusion Sublingual administration of Tongqiao Jiuxin Oil could achieve a positive efficacy with good safety,and significantly improve the overall quality of life in UAP patients with qi stagnation and blood stasis syndrome.
引文
[1]苏海燕,田瑞媛,薛茜,等.血脂康片联合氯吡格雷治疗不稳定型心绞痛伴动脉粥样硬化的临床疗效及安全性[J].实用心脑肺血管病杂志,2017,25(3):77-79.DOI:10.3969/j.issn.1008-5971.2017.03.019.SU H Y,TIAN R Y,XUE Q,et al.Clinical effect and safety of Xuezhikang tablets combined with clopidogrel in treating unstable angina pectoris patients complicated with atherosclerosis[J].Practical Journal of Cardiac Cerebral Pneumal and Vascular Disease,2017,25(3):77-79.DOI:10.3969/j.issn.1008-5971.2017.03.019.
[2]柯元南,陈纪林.不稳定性心绞痛和非ST段抬高心肌梗死诊断与治疗指南[J].中华心血管病杂志,2007,35(4):295-304.DOI:10.3760/j.issn.0253-3758.2007.04.003.KE Y N,CHEN J L.Guideline for diagnosis and treatment of patients with unstable angina and non-ST-segment elevation myocardial infarction[J].Chinese Journal of Cardiology,2007,35(4):295-304.DOI:10.3760/j.issn.0253-3758.2007.04.003.
[3]薛博瑜,吴伟.中医内科学[M].3版.北京:人民卫生出版社,2016:86-93.
[4]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:69-73.
[5]原国家食品药品监督管理局.中药、天然药物治疗冠心病心绞痛和女性更年期综合征临床研究技术指导原则[J].中国医药导刊,2011,13(8):1320.State Food and Drug Administration.Guiding principles for clinical study of traditional Chinese medicine and natural medicine in the treatment of coronary heart disease,angina pectoris and female climacteric syndrome[J].Chinese Journal of Medicinal Guide,2011,13(8):1320.
[6]刘国仗,吴宁,胡大一,等.心血管药物临床试验评价方法的建议[J].中华心血管病杂志,1998,26(6):5-13.DOI:10.3760/j.issn.0253-3758.1998.06.001.LIU G Z,WU N,HU D Y,et al.Recommendations of evaluation methods for clinical trials of cardiovascular drugs[J].Chinese Journal of Cardiology,1998,26(6):5-13.DOI:10.3760/j.issn.0253-3758.1998.06.001.
[7]WARE J E,KOSINSKI M,KELLER S D.SF-12:how to score the SF-12 physical and mental health summary scales[M].Boston:New England Medical Center,1995:29-38.
[8]周挺,马爱霞.构建EQ-5D-5L量表效用积分体系的国际研究现状分析[J].中国卫生经济,2016,35(12):15-17.DOI:10.7664/CHE201612003.ZHOU T,MA A X.Analysis on international research progress of developing EQ-5D-5L Value Sets[J].Chinese Health Eoconomics,2016,35(12):15-17.DOI:10.7664/CHE201612003.
[9]UPADHYAY O P,OJHA J K,BAJPAI H S.Experimental study on hypolipidaemic activity of Kustha(Saussurea Iappa Clarke)[J].J Res Ayurveda Siddha,2010,15:52-63.
[10]赵培,岳少乾,马妍,等.苏合香对脑微血管内皮细胞氧糖剥夺/复氧损伤的影响[J].中国临床药理学杂志,2016,32(9):847-849.DOI:10.13699/j.cnki.1001-6821.2016.09.025.ZHAO P,YUE S Q,MA Y,et al.Effects of Storax on the injury of brain microvascular endothelial cells induced by oxygen-glucose deprivation/reoxygenation[J].Chinese Journal of Clinical Pharmacol,2016,32(9):847-849.DOI:10.13699/j.cnki.1001-6821.2016.09.025.
[11]李静,常改.西雅图量表测量冠心病患者生活质量的评价[J].中国公共卫生,2004,20(5):594.DOI:10.11847/zgggws2004-20-05-57.LI J,CHANG G.Evaluation of quality of life in patients with coronary heart disease by Seattle Scale[J].Chinese Journal of Public Health,2004,20(5):594.DOI:10.11847/zgggws2004-20-05-57.
[12]PICKARD A S,JOHNSON J A,PENN A,et al.Replicability of SF-36 summary scores by the SF-12 in stroke patients[J].Stroke,1999,30(6):1213-1217.DOI:10.1161/01.str.30.6.1213.
[13]LAM C L,TSE E Y,GANDEK B.Is the standard SF-12 health survey valid and equivalent for a Chinese population?[J].Quality of Life Research,2005,14(2):539-547.DOI:10.2307/4038787.
[14]National Institute of Health and Care Excellence.Guide to the methods of technology appraisal 2013[R].London:National Institute of Health and Care Excellence,2013.
[15]邢亚彬,马爱霞.欧洲五维健康量表EQ-5D-5L中文版的信效度研究[J].上海医药,2013,34(9):40-43.DOI:10.3969/j.issn.1006-1533.2013.09.021.XING Y B,MA A X.Study on reliability and validity of Chinese version of EQ-5D-5L[J].Shanghai Medical&Pharmaceutical Journal,2013,34(9):40-43.DOI:10.3969/j.issn.1006-1533.2013.09.021.
[16]JOHNSON J A,PICKARD A S.Comparison of the EQ-5D and SF-12 health surveys in a general population survey in Alberta,Canada[J].Medical Care,2000,38(1):115-121.DOI:10.1097/00005650-200001000-00013.
[17]ELDERON L,SMOLDEREN K G,NA B,et al.Accuracy and prognostic value of American Heart Association:recommended depression screening in patients with coronary heart disease data from the Heart and Soul Study[J].Circ Cardiovasc Qual Outcomes,2011,4(5):533-540.DOI:10.1161/CIRCOUTCOMES.110.960302.2019020720190325
[2]柯元南,陈纪林.不稳定性心绞痛和非ST段抬高心肌梗死诊断与治疗指南[J].中华心血管病杂志,2007,35(4):295-304.DOI:10.3760/j.issn.0253-3758.2007.04.003.KE Y N,CHEN J L.Guideline for diagnosis and treatment of patients with unstable angina and non-ST-segment elevation myocardial infarction[J].Chinese Journal of Cardiology,2007,35(4):295-304.DOI:10.3760/j.issn.0253-3758.2007.04.003.
[3]薛博瑜,吴伟.中医内科学[M].3版.北京:人民卫生出版社,2016:86-93.
[4]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:69-73.
[5]原国家食品药品监督管理局.中药、天然药物治疗冠心病心绞痛和女性更年期综合征临床研究技术指导原则[J].中国医药导刊,2011,13(8):1320.State Food and Drug Administration.Guiding principles for clinical study of traditional Chinese medicine and natural medicine in the treatment of coronary heart disease,angina pectoris and female climacteric syndrome[J].Chinese Journal of Medicinal Guide,2011,13(8):1320.
[6]刘国仗,吴宁,胡大一,等.心血管药物临床试验评价方法的建议[J].中华心血管病杂志,1998,26(6):5-13.DOI:10.3760/j.issn.0253-3758.1998.06.001.LIU G Z,WU N,HU D Y,et al.Recommendations of evaluation methods for clinical trials of cardiovascular drugs[J].Chinese Journal of Cardiology,1998,26(6):5-13.DOI:10.3760/j.issn.0253-3758.1998.06.001.
[7]WARE J E,KOSINSKI M,KELLER S D.SF-12:how to score the SF-12 physical and mental health summary scales[M].Boston:New England Medical Center,1995:29-38.
[8]周挺,马爱霞.构建EQ-5D-5L量表效用积分体系的国际研究现状分析[J].中国卫生经济,2016,35(12):15-17.DOI:10.7664/CHE201612003.ZHOU T,MA A X.Analysis on international research progress of developing EQ-5D-5L Value Sets[J].Chinese Health Eoconomics,2016,35(12):15-17.DOI:10.7664/CHE201612003.
[9]UPADHYAY O P,OJHA J K,BAJPAI H S.Experimental study on hypolipidaemic activity of Kustha(Saussurea Iappa Clarke)[J].J Res Ayurveda Siddha,2010,15:52-63.
[10]赵培,岳少乾,马妍,等.苏合香对脑微血管内皮细胞氧糖剥夺/复氧损伤的影响[J].中国临床药理学杂志,2016,32(9):847-849.DOI:10.13699/j.cnki.1001-6821.2016.09.025.ZHAO P,YUE S Q,MA Y,et al.Effects of Storax on the injury of brain microvascular endothelial cells induced by oxygen-glucose deprivation/reoxygenation[J].Chinese Journal of Clinical Pharmacol,2016,32(9):847-849.DOI:10.13699/j.cnki.1001-6821.2016.09.025.
[11]李静,常改.西雅图量表测量冠心病患者生活质量的评价[J].中国公共卫生,2004,20(5):594.DOI:10.11847/zgggws2004-20-05-57.LI J,CHANG G.Evaluation of quality of life in patients with coronary heart disease by Seattle Scale[J].Chinese Journal of Public Health,2004,20(5):594.DOI:10.11847/zgggws2004-20-05-57.
[12]PICKARD A S,JOHNSON J A,PENN A,et al.Replicability of SF-36 summary scores by the SF-12 in stroke patients[J].Stroke,1999,30(6):1213-1217.DOI:10.1161/01.str.30.6.1213.
[13]LAM C L,TSE E Y,GANDEK B.Is the standard SF-12 health survey valid and equivalent for a Chinese population?[J].Quality of Life Research,2005,14(2):539-547.DOI:10.2307/4038787.
[14]National Institute of Health and Care Excellence.Guide to the methods of technology appraisal 2013[R].London:National Institute of Health and Care Excellence,2013.
[15]邢亚彬,马爱霞.欧洲五维健康量表EQ-5D-5L中文版的信效度研究[J].上海医药,2013,34(9):40-43.DOI:10.3969/j.issn.1006-1533.2013.09.021.XING Y B,MA A X.Study on reliability and validity of Chinese version of EQ-5D-5L[J].Shanghai Medical&Pharmaceutical Journal,2013,34(9):40-43.DOI:10.3969/j.issn.1006-1533.2013.09.021.
[16]JOHNSON J A,PICKARD A S.Comparison of the EQ-5D and SF-12 health surveys in a general population survey in Alberta,Canada[J].Medical Care,2000,38(1):115-121.DOI:10.1097/00005650-200001000-00013.
[17]ELDERON L,SMOLDEREN K G,NA B,et al.Accuracy and prognostic value of American Heart Association:recommended depression screening in patients with coronary heart disease data from the Heart and Soul Study[J].Circ Cardiovasc Qual Outcomes,2011,4(5):533-540.DOI:10.1161/CIRCOUTCOMES.110.960302.2019020720190325